Kornimate/medical-research-clean huggingface dataset:
an efficacy & safety study of bms-512148 in combination with metformin extended release tablets

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical research study is to learn if initiating treatment with bms-51248 (dapagliflozin) in combination with metformin xr can improve diabetes control in patients with type 2 diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin xr. the safety of this treatment will also be studied


Eligibility criteria:
inclusion criteria: * males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control * drug naive or treated with anti-diabetic medication for \< 24 weeks since original diagnosis * c-peptide ≥ 1.0 ng/ml * body mass index ≤ 45.0 kg/m * serum creatinine \< 1.50 mg/dl for men or \< 1.40 mg/dl for women exclusion criteria: * ast and/or alt \>3.0 times the upper limit of normal (uln) * serum total bilirubin \> 2.0 mg/dl * creatine kinase \> 3x the upper limit of normal (uln) * symptoms of severely uncontrolled diabetes * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
a study of fcx-007 for recessive dystrophic epidermolysis bullosa (rdeb)

Conditions: Epidermolysis Bullosa Dystrophica, Recessive

Summary: the purpose of this study is to evaluate the safety of fcx-007, evaluate type vii collagen (col7) expression and the presence of anchoring fibrils and to analyze wound healing as a result of fcx-007 administration in subjects with recessive dystrophic epidermolysis bullosa (rdeb). funding source- fda oopd

rdeb is a rare skin and connective tissue disease characterized clinically by skin fragility with easy blistering, erosion and scarring of skin and mucous membranes, and caused by the deficiency of the protein type vii collagen (col7). the objective of this study is evaluate the safety of fcx-007 intradermal injections in rdeb subjects. additionally, the trial will evaluate col7 expression, the presence of anchoring fibrils, as well evidence of wound healing. approximately twelve subjects are expected to enroll in the phase i/ii trial. phase i will enroll approximately six adult subjects. phase ii will enroll approximately six subjects both adults and pediatric (aged seven (7) years or older). all subjects will receive fcx-007 to one or more paired target rdeb wounds. proof of mechanism will be monitored through digital photography of target wounds and assays conducted on biopsies taken from intact skin sites where fcx-007 is administered.

Eligibility criteria:
key inclusion criteria: 1. age 1. phase i: eighteen (18) years or older. 2. phase ii: seven (7) years or older. 2. diagnosis of recessive dystrophic epidermolysis bullosa (rdeb) key exclusion criteria: 1. medical instability limiting ability to travel to the investigative center. 2. active infection with hiv, hepatitis b or hepatitis c or evidence of other systemic infection 3. current evidence of metastatic squamous cell carcinoma at the site to be injected 4. clinically significant abnormal laboratory result or other significant clinical abnormalities 5. receipt of a chemical or biological study product for the specific treatment of rdeb in the past six months

Keywords: rdeb
the effectiveness of wet cupping on persistent non-specific low back pain

Conditions: Low Back Pain

Summary: the hypothesis of this study is that the improvement of numeric rating scale (nrs) for pain at the end of the study will be greater in the wet cupping treatment group than in the waiting control group.


Eligibility criteria:
inclusion criteria: * patients who have had non-specific low back pains at least 12 weeks now. exclusion criteria: * patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome). * patients who are inappropriate to the wet cupping treatment. * aids, active hepatitis, tuberculosis, syphilis * patients who regularly take anticoagulants, antiplatelet drugs * anemia, thrombocytopenia * hemorrhagic disease like hemophilia * diabetes * severe cardiovascular disease * kidney diseases (renal failure, chronic renal disease) * patients who have experiences of wet cupping treatment during last 3 months. * patients who have had treatment for low back pain during last 2 weeks. * patients who are in pregnancy or have plan to conception. * patients who have vertebra surgery or have plan of surgery. * patients who are inappropriate to join this trial judged by the radiologists or specialists.

Keywords: persistent non-specific low back pain wet cupping cupping numerical rating scale
eras in pediatric & adolescent gynecology preoperative counseling

Conditions: Enhanced Recovery After Surgery; Gynecologic Disease

Summary: the investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for eras improves post-surgical pain scores. the investigator will also assess participant compliance to eras-prescribed medications, and functionality (return to school). each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

enhanced recovery after surgery (eras) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (pag) participants. however, the individual elements of eras that are associated with positive outcomes have not been identified. pre-operative counseling and education is a standard component of eras. in pediatric and adolescent gynecology (pag), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. it is possible that direct participant involvement in eras pre-operative counseling could be an important factor to improve post-surgical outcomes. to investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on eras outcomes in the pag population. the investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for eras improves post-surgical pain scores. the investigator will also assess participant compliance to eras-prescribed medications, and functionality (return to school). each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

Eligibility criteria:
inclusion criteria: * 9- 17 years of age * patient is undergoing abdominal surgery and being managed under the eras protocol exclusion criteria: * developmental delay (iq \< 70) determined by documentation in medical record * emergency or non-elective surgical cases * patients who attend clinic appointments independently from their caregiver

Keywords: gynecology eras pediatrics
evaluation of pain in preterm newborn

Conditions: Pain; Preterm Newborn

Summary: the purpose of this study is to correlate the composite pipp-r (premature infant pain profile-revised) scale and the parasympathetic nervous system (heart rate variability).

the premature newborns hospitalized for several weeks are exposed to a significant number of nursing procedures or painful or stressful medical. repeated pain in the neonatal period may have negative consequences in the short and / or long term. the diagnosis of pain remains difficult because based on the hetero-assessment involving the use of validated scales. the pipp-r scale (premature infant pain profile-revised) appears to be the most complete and best validated scale as composite (behavior items, vegetative and contextual). however, it is rarely used in routine care in france. alternatives to clinical scoring the pain level were described, in particular the analysis of the variability of the heart rate \[vhr\] by hfvi index (high frequency variability index) or skin conductance. the analysis of the spectral components of high frequencies or hfvi would be an indicator of parasympathetic activity. the hfvi was compared to the edin scale, purely behavioral level, proposed as chronic pain marker. skin conductance would be a stress marker reflecting variations of the sympathetic system. these techniques are currently marketed for routine use. however, these methods have been compared and the nipe (newborn infant parasympathetic evaluation), which assesses the hfvi index, was not compared to a validated scale procedural acute pain (such as pipp-r). it seems important, before disseminating these methods, explore the consistency of these techniques with each other and validated scales, and their acceptability by nurses.

Eligibility criteria:
inclusion criteria: * newborns with gestational age less than 36 weeks * hospitalization in neonatology unit or intensive care unit * signature of major parental consent for participation of their child exclusion criteria: * brain injury (intraventricular haemorrhage\> grade 2 or peri- ventricular leukomalacia extended) * administration of anticholinergic or adrenergic antagonist in the previous 48 hours * administration of curares * genetic abnormality or severe malformation
glucagon-like peptide 1, glucose metabolism and gastric bypass

Conditions: Post-bariatric Surgery

Summary: the overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. the central hypothesis guiding this project is that the reconfiguration of intestinal transit with the roux-en-y will increase the release of insulinotropic gi hormones, termed incretins that improve insulin secretion and glucose metabolism. the study is divided into three specific aims. 1. to determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp. 2. to compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after rygb and asymptomatic surgical and non-surgical individuals. 3. to quantify the contribution of glp-1 to incretin effect enhancement following surgery.

the overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. the central hypothesis guiding this project is that the reconfiguration of intestinal transit with the roux-en-y will increase the release of insulinotropic gi hormones, termed incretins that improve insulin secretion and glucose metabolism. the study is divided into three specific aims. 1. to determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp. 2. to compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after rygb and asymptomatic surgical and non-surgical individuals. 3. to quantify the contribution of glp-1 to incretin effect enhancement following surgery.

Eligibility criteria:
inclusion criteria: * age 18-65 * healthy control without diabetes or active organ disease * individuals with bariatric surgery * recurrent hypoglycemia post gastric bypass exclusion criteria: * pregnancy * significant anemia * diabetes currently unless pre-op for bariatric surgery procedure * gi obstruction

Keywords: gastric bypass glucose metabolism hypoglycemia
effects of sleep, fatigue, and timing of post-dates inductions among nulliparas

Conditions: Pregnancy, Prolonged

Summary: this randomized clinical trial will examine if there are any differences between post-dates inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the evening for first-time mothers. sleep and fatigue measures will be measured to see if they differ by time of induction. other measures will include the rate of births within 24 hours of admission, length of labor, use of labor analgesics, and method of delivery.

randomized clinical trial of first-time pregnant women requiring post-dates induction (induction after 40 weeks gestation). women will be randomized to a labor induction time in the morning or the evening. on hospital admission once women have signed the study consent, they will complete sleep questionnaires and a fatigue assessment. fatigue and sleep time assessments will subsequently done by the study subject every 4 hours until women enter active labor. at the onset of active labor, assessments will stop. labor outcomes and patient satisfaction will be obtained once women deliver.

Eligibility criteria:
inclusion criteria: * pregnant at 40 weeks gestation or more * nulliparous * 14 years old or older * english or spanish speaking * healthy maternal status * labor induction able to be scheduled exclusion criteria: * less than 40 weeks gestation * multiparous * younger than 14 years old * not able to speak or write in english or spanish * fetal or maternal status requires immediate induction

Keywords: labor, induced sleep fatigue patient satisfaction circadian rhythm
radio-guided surgery with drop-in beta probe for 68ga-psma, in high-risk prostate cancer patients eligible for robotic-assisted radical prostatectomy.

Conditions: Prostate Cancer; Positron Emission Tomography; PSMA

Summary: the goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68ga-psma-11 pet/ct in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.

study phase: phase ii primary objective: to evaluate the diagnostic accuracy of the combined approach with β-probe and 68ga-psma-11 pet/ct in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. the histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity. secondary objectives: * the identification of the most appropriate tumor-to-background ratio (tbr) able to correctly locate the signal emitted by psma-positive lymph nodes compared with the signal derived by the background rumor. * safety and toxicity analysis regarding the intraoperative application of the β-probe. * the comparison between the signal detected by the β-probe and 68ga-psma-11 pet/ct images. * the correlation of the signal detected by the β-probe with the psma expression (psma staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens drug dosage, formulation, administration: intravenous administration of 1.1 mbq/kg of 68ga-psma-11. primary endpoint: primary: sensitivity and specificity in a per-region analysis. secondary endpoints: * comparison of β-probe intra-operatory measurements with ex-vivo ones. * comparison of β-probe measurements and 68ga-psma-11 semi-quantitative parameters (suvmax and psma-tv). * comparison of β-probe measurements and psma expression assessed by ihc (psma staining).

Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer * high-risk prostate cancer (t\>t2c and/or psa\>20 and/or isup\>3) * patients suitable for radical prostatectomy + pelvic lymph node dissection * 68ga-psma-11 pet/ct performed within 4 weeks prior to surgery * psma positive pelvic lymph nodes detected at 68ga-psma-11 pet/ct * age \>18 years old * willing to sign informed consent exclusion criteria: * patient unfit for surgery * m1 stage (any m) detected at 68ga-psma-11 pet/ct or other imaging modalities performed during diagnostic wok-up evaluation * unable to tolerate pet scan

Keywords: psma radio-guided surgery radio guided surgery lymph node dissection prostate cancer pet positron emission tomography
the effect of shotblocker, finger puppet and balloon method during intramuscular injection

Conditions: Children

Summary: the aim of the randomized controlled study is to examine the effects of shotblocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on children's pain and fear level.

the aim of the randomized controlled study is to examine the effects of shotblocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on 7-12 age group children on pain and fear level. the purpose of the research and all the working processes were explained to the children and parents by the researcher. children who met all eligibility criteria were invited to participate in the study with their parents. the children and their parents were informed about the study, they were included in the study by announcing that they would be in one of the four groups, and this group was randomly determined. before starting the application, verbal and written consent was obtained from the parents of the children by reading/reading the informed voluntary consent form. the child and parent were informed by the researcher about the pain and fear level assessment tools and application before and after the procedure.

Eligibility criteria:
inclusion criteria: * children who volunteered to participate in the study and who met the inclusion criteria exclusion criteria: * children who did not volunteer to participate in the study
reducing the duration of untreated psychosis

Conditions: First Episode Psychosis

Summary: the study examines the possible effect of a community campaign to decrease the duration of untreated psychosis in persons with their first episode of a psychotic disorder.

the study examines whether a community campaign can reduce over time the duration of untreated psychosis (dup) among persons with first episode psychosis (fep). the dup of mental health patients with fep who sought services at a public outpatient or an inpatient facility was assessed for a 15 month period prior to the campaign launch. this serves as the baseline or historical control. the dup will continue to be assessed for another 3 years. the hypothesis being tested is that there will be a significant decrease in dup between baseline, one-year, two-year and three-year follow-ups. this study is being carried out with latinos in los angeles county because as a group, particularly among spanish-speaking immigrants, latinos are at high risk for prolonged dup.

Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual-4 criteria for a psychotic disorder * of latino origin exclusion criteria: * has a neurological disorder or suffers from brain trauma
alteplase in elderly acute ischemic stroke (ais) patients during hospitalization

Conditions: Stroke

Summary: the objective of the study is to find out the in-hospital clinical outcomes among chinese acute ischaemic stroke (ais) patients, who were treated with intravenous (iv) recombinant tissue plasminogen activator (rt-pa) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).


Eligibility criteria:
inclusion criteria: * patient registered in the chinese stroke centre alliance (csca) platform from aug 2015 to jul 2019 * ≥18 years old * diagnosed as acute ischemic stroke (ais) at admission * arrived or admitted into hospital within 4.5 hours of symptom onset * for patients in the iv rt-pa groups only: received iv rt-pa within 4.5 hours of symptom onset exclusion criteria: * documented intravenous thrombolysis (ivt) absolute contraindication * key data missing (age, gender, baseline national institutes of health stroke scale \[nihss\], time of symptom onset, ivt treated or not, time of iv alteplase treatment) * received thrombolysis agents other than iv rt-pa (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase) * received endovascular treatment * received iv rt-pa after 4.5 hours of symptom onset
emergency department interventions to improve blood pressure follow-up

Conditions: Hypertension

Summary: hypertension affects approximately 65 million people in the united states and approximately 20 million individuals remain undiagnosed. in emergency room visits, many as one third of the patients were noted to have elevated bp readings, two thirds of which could benefit from further therapy or closer clinic follow-up. however primary care follow-up after discharge with an elevated bp is surprisingly low. the purpose of this study is to measure the follow-up rate after the emergency room visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.

hypertension is a very common disease, affecting approximately 65 million people in the united states. as many as 30 % of people with hypertension, approximately 20 million individuals, remain undiagnosed. as many as one third of patients seen in ed were noted to have elevated bp readings in prior studies. approximately 5% of emergency department (ed) patients have severely elevated blood pressure. prior studies suggest that as many as two thirds of ed patients with elevated bp can benefit from further therapy or closer clinic follow-up. however primary care follow-up after ed discharge with an elevated bp is surprisingly low. the purpose of this study is to measure the follow-up rate after the ed visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.

Eligibility criteria:
inclusion criteria: * 19 years of age or older * diastolic bp 90 mm hg or systolic bp 140 mm hg * diabetes and chronic kidney disease who have a diastolic bp 80 mm hg or systolic bp 130 mm hg exclusion criteria: * unable/unwilling to provide informed consent * acute anxiety state * any subject on pain medication which compromises their ability to consent
practice of ventilation and adjunctive therapies in covid-19 patients.

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: practice of ventilation and adjunctive therapies in covid-19 patients. an observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated covid-19 patients during the first and second surge of covid-19 in the netherlands.


Eligibility criteria:
inclusion criteria: * receiving invasive ventilation or high-flow nasal oxygen for covid-19 for sars-cov-2 * admitted to one of the icus of the participating hospitals exclusion criteria: * none
analysis of adherence & associated factors in teenagers undergoing treatment of acne vulgaris with differin® gel 0.1%

Conditions: Acne

Summary: the primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.

same as above.

Eligibility criteria:
inclusion criteria: * adolescent subjects with a diagnosis of moderate to severe acne vulgaris exclusion criteria: * subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)