Kornimate/medical-research-clean huggingface dataset:
gene expression in monocytes of growth hormone deficient children

Conditions: Growth Hormone Deficiency

Summary: the growth hormone (gh) is mainly synthesized in the anterior portion of the pituitary gland and has an effect on different body areas. secreted in the circulatory stream, growth hormone reaches the liver and here stimulates the secretion of somatomedin c better known as insulin-like growth factor 1 (igf), which constitutes its main anabolic effector. growth hormone deficiency (ghd) is characterized by a delay in the statural growth in children and is correlated with a worsening of body composition, cognitive functions, lipid metabolism, bone mineralization, cardiac performance and exercise in adults. recombinant gh (rhgh) replacement therapy can correct these alterations and therefore improve the quality of life in treated patients, and accelerate growth in children. the optimal dosage of rhgh varies for each patient, as the response to treatment suffers from considerable inter-individual variability. to date, igf1 is the only available biomarker whose plasma levels correlate with replacement therapy. it is important to underline how somatomedin c does not provide information about the optimal posology of rhgh for each patient in order, therefore, to predict its adverse events and efficacy. in addition, it has been shown that the effects mediated by the somatotropic hormone on some tissues are direct, therefore independent of the action of igf1, whose plasma levels are not, in this case, predictive of therapeutic response. for this reason, it is therefore necessary to identify a more specific biomarker capable of monitoring the efficacy, individual responsiveness and any adverse events in patients receiving somatotropic hormone. the gh receptor (ghr) is expressed in several cells, including monocytes. it is therefore possible that the response of monocytes to the somatotropic hormone partially mirrors that of the chondrocyte and other cell types. given the difficulty of obtaining osteomuscular biopsies or specific body areas in which gh mediates its biological action, the published works have identified the specific cell line in which to study the molecular effects of the hormone in monocytes, thanks to their easy accessibility and high number of ghr. in consideration of this, the investigators propose to stimulate monocytes of healthy and ghd children in vitro with rhgh and through next generation sequencing to identify the characteristic gene expression profile. the gh responsive genes identified with this study can be used for correlation studies on the response to rhgh treatment.


Eligibility criteria:
inclusion criteria: * height lower the 3th percentile exclusion criteria: * any endocrinopathy * liver, kidney or haemolymphopoietic system disorders * celiac disease or other chronic malabsorption conditions * genetic syndromes (such as turner's s., cystic fibrosis or down s.) * drug therapies interfering with growth
patients with stage iii-iva nasopharyngeal carcinoma with or without a mobile medical platform full-course nutritional intervention

Conditions: Nasopharyngeal Carcinoma

Summary: to study the difference in the proportion of patients with nasopharyngeal carcinoma who lost more than 10% of their body weight within 1 month after radiotherapy and chemotherapy using the mobile platform for whole-process individualized nutritional rehabilitation management compared with conventional nutritional rehabilitation management.


Eligibility criteria:
inclusion criteria: * 1.voluntarily participate and sign the informed consent in writing. * 2.stage iii-iva (ajcc 8th edition staging) . * 3.received induction chemotherapy + concurrent chemoradiotherapy . * 4.18-70 years old. * 5.pathologically diagnosed with non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, that is, who type ii or iii). * 6.no previous anti-tumor therapy . * 7.ecog score 0-1. * 8.ensure contraception during the study period. * 9.hemoglobin (hgb) ≥90 g/l, white blood cell (wbc) ≥4×109/l, platelet (plt) ≥100×109/l. * 10. liver function: alt, ast \< 2.5 times the upper limit of normal (uln), total bilirubin \< 2.0 × uln. * 11. renal function: serum creatinine \<1.5×uln. * 12.able and willing to use a mobile phone or tablet to fill in the electronic scale. exclusion criteria: * 1.received antitumor therapy in the past. * 2. the pathology was keratinizing squamous cell carcinoma (who type i). * 3.pregnant women who are in the reproductive period and have not taken effective contraceptive measures. * 4. has suffered from other malignant tumors (except for cured basal cell carcinoma or carcinoma in situ of the cervix). * 5.patients with significantly low heart, liver, lung, kidney and bone marrow functions. * 6.serious, uncontrolled medical diseases and infections. * 7.concurrent use of other experimental drugs or other clinical trials. * 8. refused or unable to sign the informed consent to participate in the trial. * 9.those who have other contraindications to treatment. * 10.persons with personality or mental disorders, no capacity for civil conduct or limited capacity for civil conduct.

Keywords: nasopharyngeal carcinoma mobile platform nutritional intervention radiotherapy
comparison of preemptive analgesic effects of dexketoprofen versus dexmedetomidine on abdominal hysterectomy patients

Conditions: Pain

Summary: the aim of this study is to investigate comparison of preemptive analgesic effects of dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal hysterectomy.

abdominal hysterectomy is associated with moderate to severe postoperative pain which has unfavorable effects on patient's recovery and procedure's outcome. administration of opioid analgesics is routinely practiced but is limited with dose-related adverse effects.\[1\] within this concept, combining an opioid with different analgesics acting by different mechanisms as multimodal analgesia is recommended for effective post-operative pain control dexketoprofen trometamol is a newly developed, centrally acting nsaid with potency similar to that of μ-opioid agonists.\[4\] in a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability. dexmedetomidine is a highly selective α2 adrenoceptor agonist that provides sedation, analgesia, and sympatholysis. these characteristics make dexmedetomidine useful anesthetic adjunct during operation. previous studies report that intravenous has a definitive role in postoperative analgesia through the reduction of opioid consumption the aim of this prospective randomized, double-blind study is to evaluate the analgesic efficacy and opioid sparing effects of preemptive single dose of dexketoprofen trometamol in comparison with dexmedetomidine in the patients abdominal hysterectomy , over a 24-hour (h) investigation period. after institutional approval and informed consent had been obtained, 60 patients scheduled for abdominal hysterectomy randomly allocated into two equal groups. patients received ıv dexketoprofen 50 mg (group i), ıv dexmedetomidine 1mcg/kg (group ii) after anesthesia induction and 10 minutes (min) before surgical incision. patient controlled analgesia was supplied postoperatively using morphine. hemodynamics, visual analogue scale (vas), sedation score, morphine consumption, and side effects were recorded every and at 2, 6, 12 and 24 h after surgery.

Eligibility criteria:
inclusion criteria: * 18- 65 year female * scheduled for elective abdominal hysterectomy * no known allergies to drugs * asa i-ii patients exclusion criteria: * pregnancy * drug or alcohol abuse * history of allergic reaction to any of the study drugs * ongoing opioid, and non-steroidal anti-inflammatory * analgesic therapy * cardiac, respiratory, hepatic and/or renal failure * history of peptic ulcer disease

Keywords: postoperative pain dexketoprofen trometamol dexmedetomidine
resilience measurement in older adults with late-stage lung cancer

Conditions: Lung Cancer Stage III; Lung Cancer Stage IV

Summary: the purpose of this study to test measures of physical and psychological resilience while using self-system therapy (sst), to treat depression and lung-cancer-related distress in older adults (65 years and older).

the investigator will examine the feasibility of delivering measures of psychological and physical resilience while delivering the sst intervention. the investigator will also examine whether participation in sst can help alleviate symptoms of depression and distress while helping improve overall physical functioning in older adults with advanced lung cancer.

Eligibility criteria:
inclusion criteria: * age 65 or older * english-speaking * the patient has a diagnosis of late-stage (iii-iv) lung cancer and is living at his/her home. exclusion criteria: * unable to provide informed consent * visual or hearing impairments that preclude participation * serious mental illness
transdiagnostic group behavioral activation for autistic adults

Conditions: Autism Spectrum Disorder; Depression, Anxiety; Anxiety; Anger

Summary: the purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a telehealth group behavioral activation therapy (gbat) for autistic adults.

detailed description: this study is being done to demonstrate the feasibility, acceptability and effectiveness of a telehealth group behavioral activation therapy (gbat) for autistic adults. gbat is intended to help adults manage stress, anxiety, down moods, and anger. similar programs have been shown to be effective in other contexts but has not yet been used for autistic adults or delivered via telehealth. because this is a new intervention, the investigators are interested in learning 1) whether gbat can be done with autistic adults (feasibility), 2) what autistic adults think about gbat (acceptability), and 3) whether gbat is effective for helping autistic adults cope with their feelings. results from this study will be used to inform adaptation to the intervention and planning for future studies to further explore its effectiveness. for this initial feasibility study, 8 autistic adults (18-40 years old) with viq and nviq\>85, reading composite at least 6th grade level and elevated symptoms of depression, anxiety or anger will be recruited.

Eligibility criteria:
inclusion criteria: 1. be 18-40 years old 2. have a confirmed diagnosis of autism spectrum disorders (asd). 3. have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in the telehealth videoconferencing sessions 4. \*have a viq and nviq of 85 or above 5. \*have at least a 6th grade reading composite 6. \*have elevated symptoms of depression, anxiety or anger. this will be determined based on scoring above the borderline or mild threshold on at least one of 3 screening measures (mini; asr; dass-21). exclusion criteria: 1. are younger than 18 years old, or older than 40 years old (children are excluded because the focus is on adapting gbat for adults; individuals above 40 are excluded to restrict the adult focus to young adults that are more likely to be in similar life stages). 2. do not have an asd diagnosis (because the study as the purpose of the current research is to examine gbat's feasibility with autistic adults). 3. both viq and nviq below 85 or less than 6th grade reading level 4. do not have elevated scores of depression, anxiety, or anger on the symptom screening measures. 5. are unable to understand english fluently (because the instruments being investigated are currently only validated in english and the intervention will be delivered in english). 6. are currently enrolled in another behavioral therapy or psychotherapy targeting depression, 7. the pi's clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).
prove queri project #1

Conditions: Prevention and Control

Summary: the overall goal of this project is to test two strategies for implementing a shared decision making tool to be used by providers while talking to patients about lung cancer screening. eight participating sites will be randomized to compare standard implementation with intensive implementation. additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. finally, the investigators will survey patients to evaluate the effects of decision precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

the overall goal of this quality improvement project is to test two strategies for implementing shared decision making, which incorporates the decision precision lung cancer screening tool. the investigators will use multi-site, cluster-based randomization to compare standard implementation with intensive implementation. additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. finally, the investigators will have a human subjects research component to evaluate the effects of decision precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

Eligibility criteria:
inclusion criteria: * patients at participating sites without documented exclusions for lung cancer screening who have had initial lung cancer screening clinical reminders resolved during the recruitment period exclusion criteria: exclusions for initial lung cancer screening clinical reminders: * history of lung, pancreatic, liver or esophageal cancer * a health factor on file indicating they have a life expectancy of less than 6 months or who already had a chest ct in the past 12 months

Keywords: decision support patient preferences risk adjustment
optimal method of pain management in patients with multiple rib fractures

Conditions: 3 or More Rib Fractures

Summary: rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. hence, it is crucial to manage pain associated with rib fractures. currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications. an alternative pain management option is the on-q® pain relief system. it is an fda-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. one study by truitt et al (2010)demonstrated that the on-q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. however, that study sample was small and did not have a comparison group. in this study, we will compare two groups: 1) on-q system and 2) epidural analgesia. we hypothesize that trauma patients with three or more rib fractures, who receive pain management through the on-q® pain relief system achieve discharge criteria earlier and thus have a shorter hospital length of stay (los) when compared with epidural analgesia.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. three or more rib fractures; 3. pain 1. severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), or 2. mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours; 4. patient has capacity to provide informed consent, as determined by: 1. clinical assessment by study staff md who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the md; 2. gcs 15; 3. clinical assessment by independent md who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the md. exclusion criteria: 1. lack capacity to provide informed consent; 2. intubation at time of enrollment; 3. contraindications to procedure (e.g. known allergy to local anesthetics). 4. presence of infection at site of catheter placement; 5. current use of anticoagulant medication; 6. known allergy to silver; 7. inability to obtain informed consent; 8. body weight \> 300 lbs; 9. pregnancy; 10. significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease). all women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. a positive test result excludes the patient from inclusion in the study.

Keywords: on-q epidural analgesia
a study evaluating physical activity and joint health in severe haemophilia a patients ≥12 years treated once weekly with efanesoctocog alfa

Conditions: Hemophilia A, Severe

Summary: freedom is a multicentre, open-label, single-arm, phase 3b study in europe that aims to enrol approximately 90 previously treated severe haemophilia a patients aged ≥12 years, currently on prophylaxis. after a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 iu/kg once-weekly for 24 months (additional preventive dose not permitted). an activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study. the primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in international physical activity questionnaire (ipaq) at month 24. secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by head-us, hjhs and mri; occurrence of bleeds, injuries, pain. safety and tolerability of efanesoctocog alfa will also be evaluated.


Eligibility criteria:
key inclusion criteria: * previous treatment for haemophilia a with any marketed recombinant and/or plasma-derived fviii for at least 150 eds. * having received prophylactic treatment with any marketed recombinant and/or plasma fviii or emicizumab per local label for at least 12 months preceding enrolment. * having 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and 6 months data on bleeding episodes prior to baseline visit. * willingness and ability to complete training in the use of the study epd and to use the epd in their own smartphone throughout the study. * willingness and ability to use the activity tracker provided by the sponsor to measure physical activity and heart rate. * be able and willing to administer efanesoctocog alfa intravenously at home. key exclusion criteria: * serious musculoskeletal and/or neurological impairment limiting the mobility and the physical ability to a degree that makes the patient unsuitable for the study as judged by the investigator. * other known coagulation disorder(s) in addition to haemophilia a. * history and/or current positive inhibitor test defined as ≥0.6 bu/ml. * treatment with nsaids above the maximum dose specified in the prescribing information within 2 weeks prior to screening. * systematic treatment within 12 weeks prior to screening with chemotherapy and/or other immunosuppressive drugs. * treatment with an investigational product within 30 days or 5.5 half-lives prior to screening, whichever is longer. * major surgery within 12 weeks prior to screening or planned major orthopaedic surgery to occur during the study. * at baseline visit, patients who have not been compliant in using the activity tracker.

Keywords: blood coagulation disorder coagulation protein disorder haemophilia fviii efanesoctocog alfa
validation of a diagnostic tool for postprandial hypoglycaemia in patients after roux en y gastric bypass surgery

Conditions: Post Prandial Hypoglycemia

Summary: roux-en-y gastric bypass (rygb) leads to weight reduction but has also some unwanted side effects. a part of this population will develop postprandial reactive hypoglycemia (pprh). at this moment no validated diagnostic tool exists for pprh. the aim of this study is to prove an association between the sigstad´s score and the lowest postprandial glucose level in patients after rygb surgery. this is investigated using a liquid mixed meal tolerance test (lmmtt). as a secondary hypothesis, associations between edinburgh hypoglycemia scale (ehs) and postprandial glucose levels are investigated. furthermore, changes of insulin and glp-1 levels during the test are analysed. patient characteristics including co-morbidities are studied as possible influencing parameters. moreover, a healthy control group is included to validate the results. finally, a flowchart/diagnostic method will be proposed for diagnosing patients who had a rybg surgery with symptoms suggestive of pprh. besides the lmmtt, participants at the ghent university hospital will undergo additional tests such as a solid mixed meal tolerance test (smmtt) and continuous glucose monitoring (cgm). associations between sigstad score, ehs and the lowest glucose measured during cgm and smmtt will be investigated and compared to the results of the lmmtt.


Eligibility criteria:
inclusion criteria: * for gbs group: primary gbs, 1-5 years post surgery * for control group: 10 subjects bmi 18-25kg/m² and 10 subjects bmi \>30 kg/m² exclusion criteria: * antidiabetic medication (oral or injectable), somatostatin analogs * use of systemic corticosteroids * for gbs group: any surgery after rygb affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis * for gbs group: any surgery before rygb affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis, sleeve gastrectomy * known renal insufficiency: cdk ≥ 4 * known liver cirrhosis * known cardiovascular risk: nyha ≥ iii * mental incapacity * language barriers with inability to communicate with research staff * anemia hb \< 6.2 mmol/l (10.0 g/dl) * cancer within \< 5 years * pregnancy * allergy to the fresubin e * allergy to components of the solid mixed meal (white bread, cheese spread, margarine, orange)

Keywords: roux en y gastric bypass surgery, hypoglycemia, postprandial
safety and tolerability of lactoferrin/fos in very low birth weight infants

Conditions: Safety Issues; Tolerance; Very Low Birth Weight Infant

Summary: this study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. it also has antimicrobial and immunomodulation activities.

aim 1: to evaluate the safety and tolerability of three different lactoferrin/fos doses in preterm infants 1. lactoferrin/fos related adverse events and serious adverse events 2. time reaching full feeds while receiving lactoferrin/fos (120 ml/kg/day) 3. episodes of not receiving enteral feedings for \> 24 hours once feeding is initiated aim 2: to evaluate lactoferrin/fos absorption and excretion 1. examine lactoferrin/fos levels in saliva, urine, plasma, and stool 2. examine lactoferrin levels in materal and human donor milk aim 3: to evaluate the effect of lactoferrin/fos on the intestinal microbiome structure

Eligibility criteria:
inclusion criteria: * \< 15 days of age and receiving enteral feedings * \< 1500 grams birth weight * \< 37 weeks gestation exclusion criteria: * congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, hirschsprung disease, malrotation) * known necrotizing enterocolitis or bowel perforation

Keywords: lactoferrin/fos supplementation