Kornimate/medical-research-clean huggingface dataset:
copeptin in the diagnosis of post-operative insipidus diabetes after pituitary surgery

Conditions: Pituitary Surgery

Summary: endoscopic trans-sphenoidal pituitary endoscopic surgery is one of the main axes of management of tumours of the sellar region. central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery, with a prevalence of up to 30% of cases. it is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin (avp) by the posterior pituitary (melmed et al, 2017). in the absence of specific treatment, diabetes insipidus can lead to severe ionic and osmotic disorders, mainly acute dehydration with the risk of severe consequences particularly neurological. monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period. to date, diabetes insipidus is initially suspected before the appearance of major polyuria. several biological assays (urinary density, natraemia, urinary osmolarity and plasma) can help to confirm the diagnosis, but the sensitivity and specificity of these biomarkers remains quite low for this indication. the determination of mva is difficult because this hormone is unstable ex vivo. to date, its use in current practice remains complicated. mva and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions. copeptin has a relatively short in vivo half-life of about 25 minutes, as does mva, but is more stable in vitro when blood has been drawn. its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest.

objective is to study the interest of copeptin dosage as an early predictive marker for the diagnosis of post-operatice diabetes insipidus in trans-sphenoidal endoscopic pituitary surgery.

Eligibility criteria:
inclusion criteria : adult patient patient undergoing pituitary surgery for tumour of the sellar region patient consenting to participate to the study patient enrolled in the national healthcare insurance program exclusion criteria : patient with preoperative diabetes insipidus. patient undergoing pituitary surgery for suspicion of craniopharyngioma patient undergoing pituitary surgery for pituitary metastases patient under 18 years

Keywords: pituitary surgery post-operative insipidus diabetes copeptin
pharmacokinetics of tricaprilin including food effect on ketone body production

Conditions: Alzheimer Disease

Summary: this is a phase i, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (pk) study recruiting healthy, adult, male subjects.


Eligibility criteria:
inclusion criteria: * healthy adult male, ages 18 - 55 * able to consume a regular diet and one high fat meal; no specific dietary requirements * cohort 2 (asian subject population) restricted to being of japanese or chinese heritage exclusion criteria: * presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject * has been on a ketogenic diet as supported by review of a food diary * has positive urine drug screen or alcohol results at screening
dose-ranging study of the bimatoprost ocular insert

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

Summary: the bimatoprost ocular insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. this study evaluated the safety and efficacy of two different doses of the bimatoprost ocular insert, compared to an active control arm with timolol ophthalmic solution (0.5%).


Eligibility criteria:
key inclusion criteria: * written informed consent * at least 18 years of age * diagnosis in both eyes of either primary open-angle glaucoma (poag) or ocular hypertension * best corrected-distance visual acuity score equivalent to 20/80 or better * stable visual field * central corneal thickness between 490 - 620 micrometers inclusion criteria at the randomization visit: ("t" is defined as time and "hr" is defined as hour\[s\]) * iop for each eye is ≥ 23 mm hg at t=0 hr, ≥ 20 mm hg at t=2 hr and t=8 hr. * inter-eye iop difference of ≤ 5.0 mm hg at t=0 hr, t=2 hr and t=8 hr. * iop for each eye is ≤ 30 mm hg at t=0 hr, t=2 hr and t=8 hr. key exclusion criteria: * any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol * a cardiac or pulmonary condition that in the opinion of the investigator would contraindicate the use of beta-blocker drops * cup-to-disc ratio of greater than 0.8 * significant risk of angle closure due to pupil dilation, defined as a shaffer classification of less than grade 2 based on gonioscopy * ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date * laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months * past history of any incisional surgery for glaucoma at any time * past history of corneal refractive surgery * corneal abnormalities that would interfere with accurate iop readings with an applanation tonometer * current participation in an investigational drug or device study or participation in such a study within 30 days of screening * inability to adequately evaluate the retina * participants who will require contact lens use during the study period. * participants who currently have punctal occlusion * pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
french post-inscription study on sacral neuromodulation in the treatment of fecal incontinence

Conditions: Fecal Incontinence

Summary: the aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of interstim system in patients indicated to sacral neuromodulation therapy for fecal incontinence. this study will provide additional data about safety and effectiveness of the usage of interstim system in fecal incontinence environment and at the same time will confirm that results from clinical trials can be transposed to clinical practice.


Eligibility criteria:
inclusion criteria: * patient willing to sign the data release form stating the non opposition to the study conduct; * patient able to understand information given by the investigator in terms of data collection and publication; * at least 18 years old or older. * patient indicated to sacral neuromodulation testing with interstim® system. exclusion criteria: * replacement of an existing sacral neuromodulation system (implanted before inclusion period) without any evidence of benefits during a testing period. * patient unwilling to comply to data collection and publication rules.
hypotension in children with down syndrome with anesthesia induction

Conditions: Hypotension on Induction

Summary: children generally undergo induction of anesthesia by inhalation of sevoflurane. children with down syndrome experience bradycardia with induction of anesthesia using sevoflurane. it is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

children generally undergo induction of anesthesia by inhalation of sevoflurane. this is particularly relevant for children with developmental delays as to avoid placement of an iv while awake. however, children with down syndrome experience bradycardia with induction of anesthesia using sevoflurane. it is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

Eligibility criteria:
inclusion criteria: children \<18 years old requiring general anesthesia with inhalation induction down syndrome asa physical classification 1-3 exclusion criteria: patients \>18 years of age patients without down syndrome cyanotic congenital heart disease use of antihypertensive medications pulmonary hypertension patients undergoing intravenous induction of anesthesia asa physical classification other than 1-3 emergency procedure
quality of life after myocardial infarction

Conditions: Myocardial Infarction

Summary: this is an observational study to determine the association between social support and functional status after a myocardial infarct

primary objectives: our primary objective is to determine among patients hospitalized for a myocardial infarction, the impact of emotional support on functional outcomes at two years as measured by a valid measure of functional health, the sf-36. secondary objectives: our secondary objectives are: 1. to determine the types of social support which are perceived as being most helpful to patients. 2. to determine whether women and minority patients have unique views on the types of support that are helpful. 3. to determine among patients admitted for myocardial infarction, the impact of social support on length of stay and hospital readmissions. hypothesis: our hypotheses are as follows: 1. patients who are hospitalized for a myocardial infarction and who have high emotional support will have better long-term functional status compared to those patients who have low support. 2. patients with high emotional support will be more likely to adhere to protocols such as taking their medications, keeping appointment, and enrolling in cardiac rehabilitation. 3. patients with high emotional support will have lengths of hospitalization which are shorter than their estimated geometric mean as compared to patients who have low support. 4. the types of social support which are perceived as most helpful in disease management will be influenced by gender and ethnicity. long-term objectives: the long-term objective is to determine the mechanisms by which social support impacts on functional health and to utilize this data to develop future interventions that can be targeted toward a culturally and ethically diverse cohort of patients with coronary artery disease. overall, the goal is to use this data to prevent functional disability and improve quality of life among patients with coronary artery disease.

Eligibility criteria:
* patients who have had a documented myocardial infarction by ekg and laboratory criteria will be eligible. the attending cardiologist of these patients will be approached. once the attending cardiologist declares that a patient is clinically stable enough for participation, they will be approached, told about the study, and asked if they wish to participate.

Keywords: myocardial infarction social support
preventing seroma formation after axillary lymph node dissection for breast cancer by early vacuum assisted closure

Conditions: Breast Neoplasms

Summary: axillary dissection is the standard treatment for breast cancer patients with positive nodes. however, seroma formation after axillary dissection remains the most common early complication to breast cancer surgery. it can delay the initiation of adjuvant therapy, predispose to wound infection, delay wound healing and has also been linked to arm lymphoedema. based on some studies and our experience that vacuum assisted closure （vac）is effective in complex wound failures following axillary dissection and groin dissection, we use vac to prevent seroma formation after extensive axillary dissection. this study is aimed to evaluate the efficacy, safety and economics benefits of early vac application on postoperative complications and wound healing after extensive axillary dissection in comparison to conventional suction drain.


Eligibility criteria:
inclusion criteria: * written informed consent * patients diagnosed with breast cancer, receiving modified radical mastectomy and axillary dissection； * body mass index ≥28； * drainage volume within the first 48 hours is more than 200 ml. exclusion criteria: * subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (pt), quick, activated partial thromboplastin time (aptt), fibrinogen level, or thrombocytes. * subjects having previously had axillary surgery, * subjects having undergone irradiation therapy to the axillary tissue * subjects having ever received chemotherapy before the surgery, * subjects with known hypersensitivity to components of the surgical sticky membrane

Keywords: seroma formation axillary lymph node dissection breast cancer early vacuum assisted closure
postoperative pressure injury in patients undergoing prone spinal surgery

Conditions: Pressure Injury

Summary: patients undergoing surgery under general anesthesia are susceptible to pressure-induced soft tissue damage because there is no change in posture over an extended period of time. in particular, when the patient is in a prone position, unlike the supine position, the bony protruding portion of the front side must support the weight, which is more vulnerable to pressure injury. previous studies have shown that the incidence of pressure injury during surgery varied from 5% to 66% and was more likely to occur in patients with long operating times, prone position, obesity, and poor skin condition. these pressure injuries increase postoperative complications, length of stay, and medical costs. therefore, the investigators analyze the incidence of pressure injury in prone position and re-examine the risk factors of pressure injury.

all of the anesthetic and surgical procedures performed on the subject during the period from the time the subject enters the operating room to the time the subject go to the recovery room are the same as those for the existing spine surgery. immediately after entering the operating room, immediately before going to the recovery room, and at postoperative day 1 and 2, the patient's systemic skin condition is assessed to determine whether pressure damage has occurred. the primary endpoint is the incidence of pressure injury in the subject compared with the incidence of pressure injury in previous studies. to identify the risk factors for the occurrence of pressure injury, the investigators will statistically analyze the data collected with the assumption that this is related.

Eligibility criteria:
inclusion criteria: * adults patients undergoing elective spine surgery in prone position under general anesthesia exclusion criteria: * pre-existence of pressure injury
study on the induction of food tolerance in babies

Conditions: Food Hypersensitivity

Summary: this general population based, randomized controled trial aims at answering two major hypotheses: first, systematic early introduction of solid foods decreases the incidence of food allergy and dietary restrictions by the age of one year. second, stimulation with the symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe allergic symptoms.

all new born babies living in the city of oulu are recruited to the study (n=1380) at their first health nurse visit (at or before 1 month of age) in the local primary care child health clinics. families in the intervention group will get an instruction booklet including information on early systematic introduction of solid foods starting at the age of 4 months, with foodstuff from all major groups in diet by the age of 6 months (vegetables and fruits, wheat and other grains, meat, fish, egg, dairy products). furthermore, the booklet includes information and instructions on food related symptoms and atopic eczema. babies with mild symptoms are encouraged to continue the symptom-eliciting food. all families fill out monthly internet-based questionnaires on food diary, symptoms, diagnoses and health care visits until the age of 1 year.

Eligibility criteria:
inclusion criteria: * all newborn babies attending local child health clinics exclusion criteria: * parents unable to communicate with finnish language (questionnaires in finnish)
southeastern collaboration to improve blood pressure control

Conditions: Hypertension

Summary: the central objective of this proposal is to rigorously compare two strategies designed to improve bp control in primary care practices serving rural southeastern african americans with low socioeconomic status (ses) living in the "black belt". in year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. in years 2-5, the investigators will test the interventions. year 2-5, aim 3: enroll 80 practices and 25 african american patients with uncontrolled htn at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the uh2 phase compared with enhanced usual care. the study's 4 arms are: 1. enhanced usual care: practices are provided with educational materials and tools to enhance patient care 2. peer coaching: patients enrolled in these practices will be matched with a peer coach. the peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques 3. practice facilitation: practices randomized to this arm will work with a practice facilitator. practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction 4. peer coaching and practice facilitation: practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.


Eligibility criteria:
inclusion criteria: * african american adults aged 19-85 years * uncontrolled htn, defined as bp \>140/90 mm hg at the time of study enrollment * black belt resident * english speaking * willing to work with a peer coach * willing to sign informed consent exclusion criteria: * plans to move out of the area within the next two years * advanced illness with limited life expectancy * pregnant or plans to get pregnant in the next year * advanced chronic kidney disease (estimated glomerular filtration rate \<45 ml/min/1.73 m2) * unwillingness to work with a peer coach or to sign informed consent
long-term effectiveness and safety in hepatitis-co-infected patients

Conditions: Human Immunodeficiency Virus-Infection

Summary: the aim of the study is to observe the tolerability and effectiveness of kaletra in human immunodeficiency virus/hepatitis-b virus and human immunodeficiency virus/hepatitis-c virus co-infected patients.


Eligibility criteria:
inclusion criteria: * patients infected by hiv-1 and hbv or hcv * age ≥18 years * patients who were initiated on a lpv/r containing antiretroviral (arv) regimen exclusion criteria: - contraindications as described in smpc (summary of product characteristics) at the time of prescription

Keywords: human immunodeficiency virus co-infection with hepatitis b or hepatitis c tolerability effectiveness
energy expenditure and substrate oxidation in a whole room calorimeter

Conditions: Overweight; Obesity; Body Weight

Summary: the investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting.

the purpose of this study is to determine the duration and time course of the thermic effect of single meals consumed by subjects who have been previously fasting for 12 hours overnight. capturing the full thermic effect of a meal may take up to 8 hours, depending on the calorie load, nutrient composition of the meal, and rate of digestion. the investigators will test meals consisting of conventional foods that are low (20% of energy), moderate (40% of energy) or high (60% of energy) in fat calories, as fat is thought to slow the digestive process. the investigators will test a liquid meal, that is high (60% of energy) in fat calories, as liquid foods are thought to move more quickly through the digestive process. another purpose of this study is to determine the test-retest reproducibility for the meals described above. to accomplish reproducibility, a volunteer will be permitted to repeat a test day two times using the same test meal.

Eligibility criteria:
inclusion criteria: * body mass index 18.5 - 39.9 kg/m2 exclusion criteria: * bmi \ 40 kg/m2 * presence of untreated or uncontrolled metabolic diseases * presence of gastrointestinal distress or disorders that prevent consumption of a study meal (in particular, the high fat meals) * presence of crohn's disease, irritable bowel syndrome, or colitis * previous gallbladder removal * presence of cancer or other serious chronic disease * implanted medical device that is battery operated, such as a pacemaker, defibrillator, electrocardiograph, or nerve simulator * presence of a large amount of metal in the body such as a hip implant * current use of tobacco in any form * claustrophobia * dietary restrictions that would interfere with consuming study meals * pregnant or nursing within the last 6 months, or plan to become pregnant

Keywords: thermic effect of feeding thermogenesis calorimeter fuel utilization
efficacy of the act of urination to relief the pain during flexible cystoscopy procedure.

Conditions: Hematuria; Bladder Ca; Bladder Stone; Urologic Diseases

Summary: this research is about modification during routine cystoscopy (scope in the bladder) procedure \[ experimental research \]. the goal of the study is to evaluate patient experience with cystoscopy by using procedural modification to reduce pain perception. the investigator aim for quality improvement of the current methods of cystoscopy to achieve a better patient experience.

study area -department of urology, hospital universiti sains malaysia. study population. -patient who is required for flexible cystoscopy procedure attending urology unit in hospital usm participants inclusion criteria : • adult (\>18 years old) exclusion criteria: * analgesic use within 24hours * history of stricture ,urinary tract infection, existing urethral pain * secondary procedure(example stent, stone removal, fulguration) withdrawal criteria * change of mind * found to be outside the parameters of inclusion criteria, and inside the parameters of exclusion criteria * breach of protocol

Eligibility criteria:
inclusion criteria: * age more 18 years old exclusion criteria: * analgesic use within 24hours * history of stricture ,urinary tract infection, existing urethral pain * secondary procedure(exp stent, stone removal, fulguration)