Kornimate/medical-research-clean huggingface dataset:
single-dose vaginal dinoprostone and hysterectomy

Conditions: Hysterectomy

Summary: in this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. the reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect


Eligibility criteria:
inclusion criteria: * • patients presenting for hysterectomy for any benign indication including uterine fibroids. * age ≥ 18 years * pre-operative hemoglobin \>8 g/dl * willing to have dinoprostone or a placebo prior to hysterectomy * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * • patients with known or suspected endometrial/ovarian/cervical cancer. * patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia. * patients currently undergoing treatment for any type of cancer. * patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism) * history of allergic reactions to dinoprostone.
metabolic effects of rowing multi-races events

Conditions: Diet; Nutritional Status; Fatigue; Maximal Exercise

Summary: the aim of this study was to assess the relevance of nri or athletes' nri (anri) utilization to detect nutrition-related risks of failure in competition in the particular population of rowers. in the morning, 60 to 90 minutes before the first race of a national level multi-races competition (three races for each subjects), body weight were measured and blood samples were collected with subjects at rest and in post-absorptive condition (last meal at least 2.5 hours before blood collection). body weight was also recorded in the same conditions six weeks before the competition to calculate weight state (actual weight /usual weight ´ 100) and subjects were asked to identify the date of diet beginning. body weight was measured using a floor scale (mettler-toledo floor scale, france), body mass index (bmi) was calculated from the ratio of weight (in kg) by height squared (in meters) and training volume (total duration of training in a week) was determined after discussion with athletes and coaches.


Eligibility criteria:
inclusion criteria: competitors, volunteers exclusion criteria: non competitors
dapagliflozin in the treatment of heart failure

Conditions: Heart Failure

Summary: prospectively evaluation the safety and efficacy of the sodium-glucose cotransporter-2 (sglt2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction

heart failure (hf) is a complex clinical syndrome characterized by the reduced ability of the heart to pump and/or fill with blood. from a physiological point of view, hf can be defined as an inadequate cardiac output to meet metabolic demands. hf is a growing public health problem, with an estimated 63 million people affected worldwide , with hf being the underlying cause of more than 1 million hospitalizations every year. these hospitalizations are associated with poor prognosis (50% rate of re-hospitalization within 6 months after discharge and around 33% rate of death within 12 months after discharge), in addition, the prevalence of patient with hf and reduced ejection fraction (hfref) is higher and has greater mortality rates than those with preserved ejection fraction (hfpef). sodium-glucose cotransporter-2(sglt2) inhibitors are a novel class of anti diabetic agents that promote urinary glucose excretion by inhibiting glucose and sodium reabsorption from the renal proximal tubules and have recently been investigated in several large randomized controlled trials for cardiovascular safety and efficacy in patients with type 2 diabetes . more recently, the dapa-hf trial which showed that dapagliflozin significantly improved the outcomes of patients with hfref and reduced the risk of the composite outcome of cv death or the worsening of hf versus placebo by 26% irrespective of the presence or absence of t2dm, demonstrated the significance of sglt2 inhibitors as novel therapeutic agents in heart failure. in may 2020,the fda approved astrazeneca's dapagliflozin (forxiga) for the treatment of heart failure with reduced ejection fraction (hfref) in adults with and without type 2 diabetes (t2d), marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present. this study is established to investigate safety and efficacy of dapagliflozin in non-diabetic patients with heart failure.

Eligibility criteria:
inclusion criteria: * patients age \> 18 years * diagnosis of heart failure nyha class ii- iv * lvef ≤ 40% on echocardiography exclusion criteria: * estimated glomerular filtration rate \<30 ml/min/1.73m2 * pregnant or lactating women
pathways 2 success

Conditions: Conduct Disorder; Oppositional Defiant Disorder

Summary: this study involves a 3-arm randomized controlled trial designed to investigate the feasibility and acceptability of three preventive interventions designed to reduce risk for escalations in adolescent conduct problems. high school students identified to be at risk for conduct problems will be randomly assigned to one of three intervention options, including a mindfulness-based program, a mindfulness-based program augmented by a new mobile app, and a life skills program. assessments related to intervention outcomes will be completed by adolescents, parents/guardians, and teachers at baseline, 2 weeks post-intervention, and at a 3-month follow-up.


Eligibility criteria:
inclusion criteria: 1. a 9th or 10th grade student in a partner school district 2. referral due to elevated social/emotional risk indicated on a standardized screening tool or a referral from school support staff due to concerns about school-based conduct problems 3. adolescents and their parents must be fluent in english exclusion criteria: 1. currently receiving special education services (i.e., an iep) due to a behavioral or emotional disturbance 2. existing diagnoses of autism spectrum disorder, pervasive developmental disorders, developmental/intellectual disability, or serious psychiatric disorders requiring specialized mental health treatment (e.g., psychosis, bipolar, substance use disorder, etc.)
th9507 extension study in patients with hiv-associated lipodystrophy

Conditions: Lipodystrophy; HIV Infections

Summary: assessing the efficacy and long-term safety of a 2 mg dose of th9507, a growth hormone-releasing factor analog, in hiv subjects with excess abdominal fat accumulation

hiv lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (art) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. data from the first phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg th9507, a growth hormone releasing factor (grf), to hiv- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (vat) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (sat). the present study is aimed at confirming the observations made during the first phase 3 study.

Eligibility criteria:
inclusion criteria: * subjects who have completed the 26 weeks treatment period of the th9507-ctr-1011 study. * signed informed consent before any trial-related activities. exclusion criteria: * fasting blood glucose \>8.33 mmol (150 mg/dl) at the end of the th9507-ctr-1011 study.

Keywords: hiv lipodystrophy abdominal fat accumulation growth hormone releasing hormone hiv-associated lipodystrophy treatment experienced
phase 1 study of fusilev to prevent or reduce mucositis in patients with non-hodgkin's lymphoma receiving folotyn

Conditions: Non Hodgkin's Lymphoma

Summary: the purpose of this study is determine the optimal dose and schedule of fusilev to prevent or reduce mucositis in patients with non-hodgkin's lymphoma receiving folotyn treatment.

this is an open label, uncontrolled, nonrandomized, multicenter, dose finding, phase 1 study primarily to determine the optimal dose and schedule of fusilev to prevent or reduce folotyn-related grade 3 or higher oral mucositis.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * patients with relapsed or refractory nhl who are eligible for folotyn treatment. patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography \[ct\] * progressive disease or persistent disease after at least 1 prior treatment * ecog performance status ≤ 2 * adequate hematological, hepatic, and renal function exclusion criteria: * active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) * congestive heart failure * uncontrolled hypertension * known human immunodeficiency virus (hiv)-positive diagnosis * active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment * major surgery within 14 days of enrollment * pregnant or breast-feeding women * symptomatic central nervous system (cns) metastases or lesions for which treatment is required. patients who received prophylactic cns treatment are eligible * previous exposure to pralatrexate
glucocorticoids withdrawal in early systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus; Glucocorticoids; Therapy Withdrawal

Summary: this is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive systemic lupus erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.


Eligibility criteria:
inclusion criteria: * diagnosis of sle according to the eular/acr criteria within three years from screening visit * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations * aged 18 to 75 years old, inclusive, at the time of informed consent * documented diagnosis of sle according to the current acr criteria * stable immunosuppressive treatment for sle for a minimum of one year/six months * stable treatment with antimalarials for a minimum of 3 months * stable (lasting for at least 6 months) low disease activity exclusion criteria: * disease activity (non lldas) within 6 months prior to screening * concomitant ongoing conditions (e.g. asthma, crohn's disease) that require treatment with systemic gc (excluding topical or inhaled gc). * unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule * nursing mothers, pregnant women or women planning to become pregnant during the study.
subcostal tap block with liposomal bupivacaine versus bupivacaine in donor nephrectomy patients: a prospective study

Conditions: Acute Pain

Summary: the primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

the primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients. background and treatment procedure: liposomal bupivacaine is a multi vesicular formulation of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to bupivacaine which provides up to 24 hours of analgesia post injection. these two medications have been compared using a infiltration or injection at the site of incision but have yet to be compared when used during a tap block. a tap block is an injection of local anesthetic under the covering of the transversus abdominis muscle layer. this layer is found using an ultrasound which is a beam of high frequency sound that allows one to visualize images in the body. then using this ultrasound we can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is injected into this plane. this is done on both sides of the abdomen to provide analgesia to the skin, muscle, and fascial layers of the abdomen. population: adult patients who are undergoing a donor nephrectomy rationale: it will be useful to determine if one formulation or the other provides better and longer lasting pain control for patients undergoing abdominal procedures.

Eligibility criteria:
inclusion criteria: * presenting for donor nephrectomy exclusion criteria: * non english speaking * chronic pain condition * taking chronic opioids
clinical applicability of the device belk in the rehabilitation process

Conditions: Application Site Atrophy

Summary: pilot, interventional, randomized of parallel groups and multicenter clinical trial.


Eligibility criteria:
inclusion criteria: * patients of both sexes. * patients aged between 18 and 85 years. * patients with knee arthroplasty in the immediate postoperative period. * sign in informed consent. exclusion criteria: * physical or psychological pathologies that prevent patient participation. * tumor arthroplasty. * knee replacement prosthesis. * impossibility of holding the device. * patients with a pacemaker.
models of care in the transition from the secondary to the primary sector among the frailest elderly

Conditions: Frail Elderly Syndrome; Transitional Care; Frailty; Readmission; Aging; Elderly

Summary: in most western countries the elderly population increases rapidly. in denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). a large part of the elderly population is at high risk of hospitalization including more admissions and increased morbidity and mortality. the number of hospital beds is declining persistently, calling for shorter lengths of stay (los). increasingly complex treatments now take place outside hospital. presently, many danish regional hospitals establish geriatric wards and other geriatric in-hospital and outpatient services to overcome these challenges. the aim of the present phd-study is to investigate the effects of different models of transitional care among the frailest elderly patients.

design population: the frailest acutely admitted geriatric patients aged +75. intervention: early follow-up visits after discharge. comparison: usual care follow-up. outcomes: the primary outcome is readmission within 30 days after discharge. secondary outcomes are: mortality 30 days after discharge and 90 days after admission, length of stay (los), direct discharge from the emergency department, time at home before readmission, duration of readmission and physical functional status 30 days after discharge. methods the first study is conducted as a randomized controlled trial (rct) using two different degrees of intervention. the second study is a cohort study of an unexposed control group. the third study is sub-group analyses of the rct data according to frailty status and type of dwelling. a focus group comprised of included patients and relatives will be set to identify additional patient related outcome measures (proms) and to participate in an advisory group throughout the remaining project.

Eligibility criteria:
inclusion criteria * aged 75 years or older * living within the municipality of aarhus (except for the control group, see below) * mpi-score = 2 (moderate frailty) or mpi score = 3 (severe frailty) exclusion criteria * included in any other kind of follow-up schemes * declared terminally ill or undergoing palliative care at admission * admitted from one specific temporary nursing home with geriatric medical assistance * discharge or transfer to another department, including hospice * mpi-score = 1 (low frailty) * discharged to one specific temporary nursing home with geriatric medical assistance * the patient does not want a visit after discharge

Keywords: elderly hospital at home readmission transitional care frailty patient related outcome measures
coadministration of ezetimibe and simvastatin in patients with primary hypercholesterolemia (p05457)

Conditions: Hypercholesterolemia

Summary: evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (ldl)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme a (hmg-coa) reductase inhibitors.


Eligibility criteria:
inclusion criteria: * patients with hypercholesterolemia who satisfy the following criteria: * patients who have used any of the following hmg-coa reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose ldl-cholesterol level during the treatment had not reached lipid management target indicated below * age: 20 years of age or older (at the time of obtaining informed consent) * sex: both males and females * inpatient/outpatient: out-patients exclusion criteria: * patients for whom any of the following is applicable: * patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dl * patients with homozygous familial hypercholesterolemia * patients with creatine phosphokinase (cpk) \> 2x upper limit of normal (uln) measured at the start of the observation period or the treatment period. * patients with serious hepatic disorder, or patients with alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2x uln measured at the start of the observation period or the treatment period. * patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets * pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study. * patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (however, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.) * patients who are using cyclosporine from after the start of the observation period * patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate * patients with a history of ezetimibe use * patients with hyperlipidemia associated with the following diseases: * hypothyroidism * obstructive gall bladder or biliary disease * chronic renal failure * pancreatitis * patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc * patients who have received an investigational drug within 4 weeks of the start of the observation period * other patients deemed not appropriate for study entry by the investigator
the optimal number of fiducial marker for stereotactic body radiotherapy

Conditions: Lung Cancer; Liver Cancer; Pancreatic Cancer; Renal Cell Carcinoma

Summary: this is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (sbrt) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. here's a breakdown of the key components of the study: study design: prospective, single-center, exploratory clinical study. patient enrollment: the study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided sbrt. each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases. informed consent: patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved. intervention: enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. during this process, fiducial markers will be implanted according to the study protocol. monitoring: following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. this includes any complications or side effects resulting from the marker implantation process. success rate: the study will assess the success rate of fiducial marker implantation. this likely involves evaluating the accuracy and reliability of marker placement for guiding sbrt treatment. sbrt treatment error: the study will also monitor sbrt treatment errors. this involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration. overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided sbrt for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy.


Eligibility criteria:
inclusion criteria: * patient with lung cancer, liver cancer, renal cancer, pancreatic cancer. * going to have sbrt. exclusion criteria: * needle insertion route impeded by skeletal structures and close to blood vessels which have high risks of puncture bleeding; * poor organ function (e.g. poorly controlled high blood pressure); * poor compliance, unable to complete coordination; * participant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Keywords: fiducial marker sbrt lung caner liver cancer pancreatic cancer renal cell carcinoma
psychosocial situation of children with rare solid abdominal tumors and their families

Conditions: Neuroblastoma; Nephroblastoma; Hepatoblastoma

Summary: families of children with rare diseases (i.e., not more than 5 out of 10.000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and his/her siblings. the aim of the present research project is to examine the psychosocial burden of the children with rare solid abdominal tumors and their family in order to draw attention to a possible psychosocial care gap in this population.

the central objective of the cross-sectional study is to show the psychosocial supply gap for families with children and adolescents affected by rare diseases in the field of oncology pediatric surgery. among the rare diseases that are included are rare solid abdominal tumors. in order to have a comparative sample, additional data of a matched control group are collected. central standardized psychosocial outcomes will be assessed from the perspectives of the parents and the affected child.

Eligibility criteria:
inclusion criteria (families of rare disease): * family with at least one child between 0 and 17 years with rare solid abdominal tumors. * consent to participate in the study. * sufficient knowledge of the german language of parents and children. exclusion criteria (families of rare disease): - severe acute physical, mental and/or cognitive impairment of the child, so that the questionnaire survey does not appear possible and/or unreasonable at this stage. inclusion criteria (control group): * family with at least one child between 0 and 17 years who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints * consent to participate in the study. * sufficient knowledge of the german language of parents and children. exclusion criteria (control group): - families of children with a congenital or chronic disease.

Keywords: rare diseases