Kornimate/medical-research-clean huggingface dataset:
feasibility of using the cgm during toc from in persons with t2d using insulin

Conditions: Diabetes; Type 2 Diabetes

Summary: using the libre during the toc with persons with t2d will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. this study aims to assess this with inpatients using insulin.

integrating the use of the libre during the toc will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. inpatients admitted to the medical-surgical units would be considered based on the inclusion and exclusion criteria. if the patient qualifies they would be consented to participate in the trial. in addition they would be given a script for refills. primary outcome is change in hba1c and secondary outcomes at baseline and 90 days include satisfaction, number of ed/inpatient visits, completion of follow-up appointment, and duration of cgm use.

Eligibility criteria:
inclusion criteria: * persons with t2dm * persons on atleast 3 injections of insulin/day * persons whose insurance will cover the device exclusion criteria: * persons with adhesive allergy * pregnant women * persons with ckd 4/5 or on dialysis

Keywords: continous glucose monitoring
expression of stress markers during meth treatment (express+)

Conditions: Substance-Related Disorders; HIV

Summary: this is a non-randomized behavioral trial that aims to investigate whether changes in inflammatory and type i ifn expression coincide with changes in methamphetamine use and viral load over the course of 12 weeks in hiv-positive people assigned male at birth with and without methamphetamine use disorder.

this is a within-subjects, two-arm study with 35 hiv-positive people assigned male at birth receiving contingency management for treatment of methamphetamine use disorder and 20 hiv-positive people assigned male at birth serving as a non-substance-using healthy control (n=55 total). hiv-positive participants with methamphetamine use disorder who meet the eligibility criteria will be assigned to the contingency management treatment group. hiv-positive participants who do not use substances and meet the specific criteria will be assigned to the non-substance-using control group. participants will be observed over 8 weeks, with another follow-up 4 weeks thereafter.

Eligibility criteria:
inclusion criteria: for contingency management: 1. assigned male sex at birth 2. 18 to 45 years of age 3. reports having sex with men in the past 12 months. 4. hiv-positive (confirmed by certification or by hiv rapid test) 5. has an hiv care provider (last seen in the past 12 months) 6. has a current antiretroviral prescription 7. meets the dsm-5 criteria for methamphetamine use disorder using scid-5 8. urine test is positive for methamphetamine within 30 days of their screening visit 9. seeking treatment for methamphetamine use disorder. 10. ability to attend twice weekly appointments for drug testing and treatment for non-substance-using control: 1. assigned male sex at birth 2. 18 to 45 years of age 3. reports having sex with men in the past 12 months. 4. hiv-positive (confirmed by certification or by hiv rapid test) 5. has an hiv care provider (last seen in the past 12 months) 6. has a current antiretroviral prescription exclusion criteria: for contingency management: 1. identifies as (cis- or transgender) female 2. reports another current or past substance use disorder 3. reports being in another intervention or clinical trial for substance use 4. positive test for opioids, cocaine, and/or mdma for non-substance-using control: 1. identifies as (cis- or transgender) female 2. positive test for methamphetamine, opioids, cocaine, and/or mdma. 3. reports substance use (methamphetamine, opioids, cocaine, mdma, hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 months 4. reports past or current substance use disorder
oral paracetamol premedication effect on maternal pain in amniocentesis

Conditions: Amniocentesis

Summary: this randomized controlled trial, compares perioperative and postoperative pain score by using visual analog scale in pregnant women undergoing amniocentesis. the experimental group will be given oral paracetamol premedication whereas the controlled group will be given oral placebo premedication.

perioperative and postoperative amniocentesis are often painful which cause concerns to those who has to undergo amniocentesis. anxiety is one of the factor that may prolong operative time, resulting in an increase risk of complication from the procedure. furthermore, pregnant women, in order to relief the pain, might require others drugs, which has both maternal and fetal side effect. so in conclusion, this study aims to compare efficacy of oral paracetamol premedication and oral placebo premedication by using visual analog scale to evaluate pain.

Eligibility criteria:
inclusion criteria: * singleton pregnant women undergo amniocentesis for the first time at rajavithi hospital in 2016-2017 exclusion criteria: * pregnant women with psychiatric disorder * contraindicated to paracetamol * pregnant women undergoing amniocentesis due to fetal anomaly * take oral paracetamol or other analgesics within 24-48 hrs before operation * deny to participate the research
symptom identification and management in patients with hematological malignancy during follow-up care

Conditions: Hematologic Malignancy

Summary: the aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed pro (hm-pro) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy.

design: a two-arm prospective randomized controlled trial. population: patients diagnosed with chronic myeloid leukemia (cml), clonal cytopenia of unknown significance (ccus), myelodysplastic syndrome (mds) or myeloproliferative neoplasia (mpn). patients will be recruited from the outpatient clinic at the dept. of hematology at rigshospitalet in denmark. patients will be identified and screened by their physician. patients who are eligible for study inclusion will hereafter be approached, informed and recruited by the primary research investigator. included patients will be randomized and allocated 1:1 to an intervention group or a control group. the intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. seven days prior to the scheduled visit, the patient will receive an electronic invitation via redcap to complete and send pro data (hm-pro). prior to each appointment pro data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients. the control group will receive standard care in the outpatient clinic. the patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control. data collection: the questionnaires will be distributed and completed by patients electronically via redcap consisting of clinical data, pro data (hm-pro) and endpoint measures (see below). * primary outcome: change in qol measured by eortc-qlq-c30, global health domain, at 12 months. * secondary outcomes: change in symptoms of depression and anxiety measured by hads, change in symptom burden measured by mdasi symptom scale and clinical data outcomes at 12 months.

Eligibility criteria:
inclusion criteria: * adults \> 18 years * diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, rigshospitalet * the patients can be included approximately six months after initial diagnosis if in stable condition. * able to manage an e-mail account exclusion criteria: * patients who do not understand, read and speak danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.

Keywords: hm-pro symptom management patient reported outcome
stress in couples undergoing assisted reproduction technology with different cycles and its impact on pregnancy outcomes

Conditions: Infertility

Summary: with the development of assisted reproductive technology (art), more and more infertile women are obtaining their offspring through assisted reproductive technology. however, a growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during art treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of art. the purpose of this study is to investigate the stress faced by participants undergoing art with different cycles and to further investigate its impact on pregnancy outcomes.

with the rapid social and economic development in recent years, the incidence of infertility has increased significantly due to environmental pollution, poor lifestyle habits and increasing stress in various areas. according to global statistics, one in six married couples suffers from infertility. with the development of assisted reproductive technology (art), more and more infertile women are obtaining their offspring. in clinical practice, however, a significant proportion of patients undergoing art have low embryo implantation and pregnancy rates and experience recurrent implantation failure (rif). a growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during art treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of art. this effect is more pronounced in patients with multiple failed transfers. in this study, investigators intend to investigate the stress faced by participants undergoing assisted reproduction with different cycles to provide a reliable basis for future psychological interventions and health education for this group of patients and improve the quality of life of infertility patients.

Eligibility criteria:
inclusion criteria: * female partners' \>18\< 40 years * patients undergoing assisted reproductive technology exclusion criteria: * female partners with polycystic ovary * female partners with insufficiency or premature ovarian failure * female partners with endometriosis * female partners with abnormal profile of thyroid hormones * chromosomal abnormalities of either spouse * mental disorder of either spouse

Keywords: infertility cycle
phase 3 study with ciprofloxacin dispersion for inhalation in non-cf bronchiectasis (orbit-4)

Conditions: Non Cystic Fibrosis Bronchiectasis

Summary: this study (ard-3150-1202, orbit-4) will evaluate the safety and efficacy of inhaled pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-cf) bronchiectasis with a history of pulmonary exacerbations and chronic p. aeruginosa infections.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of non-cf bronchiectasis * history of p. aeruginosa respiratory infections * at least two pulmonary exacerbations treated with antibiotics in the previous year exclusion criteria: * have a clinical diagnosis of cf * are pregnant

Keywords: non cystic fibrosis bronchiectasis, pulmaquin, ciprofloxacin, pseudomonas aeruginosa
the impact of noradrenaline on ventriculo-arterial coupling and central cardiovascular energy delivery

Conditions: Heart Diseases

Summary: the study aims to examine how noradrenaline in combination with venous return influences the energy transmission from heart to central circulation and arteries - also called arterio-ventricular coupling.

after being informed about the study 40 elective cabg patients with written informed consent will undergo assessment of their arterio-ventricular coupling postoperatively after coronary bypass graft surgery. whilst still in deep general anesthesia on the ct icu the study population will be assessed by echocardiographic examination (transthoracic and transesophageal), blood pressure tracing by arterial line, respiratory data and ecg in 4 different situations. initially the individual patient is either considered fluid responsive (svv \>13%) og non- responsive (svv\<13%) by using stroke volume variation assessed by echocardiography. in case of fluid responsiveness a fluid bolus of 4ml/kg of crystalloid fluid is given until svv drops below 13% and the patient can be considered as fluid non responder. right afterwards the study patient is stabilized with a baseline dose of noradrenaline (na) intravenously in a supine position (situation 1). situation 2 will be a slight increase in na dose stabilizing mean arterial pressure in a "baseline + 20mmhg" state. after reversing the na dose back to base line level the patient is allowed a short period of rest to wean of drug effect (4-5 x t1/2, appr. 12min). subsequently the patient is to be placed in a 20% semi upright position (anti-trendelenburg) causing an increase in fluid responsiveness (situation 3). following a phase of equilibration the dose of na is again titrated up to obtain a 20mmhg increase in mean arterial pressure (situation 4). there will be logging of arterial pressure curve and vti-tracing i lvot simultaneously (ultrapower, upwr) as well as calculation of energy delivery, cardiac power, oscillatory power and -fraction and both arterial and ventricular elastance in every of those 4 situations.

Eligibility criteria:
inclusion criteria: * elective coronary artery bypass graft surgery * requirement for noradrenaline/norepinephrine exclusion criteria: * lack of informed consent * patient unsuitable for mean arterial pressure (map) elevation of 20mmhg * patient requiring different blood pressure range due to medical/surgical needs * poor image quality due to patient factors

Keywords: noradrenaline heart surgery intensive care cardiac physiology
evaluation of the performance of contour next® and contour plus elite® bgms in neonates using capillary blood samples

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to extend the intended use of two bgmss to include testing of neonatal blood by health care professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.

this trial will evaluate the performance of both the contour next bgms and contour plus elite bgms using blood from neonates within a hospital ward, e.g. routine/newborn nurseries, special care nurseries, neonatal intensive care unit (nicu). the investigational bgmss will be tested by a point-of-care operator using residual heel-stick capillary blood samples from neonates who underwent routine prescribed testing.

Eligibility criteria:
inclusion criteria: * residual capillary (heel-stick) blood samples from neonates (less than 28 days of age) after birth as part of prescribed testing. * sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing. exclusion criteria: * samples from subjects who are ≥ 28 days of age. * samples from subjects who have previously been enrolled into this study.
evaluation of effect of different ventilator mods on atelectasis in patients undergoing laparoscopic surgery

Conditions: Atelectasis; Atelectases, Postoperative Pulmonary

Summary: in this study researchers aim to evaluate effect of different ventilation modalities on the developments of atelectasis by using ultrasound.

patients undergoing laparoscopic surgery will be randomly assigned either volume controlled ventilation group or pressure controlled volume guaranteed ventilation group. all patients will be performed lung ultrasonography pre and postoperatively to evaluate the development of lung atelectasis and effect of different ventilation modalities on the development of atelectasis.

Eligibility criteria:
inclusion criteria: * undergoing laparoscopic surgery * asa status i-ii exclusion criteria: * gastroesophageal reflux * obstructive sleep apnea syndrome * bmi\>30 * severe lung and heart disease * asa status iii-iv

Keywords: postoperative atelectasis mechanical ventilation laparoscopic surgery lung ultrasonography volume controlled ventilation pressure controlled
impact of early enteral feeding on splanchnic blood flow after surgery for critical heart disease in the newborn

Conditions: Congenital Heart Disease

Summary: the objective of this study is to determine the impact of early post-operative feeding on splanchnic blood flow, cardiac output and end organ perfusion, and the patients overall clinical outcomes.

neonates with critical congenital heart disease (chd) undergoing surgery often have postoperative decreases in cardiac output. these hemodynamic changes can result in varying levels of organ dysfunction, ranging from the subclinical to the more overt. although this low cardiac output syndrome (lcos) and accompanying multiorgan dysfunction syndrome (mods) is in large part transient, the rapidity and completeness of resolution can vary greatly. during postoperative care in the intensive care unit, knowledge of this phenomenon must be balanced against the desire to initiate enteral nutrition. many studies have demonstrated that timely initiation of enteral feeds in the intensive care can reduce mortality, morbidity and costs. practically speaking, the decision to initiate feeds is made based on the patient's postoperative hemodynamic status, a normal lactate, absence of vasopressor agents and presence of bowel sounds. trophic enteral feeding can usually commence 24h postoperatively, even after complicated neonatal heart surgery, the vast majority of postoperative neonates suffer no apparent ill effects from this management strategy. however, recent data have demonstrated an exceedingly high incidence (3.3-6.8%) of necrotizing enterocolitis (nec) in chd patients; a disease for which diminution in splanchnic blood flow and disruption of the mucosal barrier are felt to play an important role. these data suggest the combination of diminished cardiovascular reserve, cyanosis and increased myocardial oxygen demands may promote the development of nec. preliminary data from sickkids (chanthong and sivarajan, 2008) demonstrates an nec incidence of 8% in chd patients. patients with nec also accounted for 25% of all cardiac arrests in cardiac ccu.

Eligibility criteria:
inclusion criteria: * neonates ≤ 30 days of postnatal age at time of operation * birthweight \> 2.5 kg * gestational age at birth ≥ 35 weeks * patients requiring cardiac surgery who are expected to remain intubated in the cciu for \> 48 hours * informed consent by parent or guardian * approval by treating critical care staff physician exclusion criteria: * patients with heterotaxy or pre-existing renal or abdominal pathology (eg. preoperative diagnosis of nec). * need for ecmo after repair within the study period (data up to that point will be recorded and analyzed). * parent refusal of formula for purposes of study * patient on vasopressin or norepinephrine infusion * parent or legal guardian refuse consent

Keywords: neonates congenital heart disease postoperative feeding splanchnic blood flow
chronic migraine prophylaxis: ultrasound-guided greater occipital nerve block versus medical treatment

Conditions: Greater Occipital Nerve Block; Medical Treatment; Chronic Migraine

Summary: the aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine.

primary headache disorders, particularly migraine and tension-type headache (tth) are common worldwide and commonly result in widespread and substantial disability. chronic migraine (cm) is defined as "headache occurring on 15 or more days per month for more than 3 months which has the features of migraine headache on at least 8 days per month". the prevalence of cm in the general population is about 2%. it negatively affects emotional and family relationships, education, economic status, and general health. migraine headaches might become quite severe and incapacitating for patients and management can be challenging even in experienced clinics. prophylactic interventions may include pharmacotherapy, behavioral therapy, physical therapy and other strategies. management often requires the simultaneous use of these different therapeutic modalities. once the headaches become refractory to conventional pharmacologic management minimally invasive techniques such as peripheral nerve blocks are feasible for pain relief and help to decrease the frequency of the attacks. preventive medications for chronic migraine treatment are less well studied than they are for episodic migraine. in addition, some trials evaluating treatment of chronic migraine are limited by one or more methodologic problems, such as small size, concomitant use of other prophylactic medications and/or lack of a specific headache diagnosis.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old. 2. both sexes. 3. patients with chronic migraine. exclusion criteria: 1. age less than 18 years. 2. patients with medication overuse headache. 3. patients who had used acute pain medications within 24 hours prior to the study visit. 4. history of injury to the area of the gon. 5. any prior adverse reactions to local anesthetics. 6. patients with impaired sensation in the occipital area. 7. any neurological or dermatological disease that may have affected skin sensation, bleeding tendency, any skull defect.
evaluation of zinc and / or micronutrient supplementation on intestinal flora, diarrheal disease burden, intestinal mucosal integrity and growth among children of pakistan

Conditions: Malnutrition; Diarrhea; Pneumonia; Growth

Summary: information on the mechanisms of zinc is still in developing phase. ecological and biological implications of long term zinc supplementation at population level requires assessment. the trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.

who has recommended the use of zinc for the treatment of acute diarrhea. literature supports up-scaling of zinc supplementation programs to prevent childhood illnesses, such as diarrhea and respiratory infections, and its subsequent co-morbid conditions. as the potential mechanisms of action of zinc still remains to be established, this trial is proposed to evaluate the relationship of intestinal microbial flora, intestinal permeability, morbidity patterns and response to various enteric pathogens in a representative birth cohort randomly allocated to receive daily zinc and micronutrients from 6-18 months of age, and a control population.

Eligibility criteria:
inclusion criteria: * children of ages 2 weeks to 6 months for recruitment into the trial. children of ages 6 months and onwards would eligible to receive intervention (in the form of micronutrient sprinkles) exclusion criteria: * children with obvious congenital anomalies.

Keywords: malnutrition diarrhea pneumonia growth zinc supplements microbiome