Kornimate/medical-research-clean huggingface dataset:
early total enteral feeding versus convention enteral feeding in preterm infants 27-32 weeks of gestation

Conditions: Very Preterm Maturity of Infant; Enteral Feeding Intolerance

Summary: the objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (etef) with those started on conventional enteral feeding (cef).

enrolled participants will be randomly assigned to one of two study groups: 1) early total enteral feeding (etef) or 2) conventional enteral feeding (cef). regardless of study group assignment, mother's own breast milk (mom) is the feed of choice and donor human milk is being offered if the mom is not enough to complete the intervention as assigned intervention group: feeds will be initiated with a target volume of 80 ml/kg/day starting within the first two hours after birth. volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5. control group: this group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as total parenteral nutrition. volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.

Eligibility criteria:
inclusion criteria: preterm neonate with gestational age of 27-32 weeks exclusion criteria: 1. antenatally diagnosed gi malformation 2. baby born with absence or reversal of end diastolic flow on antenatal umbilical artery doppler. 3. presence of major congenital anomalies at birth 4. need of vasopressor support at the time of randomization 5. requiring positive pressure ventilation \> 60 sec with apgar score \< 4 at 1 minute
n-acetylcysteine effects on tetrahydrocannabinol

Conditions: Healthy

Summary: the overall purpose of this study is to examine the effect of n-acetylcysteine (nac) on the acute effects of delta-9-tetrahydrocannabinol (thc). this will be tested by pretreating healthy individuals with nac and then assessing their responses to thc.


Eligibility criteria:
inclusion criteria: * exposed to cannabis at least once in lifetime exclusion criteria: * cannabis naive * individuals with a documented allergy to n-acetylcysteine

Keywords: cannabis marijuana thc n-acetylcysteine psychotic disorders
clinical evaluation of a test for monitoring the recurrence of bladder cancer

Conditions: Bladder Cancer

Summary: the objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. the study is conducted at locations within and outside of the united states. testing is performed on urine specimens provided by eligible enrolled patients. results from this study will not be used for patient management decisions.


Eligibility criteria:
inclusion criteria: * subject is ≥ 40 years of age * subject has provided documented informed consent as required by the reviewing irb or ec. experimental bill of rights will be documented for all subjects enrolled in applicable states. * subject is considered disease positive within 12 months (365 days) of enrollment. * at the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen. * subject has agreed to provide at least 60 ml of voided urine for study purposes at the enrollment visit. * subject has agreed to provide at least 60 ml of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the longitudinal cohort. * any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. for each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled. exclusion * subject has been previously enrolled into the study. * urine specimen to be used for study purposes is from the first morning void. * subject has had an excision procedure within six weeks (42 days) of enrollment. * the subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment.
respiratory quotient in post roux-en-y gastric bypass patients

Conditions: Morbid Obesity

Summary: through the values of respiratory quotient (rq) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. experimental and clinical studies have shown that after roux-en-y gastric bypass (rygbp) there is a decrease in the values of rq, which may be associated with increased lipid oxidation in the postoperative period. diet induced thermogenesis (dit) is an important part of total energy expenditure. we would like to know how it functions among rygbp patients. the purpose of this study is to evaluate the rq and dit of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.


Eligibility criteria:
inclusion criteria (bariatric patients post-op) * with more than 1 year after surgery * consent given to participate exclusion criteria: * pregnant women * malnourished patients (anemia) * tiroid disorders without treatment

Keywords: respiratory quotient fat oxidation morbid obesity bariatric bariatric surgery
comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

Conditions: Total Hip Replacement; Coxarthrosis

Summary: the main objective of the study is to compare the use of single-use ancillary reaming material during total hip replacement and conventional reusable ancillary reaming material. the assessment will focus on the medico-economic differences found in this prospective randomized study

in orthopaedics, the ancillary equipment is a generic term that includes all the instruments necessary for hip replacement surgery. the surgeon remains very dependent on these boxes of instruments, including rasps, reamers and trial implants (stems and trial heads), which are required in thr. each instrument set is generally packaged in 2 or 3 boxes and each surgeon has a limited number of instrument sets at his disposal per operating day. each ancillary device has a purchase cost, a maintenance cost (paid by the laboratories or distributors) and a sterilization cost, (paid by the health care institutions). single-use reamers are instruments that are used on a single patient and then discarded. performance and safety of use are optimized by providing a sterile and new product for each use. therefore, it seems judicious to compare the medico-economic differences between the use of single-use reamers versus reusable reamers within a classic ancillary. this study will compare the costs incurred, the waste produced, the operating time, the satisfaction of the surgeon after the use of single-use reamers during total hip replacement, versus conventional re-sterilizable ancillary and verify the equivalence, three months after surgery, of clinical and radiological results.

Eligibility criteria:
inclusion criteria: * - patient, male or female, over 18 years of age, eligible for a first-line total hip replacement for isolated coxarthrosis * patient registered to the national health system * patient able to understand information about the protocol and answer to questionnaire exclusion criteria: * pregnant, breastfeeding or potentially pregnant woman * major disability * history of hip replacement surgery * any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research. * morbid obesity as defined by body mass index (bmi) \>40 kg.m-2 * history of recent infection at the surgical site * surgical contraindication * refusal to participate

Keywords: prospective randomized study medico-economic sterilization single use reamer ancillary
clonidine versus phenobarbital as adjunctive therapy for neonatal abstinence syndrome

Conditions: Neonatal Abstinence Syndrome

Summary: the purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (nas).


Eligibility criteria:
inclusion criteria: * infants greater than or equal to 35 weeks gestation age * admitted to the neonatal intensive care unit * failed monotherapy with morphine sulfate therapy exclusion criteria: * neonatal abstinence syndrome due to iatrogenic causes * unable to take oral medications at any point during their treatment * infants in the custody of the department of child protective services with no legal guardian identified at the time of enrollment
study on metabolic parameters of sertindole in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on metabolic parameters and syndrome in patients with schizophrenia.

the prevalence of metabolic syndrome is estimated to be around 20-25% of the population and is particularly high in patients with schizophrenia. individuals with metabolic syndrome are twice as likely to die from, and three times as likely to suffer from a heart attack or stroke compared to individuals without the syndrome. patients on atypical antipsychotic medication should be considered a high risk group for diabetes and cardiovascular disease. weight gain is common in patients taking neuroleptics and atypical antipsychotics, and excessive body weight is a risk factor for type 2 diabetes.

Eligibility criteria:
inclusion criteria: * patients with schizophrenia * participation in 11286 study * capable of completing all study-related activities for the duration of the study

Keywords: schizophrenia
intranasal fentanyl for pain management

Conditions: Trauma; Pain

Summary: goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of fentanyl versus the reduction in pain achieved from intravenous fentanyl. it is hypothesized that pain should be reduced following fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.

currently, pre-hospital providers have the ability to administer analgesia to patients through only intravenous routes. often times patients have been exposed to the elements, present with poor anatomy, or are in such a position that makes establishing intravenous impractical or impossible. the lack of delivery method than prevents the patients from receiving humane and indicated pain medication. in patients who access is achieved, they are first subjected to a painful procedure that often will be repeated within twenty-four hours by most hospital policies and than subjects them to potential infection risk, being often times in less than aseptic conditions. the goal of the study will be to test the method of administration of pain medication using atomization through an intra-nasal route as compared to the current standard of drug administration intravenous. the medication to be administered will be fentanyl, a previously established and approved pre-hospital analgesic medication. as with any drug there are potential risks associated with unknown side effects or allergies, the risk would not be enhanced given the use of a different delivery device. specific risks associated with the use of this delivery route would include but not be limited to potential soft tissue injuries, epistaxis, and aspiration the study will measure reduction in pain following the delivery of atomized fentanyl via intra-nasal administration as compared with intravenous. we will ask participants to quantify their pain using the wong-baker faces pain scale (previously established valid instrument of pain assessment) and assign a number to the pain they are feeling. the drug will than be administered using the atomizer and two subsequent reports of pain using the same scale will be taken along with vital signs.

Eligibility criteria:
inclusion criteria: * persons who meet the current state of michigan county of oakland and county of genesee pre-hospital pain requiring analgesia. * examples of these patients would be those with fractures, kidney stones, or traumatic injuries, burns. exclusion criteria: * patients who have compromised nasal pharynx such as those who have obvious fractures or epistaxis. * additionally patients who are in the supine position for cervical spine immobilization will be excluded.

Keywords: pre-hospital intra-nasal fentanyl patients requiring analgesia
longitudinal tracking and intervention platform for medicare advantage patients

Conditions: Frailty

Summary: this study investigates whether a health tracking platform improves an elderly person's health with regards to frailty over the course of a year. secondary research questions examine which instruments are the best predictors of frailty to improve preventative measures in the future.

all patients presenting to the annual wellness visit at stanford hospital will be considered for this study. eligible who consent will be asked to conduct several activities, which will be video taped and timed. the activities include: * timed up and go: patients will be asked to rise from a chair and walk 10 feet (3 m), turn, walk back to the chair, and sit down. * quickdash tasks: open a jar, carry a shopping bag, cut food with a knife, wash back, wash a wall, and hammer a piece of wood. * koos jr tasks: go up/down stairs, stand upright * promis pf tasks: lift heavy object repeat x5, shoelace or buttons, wash hair patients will then be asked to complete a survey consisting of a number of validated questionnaires used to collect patient reported outcome measures and assess frailty. patients will be randomly assigned to one of two conditions, the control condition or the frailty wellness platform condition. patients assigned to the frailty wellness platform condition will be given an orientation to a health tracking program. they will be asked to fill out the questionnaires at 3 separate time points on the program site (accessed via phone or computer) at 3 months, 6 months, and 9 months, following orientation. one year later, at the patient's second annual wellness visit, the patient will be asked to fill out the health risk assessment and the study will conclude.

Eligibility criteria:
inclusion criteria: * geriatric patients \>65 years of age exclusion criteria: * none
the study for the "cervical cancer screening and treatment algorithms study using hpv testing in africa"

Conditions: HPV Infection

Summary: the main objectives of cesta are (1) to compare the efficacy of two cervical cancer screening algorithms: hpv test followed by visual inspection with acetic acid (via) and treatment (hpv + via + treat) and hpv test followed by immediate treatment (hpv + treat). the study will be conducted to address its objectives in women living with hiv (from now on called hiv positive women); and 2) to evaluate the performance of other techniques for primary screening and as triage for hpv positives wlhiv. 1,500 women living with hiv wlhiv will be recruited from hiv care clinics, also called antiretrovirals (arv) clinics in south africa. after giving informed consent, women will be screened with hpv testing and those that have a hpv positive test will be randomized at a 4:1 ratio into hpv + via + treat (arm 1) and hpv + treat (arm 2). women in arm 1 will receive via and only positive for via will be treated. in arm 2, all hpv positive women will be treated. women that are eligible for ablative treatment will be randomized into treatment with ta or cryotherapy in both arms. others will be referred to colposcopy. after via in arm 1 or before treatment in arm 2, the nurses will collect 2-4 biopsies on all hpv positive women. the biopsies will be used as gold standard for disease detection. treated women will be called by telephone after 1 week and 1 month to assess side-effects and satisfaction with the procedures. cervical samples from women will be tested with hpv dna test and hpv mrna test to evaluate different screening tests for wlhiv. all women with a positive hpv test (treated or not) will be called back after 1 year for a follow-up visit. at this visit, women will be screened with hpv testing and via and 2-4 colposcopy-directed biopsies will be taken from all hpv positive women. women with remaining/recurrent cin2+ disease will receive appropriate management.


Eligibility criteria:
inclusion criteria: * willing to disclose hiv status * hiv negative women aged 30-54 years; hiv positive women aged 25-54 years * mentally competent to give informed consent * physically able to have a pelvic exam exclusion criteria: * women reporting no previous sexual activity * history of cervical cancer * treatment for cervical precancer in the last six months * hysterectomy * pregnancy * serious pre-existing medical conditions (e.g. history of bleeding disorders, serious physical or mental disease)

Keywords: via triage hiv serostatus
study to assess the efficacy and safety of bdp hfa nasal aerosol in patients 12 years and older with sar

Conditions: Seasonal Allergic Rhinitis; Hayfever

Summary: this is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with sar.


Eligibility criteria:
key inclusion criteria: * male or female patients 12 years of age and older, as of the screening visit (sv). * general good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study. * a history of sar to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study screening visit (sv). the sar must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period. * a demonstrated sensitivity to relevant tree/grass pollen known to produce sar through a standard skin prick test. a positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. documentation of a positive result within 12 months prior to screening visit (sv) is acceptable. * other criteria apply key exclusion criteria: * participation in any investigational drug study within the 30 days preceding the screening visit (sv) or planned participation in another investigational drug study at any time during this study. * history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the sv). * history of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (sars)\] within the 14 days preceding the screening visit (sv), or development of a respiratory infection during the run-in period. * use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the screening visit (sv) and/or plans for use during the entire treatment duration. * other criteria apply

Keywords: seasonal allergic rhinitis hayfever
ketamine-enhanced prolonged exposure therapy in ptsd

Conditions: PTSD

Summary: the purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of posttraumatic stress disorder (ptsd) among veteran receiving prolonged exposure therapy.

in this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (pe) therapy for ptsd. veterans who meet criteria for ptsd and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus pe vs ketamine plus pe). participants receive the study drug via intravenous infusion once per week for 3-weeks.

Eligibility criteria:
inclusion criteria: * male or female veterans between the ages of 18 and 75 years * diagnosis of ptsd * ability to provide written informed consent exclusion criteria: * females who are currently pregnant or breastfeeding * current high risk for suicide * history of moderate/severe head injury * history of psychosis * current episode of mania/hypomania * severe substance and/or alcohol use disorder in the last 6 months

Keywords: post-traumatic stress disorder
quality initiative to improve glucose control in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: the goal of the twine / university of michigan diabetes quality improvement initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (cgm) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria: * michigan medicine patient treated by a physician in the family medicine department at the chelsea health center * diagnosis of t2d as recorded in the patient's problem list or as documented by medication list and lab results * hba1c \>8 for the high-risk sub-cohort exclusion criteria: * individuals for whom tight control (ie a1c \< 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition * individuals with cognitive or psychological diagnoses that might make cgm or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia * women who are pregnant or breast feeding * individuals who had previous bariatric surgery
a study in healthy men to test whether esomeprazole influences the amount of bi 3000202 in the blood

Conditions: Healthy

Summary: the main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of bi 3000202 in plasma.


Eligibility criteria:
inclusion criteria: 1. healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests 2. age of 18 to 55 years (inclusive) 3. body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) 4. signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial exclusion criteria: 1. any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator 2. repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 bpm 3. any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.