Kornimate/medical-research-clean huggingface dataset:
alfentanil versus remifentanil in patient-controlled sedation during endoscopic retrograde cholangiopancreatography (ercp)

Conditions: Biliary Tract Diseases; Pancreatic Diseases

Summary: self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, pcs) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ercp). however, it is not known which opioid would be the most suitable for pcs. the aim of this double-blind study was to compare remifentanil and alfentanil in pcs during ercp.

deep sedation with propofol has been suggested necessary for successful performance of endoscopic retrograde cholangiopancreatography (ercp).airway obstruction, hypoventilation and hypoxemia occurs in deeply sedated patients with a high incidence of 12-30%.as a result of frequent hypoxemia events, deep sedation is associated with increased morbidity and mortality.careful monitoring of vital signs and involving of anesthesia-trained personal are recommended for deeply sedated patients.self-administration of propofol by the patient him- or herself (patient-controlled sedation, pcs)could be a safer way to use propofol without the presence of an anesthesiologist. in comparison to the anesthesiologists managed deep sedation the main advantages of pcs are reduced consumption of anesthetics and faster recovery.a combination of propofol and different opioids is widely used for pcs however, it is not known which opioid would be the most suitable one. remifentanil is a potent opioid with ultra short duration of action and usually administered as a constant infusion. the elimination half-life of alfentanil is 8-32 minutes being about 3 times longer, than that of remifentanil. both opioids have been evaluated previously in pcs but comparative studies are lacking. this study was carried out in order to compare remifentanil and alfentanil in pcs during ercp in terms of propofol consumption, sedation levels, endoscopist´s and patient's satisfaction. the investigators also sought information about frequency of sedation related complications associated with the different opioids.

Eligibility criteria:
inclusion criteria: * elective ercp patients exclusion criteria: * allergy to propofol or opioid analgesics, drug addiction, inability to co-operate, asa class greater than 3, or patient's refusal.

Keywords: patient-controlled sedation propofol alfentanil remifentanil endoscopic retrograde cholangiopancreatography
postoperative antibiotic management duration following surgery for intravenous drug abuse (ivda) endocarditis (optimal)

Conditions: Endocarditis

Summary: the purpose of this study is to determine the safety and compliance of initial intravenous (iv) antibiotics followed by oral antibiotic therapy following uncomplicated ivda endocarditis. endocarditis has a high rate of sickness and death, involves a long hospitalization and a long-term use of iv antibiotics necessitating six (6) weeks of in-patient hospital stay, and comes with a high cost.


Eligibility criteria:
inclusion criteria: * the age of the patient is ≥ 18. * the patient has undergone an urgent or emergent primary cardiac valvar operation as treatment for ivda endocarditis, with blood cultures positive for streptococcus, enterococcus faecalis, staphylococcus aureus, or coagulase-negative staphylococci * the patient has received 2 weeks of postoperative inpatient iv antibiotic therapy with negative blood cultures and no residual active infection by imaging (i.e. computerized axial tomography, echocardiography) * the patient has the capacity to participate in a compliance tracking tool for medication administration (e.g. a centrally managed core site mobile medisafe compliance https://www.medisafe.com/) as confirmed by both a physician and a care management team member exclusion criteria: * inability to give informed consent * residual infection requiring iv antibiotic therapy * any persistent secondary noncardiac infection (e.g. infections of solid organs or joints) * known poor compliance or deemed incapable to comply with the compliance tracking tool * reduced absorption or inability to receive oral treatment due to a gastrointestinal disorder * any infection involving a more virulent organisms, such as fungal infections or infections with serratia or hacek infections (haemophilus, aggregatibacter, cardiobacterium, eikenella, kingella). * cancer not otherwise in remission or in need of current or future oncologic therapy * medically immunocompromised state * reoperative valvar operation for ivda endocarditis * history of habitual noncompliance * pregnancy * mental incapacity * unable to perform local or institutional medical and psychiatric follow up * unstable home environment * inadequate access to mobile cell service (geographic/rurality)

Keywords: intravenous drug abuse endocarditis oral antibiotics iv antibiotics
lead exposure, genetics, and osteoporosis epidemiology

Conditions: Osteoporosis

Summary: this study's primary objective is to assess the effects of environmental lead exposures and genetic risk factors on the development of osteoporosis in middle-aged women.


Eligibility criteria:
healthy participants in the nurses' health study who live in the greater boston metropolitan area.

Keywords: osteoporosis lead
greater occipital nerve pulsed radiofrequency for the treatment of combined migraine and cervicogenic headache (new approach)

Conditions: Greater Occipital Nerve; Pulsed Radiofrequency

Summary: combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis

traditional treatment approaches for these headaches often include pharmacological interventions, but in cases of refractory or inadequate response, interventional techniques targeting the greater occipital nerve (gon) have gained attention. radiofrequency ablation (rfa) has gained recognition as a potential therapeutic option for patients with refractory combined migraine and cervicogenic headaches. the proximal and distal ultrasound-guided approaches are widely utilized for gon rfa. these approaches aim to disrupt pain signals transmitted by the gon and provide relief of pain for these headache disorders

Eligibility criteria:
inclusion criteria: * patients diagnosed with combined migraine and cervicogenic headache according to the international classification of headache disorders (ichd) * age between 18 and 65 years. * willingness to participate and provide informed consent exclusion criteria: * previous neurosurgical procedures for headache management. * patients with contraindications for the rf technique * pregnancy or lactation * history of psychiatric disorders or substance abuse
a study to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

Conditions: Diabetes Mellitus; Hypertension

Summary: the purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension


Eligibility criteria:
inclusion criteria: * those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated trudapa tab. or trudapa m sr tab. * those who voluntarily signed a written personal information agreement to participate in this clinical study. * those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion. exclusion criteria: * patients with secondary hypertension: secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing's syndrome and polycystic kidney disease, etc.) * those who have a history of taking dapagliflozin within 4 weeks of baseline (visit 1) * those who are expected to need insulin prescription during the study period * pregnant women, breast-feeding women
epidemiological and molecular colorectal cancer registry

Conditions: Colorectal Neoplasms; Colorectal Cancer

Summary: this is a registry that invites patients undergoing colorectal surgery for colorectal cancer. epidemiological data is collected. the registry includes tumor tissue and blood banks for analyzing different genetic mutations and disease-specific biomarkers.

this is a registry that invites patients undergoing colorectal surgery for colorectal cancer. epidemiological data is collected. the registry includes tumor tissue and blood samples banks used to studied different genetic variants and disease-specific biomarkers present in patients with lynch syndrome and others hereditary cancers. the aim of this registry is to set up the necessary resources to help basic and clinical research projects on colorectal cancer (crc) within the hospital italiano de buenos aires (hiba) and promote scientific collaborations between the hiba and other institutions within and outside the country. to make this project, the following specific goals are proposed: objective 1: establishment of an efficient algorithm to enroll patients diagnosed with crc from hiba, through collaboration between the services of surgery, gastroenterology, pathology, oncology, institute of translational medicine and biomedical engineering (imtib), medical clinic and medical informatics. objective 2: development of logistics for the connection and expansion of the bank of biological samples (dna, serum) and tumor samples (tissue fixed in formalin, frozen tissue) to the crc. objective 3: development of computer software to record data about patient enrolled in a dynamic way. objective 4: development of pipelines and create a supervisory committee to regulate the future of samples and data obtained through the registry, accord the current standards of ethical code, and improve the current collaborations with foreign researchers.

Eligibility criteria:
inclusion criteria: * adult patients undergoing colorectal surgery for colorectal cancer. exclusion criteria: * unwillingness to participate.
expanded access /compassionate use protocol for relapsed or refractory cd33 positive aml patients in the usa without access to comparable or alternative therapy

Conditions: CD33 Positive Acute Myelogenous Leukemia

Summary: an expanded access/compassionate use protocol that allows access to mylotarg for relapsed/refractory aml cd33 positive patients in the usa. contact: b1761026@iconplc.com

contact: b1761026@iconplc.com

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of relapsed/refractory aml (defined as \>=5% marrow blasts by morphology), including mds, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. if bone marrow has \<5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. in select cases presenting with conversion of mrd from negative to positive, treatment with go may be allowed where no alternative treatments are feasible. or * confirmed diagnosis of relapsed or refractory apl with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available. * documentation that malignant cells express cd33 4) age \>=3 months 5) adequate non-hematologic organ function exclusion criteria: * untreated aml and mds or aml and mds in complete remission. * patients with a known history of vod/sos. * patients with a known hypersensitivity to mylotarg or its parts: hp67.6 antibody, calicheamicin derivatives or other ingredients. * participation in other studies involving investigational drug(s) (phases 1-4) during study participation.

Keywords: relapsed cd33 aml refractory cd33 aml relapsed cd33 apl refractory cd33 apl relapsed cd33 mds refractory cd33 mds
comparing transperineal to transrectal mri-us fusion prostate biopsy

Conditions: Prostate Biopsy

Summary: this will be a prospective cohort trial that compares transperineal to transrectal mri-us fusion prostate biopsy

this will be a prospective cohort trial that compares transperineal to transrectal mri-us fusion prostate biopsy among men. the target population are males that are schedule to undergo mri-us fusion prostate biopsy and have an mri of the prostate. all the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous mri imaging, and defined as region of interest (roi). first the prostate biopsy will be preformed in a transperineal approach; then a transrectal approach would be used to sample a few more cores. the primary endpoint will be to compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-mri-fusion/trus biopsies. additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-mri-fusion/trus biopsies.

Eligibility criteria:
inclusion criteria: 1. men who are scheduled to undergo, transrectal or transperineal biopsy and have an mri of the prostate. • either primary biopsy or repeated biopsy 2. age 18-90. 3. pi-rads classification of 3-5 exclusion criteria: 1. men who do not have an mri of the prostate. 2. pi-rads classification of 2 or lower 3. men who were diagnosed with prostate cancer and have begun treatment

Keywords: prostate cancer transperineal mp-mri-fusion/trus biopsies mp-mri fusion/trus transrectal biopsy
effects of raloxifene on the uterus and ovaries of premenopausal patients

Conditions: Breast Cancer; Breast Neoplasm

Summary: this research study is designed to work in cooperation with another study being conducted by the national cancer institute. the national cancer institute (nci) is studying the effects of a drug called raloxifene on premenopausal women believed to have a high risk of developing breast cancer (98-c-0123). in this study, researchers are interested in learning about the effects of raloxifene on the uterus and ovaries of the women participating in the nci study. to do this researchers plan to conduct ultrasounds on the patients enrolled in the nci study. in addition researchers plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if found to be necessary. the purpose of this study is to determine the reproductive effects of raloxifene on women who have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus (endometrium).

raloxifene is a selective estrogen receptor-modulating agent that has been recently approved by the fda for the treatment of osteoporosis in postmenopausal patients. a phase ii trial evaluating the safety and efficacy of raloxifene in premenopausal patients at high risk for developing breast cancer has been recently approved by the irb (98-c-0123). in this protocol, for assessment of the effects of raloxifene on the endometrium and ovaries, patients are scheduled to be studied with transvaginal sonography and hysterosonography, once during their menstrual cycle at periodic intervals. they are also scheduled to have endometrial biopsies as indicated. it is known that all serms (clomiphene, tamoxifen and in one small study raloxifene) raise the area under the curve of estradiol levels throughout the cycle in premenopausal women. our study is designed to study the reproductive effects of raloxifene in these young women with competent ovaries using sonography of the ovaries and endometrium, and correlating it with steroid hormone levels which would be obtained under protocol 98-c-0123.

Eligibility criteria:
women must be enrolled in nci study 98-c-0123.

Keywords: sonohysterography color doppler sonography endometrium gynecologic menstrual cycle premenopause
the influence of preoperative cardiopulmonary capacity on the perioperative lactate level

Conditions: Sensitivity Training Groups; Complication, Cardio-respiratory

Summary: the aim of this study is to identify if there exists a correlation between the preoperative cardiopulmonary capacity - measured in met's - and the perioperative lactate serum level.

the determination of the cardiopulmonary (c/p) capacity is very important for the evaluation of every patient undergoing surgery. the ability to climb at least two flight of stairs is seen to be an acceptable c/p capacity for surgery. there are several ways to evaluate the fitness of patients. a common method to estimate the cardiopulmonary capacity is defining patients through the met's (metabolic equivalents) scale. met's can be defined relatively easy through a simple questionnaire. patients with a reduced c/p capacity have less than 4 met's, patients with a relatively good c/p capacity have 4-10 met's and patients with a excellent c/p capacity have more than 10 met's. the lactate level in blood serum is a common parameter to asses anaerobic metabolism in patients. a high lactate level correlates with higher mortality rates and outcome. to yet it is not clear if there exists a correlation between the preoperative cardiopulmonary capacity measured in met's and the perioperative lactate level. we hypothysed that patients with a reduced cardiopulmonary capacity are associated with higher perioperative lactate levels, as these group of patients compensate the stressors operation/anesthesia less than patients with a good c/p capacity.

Eligibility criteria:
inclusion criteria: * age \> 18 years exclusion criteria: * cardiac surgery
mr characterisation/localisation of breast cancer

Conditions: Breast Cancer

Summary: objective: to determine the accuracy of multi-functional magnetic resonance (mr) in detecting, localising and characterising satellite lesions in relation to an index breast tumour in order to improve definition of clinical target volume after local excision. hypothesis: pre-operative multi-functional mr has high sensitivity and specificity for localising unsuspected multifocal and multicentric lesions in women diagnosed with early breast cancer.


Eligibility criteria:
inclusion criteria: * biopsy proven invasive ductal carcinoma of the breast * unifocal disease * patient proceeding to mastectomy exclusion criteria: * multifocal disease * previous surgery to ipsilateral breast * neoadjuvant chemotherapy * ferromagnetic implants * claustrophobia * cup size dd or greater
post-marketing safety surveillance of compound kuh-seng injection: a registry study

Conditions: Safety Surveillance; Adverse Drug Events; Adverse Drug Reactions; Severe Adverse Events; Severe Adverse Reactions

Summary: this registry aims to monitor the safety of compound kuh-seng injection and to identify the potential risk factors for the adverse drug reactions. compound kuh-seng injection is a kind of natural compound injection extracted from herbs kuh-seng (radix sophorae flavescentis) and rhizoma heterosmilacis japonicae.


Eligibility criteria:
inclusion criteria: * patients who use compound kushen injection in the monitoring hospitals exclusion criteria: * none
the clinical trial to investigate the pharmacokinetics and safety/tolerability of ckd-375

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of ckd-375 and d387 in healthy adults.


Eligibility criteria:
inclusion criteria: 1. healthy adults aged 19 to 55 years 2. females who are not pregnant or breastfeeding or who have surgical infertility 3. signed informed consent form 4. other inclusion criteria, as defined in the protocol exclusion criteria: 1. history of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder 2. clinical laboratory test values are outside the accepted normal range at screening 3. current smokers or those who cannot quit smoking during the period from 90 days before the first ip dosing to the last discharge. 4. subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first ip dosing to the last discharge. 5. participated in a clinical trial within 90 days prior to 1st ip dosing 6. not eligible to participate for the study at the discretion of investigator 7. other exclusive inclusion criteria, as defined in the protocol
hrqol in prostate cancer patients treated with radiotherapy

Conditions: Prostate Cancer

Summary: the study primarily aims at evaluating health-related quality of life after radiotherapy for prostate cancer, using modern hypofractionated radiotherapy schedules. study design is a prospective observational cohort study. all patients give written informed consent and fill out online validated questionnaires before, during, and after radiotherapy (yearly) up to 5 years post-treatment.

rationale: patient-reported outcomes (pros), such as health-related quality of life (hrql), have achieved an important role in the evaluation of benefits and harms after cancer treatment, including radiotherapy for prostate cancer (pca). in the past year, clinical radiotherapy protocols at the erasmus mc have been changed for external beam radiotherapy (ebrt) as well as for brachytherapy (bt). in order to evaluate the current, changed, clinical practice, we will conduct a prospective cohort study, with the main purpose to assess hrql for the current treatment options at the erasmus mc. objective: to establish hrql (start treatment - 5 years after treatment) in a prospective cohort of ≈600 patients with localized pca treated with radiotherapy within in the period ≈ 1/3/2019 - 1/12/2023. main objective: to establish changes in hrql levels (with respect to baseline) up to 5 year post-treatment, within each radiotherapy modality for prostate cancer patients, i.e. ebrt 60 gy in 20 fractions, ebrt 42.7 gy in 7 fractions, cyberknife (stereotactic ebrt) 38 gy in 4 fractions, bt 27 gy in 2 fractions, postoperative ebrt (port) 72 gy in 36 fractions, ebrt for ln+: 70 gy (prostate)/52 gy (lymph nodes) in 28 fractions. study design: prospective observational cohort study. study population: patients with prostate cancer t1c-t4 referred for radiotherapy at the erasmus mc as a primary treatment with curative intent or as first line adjuvant treatment after a prostatectomy. intervention: all interventions are according to applicable standard clinical procedures \& protocols for localized prostate cancer of the radiotherapy department. main study parameters/endpoints: hrql scores of the epic (urinary domain, bowel domain), and the iief-5 (sexual function) score. nature and extent of the burden and risks associated with participation, benefit and group relatedness: there are no additional risks or benefits for patients that participate in the study. the additional burden is to fill out questionnaires at regular intervals.

Eligibility criteria:
inclusion criteria: * clinically t1c-t4, n0 (or n+ in case of ebrt-ln+), m0 prostate cancer patient referred for radiotherapy. * willing and capable to fill out dutch questionnaires on health-related items at a computer (online questionnaires). * signed written informed consent. exclusion criteria: * previously radiation treatment in the pelvic region, for any reason. * diagnosed with other tumor in the past 12 months or known with tumor progression of another tumor. * postoperative radiotherapy with dose levels \< 72 gy.

Keywords: prostate cancer radiotherapy hypofractionation health-related quality of life