Kornimate/medical-research-clean huggingface dataset:
brim-p: a study of vemurafenib in pediatric patients with stage iiic or stage iv melanoma harboring brafv600 mutations

Conditions: Malignant Melanoma

Summary: this open-label, multicenter. single arm phase i dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (ro5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable stage iiic or stage iv melanoma harboring brafv600 mutations. participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * pediatric participants, 12 to 17 years of age inclusive * histologically confirmed surgically incurable and unresectable stage iiic or stage iv (ajcc) melanoma * positive proto-oncogene b-raf (braf) mutation result (cobas 4800 braf v600 mutation test) * measurable disease according to response evaluation criteria in solid tumors (recist) criteria * performance status: karnofsky (for participants \>/= 16 years of age) or lansky (for participants \ /= 60 * adequate bone marrow, liver and renal function * participants must have fully recovered from the acute toxic effects of all prior therapy prior to first administration of study drug exclusion criteria: * active or untreated central nervous system (cns) lesions * history of or known spinal cord compression or carcinomatous meningitis * anticipated or ongoing administration of anti-cancer therapies other than those administered in this study * previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ, and carcinoma in-situ of the cervix * previous treatment with selective/specific braf or methyl ethyl ketone (mek) inhibitor (previous treatment with sorafenib is allowed) * any previous treatment with study drug (ro5185426) or participation in a clinical trial that includes ro5185426 * pregnant or lactating females * known human immunodeficiency virus (hiv) positivity or acquired immune deficiency syndrome (aids)-related illness, active hepatitis b virus, or active hepatitis c virus
drug use surveillance of takecab for "supplement to helicobacter pylori eradication"

Conditions: Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other

Summary: the purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (takecab) tablets (triple therapy) in the routine clinical setting.

the drug being tested in this study is called vonoprazan (takecab). vonoprazan is being tested to treat people who have gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (malt) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or h. pylori gastritis. this study will look at the presence or absence of new concerns regarding the safety of triple therapy with vonoprazan tablets, amoxicillin, and clarithromycin (first-line eradication) and triple therapy with vonoprazan tablets, amoxicillin, and metronidazole (second-line eradication) for supplemental helicobacter pylori (h. pylori) eradication in the routine clinical setting. the study will enroll approximately 500 patients. first-line eradication * vonoprazan 20 mg / proton pump inhibitor * amoxicillin hydrate 750 mg * clarithromycin 200 mg if h. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful. second-line eradication * vonoprazan 20 mg * amoxicillin hydrate 750 mg * metronidazole 250 mg this multi-center trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: * participants receiving h. pylori eradication treatment for the first time * participants for whom h. pylori eradication with takecab tablets or proton pump inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive eradication treatment with amoxicillin and metronidazole exclusion criteria: * participants with previous history of hypersensitivity to ingredients in takecab tablets * participants taking atazanavir sulfate or rilpivirine hydrochloride
register kardialer computertomographie

Conditions: Evaluation of CT in Coronary Artery Stenosis

Summary: the aim of this heidelberg cardiac ct registry (register kardiale computertomographie) is to assess the diagnostic and prognostic perfomance of cardiac ct exminations in a real-world patient population.

anthropometric data, medical history and results of the ct examinations are collected in a database in order to adressing various scientific questions.

Eligibility criteria:
inclusion criteria: • subjects referred for cardiac ct examination by their physician exclusion criteria: • none
use of near infrared spectroscopy to detect muscle perfusion in the lower extremity of uninjured subjects

Conditions: Acute Compartment Syndrome

Summary: acute compartment syndrome (acs) is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the body's ability to provide blood to the muscle of the leg. this condition cuts off blood flow to the leg. left untreated, the condition can result in devastating consequences including complete loss of function of the lower extremity or amputation. near-infrared spectroscopy (nirs)-based tissue perfusion monitors are a non-invasive means of continuously monitoring the amount of oxygen in the tissues of an injured extremity. the device utilizes harmless red light to detect the proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. the purpose of this study will be to launch the first stages of validation of this device as a diagnostic tool for compartment syndrome, by observing this device in uninjured subjects.


Eligibility criteria:
inclusion criteria: * over 18 years old exclusion criteria: * any current traumatic lower or upper extremity injury * unwilling or unable to provide written informed consent * history of any anatomy-altering injury or procedure to the upper or lower extremity

Keywords: near infrared spectroscopy acute compartment syndrome
tools for lasting lifestyle changes

Conditions: Cardiovascular Diseases; Lifestyle Risk Reduction

Summary: pilot and feasibility study; a complex intervention focusing on lifestyle change to increase physical activity and reduce cardiovascular disease (cvd) risk among high risk individuals.

interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to explore study feasibility, responsiveness, participants adherence and adverse events among the participants before deciding to proceed to full-scale evaluation. enrollment of max. 20 obese people (bmi\>30) with sedentary lifestyle and increased cvd-risk (norrisk2).. participants general health status including cardiopulmonary fitness will be assessed both before and after the intervention (blood pressure, ecg, spirometry, treadmill tests vo2max, blood tests, body composition by dual-energy x-ray absorptiometry (dexa) measurements) participants´ functional capacity assessed by several range of motion tests. participants nutritional and psychological status assessed by validated questionnaires. several blood-tests and ecg will be recorded at three months. daily activity level during and six months after the intervention period monitored by polar m430 pulse watch. the participants will be interviewed with focus on their prior health, activity habits and intervention experiences at three months and six months after end of the intervention. two focus-group interviews at end of intervention.

Eligibility criteria:
inclusion criteria: 1. age 55-74 years 2. bmi\> 30 3. moderate elevated norrisk 2 score 4. motivation for lifestyle change 5. has agreed to attend and participate in a student study during the study period exclusion criteria: 1.external disease with short life expectancy 2.diseases that limit physical activity in the project 3.serious mental illness 4. previous myocardial infarction 5.ekg changes that show severe rhythm disturbance, unstable angina or heart attack 5.ekg changes that show severe rhythm disturbance, unstable angina or heart attack:

Keywords: primary intervention
study to improve the treatment of patients with heart failure by general practitioners

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether it is possible to improve the care of general practitioners for patients with heart failure. the investigators try to reach that goal by training the gp's for 90 minutes in uptitrating the recommended medication according the guidelines. after 6 month the investigators ask the patients to fill out a questionary. the investigators ask them about their quality of live.


Eligibility criteria:
inclusion criteria: * do have a general practitioners diagnosis heart failure mentioned twice in the electronical medical file. exclusion criteria: * incapacitated patients with a life expectancy of less than 2 months * seniles * patients who do not speak the dutch language

Keywords: heart failure, general practitioner, medical therapy, quality of live
docetaxel and irinotecan in gastric cancer

Conditions: Stomach Cancer; Gastric Cancer; Chemotherapy Effect

Summary: to assess the role of docetaxel and irinotecan combination in second line gastric cancer. the primary end point is response rate. secondary end points are toxicity, pfs and os.

gastric cancer is a major killer in oncology. the expected overall survival of metastatic patients is less than 2 years. moreover, most of the patients develop cachexia and worsening of performance over time. as a result, many patients are not fit for second line treatment when eligible. there is currently no approved consensus for third line treatment regimen and in most of the patients it is usually best supportive care. irinotecan and docetaxel were tested as single agents or in combination with other drugs (e.g. folfiri) in second line setting. however, the combination of these two drugs together was not tested before. both agents are active in second line setting which is considered the last chance of the patient in view of lack of evidence in third line setting.

Eligibility criteria:
inclusion criteria: * histopathological evidence of adenocarcinoma of the stomach * metastatic disease or locally advanced non-resectable disease * patients who received only one line of treatment * performance status 0,1,2 as per ecog scoring system exclusion criteria: * patients who received docetaxel or irinotecan before recruitment to this study * multiple comorbid conditions * liver or kidney impairment * severe cachexia (sarcopenia)

Keywords: gastric stomach docetaxel irinotecan chemotherapy second line
breast reconstruction following breast cancer in very high risk patients

Conditions: Breast Cancer; Malignant Neoplasm of Breast

Summary: the purpose of this study is to: 1. evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs 2. determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

primary endpoint(s) 1. define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort 2. compare immediate and delayed reconstruction outcome metrics through retrospective review secondary endpoint(s) 1. evaluate quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction. 2. compare complications and reoperations between immediate versus delayed reconstruction. 3. compare the hospital costs between immediate versus delayed reconstruction 4. evaluate the effectiveness of risk reduction strategies

Eligibility criteria:
inclusion criteria: * subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy. * subjects must be breast reconstruction candidates using implant based breast reconstruction. * subjects must have a pre-operative risk \>20% complication prediction from the breast reconstruction risk assessment (bra) score for implant-based breast reconstruction candidates * subjects must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * prior breast cancer surgical treatment * prior breast reconstruction * inability to provide written consent

Keywords: breast reconstruction mastectomy
a study of navenibart in participants with hereditary angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: this is a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (hae). the goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing hae attacks in participants with hae.


Eligibility criteria:
inclusion criteria: * documented diagnosis of hae (type 1 or 2). the following must be met: 1. documented clinical history consistent with hae 2. lab findings consistent with hae type 1 or 2 * experienced at least 2 hae attacks during the run-in period, as confirmed by an investigator based on meeting the protocol-specified definition of an hae attack. exclusion criteria: * any concomitant diagnosis of another form of chronic angioedema, such as acquired c1 inhibitor deficiency, hae with normal c1-inh (also known as hae type 3), idiopathic angioedema, or angioedema associated with urticaria. * use of therapies prescribed for the prevention of hae attacks may not be used during the trial or within the below time frames prior to the run-in period (adult participants may be on these medications at the time of the screening visit, but will need to washout prior to entering the run-in period): 1. lanadelumab within 90 days prior to run-in 2. berotralstat within 21 days prior to run-in 3. plasma-derived c1inh for ltp within 14 days prior to run-in 4. tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to run-in 5. all other prophylactic therapies, including investigational drugs, require consultation with the medical monitor

Keywords: hae angioedema
evaluate efficacy and safety in japanese subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes; High Blood Sugar

Summary: this is a 24-week randomised, multi-centre phase iii study to evaluate the efficacy and safety of dapagliflozin as monotherapy in japanese subjects with type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * men or women age ≥20 years old (either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 dm ; ≥6.5% and ≤10% at 1 week before randomization exclusion criteria: * type 1 diabetes mellitus * fpg \>240 mg/dl before randomization * subjects who have history of unstable or rapidly progressing renal disease * subjects who have severe hepatic insufficiency and/or significant abnormal liver function * significant cardiovascular history

Keywords: phase3 clinical trial type2 diabetes mellitus
italian prospective observational study assessing the effectiveness and outcomes associated with lutathera treatment in gep-nets

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Summary: this is a multicentre long-term non-interventional study of adult subjects diagnosed with unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gep-nets who have been prescribed lutathera® in standard clinical practice.

data on patients will be collected from the date when patient consent was obtained, during treatment with lutathera® and for a follow-up period until end of study (eos), defined as the time when the last enrolled patient has completed 36 months of assessments (unless early termination) after enrolment. data will be collected in accordance with routine clinical visits. the study duration will be 48 months in total: 12 months recruitment and 36 of follow-up from the last patient in.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained prior to any data collection. * patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (gep-net). * aged ≥18 years. * patients must be naïve to treatment with lutathera® at enrolment. exclusion criteria: * participation in a current or prior investigational study within 30 days preceding enrolment or within 5 half-lives of the investigational product, whichever is longer.

Keywords: gep-net gastro-entero-pancreatic neuroendocrine tumour aaa advanced accelerator applications luthatera
results from a health system-wide implementation of a quality of life questionnaire

Conditions: Medical Oncology; Cardiology; Integrative Medicine; Physical and Rehabilitation Medicine; Orthopedics; Spine; Palliative Care; Pulmonary Medicine; Primary Care

Summary: the purpose of this retrospective chart review pilot study is to research the results and scores of the qol questionnaire implemented across allina health clinics. this study will investigate average qol scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on qol scores. the results will provide insight into qol trends within different patient populations and provide guidance regarding optimal treatment plans so that allina caregivers can positively impact patients' qol.

quality measures, including quality of life (qol), have become an increasingly important area of interest for health systems across the country. systematic approaches to collect patient qol data are needed to properly understand and act on this information. at allina health, the process of systematically collecting this information began in july, 2012. the information is not only collected by providers, but used to enhance the patient experience and provide patients with an active voice in their care. by considering qol as another vital sign, allina caregivers have an instantaneous understanding of the patient's health status and can utilize the data in real time. additionally, by collecting this information at each visit, providers also have a longitudinal perspective of the patient's qol and the health of the population of individuals under their care. consequently, they can provide patients with resources and support that can have a positive impact on their health and well-being. the purpose of this retrospective chart review pilot study is to research the results and scores of the qol questionnaire implemented across allina health clinics. this study will investigate average qol scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on qol scores. the results will provide insight into qol trends within different patient populations and provide guidance regarding optimal treatment plans so that allina caregivers can positively impact patients' qol.

Eligibility criteria:
inclusion criteria: * patients seen at an allina health outpatient facility who complete a promis-10 questionnaire between july 1, 2012 and december 31, 2016. exclusion criteria: * patients who did not allow their records to be used for research purposes are not included in the study

Keywords: quality of life patient-centered care patient outcome assessment
drug interaction oral contraceptive pill (ocp)

Conditions: Hepatitis C Virus

Summary: to assess the effects of bms-650032 on pharmacokinetics (pk) of ethinyl estradiol (ee) and norelgestromin (ngmn) in healthy female subjects


Eligibility criteria:
inclusion criteria: * healthy females, 18-40 years, bmi 18 - 32kg/m². must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug exclusion criteria: * abnormal pap smear within 1 year prior to day 1 * any significant or chronic uncontrolled medical illness
tamponade vs partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases

Conditions: Placenta Accreta

Summary: to compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .

placenta accreta spectrum (pas) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium (1-2). over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of pas (3). pas is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality (4). ultrasound imaging is the most commonly used technique to diagnose pas disorders prenatally. there is also wide variation globally on the management of pas disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches (5). the conservative approaches include one-step conservative surgery, leaving the placenta in situ, the triple-p procedure, and transverse b-lynch suture (1). several techniques have been described for controlling massive bleeding associated with placenta previa caesarean sections ,including uterine packing with gauze ,balloon tamponades ,the b-lynch suture,insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries , but there is awide variation in the success rate of these maneuvers. over-sewing of the bleeding site is the most common procedure used for pph management, but in many cases, the bleeding points located in the lower segment and cervical canal are too deep and their locations are unclear because of the severity of the bleeding(

Eligibility criteria:
inclusion criteria: * 1-pregnant women with placenta previa /pas diagnosed before delivery (by ultrasound and doppler examination) . 2 - gestational age starting from 28 weeks onwards. 3- women with at least 1 previous hysterotomy (e.g. caesarean deliveries, myomectomy) 4- elective or emergent caesarean deliveries exclusion criteria: * a pre-existing decision of performing intrapartum hysterectomy
kpi-121 1% versus prednisolone for the treatment of inflammation following cataract surgery in children

Conditions: Ocular Inflammation

Summary: this study is designed to assess how kpi-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. approximately half the participants will receive kpi-121 1% eye drops and the other half will receive prednisolone acetate.


Eligibility criteria:
inclusion criteria: * be a candidate for routine, uncomplicated cataract surgery exclusion criteria: * have a post-traumatic cataract. * have suspected permanent low vision or blindness in the fellow non-study eye. * have active uveitis in either eye. * have an ocular neoplasm in either eye. * have the presence of viral, bacterial, or fungal disease in either eye. * have glaucoma, ocular hypertension, steroid-induced iop (intraocular pressure) rise or elevated iop