Kornimate/medical-research-clean huggingface dataset:
admission for respiratory disease and video regulation system

Conditions: Pediatric Respiratory Diseases

Summary: pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. it is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients. proper referral of patients calling the samu centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. obtaining objective criteria such as saturation and respiratory rate is also a real challenge. to overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone). this device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea. to the best of the investigator knowledge, there is no prospective study looking at the impact of video-regulation on the outcome of patients requiring the advice of samu centre-15 for pediatric dyspnea.


Eligibility criteria:
inclusion criteria: * age strictly less than 10 years * applicant calling the samu38 for a child with dyspnea announced or presumed by the interrogation. * patients for whom no opposition from parents has been obtained. * patients affiliated to social security exclusion criteria: * call to organize a secondary intervention (or inter-hospital transfer (tih/tiih)). * unsuccessful call (hung up when the dispatcher took the call, without the possibility of medical regulation). * refusal to take charge on arrival of rescue vector * call-back for a patient with an initial call to samu38 \< 48h * means engaged by the cta or an arm even before medical regulation.

Keywords: videoregulation dispatch
opioid dispenser for microdiscectomy/laminectomy

Conditions: Opioid Use; Pain, Postoperative; Medical Device; Laminectomy; Diskectomy

Summary: the opioid crisis continues to plague the united states. while great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. pain after surgery is often treated with opioid medications. opioid medications can have side effects. some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. opioid pain medications when used the wrong way may also be addictive. due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. however, when used properly and safely, opioid pain medications are excellent pain relievers. addinex, a technology company, has developed a device to help patients take opioids more safely. in this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. the other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. for this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. the investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. results from this study will help understand if the addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles.


Eligibility criteria:
inclusion criteria: * opioid-naive patients or intermittent opioid users within 3 months of scheduled surgery * at least 18 years old * presenting for primary elective one-level lumbar laminectomy and/or discectomy via posterior approach with participating surgeon * planned discharge on day of surgery/23 hour admission * planned discharge to home exclusion criteria: * patients with opioid-tolerance * patients without a smart-phone or without the ability to perform telehealth visits * patients unable to utilize the medication dispensing device * patients presenting for other surgeries/surgeries with combined anterior/lateral approaches * patient refusal * allergy or intolerance to opioids * planned admission after surgery * planned discharge disposition to nursing facility or skilled rehabilitation * planned use of or preference for opioid other than oxycodone * patients who are pregnant
low dose naltrexone for treatment of pain in patients with fibromyalgia - effect via a central mechanism?

Conditions: Fibromyalgia

Summary: this study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. it s a randomised, double-blinded, placebo-controlled, cross-over study. the study takes place at the multidisciplinary pain center in grindsted.

fibromyalgia syndrome is a prevalent musculoskeletal disorder characterized by pain, profound fatigue, sleep disorder, mood disturbance etc. the prevalence is estimated to be 2-8%. treatment of pain in patients with fibromyalgia is often based on opioids. however, opioids may lead to tolerance, addiction and hyperalgesia and alternative treatments are therefore warranted. low dose naltrexone (3-5mg) (ldn) has shown promising results in the treatment of pain in patients with fibromyalgia, but there is a need for further research. at the typical dose of naltrexone, 50 mg, it is an opioid antagonist. however ldn demonstrates analgesic and anti-inflammatory effects, possibly involving an antagonism of microglia in the cns. the investigators hypothesize, that ldn has a better pain relieving effect than placebo in in patients with fibromyalgia (fm). the investigators also hypothesize that ldn has a better effect upon experimentally induced pain in fm-patients, compared to placebo. a tentative mechanism is a central facilitation of the endogenous pain inbitory system.

Eligibility criteria:
patients diagnosed with fibromyalgia based on the criteria of american college of rheumatology. inclusion criteria: * widespread pain in patients with fibromyalgia (based on the above criteria) * enrolled as a patient in one of the multidisciplinary pain clinics involved in the project * inflammatory rheumatic disease (peripheral inflammation, including arthritis), must be excluded * women must be treated with a contraceptive measure, if not menopausal exclusion criteria: * cancer * treatment with opioids (other analgesic treatments in stabile dose 14 days prior to study start are allowed) * change in stabile treatment (p.n. paracetamol is allowed, but must be registered) * pregnant/breastfeeding * does not speak/understand danish * allergy to the ingredient * severe liver impairment * severe kidney impairment * acute hepatitis

Keywords: low dose naltrexone pain
study of blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a calgb clinical trial

Conditions: Leukemia

Summary: rationale: studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer. purpose: this research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a calgb clinical trial.

objectives: * monitor molecular response rates of patients receiving treatment for chronic myelogenous leukemia by quantitative reverse transcription polymerase chain reaction (rt-pcr) and quantitative southern blot monitoring of blood samples. * compare quantitative rt-pcr and quantitative southern blot results with marrow cytogenetics at the time of complete molecular response in these patients. * monitor the frequency of residual disease in patients who achieve a complete blood southern blot and marrow cytogenetic response (eradication of bcr/abl by southern blot and absence of the philadelphia chromosome by cytogenetics). outline: peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. if patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. in the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected. samples are examined by quantitative southern blot analysis with probes to bcr, quantitative reverse transcriptase-polymerase chain reaction analysis for bcr/abl fusion transcripts, and cytogenetic analysis. projected accrual: a total of 60 patients will be accrued for this study within 1.5 years.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic myelogenous leukemia (cml) * concurrent enrollment on a calgb treatment protocol for newly diagnosed or previously treated cml (e.g, clb-19804) * must not have initiated study therapy

Keywords: chronic myelogenous leukemia
skb445 for injection in solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(pk) profile, and anti-tumor efficacy of skb445 for injection in patients with advanced solid tumors.

this is an open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, pk characteristics, immunogenicity, and preliminary anti-tumor activity of skb445 monotherapy in patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. at the time of signing the icf: age between 18 -75 years, male or female. 2. subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting response evaluation criteria in solid tumors (recist v1.1). 3. eastern cooperative oncology group (ecog) score of 0 to 1. 4. expected survival ≥ 3 months. 5. subjects with adequate organ and bone marrow function confirmed by laboratory results 6. subjects of childbearing potential (male or female) must use effective medical contraception during the study 7. ability to understand and willingness to sign icf, and will be able to comply with the protocol-specified visits and relevant procedures. exclusion criteria: 1. has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter). 2. has had major surgery within 4 weeks prior to the first dose. 3. has known history of allergy to any component of skb445 or skb445. 4. has a known previous or concurrent other malignancies within 3 years prior to first dose. 5. presence of active central nervous system (cns) metastases. 6. has uncontrolled or severe cardiovascular disease. 7. has uncontrolled systemic diseases. 8. has human immunodeficiency virus (hiv) infection; has any active viral hepatitis. 9. subjects with a known history of psychiatric illness or drug abuse that would preclude the subject from complying with the study. 10. has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation. 11. has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.

Keywords: advanced solid tumors
effect of theronomic ova-all care on biomarkers of ovarian health in adult female with polycystic ovarian syndrome

Conditions: Polycystic Ovarian Syndrome (PCOS)

Summary: theronomic ova-all care is a tribiotic health product aimed at improving ovarian health in people with polycystic ovarian syndrome (pcos). in this study, a total of 16 participants with pcos diagnosed by a gynaecologist will be invited to take ova-all care, two capsule once a day, for 12 weeks. biomarkers of ovarian health will be measured at baseline, four weeks after the start of the intervention, and at the end of the intervention.


Eligibility criteria:
inclusion criteria 1. women aged 18-40 years 2. previous diagnosis of pcos by a gynaecologist 3. able to take body temperature every day for 12 weeks 4. able to attend the testing centre every 4 weeks 5. able to complete online questionnaires exclusion criteria 1. pregnancy, lactation; 2. uterine amenorrhea (such as intrauterine adhesions) 3. thyroid disease or hyperprolactinemia 4. liver and kidney dysfunction, autoimmune diseases (such as systemic lupus erythematosus), malignant tumors, mental illness 5. use of contraceptives, hormone replacement therapy (hrt), immunosuppressants and other drugs that affect ovarian function in the past 3 months. 6. smokers (\>5 cigarettes per day), alcoholics; 7. unable to cooperate with follow-up or refuse to sign informed consent.

Keywords: probiotic prebiotic postbiotic ovary menstruation polycystic ovarian syndrome
myofibroblastic transformation secondary to epithelial-stromal interactions in the keratoconus

Conditions: Keratoconus

Summary: keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism. publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (mmp). direct epithelial-stromal interactions (d-esi) have a role in the induction of metalloproteinases (mmp) and the differentiation of fibroblasts into myofibroblasts via an emmprin membrane glycoprotein (extracellular matrix membran mmp inducer - cd 147). on a healthy cornea, emmprin's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus the hypothesis is that stromal thinning of the keratoconus could be related to increased expression of emmprin by epithelial and stromal cells (resulting in increased mmp synthesis), with a preponderance at the most deformed areas. the main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients.


Eligibility criteria:
inclusion criteria: * for the cases : - suffering from keratoconus and requiring a first optical corneal transplant * for the controls: * orbital exenteration operation due to an orbital tumor * absence of any anomaly of the ocular surface observed during the slit lamp examination at the last preoperative consultation exclusion criteria: * for the cases: * keratoconus patient requiring a tectonic corneal transplant * known pregnancy, or breastfeeding * for the controls: * history of orbital radiotherapy * history of corneal surgery * history of corneal surface tumour * eye surface abnormality noted in the preoperative period * known keratoconus * known pregnancy, or breastfeeding * secondary exclusion if a keratoconus is diagnosed during the immunohistochemical analysis by visualization of bowman membrane interruption

Keywords: metalloproteinase glycoprotein cornea direct epithelial-stromal interactions fibroblasts myofibroblasts
effect of nutritional supplements on clinical outcomes in patients with prediabetes and obesity

Conditions: PreDiabetes; Obesity

Summary: this study aims to improve blood glucose and weight in patients with prediabetes and obesity through health education, nutritional supplement interventions, clinical evaluation, and close clinical follow-up.100 patients with prediabetes with obesity were randomly divided into 2 groups: life intervention group, nutritional supplement intervention group. all enrolled participants were recommended for routine diabetes lifestyle education according to the "expert consensus on prediabetes intervention in adults in china". the duration of the intervention was 3 months. the investigators aimed to compare the differences in weight, glycosylated hemoglobin, lipids and other indicators of the two groups of included populations before and after the intervention. in addition, the investigators are to explore the effects of nutritional supplement interventions on glycolipid metabolism and body weight in prediabetes with obesity.


Eligibility criteria:
inclusion criteria: * according to the american diabetes society (ada) 2010 standard: meet one of the following (1) fasting blood glucose at 100 mg/dl to 125 mg/dl; (2) sugar load 2h blood glucose at 140 mg/dl to 199 mg/dl; (3) glycosylated hemoglobin in 5.7% to 6.4% * body mass index (bmi) ≥ 25 and ≤ 35kg/m2 * have lived locally for at least half a year and have a fixed residence * no other clinical trials were participated in in the 3 months prior to the trial * mental health, being able to take care of oneself in life exclusion criteria: * people with confirmed diabetes * weight change of more than 10% over the past 3 months * pregnant or lactating women, men and women planning to become pregnant within two years, or unwilling and unable to use contraception during the study period (women only) * people who are allergic to the ingredients of nutritional supplements * those who have lost weight by any medication (including appetite suppressants such as fluprophenylpropanine, progesterone, laxatives, etc., and diet pills with various traditional chinese medicine ingredients) or surgery in the past 3 months * patients who have received medical treatment for the following diseases in the past 3 months: diabetes, cholecystitis, peptic ulcer, inflammatory bowel disease, acute urinary tract infection, hyperthyroidism, etc., or patients with chronic gastrointestinal diseases with symptoms of nausea, vomiting and diarrhea in the past month * suffer from severe organic diseases such as cancer, coronary heart disease, myocardial infarction and stroke * presence of pituitary-adrenal axis dysfunction; secondary obesity due to other diseases (e.g., cushing syndrome, hypothyroidism, etc.)

Keywords: prediabetes obesity glycosylated hemoglobin weight
a prospective randomized trial of prostate biopsy protocols comparing the vienna nomogram and a standard 10-core biopsy scheme

Conditions: Prostate Cancer

Summary: in this study, the investigators aim to determine if the vienna nomogram increases the detection rate of trus-guided prostate biopsies by conducting a prospective randomized study comparing the vienna nomogram with a 10-core biopsy protocol.

trans rectal ultrasound (trus) guided prostate biopsy remains the standard for prostate cancer diagnosis. however, the standard protocols miss 15 to 30% of cancers, leading to a variable number of repeat biopsies. in 2005 the vienna nomogram was introduced, defining the number of cores to be obtained in a prostate biopsy in relation to age and prostate volume in patients with a serum psa level of 2-10 ng/ml. the objective of the study is to determine if the vienna nomogram increases the detection rate of trans rectal ultrasound guided prostate biopsies, compared to a 10-core biopsy. this prospective randomized study enrolled men eligible for a prostate biopsy were randomized to a vienna nomogram protocol or a 10-core protocol. they were further stratified according to age (≤65; \>65 and ≤70; \>70 years) and prostate volume (≤30; \>30 and ≤50; \>50 and ≤70; \>70 cc). a subgroup analysis for patients with serum psa values between 2 and 10 ng/ml was performed.

Eligibility criteria:
inclusion criteria: * psa elevation * abnormal digital rectal examination * abnormal findings on prostate imaging exclusion criteria: * active urinary tract infection * documented previous pathological prostatitis * history of urinary retention * recent lower urinary tract surgery

Keywords: prostate cancer prostate biopsy vienna nomogram
right ventricular hypertrophy and pulmonary hypertension: a correlation analysis

Conditions: Pulmonary Hypertension

Summary: the study hypothesis is that a quantitative index can be derived from tc-99m myocardial perfusion scans that accurately identifies the presence of left ventricular hypertrophy and pulmonary hypertension. echocardiography provides the reference standard.


Eligibility criteria:
inclusion criteria: * must have an interpretable tc-99m myocardial perfusion scan and an interpretable echocardiogram. exclusion criteria: * technically inadequate noninvasive test.
drug-drug interaction study between orally administered rifampicin and vilaprisan

Conditions: Endometriosis

Summary: this study will be conducted in a single center, open-label study with a single group fixed sequence design to evaluate the effect of repeated oral administration of 600 mg rif(rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of vpr(vilaprisan) and on mdz(midazolam) as a reference (probe) substance.


Eligibility criteria:
inclusion criteria: * healthy female postmenopausal subjects * age: 45 to 65 years (inclusive) * body mass index (bmi) : ≥20 and ≤32 kg/m² * race: white exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * relevant diseases within the last 4 weeks prior to the first drug administration * existing chronic diseases requiring medication * known or suspected malignant tumors (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment) * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * regular use of medicines * repeated use of drugs during 1 week before first study drug administration which might affect absorption (e.g. laxatives, loperamide, metoclopramide, antacids, h2-receptor antagonists)

Keywords: vilaprisan pk rifampicin midazolam, cyp3a4 induction drug-drug interaction