Kornimate/medical-research-clean huggingface dataset:
multicentric evaluation of the true negative predictive value of multiparametric mri for the detection of prostate cancer using cystoprostatectomy specimen as reference

Conditions: Prostate Cancer

Summary: to evaluate the negative predictive value of mpmri in the detection of prostate cancer using cystoprostatectomy specimen as the reference

to evaluate the negative predictive value of mpmri in the detection of prostate cancer using cystoprostatectomy specimen as the reference

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer (clinical t2-t3, any n) or high risk non-muscle invasive bladder cancer (pt1 or cis) 3. no known diagnosis of prostate cancer 4. no contraindication to undergo multiparametric mri 5. signed written informed consent prior to any screening procedures being performed 6. patient affiliated to the ''national security'' regimen or beneficiary of this regimen exclusion criteria: 1. allergy against mr contrast media 2. diagnosis or previous treatment of prostate cancer 3. severe renal insufficiency (gfr \<30ml/min) 4. bladder cancer infiltrating the prostate (t4) 5. pelvic metallic implants such as hip prosthesis 6. patients scheduled for cystoprostatectomy with prostate capsule sparing 7. patients unable to provide informed consent 8. patients having a prostate biopsy \<6 month

Keywords: multiparametric mri cystoprostatectomy
cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer

Conditions: Pleural Effusion, Malignant

Summary: to assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.

the lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.first, premedication including antiemetics and hydration were performed. thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.the patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. the chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. when the drainage effusion was less than 100 ml a day, the chest tube was removed. any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.

Eligibility criteria:
inclusion criteria: * cytologically proven and previously untreated malignant pleural effusion of non-small-cell lung cancer; * an eastern cooperative oncology group (ecog) performance status (ps) of 0, 1; * a leucocyte count of≥4000µl; * a platelet count of≥100000µl; * a normal creatinine level; * serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal; * survival time ≥12 weeks. exclusion criteria: * previously treated malignant pleural effusion; * pericardial effusion； * pregnant； * uncontrolled hypertension or diabetes； * liver cihrosis.
change in airway peripheral tone in copd

Conditions: COPD; COPD, Early-Onset

Summary: small airways disease is a pathological feature in mild to moderate copd, which might be causally involved in disease progression. however, there are only limited studies available that prospectively identified patients at risk for small airway disease. our intention is to investigate the early phase of the disease. in addition, we thereby want to build up a well-defined study population of patients in an early phase of the disease with a rapid decrease in lung function as measured by oscillometry and multiple breath washout (mbw)-testing. in addition, it is our goal to identify patients in an early stage of disease and patients at risk of fast progression and/or rapid decline in lung function.


Eligibility criteria:
patients at risk for copd inclusion criteria: * smoking history (at least 10 pack years) * absence of airway obstruction (fev1/fvc ≥ 70% after salbutamol 400µg) * high symptom score (cat ≥ 10) or long acting bronchodilator therapy * age \> 35 years exclusion criteria: * respiratory infection within 4 weeks prior to inclusion * other symptomatic pulmonary disease, except bronchial asthma patients with early copd inclusion criteria: * smoking history (at least 10 pack years) * mild copd (fev1/fvc \< 70% and fev1 ≥ 70% after salbutamol 400µg) * age \> 35 years exclusion criteria: * respiratory infection within 4 weeks prior to inclusion * other pulmonary disease, except bronchial asthma

Keywords: small airway disease peripheral airway tone
effect of anti cd20 in pemphigus desease

Conditions: Pemphigus

Summary: to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.


Eligibility criteria:
inclusion criteria: * age\>18 * pemphigus corticoresistant * pemphigus cortico dependant * contre-indications : systémic steroids exclusion criteria: * age \< 18 * cardiopathie * pregnant woman * absence contraception * no consentment
interval versus continuous training on functional capacity and quality of life in patients with coronary artery disease

Conditions: Coronary Heart Disease

Summary: exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. moderate continuous training is the best established training modality for this patients. however, a body of evidence has begun to emerge demonstrating that high intensity interval training obtained better results in terms of morbidity and mortality. the purpose of this randomized clinical trial was to determine the effect of two types of exercise training: moderate continuous training vs high interval training on functional capacity and quality of life as well as verify the safety in its application. we included 72 patients with coronary artery disease by assigning one of the training modality for 8 weeks. we analyzed cyclo-ergo-spirometry data, aspect related to quality of life as well as a record of adverse events.


Eligibility criteria:
inclusion criteria: * coronary heart disease, with functional class ii-iii according to new york heart association classification system. * at least 4 weeks from acute cardiac event, percutaneous or surgery revascularization. * optimized medical treatment in adequate doses ( betablockers, ace inhibitors, ara ii, statins and antiplatelet drugs) * age \> 18 years old. * willing to participate and sign an informed consent form exclusion criteria: * residual ischemia waiting for revascularization. * any cardiac event for the last 4 weeks * abnormal ergometry with hemodynamic or clinically significant arrhythmias during the procedure. * history of severe ventricular arrhythmia * uncontrolled glycaemia or blood pressure * moderate to severe chronic pulmonary obstructive disease * osteomuscular and/or mental disorder that hampers an adequate adherence to the intervention program * other vascular diseases: rheumatologic/ autoimmune disorders, thrombopathies, hemophilia. * active oncologic disease. * treatment with corticosteroids.

Keywords: coronary heart disease interval exercise training continuous exercise training quality of life safety
comparing a diagnostic and treatment strategy of upfront ctca with soc in patients with chest pain and suspected cad

Conditions: Chest Pain; CAD

Summary: rationale: patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease (cad). in addition to high healthcare costs, some of the examinations do not assess the presence of cad, which means that patients may be undertreated and are at risk for myocardial infarction. a uniform diagnostic and treatment strategy that uses computed tomography coronary angiography (ctca) as initial examination may reduce major adverse cardiac events (mace) and may reduce healthcare costs. in addition, we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms (cag's). objectives: * to show that the intervention is non-inferior to the control with regards to clinical outcomes * to show superiority of the intervention with regards to clinical outcomes study design: national multicenter prospective randomized controlled trial. study population: patients with suspected stable cad. intervention: upfront ctca to diagnose cad and guide optimal medical therapy (omt). patients with obstructive cad and refractory angina despite omt will undergo non-invasive ischemia imaging to guide revascularization. control: standard of care. diagnosis and treatment are at the discretion of the attending cardiologist. main study end point: composite of all-cause mortality and non-fatal myocardial infarction.


Eligibility criteria:
inclusion criteria: * \>18 years exclusion criteria: * presentation with acute coronary syndrome * acute coronary syndrome within last 3 months * history of obstructive coronary artery disease on imaging * history of pci and/or cabg * severe renal failure * severe allergy to ionidated contrast medium * known pregnancy * patients with an estimated life expectancy of less than 1 year
females with severe or moderate hemophilia a or b: an international multi-center study

Conditions: Hemophilia A; Hemophilia B

Summary: this is a multi-center, international study designed to collect clinical, genetic and quality of life information on females with hemophilia, an inherited bleeding disorder. the study is designed to determine whether there are problems and issues unique to females with hemophilia.

the study involves two questionnaires: one on the diagnosis, symptoms, complications and treatment of each participant to be completed by a staff member; the other is a questionnaire to be completed by the participant on how the disease has affected her life. finally, for those participants who have not previously had genetic testing, the third part of the study is an optional blood test to determine the genetic cause, what change in the factor viii or factor ix gene, caused the hemophilia. the test results will be available to those participants who wish to learn their results. with the data we collect we will compile a database to examine the connection between the genetic cause of hemophilia and the course and symptoms of the disease.

Eligibility criteria:
inclusion criteria: * females with severe (fviii\<0.01u/ml) or moderate (fviii 0.01≤0.05 u/ml) hemophilia a * females with severe (fix\<0.01u/ml) or moderate (fix 0.01≤0.05u/ml) hemophilia b * willingness to participate in the study. exclusion criteria: * subjects who do not meet the inclusion criteria with respect to gender or hemophilia severity.
adhere-s (nis brilique)

Conditions: ACS (Acute Coronary Syndrome)

Summary: noninterventional study investigating persistence and adherence on ticagrelor in acs patients in serbia


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosed with acs - stemi or nstemi or unstable angina, invasively or non-invasively treated * patients already on treatment with ticagrelor at least for 1 month and no longer than 3 months prior to study initiation. enrolment in this study must not be trigger for ticagrelor initiation. * read and signed the informed consent form exclusion criteria: any contraindications as per approved smpc of brilique • patients with life-threatening conditions which could disable patients to comply with scheduled visits and/or not able to fill in the patient questionnaires.
citrate-based regional anticoagulation versus heparin for continuous renal replacement therapy

Conditions: Acute Kidney Injury

Summary: critically ill patients with acute kidney injury (aki) are at high risk of bleeding on account of coagulopathy, platelet dysfunction, frequent liver dysfunction and invasive procedures.in patients at high risk of bleeding, anticoagulation restricted to the circuit (regional anticoagulation) has been advocated as the method of choice.however, citrate anticoagulation may have many metabolic consequences, such as metabolic alkalosis due to citrate metabolism into bicarbonate, and in patients with liver disease, metabolic acidosis and hypocalcemia may occur.implementation of citrate-based regional anticoagulation with frequent monitoring of acid-base and electolytes is also more challenging for the nurses and does not eliminate the need of a low-dose systemic anticoagulation for thromboses prophylaxis in most of the patients. citrate-based regional anticoagulation is therefore mainly advocated only for patients at high-risk of bleeding. the investigators plan to implement an open-label randomized control trial assessing the effectiveness of citrate-based regional anticoagulation in critically ill patients with aki and with a special emphasis on the safety profile of this treatment in patients with severe liver failure.

monocentric prospective open-label randomized controlled trial at the icu of the university hospitals of geneva (switzerland). icu patients eligible if they 18 yr old and had an aki requiring crrt exclusion criteria patients excluded if they had active hemorrhagic disorders or severe thrombocytopenia (\< 50x109/l), a history of heparin-induced thrombocytopenia, severe liver failure defined as a factor v \<20% or were on the waiting list for liver transplantation. treatment assignment subjects enrolled into the trial randomly allocated to either heparin or citrate anticoagulation

Eligibility criteria:
inclusion criteria: * patients with acute kidney injury requiring renal replacement therapy (rifle criteria) * patients (males or females) \> 18 yrs old * consent form signed (or in emergency investigator's statement form) exclusion criteria: * patients with active bleeding disorders * patients with past history of heparin-induced thrombocytopenia (hit) * patients with very severe liver disease ( patients awaiting liver transplant or factor v \ 25) * pregnancy (negative pregnancy test required in child-bearing age women prior to inclusion) * enrollment in another concurrent therapeutic trial
7-week study with ct-155 in people with schizophrenia

Conditions: Schizophrenia

Summary: ct-155 is a novel prescription digital therapeutic (pdt) to treat schizophrenia

ct-155 is a novel prescription digital therapeutic (pdt) being developed by click therapeutics, inc. (click) and boehringer ingelheim (bi) using an interactive, software-based intervention to treat schizophrenia. this is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of treatment with an abbreviated version of ct-155 in adults diagnosed with schizophrenia. eligible participants must have a diagnosis of schizophrenia per the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5). participants that meet eligibility criteria will be enrolled in the study on day 1. the study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.

Eligibility criteria:
inclusion criteria: 1. has outpatient treatment status of schizophrenia. 2. is on a stable dose of antipsychotic medication(s) 3. is the solo user of an iphone with iphone operating system (ios)13 or greater capabilities or a smart phone with an android operating system (os) 9 or greater capabilities. 4. is the owner of, and has regular access to, an email address. 5. has regular access to the internet via cellular data plan and/or wifi. 6. willing and able to receive sms text messages on their smartphone and email messages, and understand how to use the downloaded study app. 7. has stable housing and has remained at the same residence for at least 12 weeks prior to screening, with no anticipated housing changes during the duration of the study exclusion criteria: 1. is currently treated with more than two antipsychotic medications. 2. is currently treated with clozapine or haloperidol. 3. has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms. 4. is currently receiving or has received psychotherapy within 12 weeks prior to screening. 5. meets either the international classification of diseases (icd-10) or dsm-5 criteria for diagnoses not under investigation. 6. has post-traumatic stress disorder (ptsd), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder. 7. has substance or alcohol use disorder. 8. currently needs or will likely require prohibited concomitant medications. 9. is currently participating in another clinical study. 10. prior participation in the ct-155-c-001 clinical study. 11. has suicidal ideation or behavior.

Keywords: prescription digital therapeutic (pdt) software-as-a medical device (samd) smartphone app schizophrenia
ola hou i ka hula: hula and hypertension

Conditions: Hypertension

Summary: physical activity is an important lifestyle modification for individuals with high blood pressure. it is part of national cardiac care guidelines for hypertension management that recommends, along with prescribing medication, lifestyle modification be promoted for improved dietary intake, and participation in about 150 minutes of moderate exercise a week. native hawaiians and other pacific peoples (nhpp) have among the highest risk for the heart disease, with mortality rates twice other ethnic groups. in many minority populations, including nhpp, hypertension develops at an early age, is more severe and is less likely to be controlled. despite the ability of physical activity to reduce blood pressure, the majority of u.s. population, do not meet physical activity recommendations and new interventions that can improve accessibility and adherence, particularly among at-risk minority populations are needed. in this research, hypertension and hula: ola hou pilot study, we plan to evaluate a culturally relevant intervention that uses hula and is consistent with the goals of recommended physical activity for improved lifestyle - moderate-intensity, prolonged physical activity cumulatively at about 150 minutes per week. hula, the traditional dance form of native hawaiians, is commonly practiced in hawai'i as a cultural practice, form of creative expression, and exercise that is structured on controlled, rhythmic movements. combining aspects of meditation, music, self-awareness with low-impact aerobic exercise, traditional hula may be particularly suitable to individuals with limited mobility and fitness and within the recommended paradigm for exercise training and secondary prevention of coronary artery disease (cad). we anticipate a hula and heart health education program will be particularly appealing to native hawaiians and other pacific people (nhpp) including pacific islanders and filipino who suffer from a significant disparity in cardiovascular health. specifically, we will determine if individuals with poorly managed hypertension and randomized to a 12-week hula and heart health education intervention will demonstrate better blood pressure levels, functional capacity, and exercise tolerance (6-minute walk test) than individuals randomized to a usual care group. we will also assess if the individuals in the hula intervention report better health-related quality of life, stress management, perceptions of discrimination, and exercise self efficacy.


Eligibility criteria:
inclusion criteria: * adult (age \> 18) with blood pressure \>140/90 or \>130/80 if also diagnosed with diabetes * under a physicians care for hypertension for at least 6 months * prescribed 2-3 hypertension medications * independently ambulatory * approval of participation from primary care physician or cardiologist exclusion criteria: * prescribed more than 4, or only 1 hypertension medication * severe cognitive dysfunction precluding informed consent and understanding of hula * pregnancy at time or during the study period
foster 100/6 mg nexthaler versus foster 100/6mg pressurized metered-dose inhaler (pmdi) in patients with controlled asthma.

Conditions: Asthma

Summary: the purpose of this study is to demonstrate the non-inferiority of foster 100/6mg nexthaler versus foster 100/6mg pmdi in terms of pulmonary function in asthmatic patients, as well as the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures. the purpose is also to assess the safety and tolerability.


Eligibility criteria:
inclusion criteria: * male or female outpatients, chinese ethnicity aged \>18 years with a clinical diagnosis of asthma for a minimum of 6 months prior to visit 1 confirmed by a chest physician according to international guidelines updated 2016 global initiative asthma (gina). * positive response to reversibility test. * fev 1 (forced expiratory volume within the first second) \>80% of the predicted normal value after appropriate washout from bronchodilators. * patients on previous regular treatment at a stable dose for at least 3 months prior to visit 1 with either high daily dose of ics ( inhaled corticosteroids) or medium daily dose of ics exclusion criteria: * pregnant or lactating woment * intermittent asthma or asthma occurring only duting episodic exposure to an allergen or a chemical sensitizer * diagnosis of chronic obstructive pulmonary disease (copd) as defined by the current glocal initiative for chronic obstructive lung disease (gold) guidelines updated 2016 * current smokers, or ex-smokers * severe asthma exacerbation leading to intake of systemic corticosteroids (\> 10 days) within 1 month prior to inclusion or moderate/severe asthma exacerbations * patients treated with monoclonal antibodies * patients treated with non-potassium sparing diuretics * patients treated with monoamine oxidase inhibitors and tricyclic antidepressants * patients who are receiving therapy that could interact with steroids

Keywords: peek expiratory flow (pef) lung function tests
effect of strain counter-strain on patients with ankle sprains

Conditions: Sports Medicine Injuries

Summary: patients (male and female) will be participate at the study complain of acute to subacute ankle sprain. orthopedic surgeons who will be responsible for the diagnosis of the all cases. the patients will under went to anterior drawer test .

age, six, height, weight (between 15 to 40 y). 1. faam test 2. single-leg loading (sll) test, for proprioception 3. knee to wall dorsiflexion lunge test for ankle dorsiflexion rom. from sitting.(modified). 4. pain (vas)

Eligibility criteria:
inclusion criteria: acute to subacute ankle sprain positive ankle anterior drawer test exclusion criteria: * recurrent ankle sprain,

Keywords: counter-strain, lateral ankle sprains, positional release, effect strain counter-strain ankle sprain
a phase iv study of the safety and efficacy of aripiprazole in combination with lamotrigine in the long-term maintenance treatment of patients with bipolar i disorder with a recent manic or mixed episode

Conditions: Bipolar Disorder

Summary: efficacy of aripiprazole in combination with lamotrigine in the long-term maintenance treatment of bipolar i disorder in outpatients with recent manic or mixed episode


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age meeting diagnostic and statistical manual of mental disorders, fourth edition (text revision) (dsm-iv-tr) criteria for bipolar i disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic exclusion criteria: * first manic episode * current manic or mixed episode with \> 2 years duration * treated with aripiprazole within the past 3 months * allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

Keywords: bipolar i disorder with a recent manic or mixed episode