Kornimate/medical-research-clean huggingface dataset:
an expanded access protocol for apalutamide treatment of participants with non-metastatic castration-resistant prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (nm-crpc).


Eligibility criteria:
inclusion criteria: * participants with confirmed prostate cancer, with evidence of castration resistance, with a rising prostate-specific antigen (psa) while on androgen deprivation therapy (adt), and for whom the treating physician believes additional therapy is indicated in the non-metastatic castrate-resistant prostate cancer (nm-crpc) setting a) willingness to continue gonadotropin releasing hormone analog (gnrha) throughout study if the participant is medically castrated * must sign an informed consent form (icf) (or the participant's legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * to avoid risk of drug exposure through the ejaculate (even participants with vasectomies), participants must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug * willingness and ability to comply with prohibitions and restrictions specified in this protocol, scheduled visits, treatment plans, laboratory, and other study procedures, including ability to swallow study drug tablets exclusion criteria: * previously enrolled in another apalutamide study or eligible for enrollment in another ongoing clinical study of apalutamide * enrolled in another interventional clinical study of anti-neoplastic agents * ongoing grade greater than (\>) 1 acute toxicity due to prior therapy or surgical procedure * concurrent therapy with medications known to lower the seizure threshold must have been discontinued or substituted at least 4 weeks prior to study entry * current or prior treatment with anti-epileptic medications for the treatment of seizures. history of seizure or condition that may predispose to seizure (including, but not limited to prior cerebrovascular accident, transient ischemic attack, or loss of consciousness within 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect)
study of upfront surgery versus neoadjuvant chemotherapy in patients with advanced ovarian cancer (sunny)

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: the purpose of this study is to answer the fundamental question, should the physicians choose surgery or chemotherapy (soc-2) in advanced ovarian cancer?

objectives: compare the efficacy and safety in patients with ajcc tnm stage iiic or iv epithelial ovarian cancer, fallopian tube cancer, or peritoneal carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront surgery. outline: this is a randomized phase iii multicenter study. patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy. patients are followed every 3 months within the first 5 years, and then every 6 months. projected accrual: a total of 488 patients will be accrued for this study within 5 years.

Eligibility criteria:
inclusion criteria: 1. women aged ≥ 18 years. 2. pathologic confirmed stage iiic and iv epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration\*). laparoscopic biopsy with pictures is recommended. \* if fine needle aspiration showing an adenocarcinoma, patients should satisfy the following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis, and c. serum ca125/cea ratio\>25. if serum ca125/cea ratio\<25 or malignancies of other origins, such as breasts and digestive tract, are suspected from symptoms, physical examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive metastasis ovarian cancer. 3. ecog performance status of 0 to 2. 4. asa score of 1 to 2. 5. adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery: 1. white blood cells \>3,000/µl, absolute neutrophil count ≥1,500/µl, platelets ≥100,000/µl, hemoglobin ≥9 g/dl, 2. serum creatinine \<1.25 x upper normal limit (unl) or creatinine clearance ≥60 ml/min according to cockroft-gault formula or to local lab measurement, 3. serum bilirubin \<1.25 x unl, ast(sgot) and alt(sgpt) \<2.5 x unl. 6. comply with the study protocol and follow-up. 7. written informed consent. exclusion criteria: 1. patients with non-epithelial tumors as well as borderline tumors. 2. mucinous ovarian cancer. 3. low grade ovarian cancer. 4. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 5. any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol. 6. other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
ceftazidime-avibactam compared with doripenem followed by oral therapy for hospitalized adults with complicated utis (urinary tract infections)

Conditions: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Summary: the purpose of this study is to evaluate the effects of ceftazidime avibactam compared to doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

a phase iii, randomized, multicenter, double-blind, double dummy, parallel group, comparative study to determine the efficacy, safety, and tolerability of ceftazidime avibactam (caz-avi, formerly caz104) versus doripenem followed by appropriate oral therapy in the treatment of complicated urinary tract infections, including acute pyelonephritis, with a gram negative pathogen in hospitalized adults

Eligibility criteria:
inclusion criteria: * 18 to 90 years of age inclusive * female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving iv study therapy and for a period of 7 days after * has pyuria with \>/= 10 wbcs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing \>/=10 to the fifth cfu (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to iv study therapy (caz-avi and doripenem) * demonstrates either acute pyelonephritis or complicated lower uti without pyelonephritis. exclusion criteria: * urine pathogen is a gram-positive pathogen or a uropathogen resistant to caz-avi or doripenem * patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal uti * patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant * patient is immunocompromised * patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality

Keywords: ceftazidime, avibactam, doripenem, ciprofloxacin, sulfamethoxazole/trimethoprim, anti-infective agents, complicated urinary tract infection,acute pyelonephritis
the role of agency and threat-immediacy in interactive digital narrative fear appeals

Conditions: Excessive Drinking

Summary: aims: the first aim of the study was to assess the effect of agency, i.e. the perception of making meaningful decisions, in an interactive digital narrative fear appeal on self-efficacy beliefs concerning the ability to reduce alcohol intake among college students. second, we assessed whether the communicated timeframe (short-term / long-term) of the threat presented in the narrative moderates the effect of agency on self-efficacy. lastly, to validate the effect of the intervention on behavioural outcomes we assesed whether self-efficacy has an effect on behavioural intention measures. the study was a 2 (agency: low / high) x 2 (time-frame: immediate / distant) between-subjects online experiment.


Eligibility criteria:
inclusion criteria: * above 18 years of age * 480 seconds survey completion time * both attention checks relating to narrative content passed * correctly identified their experimental condition in the manipulation check * did not choose to 'drink an alcoholic drink' for all decisions in the interactive narrative * did not show signs of alcohol abuse exclusion criteria: * under the age of 18 * completed the questionnaire in an unreasonably short amount of time * they failed one of the two attention checks * failed the manipulation check asking them to recall whether they were presented with short- or long-term (high / low immediacy) consequences of excessive drinking * chose an alcoholic drink for all decision points * showed signs of alcohol dependence as measured above 15 on the brief young adult alcohol consequences questionnaire (b-yaacq)

Keywords: agency fear appeal alcohol narrative
investigation and study on the status of endovascular therapy in acute ischemic stroke ischemic stroke

Conditions: Stroke; Endovascular Therapy

Summary: this study aims to build a database for patients with acute ischemic stroke who receive endovascular therapy and analyze the current situation, effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke in china.

study design is a registry, prospective, multicenter study of acute ischemic stroke patients with endovascular treatment. a database will be established including age, gender, smoking history, blood pressure, blood glucose, previous history (such as coronary heart disease, atrial fibrillation, hypertension, diabetes, stroke history, etc.), history of antiplatelet drugs, onset to treatment time, national institute of health stroke scale (nihss) score before treatment. indications for endovascular therapy refer to the current guidelines. all patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy. the effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke will be analyzed. this study will enroll up at least 1,000 patients in 70 centers in china. the primary end point are proportion of patients with good prognosis after 90 days and intracranial hemorrhage transformation type after 24 hours.

Eligibility criteria:
inclusion criteria: 1. clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke 2. age ≥18 years 3. nihss ≥ 6 4. ica or mca-m1 or mca-m2 occlusion as evidenced by mra or 4d-cta 5. ethrombectomy can be initiated (femoral puncture) within 6 hours after onset or between 6 and 24 hours after time last know well if conform to the imaging inclusion criteria: target mismatch profile on ct perfusion or mr perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is ≥ 1.8, penumbra volume is ≥ 15 ml. exclusion criteria: 1. large area cerebral infarction of anterior circulation on early ct image (more than 1/3 of cerebral hemisphere) 2. blood glucose \ 22.2mmol/l 3. other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days 4. pregnant
myocardial infarction with st-elevation

Conditions: Myocardial Infarction

Summary: mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, timi 3 flow restoration in more than 90% of patients. however, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. the lack of st-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. routine administration with primary stenting of the platelet glycoprotein iib/iiia inhibitor abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies admiral and cadillac. however, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of abciximab on st-segment elevation regression at one hour after primary percutaneous angioplasty.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age eligible for randomization in the micu * infarct within 6 hours from symptoms onset * continuous typical chest pain symptoms symptoms for more than 20 min. and-st segment elevation of more than 2 mm in more than two leads (peripheral or precordial) * signed informed consent form exclusion criteria: * ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy * known hypersensitivity to abciximab or to any component of the product or to murine monoclonal antibodies.- hemorrhagic diathesis, internal hemorrhage * hemorrhagic stroke within 2 years * ischemic stroke within the last 3 months- intra-cranial neoplasm, intracranial malformation or arteria * venous aneurysm * recent intracranial or intraspinal surgery or trauma (within two months) * recent within (2 months) major surgery- known peptic ulcer or upper gastrointestinal bleeding within the previous 6 month * known coagulation anomaly * oral anti-coagulant or low molecular weight heparin treatment- ongoing thrombolytic treatment

Keywords: myocardial infarction angioplasty coronary stenting abciximab myocardial reperfusion microcirculation ekg st elevation myocardial infarction within 6 h of symptom onset
cardiotoxicity induced by androgenics and their antagonists (tornics)

Conditions: Heart Diseases

Summary: anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of prostate cancer seems to have an impact on the cardio-vascular system. this study investigates reports of cardiovascular toxicities for treatment including anatomical therapeutic chemical (atc) classification: sex hormones (g03), hypothalamic hormones (h01c) and sex hormones used in treatment of neoplastic diseases (l02) in the french pharmacovigilance database and european clinical trials (eudract) database.

hormone replacement therapies and contraceptive pills are responsible of a wide range of cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart disease. the difference of incidence and type of cardio-vascular events between men and women are strongly related to sex hormones. androgenic agonists and antagonists are used in various indication including prostate cancer or hormone replacement therapies. this study investigates the main characteristics of patients affected by cardiovascular side effects (of which ventricular arrhythmia's, qt prolongation and torsade de pointe) imputed to drugs classified as g03, h01c and l02 according to atc. a causality assessment according to both begaud's method and the world health organization-the uppsala monitoring centre (who-umc) is systematically applied.

Eligibility criteria:
inclusion criteria: * case reported in the french pharmacovigilance database and eudract database from 01/01/1985 to 14/04/2017 * adverse event reported were including the meddra terms: soc cardiac affections and the hlt death and sudden death * patients treated with hormonal therapies included in the atc classification references: g03, h01c and l02 exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: cardiotoxicity androgens hormone replacement therapy testosterone androgen antagonists
comparison of helicobacter pylori eradication effect before and after training of gastroenterologists

Conditions: Helicobacter Pylori Infection

Summary: the researchers recruited gastroenterologists. physician subjects recruited helicobacter pylori-positive patients before and after receiving standardized training on helicobacter pylori eradication. there are no restrictions on treatment options and drugs during the trial. compare the eradication rate, adverse reaction rate, and patient compliance before and after physician training.

the researchers recruited no less than 20 gastroenterologists to participate in the study, and gastroenterologists recruited 25 patients who were over 18 years of age and were positive for helicobacter pylori for the first time. in this process, the patient population is not restricted, and the eradication program is not restricted. gastroenterologists followed up their diagnosis and treatment. researchers track and record patients' medications and adverse reactions during medication via phone or wechat to assess patient compliance. record the eradication rate. the researchers will provide standardized helicobacter pylori eradication training for the department of gastroenterology after all patients treated by gastroenterologists have been eradicated and reviewed. after the training, the gastroenterologist recruited 25 patients who were over 18 years old and were newly treated with helicobacter pylori positive. in this process, the patient population is not restricted, and the eradication program is not restricted. gastroenterologists followed up their diagnosis and treatment. researchers track and record patients' medications and adverse reactions during medication via phone or wechat to assess patient compliance. record the eradication rate. compare the eradication rate, adverse reaction rate and compliance of patients before and after the training of gastroenterologists.

Eligibility criteria:
inclusion criteria: * 1.physician specialized in gastroenterology. * 2.diagnosis and treatment conditions for h. pylori exist in the hospital where the gastroenterology doctor is located. (c13 urea breath test, c14 urea breath test, rapid urease test, stool h. pylori antigen test, histopathological test, h. pylori culture, any of the above) exclusion criteria: * 1.those who are unable or unwilling to provide informed consent. * 2.patients with h. pylori have never been diagnosed and treated.

Keywords: standardized training on helicobacter pylori eradication gastroenterologist
effect of surgical wound infection on health

Conditions: Infection

Summary: a surgical site infection (ssi) is an infection that occurs after surgery in the part of the body

morbidity and mortality were associated with increase of surgical site infections (ssis).besides, it was a financial burden and negatively impact of ssis on patient quality of life (qol).

Eligibility criteria:
inclusion criteria: * wound who had infection post surgery exclusion criteria: * women who had no infection
early detection of silent myocardial ischemia

Conditions: Ischemic Heart Disease; Silent Myocardial Ischemia; Cardiovascular Diseases

Summary: early-synergy investigates a diagnostic imaging approach in asymptomatic individuals from the general population for early detection of silent myocardial ischemia and cardiac dysfunction. the diagnostic imaging approach consists of cardiac computed tomography for coronary artery calcium scoring (ct-cac) and cardiac magnetic resonance (cmr) stress perfusion imaging. early-synergy investigates the effect of early detection of silent myocardial ischemia and cardiac dysfunction by cmr in asymptomatic individuals with increased cac. in addition, the diagnostic yield of cmr for early detection of silent myocardial ischemia and cardiac dysfunction is investigated. asymptomatic individuals at increased risk (cac ≥ 300) are therefore randomized 1:1 to either cmr stress perfusion imaging or a control group.

early-synergy is a prospective multi-center study performed in the netherlands. potential candidates for participation in early-synergy have had ct-cac scanning as part of participation in two ongoing population-based studies (robinsca and imalife) and had cac ≥300. participants are randomized in a 1:1 fashion to (1.) cmr stress perfusion imaging with feedback of clinically actionable findings or (2.) control group. in the cmr group, feedback on cmr stress perfusion imaging is provided to the participant and general practitioner only in case of cmr findings that require further management based on current clinical guidelines. participants in the control group will not receive stress cmr perfusion imaging but will be followed in time to evaluate the clinical presentation of the natural course of coronary atherosclerosis. follow-up will be performed up to 5 years in both groups by sending questionnaires and collecting medical information from health care providers and registries. additionally, blood is drawn from participants in the cmr group during the hospital visit for cmr scanning and is stored to allow evaluation of cardiac blood markers as predictors of cmr findings.

Eligibility criteria:
inclusion criteria: * participation in robinsca or imalife study * ct-cac ≥300 exclusion criteria: * history of ischemic heart disease or other cardiac disease (myocardial infarction, sudden cardiac arrest, heart failure, cardiomyopathy, congenital cardiac disease, percutaneous coronary intervention, coronary artery bypass grafting surgery, valvular surgery, other major cardiac surgery (e.g. cardiac transplantation) and/or previous invasive coronary angiography or catheter ablation) * contra-indication for stress cmr perfusion imaging (claustrophobia, cmr incompatible device (e.g., implantable cardioverter defibrillator/pacemaker), contrast agent or vasodilator intolerance, contra-indications for adenosine or regadenoson (e.g. 2nd/3rd degree atrioventricular block, severe hypotension) and/or weight \> 125 kg) * severe comorbidity and/or a life expectancy of less than 1 year * unable to provide written informed consent * pregnancy
mds on botox utility (mobility)

Conditions: Blepharospasm; Torticollis; Strabismus; Muscle Spasticity

Summary: the mobility project is a prospective, non-randomized, observational, multi-centre evaluation of health utility via the sf-12® health survey scores and the sf-6d in patients receiving botox® for therapeutic use.


Eligibility criteria:
inclusion criteria: * patients who are eligible for botox® treatment deemed medically necessary by their physician * patient (and/or patient's authorized legal representative) should provide written informed consent; a patient under the age of 18 must review and sign the patient assent form * patients at the age of or over 14 exclusion criteria: * patient is participating in a clinical trial for any botox® indication * patient with any contraindications to use botulinum toxin a