Kornimate/medical-research-clean huggingface dataset:
a non-interventional study of diafer in subjects with ckd on haemodialysis for treatment of iron deficiency

Conditions: Anaemia in Chronic Kidney Disease

Summary: the purpose of the study is to monitor initiated diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in haemodialysis patients with chronic kidney disease.

parenteral iron is the iron treatment of choice for haemodialysis (hd) patients with chronic kidney disease (ckd), who may suffer from absolute iron deficiency due to continuous blood losses and/or functional iron deficiency due to erythropoiesis stimulating agent treatment or impaired release from iron stores. much evidence indicates that adequate iron supply is necessary to achieve optimal responses to esas and thereby potentially avoid esa induced adrs. pharmacosmos has been working with dialysis providers for many years and identified a medical need for a new safe and cost-effective low dose intravenous (iv) iron that can be administered frequently. diafer® is a new low dose iron formulation based on iron isomaltoside 1000, with doses restricted to maximum 200 mg iron pr. injection. no test dose is needed and diafer® may be administered as a push injection. the primary objective of the study is to monitor initiated diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in hd patients with ckd. the scientific rationale being to fulfil a need for systematic information/auditing on applied practice including long term experience with the use of iv iron in the hd setting. this information will provide an evidence base for optimised treatment procedures.

Eligibility criteria:
inclusion criteria: * hd patients ≥ 18 years of age in a stable phase of ckd as judged by the investigator * patients must have been on hd \> 3 months * patients must have received at least one dose of iron sucrose treatment within the last 6 months exclusion criteria: * diafer® contraindications * patient not able to give informed consent * significant disease not related to ckd and likely to impact study results as evaluated by investigator * inability to estimate retrospective baseline data * planned change of iron dosing protocol or routines around iron administration during the study
genotype-guided warfarin individualized treatment

Conditions: Atrial Fibrillation; Deep Venous Thrombosis

Summary: the purpose of this study is to determine whether the international pharmacogenetic algorithm is better than the standard initiation dosing and whether the two algorithms are suitable for chinese elderly patients.

the study protocol is a multicenter, randomized, patient-blinded and controlled trial, comparing two approaches among 864 enrolled af(atrial fibrillation) or dvt(deep venous thrombosis) patients for guiding warfarin initial anticoagulation in chinese elderly patients: the intervention group using the algorithm of international warfarin pharmacogenetic consortium and its dose revision, and the control group using a standard initiation dose (2.25 mg).the study hypothesis is that the intervention group relative to the control group will increase the percentage of time in therapeutic inr (international normalized ratio) range during the first 3 months.this trial is the first prospective large-scale randomized controlled trial for elders in china. it is of great significance for promoting special crowd individualization of anticoagulants at home and abroad.

Eligibility criteria:
inclusion criteria：1) chinese male or female aged ≥18 years; 2) requiring at least 12-week warfarin therapy as judged by clinicians; 3) subjects with dvt/af and a post-therapy target inr of 1.5-2.5; 4) capable of providing written informed consent; 5) capable of maintaining excellent communications with investigators and completing trial in accordance with trial stipulations. exclusion criteria：1) subjects previously taking warfarin; 2) known genotypes of cyp2c9 or/and vkorc1; 3) subjects receiving or expecting to receive other therapies or other anticoagulants; 4) subjects with contraindications for warfarin; 5) subjects with severe cognitive dysfunctions; 6) baseline inr ≥1.5; 7) subjects with drug or alcohol dependence within the last 12 months; 8) subjects receiving blood transfusion or bone marrow transplantation within the last 2 weeks; 9) planning to receive invasive examinations (except for standard endoscopy) with a hemorrhagic tendency or undergoing surgery during trial.10) prior to randomization, subjects receiving any trial drug or device within the last 3 months or planning to receive such an investigational therapy during trial; 11) subjects with the following diagnoses or conditions: active malignant carcinomas (diagnosed within the last 5 years), but excluding adequately-treated non-melanoma skin cancer or other non-invasive or in situ cancer (e.g. cervical cancer in situ); anti-neoplastic therapy within the last 5 years (medication, radiotherapy or/and surgery); overt active disease or infection; life expectancy \<6 months; 12）other clinical reasons for unsuitable recruitment as judged by clinicians.

Keywords: af or dvt age over 18 years, acquired
personalized medicine in early stage colorectal cancer: organ preservation and immune benefit

Conditions: Colorectal Cancer

Summary: the overall aim of this study is to determine whether the immunoscore associated with histopathological features of endoscopically resected stage t1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

the frequency of stage t1 superficial colorectal cancer (crc) is around 15% and its incidence increases. in france, t1 superficial ccr is mostly treated with endoscopic submucosal dissection (esd), offering potentially curative, organ-preserving treatment. the presence of pejorative histological criteria (eg. poor differentiation, budding, lymphovascular invasion), detected in about 50% of the tumors, leads to a secondary colectomy or rectal resection with postoperative complications and significant digestive, urological, and sexual functional sequelae. strikingly, secondary surgical resection is performed in excess in 70 to 80% of the cases, given that no tumor is evidence in the colon and draining lymph nodes. organ preservation (no secondary surgery) could be offered to a larger number of patients if biomarkers could complete the histological evaluation to better predict metastatic extension to lymph nodes. our team showed that the type, density, and location of immune cells in crc strongly correlated with patients' survival at all disease stages. our team created an "immunoscore" (is) assay, based on cd3+ and cytotoxic cd8+ t-cell densities determined by digital pathology in the tumor and its invasive margin. the robustness and prognostic performance of is was validated in crc . sub-analysis of t1 tumors was not possible (only 31 cases) and tumor specimens did not result from endoscopic resection. the objective of the study is to determine whether the immunoscore associated with histopathological features of endoscopically resected stage t1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) * patient with stage t1 colorectal tumor * treated by endoscopic resection between 2014 and 2019 in one of the participating sites * sample of the resected tumor available for central analysis exclusion criteria: * other synchronous cancer * synchronous crc

Keywords: immunoscore tumor biomarkers organ preservation endoscopic submucosal dissection
propofol versus alfentanil versus nitrous oxide for moderate procedural sedation

Conditions: Sedation

Summary: this is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ed).

this was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Eligibility criteria:
inclusion criteria: * adults undergoing moderate procedural sedation in the emergency department exclusion criteria: * age \<18 years * pregnancy * intoxication * cannot give informed consent * allergy to any of the three study medications * asa physical status score \> 2 * patients who require deep procedural sedation

Keywords: propofol alfentanil nitrous oxide moderate procedural sedation moderate procedural sedation in the emergency department
seroquel xr in schizophrenia relapse prevention

Conditions: Schizophrenia Relapse Prevention

Summary: the purpose of the study is to determine whether the seroquel xr treatment for 6 months improve the relapse prevention in schizophrenic outpatients


Eligibility criteria:
inclusion criteria: * schizophrenic outpatients on at least 600 mg seroquel xr treatment for at least 1 month exclusion criteria: * severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity

Keywords: seroquel xr schizophrenia relapse prevention
pain and physical fitness in primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization in primary dysmenorrhea.

primary dysmenorrhea (pd) is a condition that occurs just before or during menstruation and is accompanied by cramp-like pain in the lower abdomen, without any pelvic pathology. pain usually begins just before or during menstruation and ends within 12-72 hours. most women with pd describe their menstrual pain as moderate to severe, which significantly affects their activities of daily living and school and work performance. in pd, functions and activities of daily living are also affected due to pain and other hormonal changes. studies have reported that musculoskeletal problems such as decreased spinal mobility, pelvic stability and postural control are observed in women with dysmenorrhea. the aim of this study is to evaluate pain and physical fitness parameters such as balance, muscle strength, and core stabilization during the menstruation and on a non-menstrual day of the cycle, in primary dysmenorrhea.

Eligibility criteria:
inclusion criteria: * between the ages of 18-25 * body mass index of 18-25 kg/m2 * having a regular menstrual cycle (28±7 days) * for the pd group; pain level \>5 according to vas during menstruation * for the control group; having a vas score of 5 or less exclusion criteria: * having given birth before * using an intrauterine device * having a health problem that causes chronic pain * having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder * being diagnosed with a gynecological or pelvic disorder such as endometriosis, ovarian cyst * having a history of abdominal or gynecological surgery within the last year * being on oral contraceptive use/hormonal therapy or antidepressant treatment * having used painkillers 12 hours before the evaluation * participating in a regular exercise program
description of the ability to learn how to handle inhaler devices in asthma

Conditions: Asthma

Summary: asthma is a major public health problem. the main treatments against asthma are delivered to the lung through several dry-powder inhaler such as turbuhaler ®, diskus® and the new ellipta® device. in real life, patient's ability to handle a device is not routinely assessed by their practitioner. we hypothesized that many asthmatics cannot properly prepare and prime their device, which may alter the positive effects observed in clinical trials.

the main objective of this study is to describe the handling of inhaler devices (diskus®, turbuhaler® and ellipta®) in patients with asthma. all participants will use each inhaler device (diskus®, turbuhaler® and ellipta®) daily for one week: * two puffs per day (diskus® and turbuhaler®), * one puff per day (ellipta®). at each visit (day 1, 8, 15 and 22), patients will have a physical exam. for each inhaler device, 4 video recordings will be performed: * video recording #1: inhalation (one puff) without any instruction of use. * video recording #2: inhalation (one puff) after reading the patient information leaflet. * video recording #3: inhalation (one puff) after watching a standardized video demonstrating correct inhaler technique. * video recording #4: inhalation (one puff) after seven days of daily use. the patient will be asked to fulfill a satisfaction survey about each inhaler device.

Eligibility criteria:
inclusion criteria: * male or female aged more than 18 years * written informed consent * diagnosis of asthma according to international guidelines (gina 2017) * social security or health insurance * women using an effective method of birth control. exclusion criteria: * previous treatment with ellipta®, diskus® or turbuhaler® * asthma exacerbation within 6 weeks before inclusion * subject having close contacts with devices (ellipta®, diskus® or turbuhaler®) users, currently or in the past * severe asthma * hypersensitivity to budesonide * chronic psychiatric disease * medical condition that may affect handling of inhaler devices * subject deprived of his/her liberty * protected adult * subject in exclusion period related to another protocol * pregnant or breastfeeding women.

Keywords: asthma inhaler device handling
diagnosis and characterization of coronary artery stenosis by doppler ultrasound

Conditions: Coronary Stenosis

Summary: the purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the lad with transthoracic pulsed doppler, and to evaluate the diagnostic power of the transthoracic doppler analysis package for detecting and estimating the degree of coronary artery stenosis. finally we hope to optimize the currently available analysis package on the basis of the comparison of the doppler with the angiographic stenosis results and evaluation.


Eligibility criteria:
inclusion criteria: * patients who are clinically suspected of having significant coronary artery stenosis. * patients with cad. * patients who are scheduled to undergo coronary angiography. * signed informed consent. exclusion criteria: * patients with arrhythmia / irregular pulse * patients with unstable conditions: unstable angina, uncontrolled chf * patients with copd * any physical or medical disability that prevent lying in supine position * patients with chest wall deformity

Keywords: doppler coronary stenosis non-invasive testing a prospective study of a new diagnostic method. study consists of a transthoracic doppler of lad. doppler to be performed prior to coronary angiography. f/u doppler examination for those who undergo pci. doppler results will be compared with coronary angiography.
recombinant factor vii for intractable postpartum haemorrhage

Conditions: Post Partum Hemorrhage

Summary: postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed and developing countries .

major postpartum haemorrhage is a dangerous complication that accounts for the highest maternal morbidity rate

Eligibility criteria:
inclusion criteria: * women with severe resistant postpartum hemorage exclusion criteria: * women without postpartum hemorage
trans-perineal trigger point dry needling for chronic pelvic pain

Conditions: Dyspareunia

Summary: chronic pelvic pain (cpp) are around 10% of gynaecology referrals.non-relaxing pelvic floor dysfunction (nrpfd) is an under-appreciated cause for cpp with dyspareunia where no other pathology exists. the effectiveness of manual therapy in studies have shown statistically significant pre and post treatment differences.however no study has reviewed the efficacy of inclusion of trans- perineal trigger point dry needling used with manual therapy for nrpfd. this study will investigate the effectiveness of trans-perineal trigger point dry needling used with manual therapy techniques for cpp.

this study will investigate the effectiveness of inclusion of trans-perineal trigger point dry needling with manual therapy treatment for chronic pelvic pain with dyspareunia and associated pelvic floor dysfunctions.the use of trigger point dry needling (trptdn) for chronic low back pain has proved beneficial.this study will evaluate the treatment outcomes of trans-perineal trigger point dry needling and manual therapy to only manual therapy for cpp. the outcomes will evaluate the number of treatment requirements between the dry needling with manual therapy group and the manual therapy group and review which group has faster resolution in pain and other associated pelvic floor symptoms.

Eligibility criteria:
inclusion criteria: * patients reporting non-cyclical cpp with dyspareunia and associated pfd with no palpable pelvic floor pathology, but with palpable high pelvic floor muscle (pfm) tone and tenderness will be referred for physiotherapy by the gynaecology team. * visceral conditions like interstitial cystitis are difficult to exclude at gynaecology review, as they mimic cpp symptoms. * smokers and non-smokers included. * nulliparous, singleton and multiparous patients. exclusion criteria: * body mass index greater than 30, makes it difficult to dry needle as the required needle length is not available. * chronic back pain over 6 months duration, under pain management team. * orthopaedic back surgeries with implants. * pelvic pathologies like endometriosis, fibroids, cysts, etc. * pregnancy related pelvic pain. * pregnant during the trial. * pelvic organ carcinomas. * undergoing cancer treatment. * post gynaecology surgeries, less than 16 weeks. * cardiovascular, gastroenterology, renal or orthopaedic surgery, less than 6 month's post-operative. * neurological conditions like stroke, epilepsy, parkinson's disease etc. * exclusion criteria for dry needling: * extreme needle phobia, rheumatoid arthritis, prolonged corticosteroid treatment, warfarin treatment, heart implants and blood clotting disorders. * participant with no significant learning disability and should be able to understand the procedure to consent for treatment. * participant should not require a chaperone during treatment.

Keywords: dry needling vulvodynia pelvic pain chronic
trial of a tailored message program to implement chf guidelines

Conditions: Heart Failure

Summary: congestive heart failure is a serious health problem in the united states and is associated with excessive morbidity and mortality. several classes of medications have been shown to improve mortality in patients with chf. despite this these medications are widely under prescribed. guidelines have been shown to improve patient outcomes and several guidelines on the management of chf have been published. implementation of guidelines is challenging and most strategies have focused on changing physician behavior. patient-based interventions have been shown to be effective in implementing guidelines on chf but they have been very labor intensive. a computer based intervention to implement chf guidelines, if effective, would be beneficial.

background: congestive heart failure is a serious health problem in the united states and is associated with excessive morbidity and mortality. several classes of medications have been shown to improve mortality in patients with chf. despite this these medications are widely under prescribed. guidelines have been shown to improve patient outcomes and several guidelines on the management of chf have been published. implementation of guidelines is challenging and most strategies have focused on changing physician behavior. patient-based interventions have been shown to be effective in implementing guidelines on chf but they have been very labor intensive. a computer based intervention to implement chf guidelines, if effective, would be beneficial. objectives: patients with chf consume a significant proportion of healthcare resources, with exacerbations of chf being the second most common reason for medical admission to va medical centers. therefore, the main objective is to understand the impact of a tailored education message program designed for direct use by patients on medical resource use. other objectives include understanding the tools impact on patient compliance and quality of life. methods: patients have been randomized to one of two groups: 1) intervention group or the 2) control group. the intervention group receives the tailored education messages program. this program assesses patients� beliefs about compliance with medications, diet, and self-monitoring. based on identified barriers to compliance, intervention patients receive a tailored educational message to dispel these beliefs and improve compliance. the control group interacts with a generic healthcare website. patients in both groups are monitored for hospitalization; emergent care visits, compliance with prescribed treatment and quality of life status: project work is ongoing.

Eligibility criteria:
inclusion criteria: ef \<40%, getting majority care at the va, not enrolled in another chf study, ability to read english. exclusion criteria:

Keywords: congestive heart failure
a multicentre, retrospective study of clinical characteristics and long-term outcomes of patients with brucellosis

Conditions: Brucellosis

Summary: this is a multicenter, retrospective clinical study, in patients with brucellosis, to analyze the clinical characteristics, complications, and the impact of different treatment options on long-term prognosis of patients with brucellosis. all hospitalized patients diagnosed with brucellosis between 2016 and 2021 were included from the electronic medical record systems of eight centers, collecting demographics, hospitalization information, clinical information, laboratories, imaging studies, treatment regimens, and disease outcome and other information.


Eligibility criteria:
inclusion criteria: * age and gender are not limited; * discharged patients diagnosed with brucellosis * specific reference to the people's republic of china's health industry standard "diagnosis for brucellosis" (ws269-2019) diagnosed as a patient with brucellosis, that is, the patient meets a suspected or clinically diagnosed case and passes the confirmatory test mentioned below at the same time either to prove: 1. brucella is isolated from any pathological material culture such as blood, bone marrow, other body fluids and excreta of patients. 2. the test tube agglutination test (sat) titer is 1:100++ and above, or the patient's course of disease lasts for more than one year and still has clinical symptoms, and the titer is 1:50++ and above. 3. complement fixation test (cft) titer is 1:10++ and above. 4. anti-human immunoglobulin test (coomb's) titer is 1:400++ and above. * volunteer to join this study. exclusion criteria: * history of severe lumbar spine trauma before the diagnosis of brucellosis; * have undergone lumbosacral surgery before the diagnosis of brucellosis; * scoliosis; * currently participating in clinical trials of other drugs or medical devices; * the researchers think it is not suitable for inclusion.