Kornimate/medical-research-clean huggingface dataset:
thermic effect of feeding in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the investigators propose to assess the contributions of the thermic effect of food intake (tef), which is the amount of energy expended to digest food, to overall energy expenditure in cystic fibrosis (cf).

total energy expenditure (tee) is comprised of the following components: resting energy expenditure (ree), thermic effect of food intake (tef), adaptive thermogenesis (at). the thermic effect of food is the amount of energy expended to digest food, and can be affected by factors such as protein / fat / carbohydrate contents of meals or the amount of time over which a meal is consumed. the investigators propose to assess the contributions of the thermic effect of food intake (tef), which is the amount of energy expended to digest food, to overall energy expenditure in cf. participants will be assigned to either a high fat liquid meal or a high protein liquid meal and assessed for components of energy expenditure in the whole room indirect calorimeter (metabolic chamber); participants will then be crossed over to the alternate liquid meal type, and differences in resting and total energy expenditure and the thermic effect of food will be assessed between the two types of meals.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cystic fibrosis by cystic fibrosis foundation-established criteria * being followed at the vcu (virginia commonwealth university) adult cystic fibrosis center * pulmonary and overall health status at baseline as assessed by pulmonary function testing and screening labs (complete blood count, liver enzymes, cholesterol, hga1c). criteria for baseline status are established for each individual patient as part of routine cf pulmonary care. * ability to understand the study procedures and to comply with them for the entire length of the study exclusion criteria: * experiencing any signs or symptoms consistent with a pulmonary exacerbation (a decline in pulmonary function testing from baseline, recorded as part of routine cf care) * undergoing treatment for a pulmonary exacerbation with a change in antibiotics or steroids from their baseline medications * tobacco users * pregnancy
reproductive function and mood in women with bipolar disorder

Conditions: Bipolar Disorder; Mental Health

Summary: this study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder.

bipolar disorder is a serious condition that can have devastating effects on social and psychological functioning. evidence suggests that medications for bipolar disorder may influence reproduction function among women. this study will determine reproductive function and mood changes in women who are currently on medication for bipolar disorder. this study will comprise women with bipolar disorder and age- and body mass index (bmi)-matched healthy controls. participants will have their reproductive function and mood changes assessed for 3 consecutive menstrual cycles. daily, participants will report about their mood, sleep patterns, life events, and any psychiatric medications; this information will be entered into a computerized system named chronorecord. in addition, participants will measure their basal body temperature and collect their urine every morning to assess for ovulation. blood collection will occur at study entry and between days 3 and 6 of every menstrual cycle to determine levels of reproductive hormones. participants will be asked to fast for 12 hours prior to every blood collection. during the first month of the study, an extra study visit will occur. participants will undergo a physical exam for determination of excessive hair growth (hirsutism) and bmi. additionally, insulin resistance will be measured, and participants will be asked to complete a questionnaire that will be used to determine their past and current menstrual function, as well as the reproductive and psychiatric history of their families.

Eligibility criteria:
inclusion criteria for all participants: * have been menstruating for at least 4 years prior to study entry * participants must be willing to travel to stanford university at own expense for study visits inclusion criteria for bipolar disorder participants: * participants should have a diagnosis of bipolar i, bipolar ii, or bipolar not otherwise specified (nos), and be under the treatment of a physician who can be contacted in case of an emergency * current treatment with any mood-stabilizing agent for a period of at least 3 months (e.g., divalproex sodium, lithium, other mood stabilizer, or atypical antipsychotic) inclusion criteria for healthy controls: * no past or present diagnosis of mental illness exclusion criteria for all participants: * current alcohol or substance abuse or dependence within 6 months prior to study entry * meets criteria for another dsm-iv axis i disorder * contraceptive steroid use within 3 months prior to study entry * current use of medication that may affect steroid metabolism * menopausal * endocrine disease such as diabetes or hypothyroidism * uncontrolled medical illness * history of long-term corticosteroid use * organic mood disorder * pregnancy or breastfeeding within 3 months prior to study entry

Keywords: women mood menarche menstruation
the efficacy and safety of ckd-501 added to d150 plus d759 therapy in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: the purpose of this study is to prove that the group treated with ckd-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

the aim of this phase 3 study was to evaluate the efficacy and safety of additional combined ckd-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of d150 and d759

Eligibility criteria:
inclusion criteria: * between 19 years and 80 years old(male or female) * type 2 diabetes mellitus * the patient who has been taking oral hypoglycemic agent at least 8weeks with hba1c 7 to 10% at screening test * bmi between 21kg/m2 and 40kg/m2 * c-peptide ≥ 1.0 ng/ml * agreement with written informed consent * hba1c 7 to 10% after run-in period exclusion criteria: * type 1 diabetes mellitus or secondary diabetes mellitus * continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening * treatment with thiazolidinedione(tzd) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with tzd, biguanide * chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening * treatment with anti-obesity drugs within 3 months
pet scan as a screening tool for liver transplant in patients with hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: this study aims at testing the utility of pet scan as a screening tool for liver transplantation in patients with hepatocellular carcinoma. patients being worked up for liver transplant for hepatocellular carcinoma will undergo a pet scan and will be followed until 2 years after transplantation. at that time survival data will be analysed according to pet scan results to determine if it can be used to predict outcome.


Eligibility criteria:
inclusion criteria: * male or female patient over 18 years of age * diagnosis of hcc confirmed by histology if available or by two imaging modalities * able to give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. exclusion criteria: * unable to give consent to the study * unable to undergo a pet scan

Keywords: transplant
educational intervention for optimizing adolescent mental health screening and treatment in pediatric residency

Conditions: Mental Health

Summary: the purpose of this study is: 1) to assess pediatric resident knowledge of adolescent mental health; 2) to assess pediatric resident comfort level for screening, assessing, and treating mental health disorders in adolescents, and; 3) to evaluate pediatric resident current practices for adolescent mental health screening, assessment, and treatment.


Eligibility criteria:
inclusion criteria: * pediatric residents * adolescent rotation exclusion criteria: * none

Keywords: pediatric resident depression screening substance abuse pediatric resident knowledge of mental health topics pediatric resident current practices for screening and treating mental health disorders pediatric resident mental health care competency
persistent pain after cesarean delivery - a danish multicenter cohort study

Conditions: Cesarean Section Complications; Cesarean Section; Cesarean Delivery; Persistent Pain; Chronic Pain; SMS; Questionnaire

Summary: in denmark, around 12,700 patients undergo cesarean delivery (cd) annually, constituting approximately 20% of all childbirths in the country. worldwide, the number is increasing each year, with more than 20 million cd performed annually. postoperative pain after cd is typically moderate to severe in intensity and still constitutes a significant challenge, balancing effective pain relief and potential side effects. correlations between moderate to severe acute pain and the development of persistent pain after cd is still unclear. postsurgical persistent pain is a significant, often unrecognized clinical problem that causes distress and diminishes the quality of life for patients. despite advances in understanding the factors contributing to persistent postsurgical pain and an increased focus on identifying patients at risk, the management and prevention of postsurgical persistent pain are still inadequate. it is important to gain further insights into this population, and we have a unique opportunity to do so by following the national cohort from the ongoing danish multicenter cohort study on pain after cesarean section (clinicaltrials.gov identifier: nct06012747) over an extended follow-up period. this involves continued prospective registration of patient-reported outcome measures (prom) collected by sms-based questionnaires in the months and years after the cd, thereby investigating the occurrence of both acute and persistent pain after cd. the outcomes are focused on pain levels, the impact of pain on physical function and neuropathic pain characteristics in the months and years following the cd. the study also aims to explore the relationship between persistent and acute pain.

the study protocol is attached in full-text (study documents).

Eligibility criteria:
inclusion criteria: * patients who, after participating in the danish multicenter cohort study on pain after cesarean delivery (clinicaltrials.gov identifier: nct06012747), consent to continue to receive questionnaires about persistent pain. * planned cesarean delivery in spinal anesthesia * patients who speak and read danish * patients with a smartphone that can receive an sms with a link to a questionnaire that can be opened online. exclusion criteria: • \<18 years of age

Keywords: persistent pain chronic pain danish cohort cesarean section cesarean delivery acute on chronic pain post operative pain sms questionnaire
development of a genetic counseling patient preference intervention for women at elevated risk for breast cancer

Conditions: Breast Carcinoma

Summary: this study develops a genetic counseling patient preference intervention for women at elevated risk for breast cancer. this study aims to develop an intervention that may deliver educational videos about breast cancer, heredity, multigene tests results and polygenic risk score, provide multigene and polygenic test results, obtain information about patients' questions/ concerns about test results to use in post-genetic test counseling, and determine patient preference (e.g. telephone) for receipt of post-genetic test counseling.

primary objective: i. develop the genetic counseling patient preference (gcpp) intervention in collaboration with community members. outline: participants attend a focus group over 90-120 minutes providing feedback on gcpp intervention.

Eligibility criteria:
inclusion criteria: * female * ages 35-64 * known elevated risk for breast cancer * the ability to speak and read english * provide written consent
accelerating cognitive gains from digital inverventions with noninvasive brain stimulation

Conditions: Aging; MCI

Summary: the overall goal of this project is to collect pilot feasibility and early efficacy data showing improvements in cognition and wellbeing in adults with mild cognitive impairment (mci) through a combination treatment of non-invasive brain stimulation (transcranial alternating current stimulation (tacs)) and a one of two digital cognitive interventions.


Eligibility criteria:
comfortably ambulatory healthy physical condition normal or corrected to normal visual auditory acuity fluency in spoken english between 60-85 years old no neurological or psychiatric disorders no substance abuse not taking anti-depressants not taking anti-anxiety medication no history of seizures no color blindness no glaucoma no macular degeneration no amblyopia (lazy eye) no strabismus (cross eyed) aneurysm clip(s) no cardiac pacemaker no implanted cardioverter defibrillator (icd) no electronic implant or device no magnetically-activated implant or device no neurostimulation system no spinal cord stimulator no internal electrodes or wires no bone growth/bone fusion stimulator no cochlear, otologic, or other ear implant no insulin or other infusion pump no implanted drug infusion device no type of prosthesis (eye, penile, etc.) no heart valve prosthesis no eyelid spring or wire no artificial or prosthetic limb no metallic stent, filter, or coil no shunt (spinal or intraventricular) no vascular access port and/or catheter no radiation seeds or implants no swan-ganz or thermodilution catheter no medication patch (nicotine, nitroglycerine) no metallic fragment or metallic foreign body in/on the body that can not be removed no wire mesh implant no tissue expander (e.g., breast) no surgical staples, clips, or metallic sutures no joint replacement (hip, knee, etc.) no bone/joint pin, screw, nail, wire, plate, etc. no iud, diaphragm, or pessary no dentures or partial plates that can not be removed no tattoo or permanent makeup no body piercing jewelry no claustrophobia

Keywords: healthy aging cognitive decline prevention brain stimulation attention memory
study of bleeding with extended administration of an oral contraceptive

Conditions: Contraception

Summary: this is an non-comparative study. there is no statistical hypothesis. the effects of extension of treatment on bleeding will be recorded and described.


Eligibility criteria:
inclusion criteria: * healthy women * age 25-40 * history of regular cycles exclusion criteria: * current or recent (within 2 months) users of hormonal contraceptives * contraindications for use of hormonal contraception * conditions which affect the absorption or metabolism of steroid hormones * bmi \> 35

Keywords: contraception
sciatic nerve block for ankle and leg fracture manipulation in the emergency department

Conditions: Ankle Fractures; Leg Fracture

Summary: the goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at emergency departments for manipulation and temporary stabilization of distal leg and ankle fractures. the trial aims to assess: * the acceptability of sciatic nerve block * the technical feasibility of sciatic nerve block * the technical success of sciatic nerve block * the analgesic efficacy of sciatic nerve block in addition to that, this study aims to * describe patient-reported and physician-reported satisfaction * assess the adverse event rate at 48 hours post intervention


Eligibility criteria:
inclusion criteria: * age \>18 * confirmed radiological diagnosis of distal tibia fracture (group 43 according to ao classification, all subtypes included); or malleolar fracture (group 44 according to ao classification, all subtypes included); or distal fibula fracture (group 4f3 according to ao classification, both the two subtypes included); or any combination of the fracture patterns described * fractures requiring manipulation in the ed to achieve temporary stabilization either as manual reduction and cast immobilization; or calcaneal pin traction (as per local policy or treating physician's preference) * capacity to understand the aim of the study, the potential benefits and harms of the proposed intervention * capacity to provide consent * capacity to provide a self-assessment of pain using the written vas scale exclusion criteria: * fractures that do not require any form of manipulation in the ed according to the treating physician (e.g., fractures with minimal or no displacement of the bony fragments, that are immobilized in a posterior leg cast by the nursing stuff/physicians assistants without any painful manipulations of the bony fragments performed by the physician) * open fractures * perisynthetic or periprosthetic fractures * distal leg/ankle fractures with neurovascular compromise * clinical signs of compartment syndrome * skin infection at the needle entry sites * diabetic neuropathy or any other known form of neuropathy that causes reduced sensation in the sciatic and/or femoral nerve territory * charcot-marie-tooth disease * known allergy to local anaesthetics or opioids * hemodynamic instability * known diagnosis of severe cognitive impairment * dementia and/or delirium (defined by a 4at score ≥ 2) * lack of capacity to provide consent and to understand the aim of the study * patient's refusal to participate in the study * bmi\>35 * body weight \< 40 kg
evaluation of the pharmacokinetics of nrl972 following pre-administration of rifampicin and cyclosporine

Conditions: Pharmacokinetics

Summary: a study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how nrl972 is processed within the body.


Eligibility criteria:
inclusion criteria: 1. males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception) 2. caucasian 3. age: 21 - 40 years 4. bw 50 - 100 kg 5. bmi 20 - 26 kg.m-2 6. healthy based on the pre-study examination 7. willing and able to provide informed consent exclusion criteria: general - all subjects 1. previous participation in the trial 2. participant in any other trial during the last 90 days 3. donation of blood during the last 60 days or a history of blood loss exceeding 300 ml within the last 3 months 4. history of any clinically relevant allergy (including hypersensitivity to the trial medications) 5. presence of acute or chronic infection 6. presence or history of any relevant co-morbidity 7. resting systolic blood pressure \> 160 or \ 95 or \< 50 mmhg 8. clinically relevant ecg-abnormalities, prolonged qtc with \> 450 msec in males and \> 460 msec in females in particular 9. presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes 10. positive serology for hbsag, anti hbc and anti hcv 11. positive hiv test 12. positive alcohol or urine drug test on recruitment (and upon admission) 13. history of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol 14. smoking more than 15 cigarettes/day or equivalent of other tobacco products 15. use of prohibited medication 16. suspicion or evidence that the subject is not trustworthy and reliable 17. suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard general - all females 18. positive pregnancy test 19. lactating 20. not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermacide gel\] should be used in addition).
efficacy and safety evaluation of ibi188 in combination with demethylating agents in treatment of patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the study is to evaluate safety, tolerability and composite cr of ibi188 plus demethylating agents in acute myeloid leukemia


Eligibility criteria:
inclusion criteria: 1. aml patients diagnosed according to who aml diagnostic criteria in 2016 (except m3-type and bcr-abl positive aml). 2. relapsed// refractory aml( ≥18 ys) or newly diagnosed elderly aml unfit for intensive chemotherapy( ≥60 ys). 3. age ≥18 years old, gender not limited. 4. ecog score of 0-2. 5. adequate organ function. exclusion criteria: 1. acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, cmml(accelerated phase and blast phase). 2. a history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) cytosis, chronic myelocytic leukemia) or acute myeloid white blood with bcr-abl1 translocation patients. 3. major surgery and vaccine treatment within 4 weeks. 4. uncontrolled concurrent diseases. 5. pregnant or breastfeeding female subjects.
a 3d hydrogel model to assess endothelial cell-macrophage interactions in simulated microgravity (or-drpd-sri2019)

Conditions: Cardiovascular Diseases

Summary: the proposal contained herein seeks to examine the effect of simulated microgravity on important cell-cell interactions that govern vascular health. the interest lies in endothelial cell (ec) and macrophage cell interactions. the investigators are proposing to first understand how microgravity effects the macrophage and ec function or pro-healing capabilities. next, the study team plans to develop a 3d tissue regeneration model in which macrophages and ecs are co-cultured in a hydrogel matrix. utilizing this model, the team will assess how microgravity influenced macrophage-ec interactions in 3d. the investigators will assess ec tubule volume (or blood vessel development), macrophage spreading and the interactions with endothelial tubule sprouts. this model will serve as a critical foundation for future grant opportunities as it allows the assessment of tissue regeneration and vascular health in a 3d tissue microenvironment

while some knowledge has been gained with regards to macrophage alterations during space travel, most of this work has been limited to macrophage cell lines and has not considered how the effects of microgravity alter macrophages' ability to stimulate tissue repair and regeneration. specifically, how the macrophage secretion profile and/or interaction with endothelial cells is altered during microgravity culture. given the extensive data showing the consequence of simulated microgravity to alter endothelial cells, and the mounting evidence that simulated microgravity affects macrophage cells, the investigators hypothesize that microgravity alters the functional response of macrophages in close association with endothelial cells. to test this hypothesis, the study team has established 2 specific aims: specific aim 1: assess the effect of simulated microgravity on endothelial and macrophage pro-healing states. specific aim 2: assess the effect of simulated microgravity on the pro-healing states of 3-dimensional co-cultured macrophages and endothelial cells. completion of the above described aims will lay a strong foundation of knowledge about the impact of simulated microgravity in important cell-cell interactions involved in tissue regeneration and healing

Eligibility criteria:
inclusion criteria: * self-reported healthy individuals * willingness to have 50mls of whole blood collected exclusion criteria: • unwillingness to have blood used in microgravity study

Keywords: macrophage microgravity blood cardiovascular disease