Kornimate/medical-research-clean huggingface dataset:
yervoy pregnancy surveillance study

Conditions: Melanoma

Summary: the study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age


Eligibility criteria:
inclusion criteria: * documented exposure to yervoy while pregnant or within 90 days of discontinuing treatment exclusion criteria: * women whose ipilimumab exposure is outside the window of pregnancy exposure * pregnancies for which there is only paternal exposure to yervoy other protocol defined inclusion/exclusion criteria could apply
combination of the vaginal laser with a moisturizing and repairing niosomal gel in the treatment of genitourinary syndrome in oncology patients

Conditions: Genitourinary Syndrome of Menopause

Summary: vaginal laser together with the use of moisturizing and repairing gels could be an effective therapy for the treatment of genitourinary syndrome in women with a history of neoplasia in whom the use of estrogens is not recommended. the purpose of this study is to evaluate the effectiveness of vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in this group of patients.


Eligibility criteria:
inclusion criteria: * patients with an established sgm diagnosis. * patients with a history of neoplasia in whom the use of estrogens as the first alternative for the treatment of gms is not recommended. exclusion criteria: * patients with concomitant vulvovaginal pathology. * patients with a diagnosis of pelvic organ prolapse grade ii or greater.

Keywords: genitourinary syndrome of menopause co2 laser
paternal psychosis after baby born

Conditions: Psychosis

Summary: a large number of studies have investigated the psychological disorders occurred in postpartum women, and found that postpartum psychosis is common in new mothers. however, the situation of paternal psychological status after they had their first baby is not assessed. the investigators hypothesized that they had a high occurrence of paternal psychosis after first baby born. in addition, different factors might influence its onset and development in new fathers.


Eligibility criteria:
inclusion criteria: * men will be the would-be fathers * chinese exclusion criteria: * age \ 50years * not willing to participating or completing the whole study at any time

Keywords: paternity psychology risk factor
the calmer project

Conditions: Acute Pain

Summary: the purpose of this study is to see if the calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit. hypothesis: while receiving treatment with calmer, infants will show lower behavioral pain scores and lower heart rates, and more stable autonomic regulation as measured by heart rate variability indices, than infants given a soother plus facilitated tucking (standard of care) during routine blood collection.

60 infants will be randomized to either receive the standard of care or the calmer during a routine blood collection.

Eligibility criteria:
inclusion criteria: * stable infants admitted to the neonatal intensive care unit at children's and women's health centre of british columbia (c\&w) * preterm infants born at 27 to 36+6 completed weeks gestational age (ga) will be included * ga is determined on the basis of the first day of the last menstrual period, early gestation ultrasonogram (in most cases) or best estimate based on neonatal examination * mothers must speak enough english to provide consent exclusion criteria: * infants who have congenital anomalies, active, ongoing infection, or have undergone surgery * infants who have received pharmacological analgesics or sedatives within 72 hours of the assessment * history of maternal abuse of controlled drugs and substances; blood collection that occurs beyond the 35th completed week (35 weeks + 6 days) ga * small for ga defined as a birth weight at least 2 standard deviations below mean for ga * higher order multiples (e.g. triplets) * infants in a cot

Keywords: managing infant pain 27 - 36+6 weeks gestation preterm infants
screening of obstructive sleep apnea syndrome in patients with resistant systemic arterial hypertension: pilot study

Conditions: Sleep Apnea, Obstructive; Resistant Hypertension

Summary: this study evaluates the utility and reliability of somnocheck micro weinmann for obstructive sleep apnea syndrome (osas) screening in patients affected by resistant systemic arterial hypertension. results are compared with a modified portable sleep apnea testing (type iii portable monitoring: somnocheck 2 weinmann).

osas is a syndrome characterized by the partial or total collapse of the high airways which determines snore, airflow limitation, hypopnea and apnea.these events cause desaturations, daytime sleepiness and an increased risk of cardio and cerebral vascular diseases. osas's prevalence is estimated between 64-83% among patients affected by resistant arterial hypertension; therefore osas's screening is mandatory during the clinical work-up of these patients. this study is a randomized, interventional, spontaneous, exploratory, cross-over and monocentric trial, which assesses the utility and reliability of the reduced cardio-respiratory monitoring (type iv portable monitoring: somnocheck micro weinmann) to estimate the prevalence of osas among patients affected by resistant systemic arterial hypertension. the results are compared with a complete cardio-respiratory monitoring (type iii portable monitoring: somnocheck 2 weinmann).

Eligibility criteria:
inclusion criteria: * resistant arterial hypertension * patients must sign the informed consent exclusion criteria: , * atrial fibrillation with haemodynamic instability * congestive hearth failure, * bmi\>45 kg/m2, * respiratory failure * renal or liver failure, * stroke, * implantable cardioverter-defibrillator (icd), * pacemaker (pm), * previous diagnosis of osas, * pregnancy, * breastfeeding, * patients must not be already enrolled in other clinical trial.
a pilot study of using video images in advance care planning in malignant glioma patients

Conditions: Advanced Brain Cancer

Summary: a randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.

a randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. subjects will have three options for their goals of care: life prolonging care, basic medical care, or comfort care.

Eligibility criteria:
inclusion criteria: * advanced brain cancer * english speaking * able to provide informed consent exclusion criteria: * folstein mini mental status score of 23 or less
effect of dexmedetomidine and bupivacaine for paravertebral block

Conditions: Fracture of Proximal Femur

Summary: fracture femur is a common that results in severe pain. many methods of regional and peripheral analgesia have been described to treat such pain. in this study the investigators consider using paravertebral block to treat post-fracture pain. additionally, they consider adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this block and hence postoperative analgesia.

fracture femur is a common injury which is associated with excruciating pain . this pain is one of the most important causes of postoperative morbidity and mortality when it is insufficiently treated pain. pain induces neuroendocrine stress response causing problems like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial ischemia and even infarction. these problems can be prevented by successful management of postoperative pain. in patients with proximal femoral fracture, the use of paravertebral blockade produces reliable level of analgesia without need for additional nursing skills or monitoring in the postoperative period. paravertebral blockade by injection local anesthetic solution alongside the vertebral column produces ipsilateral analgesia. currently available local anesthetics as bupivacaine may not provide reliable periods of analgesia resulting in block resolution before the period of worst postoperative pain. the use of a large volume of local anesthetic is one of methods to overcome this problem that may lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. adding adjuvants is another potential alternative. dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia of nerve blocks. dexmedetomidine has also been reported to enhance central and peripheral nerve blockade. alpha adrenoceptors located at the nerve endings have a possible role in the analgesic mechanisms by preventing norepinephrine release. the spinal mechanism is the principle mechanism for the analgesic action of dexmedetomidine.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical class i or ii exclusion criteria: * patient refusal. * severe or uncompensated cardiovascular disease. * severe or uncompensated renal disease. * severe or uncompensated hepatic disease. * severe or uncompensated endocrinal disease. * pregnancy. * postpartum ladies. * lactating females. * allergy to any of the study medications . * coagulation disorders. * infection at the site of needle insertion
exploratory study therapeutic fasting reduce physical limitations, quality of life during aromatase inhibitor therapy

Conditions: Breast Cancer Patients Treated With Aromatase Inhibitors

Summary: in this explorative study, the feasibility of therapeutic fasting to reduce limitations in physical well-being and quality of life of patients undergoing endocrine therapy with aromatase inhibitors will be investigated. in addition, the application of the studyu app, which is currently under development, will be monitored and the app adapted if necessary. in addition, in preparation for a larger multicenter main study, it will be examined whether the muscle and joint complaints frequently experienced by patients undergoing endocrine therapy with aromatase inhibitors (ai) can be alleviated by a 7-day guided therapeutic fasting intervention (prolonged fasting / pf) can be improved.

after baseline (t0), all patients will receive the following intervention: 7 days of online supervised prolonged therapeutic fasting (max. 350 kcal/d). following the study intervention, at t1, patients will be offered a for a potential effect as sustainable as possible in addition to a dietary change. according to the following criteria: * as plant-based as possible * rich in nutritive prebiotics * in addition, this group should include intermittent fasting/time restricted eating (16/8h) into their dietary habits (at least 6d/week). all patients will be interviewed on a regular basis and anthropometric data will be collected accordingly at following time points: * t1 (at the end of the fasting intervention). * t2 (3 months after t0)

Eligibility criteria:
inclusion criteria: * patients with curatively treated hormone receptor positive breast cancer who have been on aromatase inhibitors (ai) therapy for at least 3 months and have significant pain (nrs\>4). * informed consent. exclusion criteria: * eating disorders. * permanent medication other than endocrine therapy, which would constitute an absolute or relative contraindication to outpatient fasting, such as marcumar, lithium, antiepileptic drugs, etc. * patients with diabetes mellitus type 1 or 2 * uncontrolled cerebral seizure disorder. * participation in another diet/fasting study. * lack of willingness to store and share personal medical data within the framework of the protocol. * insufficient knowledge of the german language.

Keywords: fasting aromatase inhibitors
magnetic resonance imaging (mri) to predict outcomes of pancreatic ductal adenocarcinoma (pdac)

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma

Summary: the purpose of this study is to assess if six-dimensional magnetic resonance imaging (6d-mri) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (pdac).

the overarching goal of this pilot study is to evaluate the usefulness of a novel magnetic resonance imaging (mri) approach, which measure properties of tumor microenvironment (i.e. vascularity, fibrosis), to predict pdac response to neoadjuvant therapy (nat).

Eligibility criteria:
inclusion criteria: * pancreatic cancer patients (with resectable or borderline resectable or locally advanced tumors) who will undergo neoadjuvant chemotherapy * patients able to undergo at least two sets of mri sessions * access to a device that has the capability to sync to the fitbit (or access to a family member's, caregiver's, or friend's device) exclusion criteria: * patients who have previously been treated for pdac * patients unable to undergo mri exam w/contrast * patients with metastatic pancreatic cancer visualized on index diagnostic imaging * patients with certain metallic implants * patients experiencing claustrophobia
evaluation of the frequency of limitation of activity in patients with persistent asthma

Conditions: Persistent Asthma

Summary: evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner


Eligibility criteria:
inclusion criteria: * persistent asthma receiving long-term maintenance treatment with inhaled steroids (alone or in combination with other drugs) exclusion criteria: * patients with a diagnosis of copd

Keywords: limitations of activities persistent asthma general practitioner frequency of limitations of activities depending on gender and age-group
the effect of additional propacetamol infusion on post procedural outcome and opioid consumption during catheter ablation of atrial fibrillation.

Conditions: Arrhythmia

Summary: sedation for catheter ablation of atrial fibrillation should be performed to achieve analgesia, immobilization, and maintenance of airway. various anesthetic agents such as propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. however, propofol and midazolam causes respiratory depression and dexmedetomidine occasionally accompanies hypotension or hypertension and bradycardia. therefore, anesthetic agent that does not induce respiratory depression with stable hemodynamics is needed. propacetamol (denogan®, yungjin, seoul, korea) is injectable prodrug of acetaminophen and 1st line drug for fever and pain. in a previous study, paracetamol reduced morphine consumption after surgery. and paracetamol does not cause respiratory depression. thus, the investigators hypothesized that addition of propacetamol to previously used sedatives midazolam-remifentanil will reduce opioid consumption during the catheter ablation. therefore, the investigators designed this study to investigate the role of addition of propacetamol to previous used midazolam-remifentanil sedation. this study will compare the opioid consumption and respiratory effect of propacetamol with placebo-control for catheter ablation of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo catheter ablation for arrhythmia exclusion criteria: * subjects are ineligible if they have liver disease, kidney disease, * american society of anesthesiology class 3 or 4, * age under 20 years, * cognitive dysfunction, * disabling mental change disorder, * patients are unable to communicate or speak korean
safety and effectiveness of neurostar® transcranial magnetic stimulation (tms) therapy in depressed adolescents

Conditions: Major Depressive Disorder

Summary: to evaluate the safety and efficacy of daily, active neurostar® tms (when compared with sham treatment) in adolescents meeting criteria for major depressive disorder (mdd).

to evaluate the antidepressant effects of daily, active tms (when compared with sham treatment) in adolescents meeting criteria for major depressive disorder, single or recurrent episode. secondary: to evaluate the acute and long term safety of tms treatment in adolescent mdd subjects. to evaluate the durability of benefit of tms treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) . to evaluate the benefit of daily, active, open-label tms in phase i subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) .

Eligibility criteria:
inclusion criteria: * primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features * duration of current episode of depression ≥4 weeks and ≤3 years * clinical global impression - severity of illness ≥ 4 * resistance to antidepressant treatment in a discrete illness episode * hamd24 item 1 ≥ 2 and total score ≥ 20 * subjects able to commit to protocol visit schedule * at the end of the baseline visit, subject must have a hamd24 score of ≥ 18 and change in score may not be ≥ 25% decrease from that seen at the screening visit exclusion criteria: * prior tms, vagus nerve stimulation (vns), or electroconvulsive therapy (ect) * contraindication to tms * cardiac pacemakers, implanted medication pumps, intracardiac lines * history of neurological disorder * unstable medical conditions * any psychiatric disorder, which in the judgement of the investigator may hinder the subject in completing the procedures required by the study protocol. * significant acute suicide risk * inability to locate and quantify a motor threshold * if sexually active female, not on an accepted method of birth control. * diagnoses of the following conditions (current unless otherwise stated): * depression secondary to a general medical condition, or substance induced: * seasonal pattern of depression as defined by diagnostic and statistical manual of mental disorders (dsm-5) * any psychotic disorder (lifetime), including history of schizophrenia, schizoaffective disorder, other psychosis, psychotic features in this or previous episodes, amnestic disorder, * intellectually disabled, * substance dependence or abuse within the past year (except nicotine or caffeine), * bipolar disorder, * obsessive compulsive disorder (lifetime), * post-traumatic stress disorder (lifetime), * eating disorder (lifetime).

Keywords: child depression depression transcranial magnetic stimulation adolescent major depressive disorder tms adolescent depression
effect of front-of-pack labels in ethiopia

Conditions: Cardiovascular Diseases

Summary: ethiopia is experiencing the type of rapid food system transformation that leads to a double burden of malnutrition and increased non-communicable diseases. front-of-pack labels on packaged foods are an emerging public health strategy with the potential to address non-communicable diseases by discouraging the purchase and consumption of products with high levels of nutrients of public health concern. the aim of this study is to evaluate and compare the effectiveness of front-of-pack labeling systems to reduce the intent to purchase unhealthy foods among adults in ethiopia. the study will recruit approximately 1200 adults using a street-intercept methodology. participants will be randomized to 1 of 4 arms to complete a survey in which the presence and type of front-of-pack label differs across survey arms and asked to rate participants' intent to purchase unhealthy packaged foods.

in 2017, cardiovascular disease was the leading age-standardized cause of death in ethiopia. the national prevalence of hypertension in ethiopia in 2015 is estimated to be 16% (gebreyes et al. 2018). urban diets are rapidly changing, but not becoming healthier (wolle et al. 2020). diet quality remains poor: only 2.4% of the national population meets the who recommendation of five servings of fruit and vegetables per day. the mean estimated salt intake of 8.3 g/day exceeds the who maximum recommended intake (challa et al. 2017). processed foods are penetrating the market at a rapid pace (melesse et al. 2019; stuckler et al. 2012). increasing income has increased demand for convenience foods (minten et al. 2018). ethiopia is experiencing the type of rapid food system transformation that leads to a double burden of malnutrition and increased non-communicable diseases (popkin 2017). front-of-pack labels on packaged foods are an emerging public health strategy with the potential to address non-communicable diseases by discouraging the purchase and consumption of products with high levels of nutrients of public health concern (croker et al. 2020). however, front-of-pack labels have not been tested in the ethiopian context. additionally, there are multiple types of front-of-pack labeling systems in use around the world, such as multiple traffic light/guideline daily amounts, the nutri-score system, and nutrient-specific warning labels. therefore, the study aims to to evaluate and compare the effectiveness of front-of-pack labeling systems to reduce the intent to purchase unhealthy foods among adults in ethiopia. the study will recruit approximately 1200 adults using a street-intercept methodology. participants will be randomized to 1 of 4 arms to complete a survey in which the presence and type of front-of-pack label differs across survey arms and asked to rate participants' intent to purchase unhealthy packaged foods.

Eligibility criteria:
inclusion criteria: * age ≥18 years * purchase foods outside of the household exclusion criteria: * age \<18 years * do not purchase foods outside of the household * unable to complete the survey protocol

Keywords: nutrition packaged food
risk factors for nausea and vomiting after cesarean

Conditions: Postoperative Nausea and Vomiting

Summary: investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors.

a single prospective cohort of women submitted to cesarean section who received spinal anesthesia will be assessed for the proposed risk factors and the incidence of nausea or vomiting will be observed during the first 48 hours.

Eligibility criteria:
inclusion criteria: * cesarean section indicated * spinal anesthesia indicated exclusion criteria: * cesarean section did not occur * spinal anesthesia was not provided * another spinal technique was added to spinal

Keywords: postoperative nausea and vomiting cesarean risk factors
heparin resistance: predictors and outcomes

Conditions: Off Pump Coronary Artery Bypass Surgery

Summary: the investigators evaluated clinical impact of reduced heparin responsiveness (hrreduced) on the incidence of perioperative myocardial infarction (mi) and restenosis at 6 months after off-pump coronary artery bypass graft surgery (opcab) and identified its predictors.


Eligibility criteria:
inclusion criteria: * enrolling all consecutive patients scheduled for elective isolated multivessel opcab between april 2007 and march 2008 exclusion criteria: * presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.

Keywords: heparin responsiveness off-pump coronary artery bypass graft surgery risk factors myocardial infarction