Kornimate/medical-research-clean huggingface dataset:
bariatric surgery evaluation and assessment of treatment efficacy - intervention trial

Conditions: Heart Failure with Preserved Ejection Fraction; Atrial Fibrillation

Summary: the goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with bmi 32-40 kg/m2) and symptomatic hf with preserved or mildly reduced lvef in combination with af, as compared to standard of care. patients will be randomized to either the intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.

the primary objective is to study the effect of a bariatric surgery strategy on the hierarchical occurrence of: 1) all-cause mortality within 2 years, 2) emergency room visit or hospitalization for hf within 2 years, 3) recurrent ecg-documented af within 2 years, 4) decrease of ≥30gr of left ventricular (lv) mass on transthoracic echocardiography, and 5) improvement of ≥5 points on the kansas city cardiomyopathy questionnaire (kccq).

Eligibility criteria:
inclusion criteria: 1. signs and symptoms of hf according to the europeans society of cardiology guideline; 2. left ventricular ejection fraction ≥40%; 3. hfa-peff score ≥5 or hfa-peff score 2-4 in combination with positive stress test; 4. between 45 and 70 years of age; 5. bmi 32-40 kg/m2; 6. paroxysmal or persistent af with a rhythm control strategy; 7. willing to undergo both treatment strategies; 8. written informed consent. exclusion criteria: 1. bmi ≥40 kg/m2; 2. bmi \<32 kg/m2; 3. patients unwilling or unable to sign informed consent; 4. more than moderate mitral valve regurgitation/aortic valve regurgitation; 5. more than mild mitral valve stenosis/aortic valve stenosis; 6. inadequate echocardiographic window for the assessment of lv mass index and/or the echocardiographic criteria needed for the hfa-peff score; 7. history of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, \<3 months before inclusion; 8. scheduled for af ablation; 9. complex congenital heart disease; 10. negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders; 11. patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery; 12. any medical condition that limits life span \<2 years; 13. diseases requiring long term use of anti-inflammatory treatments; 14. the use of medication associated with substantial effects (\>5 kg) on body weight.

Keywords: atrial fibrillation heart failure with preserved ejection fraction bariatric surgery
peer i-coaching for activated self-management optimization in adolescents and young adults with chronic conditions

Conditions: Sickle Cell Disease; Chronic Kidney Diseases; Systemic Lupus Erythematosus; Childhood Cancer; Inflammatory Bowel Diseases; Stem Cell Transplant; Organ Transplant; Diabetes Mellitus, Type 1; Cystic Fibrosis

Summary: the purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.

increases in life expectancy in almost all childhood-onset chronic conditions (cocc) has brought unique challenges for adolescents and young adults (aya) who struggle to deal with the associated disease burden, manage therapies, and thrive as they develop independent self-management skills, and become active and engaged patients. the challenges that influence the lives of ayas are largely adaptive, such as making lifestyle modifications, adhering to complex medication regimens, and learning to navigate the adult health system. adding to this complexity is the need for ayas to progressively take over greater self-management responsibilities from parents. promoting activated self-management is critically important given that this shift in health care management from parents and health care providers to the aya is identified as key to successful adult outcomes. peer support interventions are well-suited to address challenges theorized as critical to ayas given the importance of peer relationships during this time. the investigators propose a mixed-methods, five-year randomized controlled trial, that will include 225 ayas (16-22 years) with coccs, to test the peer i-coaching for activated self-management optimization (picaso) versus an attention control group. this novel, mobile health intervention utilizes an established telephone/text based secure interface to allow ayas access knowledge, experience, and instrumental/emotional support from a trained peer coach (18-26 years), who has already developed independence and is an active self-manager. the investigators will determine the efficacy of picaso on self-management, patient activation, transition readiness, health-related quality, and emotional health of life across 12 months. the investigators will explore whether age, sex, race/ethnicity, chronic condition, and/or disease severity moderate the trajectory of picaso effects on self-management, patient activation, coping, emotional health and health-related quality of life. lastly, the investigators will explore mechanisms of the picaso impact by describing aya experiences with the intervention.

Eligibility criteria:
inclusion criteria: * aya 16 to 22 years * childhood onset chronic condition from 1 of 3 condition categories * read and speaks english * access to internet via computer or smart phone * access to telephone (smart phone not required as text feature can be accessed via internet) exclusion criteria: * diagnosed cognitive dysfunction * need for english translator
prevention of permanent obesity in children

Conditions: Overweight; Obesity; Child

Summary: in the county of oppland, norway, questionnaires addressing physical and mental health and socioeconomic status is issued to all (1960) families who meet for the pre-school assessment at the public health clinics in 2007. particularly growth, physical activity and diet is addressed. families who have children with a bmi \>18.9, which corresponds to bmi\>30, and living in selected municipalities in the county are invited to participate in a 5 year intervention program in order to avoid future overweight conditions in children. similarly overweight children from the rest of the county serve as controls.

background: intervention programs to limit or reduce weight in severely obese adults and adolescents are rarely successful. in the present study intervention is aimed at moderately overweight children of 6 years. families in 7 municipalities who have children with bmi \>18.9 are invited to a group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training. the families are invited to meet in groups times the first year, two times the second and one time the third year. according to personal interest the families are also invited to meet with the nurse between each of the the above gatherings. the children are examined by a pediatrician before entry and after 1, 2, 3 and 5 years with specific focus on height and weight. no blood studies are routinely done. bmi development will be related to bmis in the family, mother's weight increase in pregnancy, socioeconomic background, general health, psychological factors scored through the strengths and difficulties questionnaire, and compliance with the program. furthermore, the results are compared to similarly overweight children from the counties who are not invited to participate in the intervention program. the results are obtained through the routine health follow-up programs in school.

Eligibility criteria:
inclusion criteria: * bmi \> 18.9 * age 5-7 years * residing in oppland county exclusion criteria: * chronic disease

Keywords: overweight obesity child
optimal remifentanil concentration and thyroidectomy

Conditions: Anesthesia

Summary: the study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose. possible hemodynamic instability, respiratory depression or prolongation of awakening time are also sought.


Eligibility criteria:
inclusion criteria: * 18\<age\<67 * 6 hrs fasting * american society of anesthesiology (asa) physical status i o ii * informed consent exclusion criteria: * absence of inclusion criteria * use of cough suppressors, angiotensin converting enzyme-inhibitors, sedatives 4 weeks before surgery * arhythmia, pacemaker or unstable cardiovascular disease * hepatic or renal failure * anticipated difficulty in airways management * chronic obstructive pulmonary disease (copd), asthma, increased risk for inhalation, airway infection in the previous 4 weeks; * smoker * obesity (bmi \>35) * pregnancy * hypersensitivity to drugs administered for the study

Keywords: thyroidectomy remifentanil extubation cough target controlled infusion
study of fast-track surgery in hernia repair and laparoscopic cholecystectomy

Conditions: Surgical Training

Summary: all danish trainees in surgery in a two-year period asked for participation when enrolled in the formal five-year training program for specialty in surgery. the participants are randomized for either educational intervention or control (without intervention). the intervention group receive a skills-lab course in hernia repair followed by an opportunity to perform 20 groin hernia repairs in their departments within 4-8 weeks. their performance will be video recorded three times during the intervention and as follow-up at end of the first year of training. after termination of the hernia training program a similar program for laparoscopic cholecystectomies are made. each participant receive both intervention. the control group are video recorded at start of their first year and at end. all videos are blindly assessed with a validated rating scale of operative performance. the purpose is to assess if a fast-track program improves technical skills and if a change is sustained. furthermore we want to compare outcome in similar training programs in open and laparoscopic skills.


Eligibility criteria:
inclusion criteria: * medical doctors accepted for formal surgical training in denmark in 2010-11. exclusion criteria: * current experience in surgery exceeding need of supervision in groin hernia and cholecystectomy procedures. * employed at a non-participating hospital.

Keywords: surgery training
child follow-up in women treated with conventional ivf or icsi

Conditions: Conventional IVF, ICSI

Summary: to compare the physical, mental and motor development of babies born from pregnancy using icsi technique and and conventional ivf in non-male factor infertile couples. based on our previous rct (nct03428919), the non-male factor couples were randomly assigned to ivf or icsi, which leads to the similarity in characteristics of these two groups. hence, the result of analyzing these offsprings would be preciously valuable.

over the past two decades, intracytoplasmic sperm injection (icsi) indications have been extended and routinely applied to all cases of assisted reproductive techniques: unexplained infertility, poor-quality oocytes, low oocyte yeild, advanced marternal age, prior failed fertilization with conventional insemination, after in-vitro maturation of oocytes and for cases of cryopreserved oocytes (practice committees of the american society for reproductive medicine, 2020). in 2004, fertilization using icsi accounted for nearly 60% of all aspirations globally. in the middle east, the number of icsi cycles increased rapidly from 2000 (47.6%) to 2007 (65.2%), and reached 97.8% in the middle east in 2007 (ishihara et al, 2015). another survey recorded in europe in 2011, out of a total of 437,510 cycles of fresh embryo transfer, 68% of cycles were performed using icsi techniques. in male infertility cases, the rate of implementation of icsi increased from 76.3% to 93.3%. in particular, in cases of non-male-factor infertility, the incidence of icsi also increased from 15.4% to 66.9%. from 2008-2012, of 494 907 treatment cycles, 74.6% used icsi. in which, icsi accounts for 92.9% of the cycle of male infertility and 64.5% of the cycle of non-male-factor infertility (boulet, 2015). however, icsi is an invasive technique that bypasses the natural barriers of fertilization. this has led to concern about an increase in the incidence of anomalies in icsi-born babies as this technique is increasingly being used in all cases of contraception. in contrast, there are studies that have also compared ivf with icsi and show that in the icsi cycle, the incidence of multiple pregnancies and low birth weight infants is lower than that of ivf, although there is no difference in infant survival between the two groups (boulet et al, 2015). in addition to the short-term outcomes, the investigators also have to consider the long-term maternal and neonatal outcomes. there is still not much evidence comparing the effects of the above methods, if any, on the psychomotor development in children. therefore, the investigators decide to conduct a study to compare the physical, mental and motor development of babies born from pregnancy using icsi technique and and conventional ivf in non-male factor infertile couples.

Eligibility criteria:
inclusion criteria: * live babies born from icsi versus conventional ivf in non-male factor couples (nct03428919) * parents agree to participate in the study. exclusion criteria: * babies died after the perinatal period.
treat child alcohol use disorder (c-aud) in eastern uganda

Conditions: Alcohol Abuse; Alcohol Drinking; Alcoholism; Alcohol Use Disorder; Alcohol Dependence; Child Abuse; Child Malnutrition; Child Neglect; Child Mental Disorder; Child, Only

Summary: the investigators will investigate the existence of alcohol drinking among children living under adult supervision and care, living within the communities. the investigators will focus on the age group 6-13 years overlapping with the recommended age for primary school attendance. the project is approaching the research topic using quantitative and qualitative methods. the treat c-aud research project will therefore document to which degree alcohol drinking is a problem among children in mbale, eastern uganda.

uganda has as many other sub-saharan countries high alcohol consumption per capita and traditions for home brewing. the treat c-aud research project, with partners from makerere university in uganda, university of bergen and norwegian university of science and technology in norway, will investigate the existence of alcohol drinking among children living under adult supervision and care, living within the communities. the investigators will focus on the age group 6-13 years overlapping with the recommended age for primary school attendance. the project is approaching the research topic from comprehensive perspectives including a large cross-sectional study, interviews with parents and carers, children and stakeholders in the communities, schools and in the health system. the investigators have been including community representatives, expert groups, user groups and stakeholders in the development of screening tools and will do so in interpreting and disseminating the results. the investigators have to take the covid-19 situation into account both with regard to its effect on the research question at stake and the methods used. the treat c-aud research project will therefore document to which degree alcohol drinking is a problem among children in the communities in mbale district, eastern ugandan. the data collection is capturing cofactors such as other substance use, mental health, parenting, trauma, nutrition and growth. the development of alcohol assessment tools can be used by the health- and school-system for detection and handling of children having problems with alcohol. the investigators will collaborate closely with services in case of identification of children suffering severe harm and adhere to good clinical practice guidelines for ethical conduct, the consent procedure, follow-up and referral.

Eligibility criteria:
inclusion criteria: care-giver- child pairs * children 6-13 years * caregiver of eligible child * caregiver adult capable of giving informed consent * living in household for minimum 6 months together exclusion criteria: • caregiver or child not living in household
intraoperative imaging of a pet positive lymph node(s) using 18fdg and a dual-mode, hand-held intraoperative imager

Conditions: Head and Neck Neoplasms

Summary: this study is a prospective collection of data utilizing the imaging beta probe (ibp) in patients with positron emission tomography (pet) positive disease. a pilot clinical study involving 5 patients will be conducted using the ibp. the sterilized ibp will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. the outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. the investigators will correlate the images from the probe of the fludeoxyglucose (18fdg) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed pet scan and with the routine pathology results obtained on the surgical specimens.the experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and pet/ ct. localization between imaging modalities will be compared with respect to: detection and side of localization.


Eligibility criteria:
inclusion criteria: * men and women, 18- to 90-years old. * positive for pet positive disease in the neck. exclusion criteria: * pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care) * nursing or lactating women
enhancing therapy process with movement strategies

Conditions: Anxiety Disorders; Mood Disorders

Summary: several studies have noted the benefits of exercise programs in improving both mood and anxiety symptoms. additionally, single bouts of exercise have been shown to improve mood and anxiety. business applications report ancillary benefits of exercise as well. for example, individuals spontaneously report better ability to approach stimuli and cope with emotional experiences if doing it while exercising. the current study aims to investigate exercise during a therapy session as a potential intervention for enhancing therapeutic learning, particularly ability to better cope with emotional topics and experiencing intense emotions. in this study, patient participants will complete a therapy session while using an exercise machine and a separate therapy session while using a worry stone (control). both patient participants and therapist participants will make ratings of a variety of items, including ability to discuss emotional topics and comfort in experiencing emotions. investigators hypothesize that patients will report better ability to discuss emotional topics and more comfort in experiencing emotions following the exercise condition as opposed to the worry stone condition. investigators also hypothesize that therapist ratings will similarly indicate that patients were better able to discuss emotional topics and experience emotional content during exercise sessions.

the current study aims to investigate exercise during a therapy session as a potential intervention for enhancing therapeutic learning, particularly ability to better cope with emotional topics and experiencing intense emotions.

Eligibility criteria:
inclusion criteria: 1. adults over the age of 18 2. ability to read and provide informed consent 3. current patient or therapist at the center for anxiety and related disorders (card) 4. ability to complete exercise (e.g. no physical injuries) exclusion criteria: 1. participants considered high risk based on the acsm risk stratification guidelines (derived from par-q) 2. participants with current knee, ankle, hip, or foot injuries that could impede exercise on the machine or participants with current hand or wrist injuries that could impede use of the worry stone
incretin based therapy for poorly controlled type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (glp-1) levels. incretin based therapy is associated with improved glycemic control by boosting glp-1 levels . nevertheless, the clinical effects are in great diversity for poorly controlled type 2 diabetes patients. this study is designed to understand the pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.

background: since glp-1 receptor is encoded by glp1r ( glucagon-like peptide-1 receptor) gene, individuals may veritably respond to incretion based treatment, depending on the presence or absence of minor alleles characterized by single nucleotide polymorphisms. the genotyping of patients will be performed to compare the genetic factors and the pharmacological effects. expected results: how to select a anti-diabetic drug tailored to the individual becomes more and more important because the enormously increasing classes of treatment modality. this study could be of great help in recommending the best possible agent for an individual, improving the possibility of treatment success, and justifying if the need of expensive drugs in a given patient.

Eligibility criteria:
inclusion criteria: * i) age \> 20 years old ii)dm (diabetes mellitus) diagnosed \> 2 years iii)hba1c level of 8% to 12% iv) receiving incretin based therapy at least one month (including either glp-1 agonist or dpp(dipeptidyl peptidase)-iv inhibitor exclusion criteria: * type 1 diabetes mellitus