Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics with two new oral nicotine replacement products and nicorette® gum

Conditions: Tobacco Dependence

Summary: single-dose pharmacokinetics with two new oral nicotine replacement products and nicorette® gum.

the study is a single-dose, randomized, cross-over study. the investigational products will be given as single doses at separate visits. the product administrations comprise 30 minutes of chewing. periods without nrt, lasting for at least 36 hours, will separate treatment visits. before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. used gums will be collected and analyzed to determine the amount of remaining nicotine. subjects will also be monitored to capture any adverse events that may occur. treatment labels will be concealed from subjects and study personnel.

Eligibility criteria:
inclusion criteria: * healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and bmi between 17.5 and 30.0 kg/m2. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Keywords: smoking cessation, nicotine pharmacokinetics
effect of es-ketamine on postoperative delirium among old patients with lobectomy

Conditions: Postoperative Delirium

Summary: the purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy

this study aimed to investigate the effect of iv es-ketamine vs saline on the incidence of postoperative delirium. it was hypothesized that iv es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy

Eligibility criteria:
inclusion criteria: * 60 years old; there is no limit on the gender, asa (american society of anesthesiologists )ⅰ-ⅲ exclusion criteria: * emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week
fitness improvement in obese, pregnant women: an intervention trial

Conditions: Pregnancy; Obesity; Physical Activity

Summary: in pregnancy, the adoption or pursuit of a sedentary lifestyle contributes to the development of co-morbid conditions such as hypertension, maternal and childhood obesity, gestational diabetes, pre-eclampsia, cesarean section and delivery of large-for-gestational-age infants (lga). the aim of this study is to test the hypothesis that obese, pregnant women following a supervised moderate intensity physical conditioning program during the 2nd trimester of pregnancy will maintain a higher level of physical activity up to the end of pregnancy, as compared to women in the control group. we will also conduct a pilot study on the feasibility to examine the effects of the intervention on maternal fitness and neonatal anthropometry.

looking at the multiple needs of pregnant women with obesity, physical conditioning may offer a great opportunity to improve fitness and to decrease cardio-metabolic disturbances, to prevent excessive weight gain, to improve general health status, and to reduce health care utilization. furthermore, beneficial effects of fitness on adverse maternal health outcomes related to obesity might decrease the development of long-term obesity and metabolic repercussions in the offspring. the society of obstetricians and gynaecologists of canada (sogc) recommends that all women without contraindication be encouraged to participate in aerobic and strength-conditioning exercises as part of a healthy lifestyle during pregnancy. despite these recommendations, obese women are inactive during pregnancy and are currently still at high risk of poor physical fitness. thus, although exercise clearly improves maternal health status and thus potentially prevents adverse perinatal outcomes, obese pregnant women poorly adhere to experts' recommendations about the need for exercise during pregnancy. therefore, this situation justifies the need to develop adapted strategies aimed at increasing the implementation of guideline recommendations in this population.

Eligibility criteria:
inclusion criteria: * pregnant women 18 years or older * single pregnancy * delivery at centre hospitalier universitaire de québec * pre-pregnancy bmi ≥30 kg/m2 exclusion criteria: * multiple pregnancy * diabetes or chronic hypertension prior to pregnancy * uncontrolled thyroid problems * exercise contraindications

Keywords: pregnancy obesity physical activity cardiorespiratory fitness muscular fitness weight gain fetal growth
hydroxychloroquine to prevent covid-19 disease amongst healthcare workers

Conditions: Corona Virus Infection

Summary: the objectives of provide are to: 1. determine if prophylactic once weekly hydroxychloroquine reduces the incidence of conversion from sars-2-covnasopharyngeal swab negative to positive 2. to determine if weekly prophylactic hydroxychloroquine reduced the severity of covid-19 symptoms 3. to determine the safety of taking weekly prophylactic hydroxychloroquine


Eligibility criteria:
inclusion criteria: * 18 years of age or older to participate. * healthcare workers with primary practice in intensive care unit, general internal medicine, * covid-19 testing centres, emergency rooms, and nursing homes. * covid_19 symptom free at the time of randomization and have a negative diagnostic swab. exclusion criteria: * known covid-19 positivity defined as: a laboratory confirmed case as defined by the local public health institutes * suspected covid-19 positivity defined as possessing symptoms consistent with covid-19 infections such as: headache, fever, nausea, vomiting, diarrhea, dyspnea, dry cough * healthcare workers with pre-existing retinopathy or serious visual problems * healthcare workers with known malignancies receiving active chemotherapy or immune modifying medications * healthcare workers with known autoimmune disorders * healthcare workers with known qt prolongation * history of ventricular arrhythmias * participants at risk of malignant arrythmias ○ at risk defined as: a sudden loss of consciousness with injury; anyone in their immediate family, under the age of 45year, with sudden cardiac death; anyone family history of long qt syndrome * known sensitivity/allergy to hydroxychloroquine * healthcare workers that are currently pregnant * healthcare workers that are already taking chloroquine or hydroxychloroquine * healthcare workers on colchicine or any other anti-viral medication * healthcare workers taking a medication that may interact with hydroxychloroquine (see table below * inability to take oral medications * inability to provide written consent * known g6pd deficiency
detection of acid sphingomyelinase/ceramide pathway activation in radiotherapy patients using intravoxel incoherent motion (ivim) diffusion-weighted magnetic resonance imaging and serum biomarkers

Conditions: Metastatic Disease to Bone; Metastatic Disease to Soft Tissue

Summary: the purpose of this study is to find out if special blood tests and imaging scans can help evaluate the effects of the radiation the patient receives as part of standard treatment. the patient will undergo either stereotactic or conventional radiation treatment as determined by the treating doctor. previous evidence suggests that blood flow to tumors is affected by the amount (dose) of radiation that it receives. this effect may be seen as soon as 1-2 hours after the radiation is given. this study will evaluate if these changes can be seen and measured by performing a special type of scan called intravoxel incoherent motion (ivim) diffusion-weighted magnetic resonance imaging (mri) and a blood test. ivim mri is a research exam which is similar to a standard mri exam, with only a slight difference in the technical parameters used to acquire the images.


Eligibility criteria:
inclusion criteria: * histologically proven cancer * patients deemed clinically appropriate for radiation treatment as part of the standard care provided by their treating physician, and will receive either 24 gy (one fraction) or 3 gy x 10 fractions. * life expectancy \> 6 months * kps\>60% * age ≥ 18 years old. exclusion criteria: * pregnant patients * patients who are unwilling or unable to undergo mri including patients with contraindications to mri such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc * prior radiotherapy to the site of intended treatment * patients with tumor involving brain or spinal cord * platelet count \<75,000/μl, hgb level \<9 g/dl, wbc \<3500/μl * presence of metastases in the upper thoracic spine (in order to avoid dw- mri parameter measurement variability due to cardiac motion) * lesions \<1.5 cm (to assure robust measurements) * non-english speaking patients

Keywords: intravoxel incoherent motion (ivim) diffusion-weighted magnetic resonance acid sphingomyelinase/ceramide pathway activation 15-104
urinary tract dilations in prenatal and postnatal life

Conditions: Urinary Tract Dilatation

Summary: the goals of this study are to use a questionnaire survey to determine the state of awareness of the diagnosis and management of patients with urinary tract dilation across several medical professionals, to predict the severity of the postnatal course and surgical intervention in fetuses with urinary tract dilation detected during pregnancy, and to create a model of prenatal and postnatal care for patients with dilation of the urinary tract for multidisciplinary use.

currently, in slovakia, a multidisciplinary standard of health care for patients with dilation of the urinary tract is not present. prenatal diagnosis of anomalies of the urinary system includes the entire spectrum of anomalies, genetic diseases or anatomical deviations, which have a non-uniform classification and different terminology in a wide range of literature. therefore, prenatal diagnosis of these anomalies, as well as dilation diseases of the urinary tract, in different centers is different, often subjective and outdated. however, some findings on the urinary tract, even with regard to the sex of the fetus, require great attention, defining the degree of severity and precisely targeted management, the task of which is to prevent serious complications in postnatal life. dilative diseases of the urinary tract may not be clinically obvious after birth, but in the long term, if they are not detected, serious and irreversible kidney damage may occur. the goals of this study are therefore 1. to confuse the current situation in the multidisciplinary medical sector regarding the issue of dilations of the urinary tract; 2. in the conducted study to identify fetuses with such a degree of dilation of the urinary tract (according to the utd classification from 2014) that requires stricter management in the prenatal and postnatal period and which are at high risk of surgical intervention postnatally and 3. subsequently create a model of health care for multidisciplinary cooperation for a patient with dilation of the urinary tract.

Eligibility criteria:
inclusion criteria: * singleton pregnant women whose fetuses were diagnosed with dilation of the urinary tract as an isolated us finding before the 28th week of pregnancy. fetal patients with subsequent us control in the third trimester after the 28th week of pregnancy. * newborns and children with prenatally diagnosed utd, which, depending on the severity, required a postnatal examination by a pediatric nephrologist within a month after birth and then in his follow-up up to 6 months after birth. exclusion criteria: * multiple pregnancies * urinary tract dilation in fetuses diagnosed in the third trimester * associated anomalies in fetuses * aneuploidy * newborns and children monitored by someone other than a selected pediatric nephrologist patients who were lost from follow-up

Keywords: prenatal diagnosis prenatal ultrasound
noninvasive ultrasound assessment of detrusor dysfunction

Conditions: Bladder Dysfunction; Overactive Bladder; BPH With Urinary Obstruction

Summary: the purpose of this study is to test a new ultrasound method called quantitative ultrasound bladder vibrometry to detect abnormal bladder function.

the purpose of this study is to evaluate the effectiveness of quantitative ultrasound bladder vibrometry (qubv) as a noninvasive tool for detrusor overactivity assessment and for benign prostatic hyperplasia (bph) treatment selection. participants in this study will have a qubv ultrasound performed at the same time as a urodynamic study that had been ordered as part of their regular clinical care.

Eligibility criteria:
inclusion criteria: * aim1: age \>18 scheduled to undergo uds for their clinical care for one of the included diagnoses. -aim2: inclusions: age \>45 scheduled to undergo selective photovaporization of the prostate. exclusion criteria: * aim1:obesity (bmi \>35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as for uterine or colorectal cancer), prior bladder surgery (including prostate resection), and pregnant or breast-feeding women. * aim2:obesity (bmi \>35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as colorectal cancer).

Keywords: detrusor pressure bladder compliance ultrasound ultrasound vibrometery
ctsi-ipad for vented patient communication

Conditions: Respiratory Failure

Summary: this study will enroll 75 mechanically vented adults in the icu to compare self-reported ease of communication, patient satisfaction, and patient anxiety and frustration levels between a group using a communication application on an ipad and a group using standard methods of communication while mechanically vented.

the investigators will randomize patients to either an ipad application available for communication or usual care. an existing ipad communication application (proloquo2go) that allows picture or text to voice communication was tailored to needs of adult mechanically ventilated (mv) patient. in the tailored application, common messages for an adult mv population are depicted on picture tiles organized into folders. when patients touch a picture tile either additional message options appear or a phrase or word is spoken by the device. access to a pop-up keyboard on each screen allows patients to easily type unique text to voice messages. intervention: patients will be randomized to either an ipad with the tailored communication application or usual care. patients randomized to the ipad group will be given a brief introduction to the communication application and then will be asked to communicate four messages to verify understanding. patients who are unable to successfully use the ipad with the initial introduction will remain in the study. research staff will continue to assist the patient daily and a speech language pathologist will be consulted to facilitate the patients ability to use the device. the ipad will remain at the bedside to be used for communication as desired for the remainder of the time the patient is on the ventilator. a manual providing instruction for the ipad and application operation will be at the bedside of all patients randomized to the intervention group. research staff will visit patients daily to assist with any problems encountered and will also be available by phone to assist as needed. although patients will be encouraged to use the ipad for communication, use of other strategies or tools will not be restricted.

Eligibility criteria:
inclusion criteria: 1. sufficient motor and visual function to allow use of touch screen 2. mechanically ventilated 3. awake and able to participate in informed consent discussion exclusion criteria: 1. non-english speaking 2. receiving ventilator support prior to admission. 3. delirium present in the last 24 hours 4. tracheostomy 5. structural neurological injury (such as stroke or traumatic brain injury) 6. coma 7. deep sedation (richmond agitation scale \> -2)
evaluation of the h-coil transcranial magnetic stimulation (tms) device in the treatment of bipolar depression

Conditions: Bipolar Depression

Summary: this study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the h-coil deep tms device in bipolar depression.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar depression exclusion criteria: * no other axis i disorder * risk factors for convulsions
the anti-snoring bed

Conditions: Snoring

Summary: habitual snoring is a widespread complication. most snorers snore predominately when sleeping in supine position. therefore, therapeutic interventions force snorers to avoid supine position. devices that restrict the sleeping position or raise alarms when the user obtains the supine position cause discomfort or disrupt sleep resulting in low compliance. therefore, anti-snoring mechanisms, which lift the trunk of the user without disturbing sleep, have been proposed. we set out to investigate whether individual interventions provided by beds with lifting mechanisms are able to stop snoring within three minutes (success rate) and whether the bed reduces the snoring index (number of total snores divided by total time in bed). in addition, we investigat whether the trunk elevation provided by the bed is interfering with the subjective sleep quality assessed using the groningen sleep quality score. subjects are observed for four nights (adaptation, baseline, and two intervention nights). during intervention nights, the bed lifts the trunk of the user in closed-loop manner. subjects are divided in three groups (non-snorers, snorer group one, and snorer group two). non-snorers are lifted by the bed at random time points during the night. in snorer group one, a stepwise increase of the bed inclination is compared with going directly to a randomly selected angle. in snorer group two, the influence of a small inclination angle (10°) and a big inclination angle (20°) is compared..


Eligibility criteria:
inclusion criteria: * none exclusion criteria: * pregnancy * previously diagnosed sleep-related breathing disorders * chronic lower back pain * heart insufficiency that might impede sleeping in supine position * inability to follow the procedures of the study, e.g. due to language problems
pain after insufflation for robotic sacrocolpopexy (pairs) trial

Conditions: Pelvic Organ Prolapse

Summary: this study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. subjective pain and narcotic usage after surgery will be measured.

this is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. each surgery will be performed by a board-certified female pelvic medicine \& reconstructive surgery (fpmrs) surgeon with a standard technique other than pneumoperitoneum level. a sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. patients will be stratified by hysterectomy prior to randomization. postoperatively, patients will be evaluated with a visual analogue scale (vas) as well as prescribed narcotic analgesic use and followed up to 2 weeks.

Eligibility criteria:
inclusion criteria: * scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse. * age 18-90 years * can read and understand the consent form and consents to the procedure exclusion criteria: * patients undergoing other procedures * patients who do not consent to participate.

Keywords: sacrocolpopexy pneumoperitoneum postoperative pain
role of inflammatory markers and doppler parameters in late-onset fetal growth restriction: a machine learning approach

Conditions: Fetal Growth Restriction; Inflammatory Response

Summary: fetal growth restriction (fgr) is a serious complication in pregnancy that can lead to various adverse outcomes. it's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. the study focuses on the role of inflammation in fgr, introducing new blood markers for better understanding and diagnosis. it also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict fgr based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges.

fetal growth restriction (fgr), also known as intrauterine growth restriction, is a prevalent pregnancy complication with potentially negative outcomes for newborns. the condition's causes are varied, involving genetic factors, maternal inflammation, infections, and other pathologies. fgr is categorized based on its onset: early-onset fgr occurs before 32 weeks' gestation, while late-onset happens after 32 weeks. late-onset fgr, though less risky in perinatal complications compared to early-onset, is linked to an increased risk of hypoxemia and neurodevelopmental delays. diagnosis primarily relies on ultrasound measurements and doppler flow analysis of specific arteries. the study highlights the complexity of diagnosing and managing late-onset fgr, emphasizing the unclear pathophysiological mechanisms. it proposes the exploration of inflammatory processes and the potential role of new markers such as the systemic immune inflammation index (sii), systemic inflammatory response index (siri), and neutrophil-percentage-to-albumin ratio (npar) for understanding fgr. these markers are easily measured through blood tests and are significant in various diseases. the text also discusses the challenges of applying advanced diagnostic methods in low-income countries due to the need for sophisticated equipment, contrasting with the accessibility of artificial intelligence and machine learning models via the internet. the study aimed to assess the impact of inflammatory processes on late-onset fgr by analyzing npar, along with other markers, and evaluating their predictive value using machine learning algorithms.

Eligibility criteria:
inclusion criteria: * between the ages of 18-45 * completed their pregnancy follow-up in our center * pregnant women whose data can be accessed * singleton pregnancies without systemic maternal comorbidities other than fgr exclusion criteria: * multiple pregnancies * having a maternal disease * fetal congenital and chromosomal anomalies * chronic drug use, alcohol and cigarette use * accompanying additional pregnancy complications during follow-up * cases whose data cannot be accessed

Keywords: fetal growth restriction inflammatory markers machine learning algorithms