Kornimate/medical-research-clean huggingface dataset:
a double-blind pharmacokinetic interaction study evaluating the effect of a single iv infusion of ggf2 or placebo on midazolam pharmacokinetics in patients with heart failure

Conditions: Heart Failure

Summary: the study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of ggf2 .

this drug-drug interaction (ddi) study evaluates the potential effect of intravenously administered ggf2 on the elimination kinetics of midazolam.

Eligibility criteria:
inclusion criteria: * if female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility * if male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product * stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months * all cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to day 1 exclusion criteria: * any previous exposure to ggf2 or other neuregulins * initiation or change of a prescription medication within the 2 weeks prior to day 1, and/or concomitant medication regimen is expected to change during the course of the study * known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of ggf2 diluent * known specific hepatic disease; total bilirubin \>2 mg/dl, ast \> 100 iu * history of hepatic impairment (hepatitis b and c) * type i diabetes * documented stroke or transient ischemic attack (tia) within 2 months of study enrollment
evaluating the safety and effectiveness of the laminar left atrial appendage closure system

Conditions: Atrial Fibrillation

Summary: the objective of this study is to demonstrate safety and effectiveness using a percutaneous delivery system of the laminar left atrial appendage closure system to treat patients with nvaf to reduce the risk of thromboembolism from the left atrial appendage (laa).


Eligibility criteria:
inclusion criteria: * 1. subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (af). * 2. subject must be ≥18 years of age. * 3. subject has a calculated cha2ds2-vasc score of 2 or greater. * 4. subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months. * 5. subject must have at least two international normalized ratios (inrs); 2-3, if on warfarin. * 6. subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy. exclusion criteria: * 1. subject who requires anticoagulation for a condition other than af. * 2. subject with a new york heart association (nyha) classification equal to iv. * 3. subject with a history of or implanted atrial septal defect (asd) device or patent foramen ovale (pfo) device that would interfere with the investigational device placement. * 4. subject with valvular disease.

Keywords: left atrial appendage closure
remineralization potential of pearl powder compared to cpp-acp on enamel white spot lesions

Conditions: White Spot Lesion

Summary: the aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate.

the aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. the remineralisation potential will be assessed both visually and by standardised photographic image analysis. the follow up will be up to 12 months.

Eligibility criteria:
inclusion criteria: * males or females. * age: 12-25 years old. * patients with good oral hygiene. * co-operative patients who show interest to participate in the study. exclusion criteria: * patients with bad oral hygiene. * lack of patient's approval and compliance. * presence of abnormal oral, medical, or mental condition. * patients who are allergic to milk products. * pregnant and lactating women.
atrial fibrillation and cancer: a nationwide french cohort study

Conditions: Atrial Fibrillation; Cancer; Thromboembolism; Bleeding

Summary: atrial fibrillation (af) is a common complication associated with cancer but the risk of af according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known. the objective of this study is to use a very large french nationwide cohort to adress thèses questions.


Eligibility criteria:
inclusion criteria: * adult hospitalized patients * with an icd-10 code discharge from january 2010 to december 2019 in the french national hospital discharge database (pmsi programme de médicalisation des systèmes d'information) exclusion criteria: * children
haic of folfox plus sorafenib vs haic of folfirinox plus sorafenib for advcanced hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib compared with haic of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with advanced hepatocellular carcinoma (hcc)


Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: platelet count ≥ 75,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 30 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma hepatic artery infusion chemotherapy oxaliplatin, 5-fluorouracil and leucovorin (folfox) irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (folfirinox) sorafenib
diabetic retinopathy and the myvisiontrack® (drama) study

Conditions: Diabetic Retinopathy; Diabetic Macular Edema

Summary: the purpose of this study is to determine the effect of enhancements to the myvisiontrack® in regards to patient compliance and test-retest variability. additionally, the ability of myvisiontrack® to detect changes in vision function will be evaluated.

the results of this study will provide the basis for patient self-monitoring of visual function with the myvisiontrack®, and for reporting, storage, and maintenance of collected data. the myvisiontrack® is intended to be used remotely by patients to monitor their disease. in the case of significant changes, patients will be prompted to visit their ophthalmologist. it is hypothesized that this can lead to earlier detection of disease progression, which, in turn, can lead to earlier treatment and better prevention against vision loss due to diabetic retinopathy (dr).

Eligibility criteria:
inclusion criteria: * dr or amd requiring treatment at time of study initiation * macular edema involving the central subfield based on clinical judgment * no noticeable central subfield atrophy * patients willing and able to comply with all study and follow-up procedures (including the handling of the myvisiontrack™ device) exclusion criteria: * any ocular pathology other than dr or amd * any other concurrent systemic illness affecting the retina and visual function * dementia or other neurological or psychological limitation that would prevent patients from performing self-testing of visual function * past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve * use of investigational drugs at the time of screening, or within 60 days (excluding vitamins and minerals) * pregnancy

Keywords: diabetic retinopathy diabetic macular edema macular edema maculopathy home monitoring shape discrimination hyperacuity psychophysical testing
kerecis real-world fish skin graft registry

Conditions: Wounds; Pressure Ulcer; Diabetic Foot Ulcer; Venous Leg Ulcer; Surgical Wound; Soft Tissue Reinforcement

Summary: multi-center, observational (i.e., non-interventional), open-label, real-world registry on the use of kerecis devices

this observational (i.e., non-interventional), post-market, real-world, registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using kerecis devices in routine medical practice within a wide variety of united states (us) medical practice settings. these clinical data will be used at kerecis for many purposes, which include, but are not limited to, device safety and performance evaluation as part of routine patient care and post-market clinical follow-up data commitments to regulatory authorities around the world.

Eligibility criteria:
inclusion criteria: * provided informed consent * has at least one target wound treated with a kerecis device according to physician medical judgement within one calendar month prior to the registry enrollment date exclusion criteria: * none
comparison between nurse-administered propofol sedation and diazemuls / pethidine in outpatient colonoscopy

Conditions: Colonoscopy

Summary: colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology. different modalities of pain control have been described in the past. propofol is a perfect drug for endoscopic procedure since it has the characteristic of fast onset, short half-life and early recovery. its unfamiliarity and its potential cardiovascular and respiratory side effect make it unpopular to endoscopists. recent reports showed propofol is safe in bolus titration by nurse in caucasian in all endoscopic procedures. our previous pilot study showed nurse administered propofol sedation (naps) is effective and safe and highly acceptable by chinese patients. here we conduct a randomized controlled study to compare the effectiveness of naps versus traditional sedation.


Eligibility criteria:
inclusion criteria: * age 18-65 undergoing elective outpatient colonoscopy exclusion criteria: * american society of anesthesiologist class iii or above * history of difficult endotracheal intubation * known allergy to propofol, eggs or soy products, opioid, benzodiazepines * previous colectomy

Keywords: propofol colonoscopy sedation pain compare naps versus diazemuls in outpatient colonoscopy
correlation of intravascular injection rate and severity of cervical neural foraminal stenosis

Conditions: Analgesia, Epidural

Summary: this study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection

cervical transforaminal epidural steroid injection (ctfesi) is useful option to improve cervical radicular pain. however, severe complication can occur by ctfesi such as epidural hematomas, infection, inadvertent intramedullary cord injections, and embolic infarct when inadvertent intra-arterial injection of particulate steroids has occurred. the incidence of intravascular injection during ctfesi was known as 20.6% \~ 32.8% and it is higher than other level of spinal transforaminal epidural injection. to avoid complication due to intravascular injection during ctfesi, risk factors was should be evaluated. however, there was no study about risk factors of intravascular injection during ctfesi. the investigators could assume the severity of cervical neural foraminal spinal stenosis could affect the incidence of intravascular injection, pain intensity and effectiveness during ctfesi. thus, the investigators designed this study to investigate whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during ctfesi.

Eligibility criteria:
inclusion criteria: * patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus. exclusion criteria: * pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
phenethyl isothiocyanate in preventing lung cancer in people who smoke

Conditions: Lung Cancer

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. phenethyl isothiocyanate may be effective in preventing lung cancer in smokers. purpose: phase i trial of phenethyl isothiocyanate in preventing lung cancer in people who smoke.

objectives: i. determine the maximum tolerated dose of oral phenethyl isothiocyanate in smokers. ii. measure the steady state pharmacokinetics of phenethyl isothiocyanate required to maintain a steady state of this substance during the hours of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (nnk) exposure in these patients. iii. obtain preliminary data on the perturbation of nnk metabolism by phenethyl isothiocyanate in these patients. outline: patients complete a questionnaire containing a smoking and dietary log to assess cigarette and cruciferous vegetable consumption. patients receive phenethyl isothiocyanate orally 4 times a day for 30 days. cohorts of 3-6 patients receive escalating doses of phenethyl isothiocyanate until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. patients are followed on days 35, 36, and 43. projected accrual: a total of 15-27 patients will be accrued for this study over 4-6 months.

Eligibility criteria:
disease characteristics: asymptomatic smokers who either refuse to or cannot stop smoking urinary cotinine levels greater than 100 ng/ml willing to adhere to certain dietary restrictions limiting intake of cruciferous vegetables (watercress, broccoli, radishes, mustard, brussels sprouts) while on study patient characteristics: age: not specified performance status: not specified life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 1.6 mg/dl transaminases less than 2 times normal renal: creatinine less than 1.6 mg/dl urinary rbc levels 0-2 urinary wbc levels at least 0-2 pulmonary: no dyspnea at rest other: no concurrent illness, condition, or symptom that would preclude study not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: not specified

Keywords: non-small cell lung cancer small cell lung cancer
implementation of the model of modifiable factors specific to problematic internet use in adolescents

Conditions: Internet Addiction; Problematic Internet Use

Summary: the study aimed to investigate the impact of a nursing care program based on the model of modifiable factors specific to problematic internet use in adolescents on adolescents' problematic internet use, self-regulation, family relationships, and coping levels.

this study constitutes a part of the doctoral thesis titled "development of a nursing intervention model specific to problematic internet use in adolescents"

Eligibility criteria:
inclusion criteria: * voluntarily agreeing to participate in the study, * being between the ages of 12-18, * receiving outpatient follow-up at the child and adolescent mental health clinic, * having a problematic internet use (piu) issue (piu is assessed according to the criteria by the doctors at the clinic. the doctors refer adolescents who meet the criteria. these criteria are as follows: a) using the internet for longer than planned, b) experiencing withdrawal symptoms when unable to access the internet, c) failing to control internet usage, d) being excessively preoccupied with the internet, e) losing interest in offline hobbies, f) a desire to use the internet more, g) continuing excessive internet use despite knowing it negatively affects their life, h) using the internet to escape problems, i) lying about internet use). exclusion criteria: * having a speech, hearing, or self-expression impairment, * having received or currently receiving professional support related to piu.

Keywords: adolescent problematic internet use nursing model
obstructive sleep apnea - autonomic and vascular exploration

Conditions: Obstructive Sleep Apnea

Summary: the goal of this clinical trial is to assess the effect of cpap withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. the main question it aims to answer is: • is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway pressure, cpap) on endothelial function and baroreflex sensitivity? participants will stop using their cpap for 2 weeks and the investigators will assess vascular and autonomic function before and after the withdrawal. researchers will compare endothelial and autonomic function at baseline and after 2 weeks of withdrawal to see if there are differences. moreover, they will assess the association between pulse wave amplitude drop profile and effect of cpap withdrawal.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * diagnosed with osa (ahi ≥15 events/h), confirmed during screening period * adequately treated with cpap therapy for ≥6 months * able to give informed consent as documented by signature exclusion criteria: * professional drivers will be excluded from the study because temporary withdrawal of cpap may induce drowsiness. * we will also exclude patients with conditions that may affect endothelial and autonomic function: * known diabetes * known heart failure * known chronic kidney disease * pregnant or lactating women * morbid obesity (≥40 kg/m2) * known excessive alcohol consumption * known dementia (especially dementia with lewy bodies). (61) * patients using alpha and beta blockers * known atrial fibrillation * inability to follow the procedures of the study due to language problems or psychological disorders.

Keywords: osa cpap
follow-up of study an004t to assess the persistence of allert efficacy during the 2nd to 4th season after treatment

Conditions: Birch Pollen Allergy

Summary: study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an allert 50 µg or 100 µg maintenance dose administered in previous study an004t in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

multicenter, international, parallel-group follow-up study of subjects randomized and treated in study an004t (allert 100 µg, allert 50 µg, placebo) and followed over the 2nd, and if appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during the 1st year, open-label in the 2nd and 3rd years).

Eligibility criteria:
inclusion criteria: 1. any subject having been randomized in the an004t trial and had received at least one injection 2. any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments exclusion criteria: 1. any subject having received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since an004t and before visit 1 2. any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days 3. any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device 4. any subject not covered by medical insurance 5. any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period 6. any subject having received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion 7. any subject having used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period

Keywords: rhinoconjunctivitis birch pollen desensitization allergen immunotherapy
physiological and psychological profiles

Conditions: Healthy Volunteer; Female

Summary: the participation of women in high-impact sports such as rugby and basketball has been steadily increasing in saudi arabia. these sports are known for their physical demands and competitive nature, which have heightened the incidence of sports-related injuries. understanding the predictive factors for these injuries is critical for developing preventive strategies, reducing long-term health consequences, and reducing healthcare burdens. therefore, this study aims to identify the predictive effect of physiological factors (e.g., muscle strength, anaerobic power, oxygen consumption) and psychological factors (e.g., self-efficacy, resilience) on sports injuries among female athletes in saudi arabia, particularly focusing on those involved in rugby and basketball. a prospective cross-sectional design will be employed, involving a total of 30 female athletes aged 18-35 years actively participating in rugby and basketball. data will be collected at the lifestyle research center through a series of physiological assessments, including maximal oxygen consumption, anaerobic power testing, isokinetic muscle strength testing, and psychological evaluations using validated questionnaires. the findings are expected to provide insights into the specific factors that increase injury risk among saudi female athletes, offering targeted strategies for injury prevention. these strategies aim not only to minimize injuries but also to reduce associated healthcare costs, thereby supporting the sustainable growth of women's sports in saudi arabia. ultimately, this study seeks to contribute to the broader objectives of vision 2030 by promoting a vibrant sports culture and enhancing public health.


Eligibility criteria:
inclusion criteria: * female athletes aged 18-35 years recruited from rugby and basketball teams in saudi arabia * actively involved in rugby and basketball * minimum of one year of experience in their respective sport * regular participation in training and competitive events exclusion criteria: * recent injury within the last six months that limits athletic performance pregnancy * presence of any chronic medical condition that could influence study outcomes * uncontrolled diabetes or hypertension