Kornimate/medical-research-clean huggingface dataset:
influence of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma and postoperative analgetic consumption in patients with total hip prosthesis implantation

Conditions: Muscle Relaxation; Muscle Trauma; Analgetic Consumption; Total Hip Replacement

Summary: the researchers want to investigate the effects of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma (serum ck, crp) and postoperative analgesic consumption in patients with total hip prosthesis replacement (general vs. spinal anaesthesia).


Eligibility criteria:
inclusion criteria: 1. patient agreement 2. indication for total hip replacement 3. age 55 - 80 years 4. weight 65 - 95 kg 5. first intervention 6. asa classification i - iii 7. general and spinal anaesthesia possible in this patient exclusion criteria: a) neuromuscular diseases b) surgery with muscle trauma (within the last 3 months) c) permanent immobility d) intramuscular injections (within the last 4 weeks) e) medication with opioids f) medication with co-analgetics g) contraindications for general or spinal anaesthesia h) dementia, cognitive dysfunction or sleep apnea -
to explore the treatment effect of various commercially available statins on patients with hyperlipidemia

Conditions: Hyperlipidemias

Summary: the primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. surveillance data (lipid profile) will be collected during course of usual clinical practice or captured upon its availability.


Eligibility criteria:
inclusion criteria: * patients diagnosed with hyperlipidemia * patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians * patients who are willing to participate in this study and who sign an informed consent form exclusion criteria: * pregnancy or breast feeding * patient are illiterate or unable to fill the questionnaire for any reason * patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin. * any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications

Keywords: statin ldl-c
prolapse and pregnancy assessment

Conditions: Pelvic Organ Prolapse

Summary: pelvic organ prolapse (pop) is one of the most common indications for gynaecological surgery. in 1997, more than 225000 inpatient surgical procedures for pop were undertaken in usa (22.7 per 10000 women) at an estimated cost of more than one billion dollars. in the uk, the disorder accounts for 20% of the women on the waiting list for major gynaecological surgery. vaginal birth, advancing age and increasing body mass are the most consistent risk factors. furthermore a racial and congenital predisposition has been reported. the cause of this disorder is likely to be multifactorial and attributable to a combination of factors, varying from patient to patient. controversy exists as to whether the pregnancy per se rather than the mode of delivery alters the risk of pop. caesarean section appears to protect against the development of prolapse. however, when a caesarean section is undertaken during the active stage of labour it may not be completely protective. ideally prospective longitudinal studies are needed to study the impact of pregnancy and childbirth on pelvic organ prolapse. unfortunately, studies to date, are small with poor follow-up and have only assessed objective outcome rendering it difficult to draw conclusions. the primary objective of our study was to objectively assess the impact of pregnancy and childbirth on pelvic organ support using the pelvic organ prolapse quantification (popq)system.


Eligibility criteria:
inclusion criteria: * singleton pregnancy exclusion criteria: * multiple pregnancies * previous prolapse surgery * medical disorders including diabetes mellitus * inflammatory bowel disease * collagen disorders

Keywords: prolapse childbirth pregnancy
phase 1 trial of endobronchial ultrasound-guided transbronchial needle injection of cisplatin for stage iv lung cancer

Conditions: Lung Cancer Metastatic

Summary: the goal of the study is to identify the maximum tolerated dose of endobronchial ultrasound-guided transbronchial injection (ebus-tbni) of cisplatin for stage iv lung cancer.

multiple studies have demonstrated feasibility and safety of delivering cisplatin directly into lung tumors using endobronchial ultrasound guided-transbronchial needle injection (ebus-tbni). this technique relies on the use of a bronchoscope with an integrated ultrasound transducer allowing real-time visualization of, and delivery of cisplatin into, tumors lying in proximity to the central airways. prior work has utilized this technique to treat loco regional recurrence in a previously radiated field. the goal of the current study is to identify the initial dose for intratumoral cisplatin.

Eligibility criteria:
inclusion criteria: age 18 years or above eastern cooperative oncology group (ecog) performance score 0-2 have known or suspected metastatic nsclc at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded based on 8.2 below). ability and willingness to provide informed consent rapid on-site cytopathologic examination (rose) performed during the procedure returns likely nsclc (informed consent will occur prior to the procedure). no research procedures will be performed if rose is non-diagnostic. a ct scan of the chest (with or without contrast) within the prior 3 months. the presence of an ebus accessible target site. these may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by ebus patients must have adequate organ and marrow function as defined below: * leukocytes ≥3,000/mcl * platelets ≥100,000/mcl * total bilirubin ≤ institutional upper limit of normal (uln) * ast(sgot)/alt(sgpt) ≤ institutional uln * glomerular filtration rate (gfr) ≥60 ml/min/1.73 m2 via ckd epi) patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial exclusion criteria: use of an investigational agent in prior 30 days pregnancy/lactation treatment with cytotoxic chemotherapy within the past 30 days prior (within the last 12 months) or ongoing radiation treatment to the study nsclc allergy to cisplatin or its derivatives patient not appropriate for the research study based on physician discretion
imetelstat in combination with paclitaxel (with or without bevacizumab) in patients with locally recurrent or metastatic breast cancer

Conditions: Locally Recurrent or Metastatic Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.

patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.

Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed adenocarcinoma of the breast that is either locally recurrent or metastatic. locally recurrent disease must not be amenable to surgical resection or radiation with curative intent * either have not received chemotherapy or may have had one prior non-taxane chemotherapy regimen for metastatic disease (there are no restrictions on prior hormonal therapy) * prior use of bevacizumab is allowed provided that it was not administered in combination with a taxane * ecog performance status 0-1 * adequate bone marrow reserve as indicated by: * anc \> 1500/ul (without use of growth factors within 7 days) * platelet count \> 100,000 (without transfusion in prior 7 days) * hemoglobin \> 9.0 g/dl exclusion criteria: * women who are pregnant or breast feeding * locally recurrent disease amenable to resection with curative intent * her-2-positive breast cancer * active central nervous system (cns) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months) * prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse * investigational therapy within 4 weeks of first study drug administration * prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration * therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed) * grade ≥ 2 neuropathy * uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place) * severe conduction disturbance including clinically significant qtc prolongation \> 450 ms (unless pacemaker in place) * active or chronically recurrent bleeding (e.g., active peptic ulcer disease) * clinically relevant active infection * known positive serology for human immunodeficiency virus (hiv)

Keywords: imetelstat imetelstat sodium grn163l telomerase inhibitor telomerase inhibition metastatic breast cancer locally recurrent breast cancer bevacizumab paclitaxel avastin taxol her-2-negative first-line chemotherapy second-line chemotherapy
improving cervical cancer screening in women living with hiv attending chronic disease clinics in semi-rural tanzania

Conditions: Cervical Cancer Screening

Summary: this study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the kilombero and ulanga antiretroviral cohort (kiularco), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). it is to assess the performance of two novel diagnostic tests (quantigene-molecular profiling histology (qg-mph) and pt monitor® immunoassay) and established tests (seegene anyplex™ ii 28 hpv test and prevo-check®) as potential triage tests for the development of future clinical decision algorithms for cc screening.

cervical cancer (cc) is the most common cancer among women living with hiv (wlwh) and the leading cause of cancer-related death in women in east africa. currently there are around 2800 wlwh in care at the chronic disease clinic of ifakara (cdci), of whom only 8% attended cc screening services in the last three years. this research project is to assess (with a mixed-method, before-/after-study) the impact of a bundle of procedures, which consists of: portable colposcopy, human papilloma virus (hpv) testing and treatment of precancerous cervical lesions by loop electrosurgical excision procedure (leep). this study is also to analyze the prevalence of cervical disease in the cohort, stratified by stage and co-infections, as well as the acceptability, feasibility and costs. additionally, it will assess the performance of two novel diagnostic tests (qg-mph and pt monitor® immunoassay) and established tests (seegene anyplex™ ii 28 hpv test and prevo-check®) as potential triage tests for the development of future clinical decision algorithms for cc screening. this is an implementational study nested within the kiularco study consisting of two interacting parts: a pre/post assessment of the impact of the bundle of interventions with mixed-methods study design and the diagnostic tests accuracy (evaluated with a cross-sectional study). the treatment investigated is regarded as standard treatment.

Eligibility criteria:
inclusion criteria: * wlwh enrolled in kiularco, who are at least 3 months on anti-retroviral treatment (art) * 18-65 years of age * non-pregnant (reported) * signed informed consent exclusion criteria: * pregnancy * known invasive cervical cancer * any condition interfering with visualization of the cervix

Keywords: women living with hiv (wlwh) cervical cancer cervical cancer prevention clinic cervical intraepithelial neoplasia human papilloma virus human immunodeficiency virus squamous intraepithelial lesion kilombero and ulanga anti-retroviral cohort quantigene-molecular profiling histology
a study to evaluate jak inhibitor cream in egfr-inhibitor-induced skin rash

Conditions: Acneiform Eruptions

Summary: epidermal growth factor receptor inhibitors (egfris) are widely used targeted agents that have been approved for the treatment of various tumor types. in some clinical studies with egfris, the incidence of dermatology ae, the skin rash, is reportedly as high as 95%, which profoundly impact the patients' quality of life. however no treament for onset skin rash has been approved to be effective by any clinical trial yet. janus kinase (jak) inhibitor, has been approved for or studied in a variety of skin conditions such as alopecia areata, atopic dermatitis, and psoriasis. thus the investigators intend to evaluate the efficacy and safety of jak inhibitor cream for the treatment of egfris-induced skin rash in cancer patients.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * pathologically conﬁrmed cancer receiving egfri-based therapy (monotherapy or as part of a combination therapy regimen). * skin rash causally related to egfri therapy of grade 1 or higher (according to mestt criteria). * ecog performance score \< 2. * able to use topical medications and complete questionnaires reliably with or without assistance. * life expectancy of greater than 6 months. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * use of any other topical medications in the treatment areas (face) within 7 days prior to randomization or duing the study. * use of tetracycline (e.g. minocycline, doxycycline) within 14 days prior to randomization or duing the study. * use of other cancer medications known to result in skin rash in the face or upper chest/upper back area within 4 weeks prior to randomization or duing the study. * known hypersentitivity to jak inhibitors. * with other skin disorders that may affect efficacy evaluation, including but not limited to: eczema, psoriasis, etc. * uncontrolled intercurrent illness. * significantly abnormal lab test. * pregnant or nursing women.

Keywords: egfr acneiform rash
irinotecan liposome(ii) combined with ivonescimab as second-line treatment for small cell lung cancer : a prospective, single-arm, multicenter clinical study

Conditions: SCLC

Summary: this study will evaluate the efficacy and safety of irinotecan liposome(ii) in combination with ivonescimab as second line treatment for sclc.

this is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of irinotecan liposome(ii) in combination with ivonescimab as second line treatment for sclc who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. histologically or cytologically confirmed sclc; 3. advanced sclc who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors; 4. the eastern cancer cooperative group (ecog) performance score of 0 or 1; 5. life expectancy of ≥3 months; 6. at least one measurable lesion is present according to the efficacy evaluation criteria for recist 1.1（lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions） 7. no untreated central nervous system (cns) metastases or cns were stable for ≥1 month after treatment 8. have adequate organ function; 9. all female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug. 10. able and willing to provide a written informed consent; exclusion criteria: 1. known allergy to irinotecan hydrochloride liposome injection (ii) and eboxizumab or drug excipients 2. history of severe active autoimmune disease 3. participated in other drug studies within 4 weeks before enrollment 4. imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk 5. history of major illness within 1 year before the first medication 6. history of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration 7. history of surgery or severe trauma within 4 weeks prior to initial dosing 8. evidence and history of severe bleeding tendency; 9. participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment 10. patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix 11. history of alcohol abuse, psychotropic substance abuse or drug abuse. other conditions considered unsuitable for this study by the investigator.

Keywords: sclc，irinotecan liposome(ii)，ivonescimab
clinical efficacy of a diabetes educational program to improve flash adherence in type 1 diabetes patients

Conditions: Type 1 Diabetes

Summary: prospective observational study to analyse the clinical effectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (icgm) adherence in adult type 1 diabetes (t1d) patients

cross-sectional prospective analysis of clinical efectiveness of a diabetes educational program to improve intermittently continuous glucose monitoring (icgm) adherence in adult type 1 diabetes (t1d) patients. glycometric data obtained through deidentified downloads from iscgm´s webpage. primary outcome was time in range (tir) 3.0-10 mmol/l (70-180 mg/d) change after the heatwave. data analysis is conducted using spss (chicago, il) statistics software. results are presented as mean ± sd values or percentages. a paired student's t-test or a wilcoxon signed-rank test were used for the analysis of differences. comparisons between proportions were analyzed using a chi-squared test. a p value \< 0.05 was considered statistically significant. the protocol was approved by the reference castilla-la mancha public health institute ethic committee (c-558).

Eligibility criteria:
inclusion criteria: * type 1 diabetes * flash user for at least 6 months. * treatment with multiple daily insulin injections (mdi). * daily scan flash frequency 4 or less exclusion criteria: * other types of diabetes * other types of diabetes treatment different from mdi (pe insulin pump)
epidemiology of decline in heart disease mortality

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to continue a study of premature coronary heart disease mortality among men and women aged 35-54 in allegheny county, pennsylvania.

background: the decline in coronary heart disease mortality apparently began around 1963 in the united states and increased in intensity in later years. in the 35-44 age groups the decline began somewhat later, perhaps around 1968. the decline has been found in all four race sex groups and in all age groups including the very old. this decline has also been noted in many other countries besides the united states. the decline of coronary heart disease mortality could obviously be a function of either a change in incidence or in case fatality or both. during the time of this decline in coronary heart disease mortality a great many changes were occurring both in the care of the cardiac patients and changes in risk factors. the fact that the decline occurred across all age as well as race, and sex groups as well as in many other countries suggested that one single factor may not have accounted for the decline. it was very unlikely that the decline of sudden death was due to improved out-of-hospital care or an early recognition of symptoms. the three percent per year decline suggested that acute precipitating factors other than the underlying atherosclerosis were the most likely factors to account for the decline, especially in the younger age groups of men. the study was designed to evaluate whether the decrease in coronary heart disease mortality was real or due to an artifact of certification practices or accuracy of diagnosis. the design was based on the fact that the best opportunity to study the decline was in the 35-44 age group. design narrative: a retrospective review was made of all death certificates certified to coronary heart disease, all other cardiovascular deaths, and all non-traumatic but possibly sudden deaths certified by the coroner. the review included autopsy records, coroner's reports, hospital records, information from certifying physicians, and interviews with next-of-kin or witnesses. a determination was made of the contribution to the decline of out-of-hospital sudden death and prior history of heart disease, other diseases, and possibly cigarette smoking. the changing mode of death for in-hospital deaths was also evaluated. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
observational study on safety and efficacy of biphasic insulin aspart in type 2 diabetes patients

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of biphasic insulin aspart under routine clinical practice conditions in israel in type 2 diabetes patients.


Eligibility criteria:
inclusion criteria: * any patient with type 2 diabetes who has hba1c greater than 7% on insulin with or without oad and who needs intensification of treatment with either novomix® 30 or novomix® 50 or novomix® 70 or combinations, will be eligible exclusion criteria: * subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. particular attention should be paid to the drug interactions that are listed within the product local label. * women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.