Kornimate/medical-research-clean huggingface dataset:
comparing two different approaches in the screening of cystic fibrosis related diabetes

Conditions: Screening of Cystic Fibrosis Related Diabetes

Summary: the incidence of cystic fibrosis related diabetes (cfrd) has risen significantly as patients' survival improves. early diagnosis of cfrd is crucial to prevent the unnecessary deterioration of lung function and nutritional status, both of which affect the patient's overall survival. the oral glucose tolerance test (oggt) is the accepted method for detecting cfrd. the cystic fibrosis trust guidelines (2004) recommend that patients with cf over the age of twelve years should be screened annually. most hospitals use an annual ogtt. performing ogtt on all cf patients is inconvenient and may not be cost effective, as patients have to starve overnight and need to spend an extra 2 hours in the hospital in addition to all the other annual review tests. in our centre, a selective approach is used. if patients have an abnormal random blood glucose and /or abnormal glycosylated haemoglobin (hba1c) and/or symptoms of hyperglycaemia or unexplained weight loss then an ogtt will be performed. the aims of this study are 1. to compare the clinical efficiency in the screening for cfrd in the two different methods: i)a selective approach , ii)an unselected annual ogtt for all patients. 2. to compare the cost effectiveness of the two approaches in the screening for cfrd.

cfrd affects 30% of all patients with cystic fibrosis (cf) by the age of twenty-five. early diagnosis of cfrd is crucial to prevent the unnecessary deterioration of pulmonary function and nutritional status, both of which affect the patient's overall survival. the selective approach takes less patient time and is less expensive. if it is equally accurate it should be used routinely. the oral glucose tolerance test (ogtt) is the accepted method for detecting cfrd and the cystic fibrosis trust guidelines recommend that patients with cf over the age of twelve years should be screened annually. yung et al, questioned this approach and argued that performing ogtt on all cf patients is inconvenient and may not be cost effective, as patients have to starve overnight and need to spend an extra 2 hours in the hospital in addition to all the other annual review tests. in this study, a selective approach in performing ogtts in the screening for cfrd will be used; this includes the use of a combination of clinical and biochemical criteria that of abnormal random blood glucose and /or abnormal glycosylated haemoglobin (hba1c) and/or symptoms of hyperglycaemia, or weight loss.

Eligibility criteria:
inclusion criteria: * first one hundred consecutive clinically stable patients with cf attending annual review from january 2009 * 16 years of age and over will be eligible for the study. exclusion criteria: * patients with an existing diagnosis of cfrd. * patients with an infective exacerbation (i.e. on a new course of antibiotics)

Keywords: adults cystic fibrosis related diabetes screening oral glucose tolerance test royal brompton & harefield foundation trust
evaluating the safety and effectiveness of liraglutide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of the trial is to assess the incidence rate and type of sadrs (serious adverse drug reactions).


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide exclusion criteria: * subjects who are or have previously been on liraglutide * subjects who have previously been enrolled in the study * subjects with a hypersensitivity to liraglutide or to any of the excipients * subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods * subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial * known or suspected abuse of alcohol or narcotics
a study to investigate the efficacy of lt-02 in patients with mesalazine refractory ulcerative colitis

Conditions: Ulcerative Colitis; Large Intestine; Diarrhea; Abdominal Pain

Summary: the participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. if the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. in total the study consists of 5 to 6 clinical visits (v1 - v6) and 1 telephone follow-up call.


Eligibility criteria:
inclusion criteria: * men and women 18 years or older who have given written informed consent * patients with proven ulcerative colitis * active disease course for the last 6 weeks or longer with bloody diarrhea * patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine. exclusion criteria: * infectious colitis, including cytomegalovirus or clostridium difficile induced colitis, * crohn's disease, * colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis, * treatment with other investigational medicinal product within 3 months prior to study entry
compliance to a hormone therapy regimen in breast cancer

Conditions: Breast Cancer

Summary: rationale: understanding how well patients comply with their treatment regimen may help doctors plan the best treatment and ongoing care. purpose: this clinical trial is studying whether patients comply with their hormone therapy regimen in women with estrogen receptor-positive stage i, stage ii, or stage iiia breast cancer.

objectives: primary * to examine the relationship between adherence to endocrine therapy and variables from the health belief model (i.e., perceived risk, barriers to and benefits of adherence, and cues to action such as physician recommendation) as well as measures of patient's perceptions of patient- and family-centered care in women with estrogen receptor-positive stage i-iiia breast cancer. outline: patients complete a 15 minute questionnaire on-line or by mail comprising questions of demographic and medical variables (i.e., age, race/ethnicity, marital and educational status, and medication side effects) as well as health beliefs and selected aspects of patient- and family-centered care. data collected from the questionnaire will be stored in an excel database. patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.

Eligibility criteria:
disease characteristics: * women diagnosed with breast cancer * stage i-iiia disease * estrogen receptor (er)-positive disease * must have begun prescribed hormonal therapy between december 2000 and december 2002 * no prior history of breast cancer patient characteristics: * female * menopausal status not specified * able to read and understand english prior concurrent therapy: * see disease characteristics * prior breast surgery, axillary surgery, and radiotherapy to the breast or chest wall allowed

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer
comparison of ly686017 with a marketed drug in the treatment of social anxiety disorder

Conditions: Social Phobia

Summary: this study is a phase 2 trial to test the efficacy of ly686017 in the treatment of social anxiety disorder.


Eligibility criteria:
inclusion criteria: * male or female outpatients at least 18 years of age and not more than 65 years of age. * must sign the informed consent document. * present at visit 1 with social anxiety disorder based on a clinical global impression-severity score of greater than or equal to 4. * females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use both a reliable primary method of birth control. * judged to be reliable and willing to keep all appointments for clinic visits, tests, and procedures required by the protocol. exclusion criteria: * have any comorbid axis i disorders (such as major depression, obsessive compulsive disorder, post-traumatic stress disorder, or panic disorder), in the opinion of the investigator, if the disorder occurred within the last 6 months. * have had any previous or current diagnoses of bipolar disorders, schizophrenia, or other psychotic disorders. * have the presence of an axis ii disorder, except avoidant personality disorder. * have a serious medical illness. * have abnormal thyroid-stimulating hormone (tsh) concentrations or are taking thyroid supplements.
the effectiveness of anti-gravity treadmill training

Conditions: Lumbar Degenerative Disc Disease

Summary: the primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (pt) program to a pt program that incorporates lower body positive pressure (lbpp) treadmill training for the patients after lumbar discectomy and fusion surgeries.

a prospective, randomized, parallel group controlled clinical study is proposed. the patients will be divided into the two study groups according to the surgical procedure: 1. patients undergoing one-level microdiscectomy for lumbar herniated disc 2. patients undergoing one-level lumbar fusion for degenerative disc disease without notable spinal stenosis. each group will consist of 60 patients (see sample size calculations below) who will be randomized into the two equal groups to undergo: 1. standard postoperative rehabilitation program 2. standard postoperative rehabilitation program with addition of lower body positive pressure (lbpp) treadmill training

Eligibility criteria:
inclusion criteria: * adults between 18 and 65 years old * willing and able to comply with protocol and pt requirements * patients with primarily radicular and back pain due to degenerative disc disease requiring one-level discectomy for herniated disc or lumbar fusion between l2 and s1 * willing and able to sign a study specific informed consent exclusion criteria: * require more than one-level surgery * no previous lumbar surgery * any ongoing health condition that would make it difficult to adhere to postoperative pt requirements * peri-operative or post-operative complications (infection, pneumonia, nerve injury, dural tear, etc.) that would constraint or delay the ability to participate in postoperative pt * bmi greater than 40 * active local or systemic infection
intraoperative use of dexketoprofen trometamol, pethidine hcl, tramadol hcl and their combinations for postoperative pain management in laparoscopic nissen fundoplication

Conditions: Laparoscopic Nissen Fundoplication

Summary: the purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic nissen fundoplication.


Eligibility criteria:
inclusion criteria: * 18-60 years old asa i-ii patients * clinical diagnosis of gastroesophageal reflux patients exclusion criteria: * allergic reactions to nsaids or opioid analgesics * body mass index exceeding 35 * pregnancy

Keywords: postoperative analgesia dexketoprofen trometamol tramadol hydrochloride pethidine laparoscopic nissen fundoplication
treatment of fecal incontinence by injection of autologous muscle fibers into the anal sphincter

Conditions: Fecal Incontinence; Anal Incontinence

Summary: aim: to investigate efficacy and safety in a new treatment with injection of autologous muscle fibers into the anal sphincter in patients with fecal incontinence. method: patients with fecal incontinence after obstetric anal sphincter rupture will be included. after inclusion, they will be offered 3 months of pelvic floor muscle training. if the patients after completion of pelvic floor muscle training still suffer from fecal incontinence, the patients will be offered treatment with autologous muscle fiber injection into the anal sphincter. the patients will be followed one year after the injection. the autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and injected into the anal sphincter. a small part of the fibers are used for analysing number of muscle stem cells and thereby the regenerative potential of the sample. the study is a pilot study.


Eligibility criteria:
inclusion criteria: * fecal incontinence * wexner score \>= 9 or affected quality of life. * understanding and speaking danish * informed consent exclusion criteria: * ongoing pregnancy * delivery in the last 12 months * colostomy * chronic inflammatory bowel disease (mb. crohn, colitis ulcerosa) * improvement after pelvic floor muscle training in an extent that makes autologous muscle fiber injection unnecessary.

Keywords: regenerative medicine fecal incontinence muscle fiber injection
repetitive transcranial magnetic stimulation (rtms) in depression

Conditions: Depression

Summary: this study will report on the outcomes of rtms administered 3 times per week, compared with the standard protocol of 5 times per week. participants will be randomly assigned to frequency condition and depressive symptomatology will be measured weekly using a range of clinician and self-rated questionnaires. participants will remain in the study for at least 4 weeks, with the option of continuing for a further 2 weeks as judged by the study psychiatrist. it is hypothesised that rtms administered three times per week will be equally as effective as rtms administered five times per week in reducing depressive symptomatology.

numerous studies have demonstrated the efficacy of active rtms over sham rtms for depression; however, few have systematically studied the optimal frequency of treatment sessions to achieve this efficacy. to date, the majority of studies have administered rtms every weekday, although this approach has not been widely contested. in addition, most studies have only assessed the effectiveness of rtms over a two week period, which has resulted in some improvement in depressive symptomatology; however, a longer treatment course would likely result in greater improvement. in this study depressed patients will be randomly assigned to receive rtms either 3 or 5 times per week, for a period of 4-6 weeks. a range of rating scales will be used to assess the improvement of depressive symptomatology within and between the two frequency groups, to ultimately determine whether tms is needed 5 times per week to achieve adequate anti-depressant effects or whether 3 times per week is sufficient in achieving a similar level of efficacy for patients.

Eligibility criteria:
inclusion criteria: * aged \>/= 18 * dsm-iv diagnosis of major depressive episode (bipolar or mdd) * madrs score \>/= 20 * able to give informed consent * psychoactive medication dosages have been stable for a period of 4 weeks prior to entry in the study exclusion criteria: * co-morbid alcohol or drug abuse or dependence (last 3 months), current eating disorder, mental retardation, schizophrenia, rapid cycling bipolar * a history of mood 'switching' in response to other treatments, which cannot be contained by concurrent treatment, e.g., mood stabiliser * pregnancy * significant neurological disorder that increases seizure risk * metal objects in the head, pacemakers, or a history of epilepsy * patients who have failed to respond to a course of ect in their current episode of depression * a high risk of suicide

Keywords: depression transcranial magnetic stimulation
glucose variability in pregnancy complicated by diabetes

Conditions: Gestational Diabetes; Continuous Glucose Monitoring; Glycemic Variability

Summary: continuous glucose monitoring (cgm) methods provide details of magnitude and duration of glucose fluctuations, giving a unique insight on daily blood sugar control. limited data are available on glucose variability (gv) in pregnancy. the aim of this study was to assess gv in normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes (gdm), and its possible association with hba1c.

recent evidence in the literature suggests that glucose variability, characterized by extreme glucose excursions, may overlap with hba1c levels in determining the risk of diabetes-related complications. fluctuating blood glucose levels prompt an increase in free radicals and endothelial dysfunction, which are the links between hyperglycemia and the activation of pathological pathways that lead to tissue damage. reece and homko postulated an association between maternal hyperglycemia-induced oxygen free radical overproduction and fetal abnormalities, with the onset of diabetes-related embryopathy.numerous studies have demonstrated that macrosomia and congenital malformations relate to glycemic control. in one study, 48-hour continuous glucose monitoring (cgm) of diurnal glucose profiles in pregnant women with type 1 diabetes was more sensitive than hba1c alone in identifying an increased risk of offspring with congenital malformations. such studies give the impression that transient hyperglycemic spikes in pregnant patients with diabetes can cause a high incidence of fetal overweight, regardless of whether or not the mother has chronic hyperglycemia. glucose variability is still a factor that has been inadequately studied in pregnancies complicated by diabetes, and little is known about its relationship with maternal-fetal outcomes.a number of studies have demonstrated the utility of cgm for monitoring diabetes in pregnancy , but none have focused the attention on the importance of glucose fluctuations during gestation. meanwhile, there has been a rapid increase in the number of new glucose variability indicators considered, although none of them seems to be definitively reliable. a better understanding of the pattern of blood glucose fluctuations in all the three trimesters of pregnancy, could help us to optimize glycemic control in pregnant women with diabetes. the aim of this study was therefore to assess glucose variability throughout the three trimesters of pregnancy in healthy women and in cases of type 1 diabetes mellitus or gestational diabetes, identifying the more representative and useful indicators of glucose fluctuations, to provide more accurate clinical informations along with hba1c and beyond.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes or gdm * able to become familiar with glucose monitoring methodologies exclusion criteria: * type 2 diabetes * pre-gestational bmi \> 35 kg/m2 * hba1c \> 8% for type 1 diabetic pregnant women

Keywords: diabetes pregnancy glucose variability continuous glucose monitoring (cgm) gestational diabetes mellitus (gdm)
functional residual capacity during different levels of high-flow in preterm infants

Conditions: Infant, Premature, Diseases; Respiratory Distress Syndrome

Summary: although there is a widespread use of highflow therapy around the world, there is still uncertainty about the most appropriate initial highflow level after nasal continuous positive airway pressure therapy. higher levels might produce excessive and harmful intra-alveolar pressures exceeding those reached during nasal continuous positive airway pressure therapy. low levels may not generate sufficient distending pressures, which may result in a loss of functional residual capacity and an increased risk of respiratory failure. therefore, the aim of this study is to assess the effect of different highflow levels on the functional residual capacity and to compare these findings to the functional residual capacity during nasal continuous positive airway pressure therapy.


Eligibility criteria:
inclusion criteria: * written informed consent by one or both parents or legal guardians as documented by signature * 30 - 35 weeks postmenstrual age * respiratory support with ncpap peep 5mbar and fio2 \< 0.30 * \> 72 hours old exclusion criteria: * inability of the parents to understand the study concept or procedures due to cognitive or linguistic reasons * congenital malformations adversely affecting lung aeration or pulmonary perfusion (e.g. congenital heart or lung defects)

Keywords: non-invasive respiratory support highflow continuous positive airway pressure functional residual capacity
an observational study of the impact of roactemra/actemra on fatigue in patients with rheumatoid arthritis (peps)

Conditions: Rheumatoid Arthritis

Summary: this prospective, observational study will assess the effect of roactemra/actemra (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (dmards) or anti tumor necrosis factor (anti-tnf) drugs. eligible patients receiving roactemra/actemra according to the standard of care will be followed for 4 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis * inadequate response to disease-modifying antirheumatic drugs (dmards) or anti-tnf (tumor necrosis factor) drugs exclusion criteria: * hypersensitivity to roactemra/actemra or any component * active infection * participation in a clinical trial in rheumatoid arthritis
analysis of lung sounds collected by resp biosensor to support decision making in monitored hospitalized pediatric patients

Conditions: Pediatric Respiratory Diseases; Asthma; RSV Infection; COVID-19

Summary: this observational clinical trial is designed to confirm whether resp™ biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.


Eligibility criteria:
inclusion criteria: 1. children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as rsv or covid 2. hospitalization projected for at least 24 hours after device placement 3. patient and parent/guardian able and willing to provide informed consent/assent. exclusion criteria: 1. patient and parent/guardian unable or unwilling to provide informed consent 2. patient expected to undergo prolonged invasive radiology procedure(s) 3. plan for discharge within 24 hours 4. patient expected to undergo major thoracic surgery 5. history of adverse reaction or allergy to tegaderm ® or similar product
sleep-disordered breathing after solid organ transplantation

Conditions: Lung Transplantation; Sleep-disordered Breathing

Summary: sleep-disordered breathing (sdb) describes a group of disorders in which partial or complete cessation of breathing occurs many times throughout the night, resulting in daytime sleepiness or fatigue that interferes with a person's ability to function and reduces quality of life. transplantation has become an important treatment modality for end-stage organ failure. transplant recipients are now living longer and, hence, develop chronic adverse medical conditions. furthermore, transplantation is associated with weight gain. despite the high prevalence of poor sleep and cardiovascular conditions among transplant patients, sdb is not well studied in these patients.

the primary research objective is to evaluate the prevalence, incidence and type (central or obstructive) of sdb in patients after lung transplantation. secondary research objectives are the evaluation of correlations between severity of sdb and clinical findings (weight, medical therapy, heart function, lung function, renal function, graft failure, ...). furthermore, the investigators will evaluate the relationship between sdb and cardiovascular morbidity.

Eligibility criteria:
inclusion criteria: * patients 1 year after lung transplantation exclusion criteria: * refusal of psg * medical contra-indication to perform psg