Kornimate/medical-research-clean huggingface dataset:
efficacy of preoperative intra gastric balloon in morbidly obese patients selected for gastric by-pass

Conditions: Morbid Obesity

Summary: to demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (bmi \> 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.

on inclusion, comorbidities associated with obesity will be recorded. after recording of the informed consent patients will be randomized in two groups: usual care or intra-gastric balloon. in the latter, a second randomization will be performed between air-filled balloon or water-filled balloon. six months later, after withdrawal of the balloon (if required), laparoscopic gastric by-pass will be performed. thereafter, patients will be followed during 6 months. on each visit, inclusion, 3 months, 6 months, surgery, 1 month and 6 months post surgery, a medical and biological evaluation will be systematically performed. the main criteria of judgement is the rate of admission in icu during more than 24 hrs during the 30 days following surgery. the secondary criteria of judgement is: the differences in pre-operative weight loss between the 2 groups, number of complications occurring during the 30 days after surgery, differences in different scales of quality of life (sf36, iwqol-lite), differences in operative time, length of hospital stay, readmissions, and medical cots between the two strategies. efficacy and tolerance of each type of balloon (air-filled or water-filled) will be compared in the intra-gastric balloon group.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * patients with morbid obesity with bmi \> 45 kg/m² requiring a gastric by-pass by laparoscopy. * no efficacy of previous treatment on obesity * firmed informed consent exclusion criteria: * patients in whom laparoscopy is contra-indicated * indication of gastric by-pass by laparoscopy retained without multidisciplinary advice * morbid obesity present since less than 5 years * severe associated pathology, non-related to obesity, impairing vital prognosis on a short or mean time * past history of gastric surgery, or gastric complication related to gastric lap-band * lack of health insurance * patient refusing to be followed 6 months before and after surgery * drug abuse * pregnancy or foreseeable pregnancy during the study * patients taking anticoagulant agents or steroids * patients with hiatal hernia \> 4 cm * patients with active ulcerated esophagitis (grade c-d in los angeles classification) * patients with duodenal or gastric ulcer * patients with gastric or esophageal varices * patients with nsaids not taking ppi * patients with bulimia

Keywords: obesity morbid obesity gastric balloon gastric by-pass morbid obesity with bmi > 45 kg/m²
egg yolk and underlying metabolisms on modifying hdl levels in individuals with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this research compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of cvd in obese people.

this research study examines the effects of changes in weight, metabolism of glucose and cholesterol in the blood through diet and behavior modification. the main objective of this study was to compare the effects of low carbohydrate intake and consumption of 3 eggs per day, and low energy diet on diabetes control and biomarkers of cvd in obese people. in addition, hdl quantity and size as well as hdl function was compared between the group who ate the whole egg and the group who did not eat the yolk.

Eligibility criteria:
inclusion criteria: 1. weight stable \> 3 months (changing \< 5%) 2. three or more of the following five criteria are met 2.1 waist circumference ≥ 90 cm (men) or ≥ 80 cm (women) 2.2 fasting blood sugar ≥ 100 mg/dl 2.3 fasting triglyceride (tg) level ≥ 150 mg/dl 2.4 fasting high-density lipoprotein (hdl) cholesterol level ≤ 40 mg/dl (men) or ≤ 50 mg/dl (women) 2.5 blood pressure over 130/85 mmhg 3. can consume food that provided in project 4. healthy exclusion criteria: 1. consume drugs i.e. weight loss drugs, herbal pills, asthma drugs, steroid drugs, thyroid drugs, insulin injections, sglt1 inhibitors drugs, sglt2 inhibitors drugs, sulfonylurea drugs, blood lipid-lowering drugs 2. people who exercise vigorously (\> 150 minutes per week) 3. people who are or have weight loss by consuming less than 30% of carbohydrates, or are losing weight by other methods or who have eaten a specific diet as prescribed by a doctor within the past 6 months 4. people who drink alcohol more than once a week 5. people who had a ldl level within 6 months \> 190 mg/dl 6. fasting blood glucose levels \> 250 mg/dl and using diabetes drugs other than metformin 7. people with heart disease, type 1 diabetes, renal impairment \> level 3a 8. history of cancer, lung disease, gastrointestinal disease 9. people who smoke, people with eating disorder, people who have received psychiatric drugs 10. become a volunteer in a research project that is conducting a study related to food consumption 11. people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months 12. pregnancy or breastfeeding 13. egg allergy

Keywords: metabolic syndrome diabetes diet eggs cholesterol weight loss
pilot study of exposure therapy for posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder

Summary: the purpose of this project is to examine the feasibility of a culturally adapted, manual based prolonged exposure therapy intervention for the treatment of spanish-speaking puerto ricans with posttraumatic stress disorder

this project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of treatments for ptsd among spanish-speaking latinos, particularly puerto ricans. this area of research is important in light of the limited treatment options currently available for spanish-speakers with ptsd and the long-term negative consequences of this condition. participants in this study are recruited by referral from mental health providers in a general health setting. patients meeting criteria for enrollment will be randomly assigned to receive either prolonged exposure therapy or treatment as usual. assessments for all participants will be collected at baseline, week 8, and week 16 after randomization.

Eligibility criteria:
inclusion criteria: * diagnosis of ptsd * caps score of at least 45 * 18 to 65 years old * spanish speaker * competent to provide informed consent exclusion criteria: * history of bipolar disease, schizophrenia or psychotic disorder * alcohol or drug abuse in the past three months * moderate to severe traumatic brain injury * applying for or receiving disability benefits * clinically judged to have a high acute suicide risk * life-threatening medical condition * currently receiving psychotherapy for ptsd or changed psychotropic medication within 2 months of randomization

Keywords: posttraumatic stress disorder prolonged exposure cognitive behavior therapy
a study to assess disease activity in adolescent and adult participants with atopic dermatitis who receive oral upadacitinib tablets in a real-world setting

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) is a skin condition that may cause a rash and itching due to inflammation of the skin. therapies spread over the skin may not be enough to control the ad in trial participants who require systemic anti-inflammatory treatment. this study will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with ad. this study also aims to understand upadacitinib utilization patterns in real-world clinical practice. upadacitinib (rinvoq) is approved in the eu for the treatment of moderate to severe ad in adults and adolescents 12 years and older who are candidates for systemic therapy. approximately 772 adolescent and adult participants with ad will be enrolled at up to 200 sites in germany. participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. the overall duration of the study is approximately 2 years. participants will attend regular visits per routine clinical practice. the effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility criteria:
inclusion criteria: * body weight \>=30 kg at baseline for participants between \>=12 and \<18 years of age. * physician confirmed diagnosis of moderate to severe atopic dermatitis at the time of enrollment. * upadacitinib initiated as per the local label. the decision to prescribe upadacitinib must have been made prior to and independently of study participation. * medical and medication history available at least for the last 6 months. exclusion criteria: - current participation in interventional research (note: this does not include non-interventional, post-marketing observational studies, or registry participation).

Keywords: atopic dermatitis (ad) upadacitinib rinvoq
decision aids for patients with nonvalvular chronic atrial fibrillation (da4afib)

Conditions: Atrial Fibrillation

Summary: the researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it.


Eligibility criteria:
1. must be 18 or older 2. must have an appointment for atrial fibrillation 3. must not have dementia 4. must not have severe hearing or vision impairment patients will be given a written consent guests that accompany patients will be given an oral consent ker unit pag members will be given an oral consent
asphyxia at birth : causes and neonatal outcome

Conditions: Neonatal Asphyxia

Summary: this is an historic cohort study based on the birth and delivery register of the hfme maternity ward. this study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal ecg) and systematic umbilical acid-gas cord blood were introduced in our maternity ward. the investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main factors including second line strategy introduction, systematic umbilical cord acid-base implementation and improvement in antenatal risk factor screening for asphyxia. the investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was improved with systematic early after birth eeg evaluation, allowing early treatment and surveillance.


Eligibility criteria:
inclusion criteria: * all births at the maternity ward of the hospital femme-mère-enfant from 1st of january 2000 to 31 december 2016 exclusion criteria: * infants born after medical pregnancy termination and born out of the hospital and secondarily hospitalized in our department will be excluded

Keywords: neonatal asphyxia neonatal acidosis fetal ecg umbilical cord acid-base status
preoperative transcranial doppler as a predictor for delirium following on-pump cardiac surgery

Conditions: Postoperative Delirium After On-pump Cardiac Surgery

Summary: postoperative delirium is an important problem in patients undergoing major cardiac surgery and associated with more complicated hospital course, increased hospital length of stay and total postoperative cost. a study shows that a low preoperative cerebral oximetry (rso2) is associated with postoperative delirium after on-pump cardiac surgery. another study showed that patients who underwent cardiac surgery with reduced cerebral blood flow (cbf) velocity in the left middle cerebral artery (mca) preoperatively are at greater risk for postoperative cognitive dysfunction (pocd). therefore, the investigators hypothesize that lower perioperative rso2 and reduced preoperative mean flow velocity (mfv) of mca are good predictors of the postoperative delirium in the patients undergoing the on-pump cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. patients in the study will be 60 or older undergoing elective major on-pump cardiac surgery exclusion criteria: 1. no communication possible due to a language barrier or deafness 2. patients diagnosed with neurocognitive disorders or psychiatric diseases (mmse or geriatric depression scale cannot be checked before surgery) 3. patients with unstable hemodynamics or intubated before surgery 4. patients diagnosed with significant (≥ 50%) intracranial stenosis confirmed by ct angiography or mr angiography 5. patients diagnosed with stroke, tia or neurologic diseases (e.g. parkinson's disease, epilepsy, dementia, or taking psychiatric medications d/t psychiatric disorders)

Keywords: postoperative delirium on-pump cardiac surgery cerebral oximetry cerebral blood flow velosity
daily subjective and objective smartphone measures of illness activity to treat bipolar disorder- the monarca ii trial

Conditions: Bipolar Disorder

Summary: bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment. recently, in the monarca i trial (nct01446406), the investigators developed and deployed a smartphone based self-monitoring system (the monarca i system) in a randomized controlled trial, to test the effect of daily reporting of subjective self-monitoring of depressive and manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms. in the monarca ii trial the investigators will develop and deploy a new version of the smartphone based monitoring system. the investigators will in a randomized controlled single blind trial investigate whether daily electronic monitoring of subjective and objective measures of illness activity using a smartphone based self-monitoring system including feedback on subjective as well as automatically generated objective data (e.g.social activity, physical activity etc.) (the monarca ii system) reduces the severity of depressive and manic symptoms and improves functioning more than a control group receiving a smartphone. all patients will be followed for 9 months with outcome assessments at baseline, after 4 weeks, after 3 months, after 6 months and after 9 months.


Eligibility criteria:
inclusion criteria: * bipolar disorder according to scan interview * ≥18 years of age * patients who previously have received a course of treatment at the clinic for affective disorders, psychiatric centre copenhagen, denmark exclusion criteria: * pregnancy * lack of danish language skills * patients who previously have received and used the monarca i system for self-monitoring

Keywords: bipolar disorder daily electronic monitoring smartphones subjective and objective smartphone data feedback loop
a comparative assessment of post extraction pain in orthodontic patients to evaluate the effects of early engagement of tooth with orthodontic wires. a single center randomized clinical trial (rct)

Conditions: Orthodontic Extraction; Orthodontic Treatment; Orthodontic Treatment Via Premolar Extraction

Summary: the goal of this clinical trial is to determine if the timing of tooth extractions (before or after initial orthodontic treatment) affects pain levels in patients who need bilateral extractions of first premolars in the upper jaw. the participants in this study are patients who require these extractions as part of their orthodontic treatment. the main questions it aims to answer are: 1. does extracting teeth before starting orthodontic treatment result in different pain levels compared to extracting teeth after alignment? 2. how do pain levels change over time after the extractions in each group? researchers will compare group a (patients who have extractions before orthodontic treatment) to group b (patients who have extractions after initial alignment) to see if the timing of the extractions affects pain levels. participants will: undergo tooth extractions either before or after initial alignment based on their group. rate their pain on an 11-point numerical rating scale at various times (2, 4, 8, 12, and 24 hours after extraction, and then daily for a week).


Eligibility criteria:
inclusion criteria: * 12 to 18-year-old orthodontic patients needing bilaterally symmetrical extractions of first premolars as a part of orthodontic treatment. angles class i with moderate to severe crowding cases, bimaxillary proclination, and angles class ii division 1 were included. exclusion criteria: * patients with poor oral hygiene, carious or missing premolars, multiple missing teeth, systemic diseases, periodontitis or patients on analgesics (nsaids, and corticosteroids) were excluded from the study.
exercise study in patient with chronic obstructive pulmonary disease (0000-036)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: to test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * 40 years and older * clinical diagnosis of copd for greater than one year * history of cigarette smoking exclusion criteria: * other lung diseases (not including copd), such as asthma * a condition that could interfere with your ability to perform exercise tests
triple treatment for detachment of retinal pigment epithelium secondary to polypoidal choroidal vasculopathy

Conditions: Choroidal Neovascularization; Retinal Pigment Epithelial Detachment

Summary: study the effectiveness of the treatment detachment of retinal pigment epithelium secondary to polypoidal choroidal vasculopathy. efficacy will be assessed by regression of polyp area after twelve months, compared to baseline. treatment under study is a triple therapy with: 1) reduced-fluence photodynamic therapy (pdt), 2) intravitreal (ivt) triamcinolone and, 3) ivt ranibizumab, for the treatment of detachment of the retinal pigment epithelium (ped) secondary to polypoidal choroidal vasculopathy (pcv).


Eligibility criteria:
inclusion criteria: * patients with pcv associated with ped near the polypoidal lesion recently diagnosed, documented by fa, icga and oct. * visual acuity between 20/40 and 20/400. * patients older than 50 years (both genders). * women must be postmenopausal for at least 12 months or surgically sterile. * no previous treatment in the study eye. * accept and sign the informed consent. * no condition that prevents the monitoring of the patient for one year. * transparent ocular media and adequate pupillary dilation to allow good images of the fundus. exclusion criteria: * blepharitis or external eye infection. * allergy to ranibizumab, verteporfin, triamcinolone, fluorescein or indocyanine green. * patients unable to provide informed consent. * concomitant ocular disease that impairs visual acuity. * any intraocular condition (such as cataract or proliferative diabetic retinopathy) in the study eye, in the opinion of the investigator, could require surgery or medication during the follow-up (1 year). * active intraocular inflammation. * patients with glaucoma and with ocular hypertension (iop \> 25mmhg). * premenopausal women. pregnancy or lactation. * effective treatment for active systemic infection or history of recurrent infection. * evidence of concomitant disease (cardiovascular, neurological, pulmonary, renal, hepatic, endocrine or gastrointestinal) uncontrolled.

Keywords: age-related macular degeneration pigment epithelial detachment polypoidal choroidal vasculopathy
t central memory cells in early localized non-segmental vitiligo

Conditions: Vitiligo

Summary: assessing the level of circulating tcms (cluster of differentiation (cd) 8+, cd3+,c- chemokine receptor (ccr)7, cluster of differentiation 45 receptor (cd45r) cells) in early localized vitiligo cases prior to treatment and after treatment in comparison to healthy controls. this, in turn, would provide insights regarding the role of tcms in vitiligo and the role of early treatment in halting disease progression and autoimmune memory formation that accounts for high recurrence rate of vitiligo

assessing the level of circulating tcms (cd8+ cd3+ ccr7+ cd45ro+ cells) in early localized vitiligo cases where samples will be processed and stained for cd8, cd3, ccr7, . ccr7, cd45r. multi-parametric flow cytometry will be used to quantify cd3+ve, cd8+ve, ccr7+ve, cd45ro+ve tcm cells percentage, which will be expressed as a percentage from the total lymphocyte gate. this will be done prior to treatment and after treatment and will be compared to healthy controls.

Eligibility criteria:
inclusion criteria: - subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration exclusion criteria: * patients who received treatment of any type (topical or systemic) within the last 3 months

Keywords: early localized vitiligo
real-world disease management and outcomes in chronic myeloid leukaemia

Conditions: Chronic Myeloid Leukaemia

Summary: chronic myeloid leukaemia (cml) diagnosis is based on the demonstration of a bcr-abl fusion transcript expressed by the philadelphia (ph) chromosome by rq-pcr and/or the demonstration of t(9;22)(q34;q11) by conventional karyotyping or interphase fish. as per standard practice, response to therapy is monitored using either molecular or cytogenetic tests or both; specifically, patients are monitored by quantitative pcr on peripheral blood, supplemented by bone marrow karyotyping if it was clinically indicated. abl kinase mutational analysis is carried out when the transcript ratio has increased over two sequential samples or on clinical demand. testing for t315i mutation is also performed for patients who fail to respond to first line tki and all patients who acquire tki resistance over the course of their treatment. data collection is initiated six months after date of diagnosis; research nurses working to agreed operating procedures and data standards visit each of the 14 hospitals in the region and abstract a core clinical dataset from the patients' medical records. the information collected includes demographic details, baseline blood count data and first line treatment. all details are abstracted onto structured forms and entered onto the web-based system, which integrates haematological malignancy research network (hmrn) and haematological malignancy diagnostic service (hmds) data. an important feature of data acquisition is the emphasis on primary source information; data from radiology reports, blood tests, clinical examination, and clinician summaries are recorded, enabling embedded algorithms in the database system to automatically generate stage and prognostic scores. further data abstraction from the medical records has been undertaken to capture information on subsequent treatment lines. information on date and cause of death were obtained from the national health service (nhs) central register.


Eligibility criteria:
inclusion criteria: • adult (18+ years) patients newly diagnosed with cml in chronic phase (icd-o-3: 9875/3) by hmds between 1st september, 2004 to 31st august, 2019 whilst resident in the hmrn region and treated within the network. exclusion criteria: none specified.