Kornimate/medical-research-clean huggingface dataset:
corticosteroids for the prevention of atrial fibrillation after cardiac surgery

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is the most common arrhythmia to occur after cardiac surgery. inflammatory response may be one etiological factor. we hypothesized that intravenous corticosteroid administration after cardiac surgery prevents af after cardiac surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo their first on-pump cabg, aortic valve replacement or combined aortic valve replacement and cabg were enrolled. exclusion criteria: * previous episodes of af or flutter * uncontrolled diabetes mellitus * systemic mycotic infection * active tuberculosis * cushing's syndrome * psychotic mental disorder * herpes simplex keratitis * serum creatinine exceeding 200 µg/ml * patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis.

Keywords: atrial fibrillation after cardiac surgery
phase 1 dose-escalation pk/pd trial in advanced cancer patients

Conditions: Advanced Cancer

Summary: primary objective: to evaluate the safety of escalating oral doses of rdea119, a mek inhibitor, in advanced cancer patients. secondary objectives: * to describe the initial pk of different doses of rdea119 when given once orally on day 1 of the study * to describe the pk of different doses of rdea119 when given orally as continuous dosing. * to examine the inhibition of mek products (p-erk), cytokine products, and other protein biomarkers * to expand the mtd dose cohort to evaluate the safety, tolerability and pk/pd of the recommended phase 2 dose * to explore the presence of genotype, pd markers, cell growth and a marker of apoptosis, in paired tumor biopsy samples of patients' tumors pre-dose and during dosing in a minimum of 10 patients in the expanded cohort


Eligibility criteria:
inclusion criteria: - histological or cytological confirmed solid tumor. - advanced metastatic or locally recurrent disease for which no proven effective therapy exists. - in the expanded mtd cohort, a minimum of 10 patients must have an accessible tumor that is amendable to biopsy (cut or needle) at the start and during the study. for patients not in the biopsy group, a block from the patient's original diagnostic biopsy/excision, if available, may be used for genotype analysis. - ecog performance status of 0-1. - life expectancy of \> or equal to 3 months. - acceptable hematology, clinical chemistry, and coagulation laboratory values. - patient must be acceptable for treatment and follow up according to the investigator. - patent must have agreed to and signed the informed consent. - patient has within normal range cardiac function as measured by echocardiogram or muga scan. exclusion criteria: - use of investigational agents or devices within the last 28 days. - major surgery within 30 days of start of study. - patients with documented cns metastasis who are not off steroids and other cns therapies - evidence of uncontrolled active infections. - other serious medical or psychiatric illness. - significant cardiac dysfunction including congestive heart failure (nyha class iii or iv); myocardial infarction or ventricular tachyarrhythmia within the last 6 months; major conduction abnormalities unless corrected with a cardiac pacemaker; prolonged qtc \>460msec. - patients with known hypersensitivity to any of the drugs or components given in this protocol. - pregnancy. - women or men of childbearing potential not willing to use effective contraception, including barrier protection. - patients with abdominal fistula, gi perforation, intra-abdominal abscess, or small bowel resection, any of which is within 6 months of study entry. - patients with abdominal radiation resulting in chronic diarrhea. - because rdea119 is primarily metabolized by cyp3a4 and cyp2c19, inhibitors and inducers of these enzymes should be avoided. - patients with known hiv infection will be excluded.
baclofen for smoking cessation in a non-psychiatric population

Conditions: Nicotine Dependence

Summary: the primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures. the secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. take the medication as directed for the trial period) than those in the placebo group. the tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

this study will test a new medication strategy designed to help smokers quit. it will evaluate baclofen, a drug currently approved and available in canada as a myorelaxant. forty five nicotine-dependent smokers will enroll in this study. fifteen will receive placebo (inactive pill), fifteen will receive baclofen 30 mg/day, and fifteen will receive baclofen 60 mg/day. once enrolled, subjects will visit camh on a weekly basis for assessment of smoking behaviour, a brief health check (vitals, bp and ae screening), delivery of brief individual smoking cessation counselling, and collection of breath, blood and urine samples (as scheduled) to a) measure levels of nicotine and its metabolites, b) conduct pregnancy and tox testing. the medication phase of this study lasts 12 weeks. two follow-up visits will be scheduled at week 13 and at six months after trial completion.

Eligibility criteria:
inclusion criteria: * male or female adults (18 years or older). * meet dsm-iv criteria for nicotine dependence, * smoke ≥10 cigarettes/day, * baseline ftnd score ≥4, co level ≥10, * have had at least one failed quit attempt in the past and are motivated to quit within 30 days of initial intake. * no previous use of medication for smoking cessation in 1 month prior to randomization. * bmi between 15 and 40 inclusive. exclusion criteria: * meet dsm-iv criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history of bipolar disorder or schizophrenia * have a past history of major depression, with historical evidence of suicidal or homicidal behaviour, or psychotic symptom, * have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization * demonstrate serious medical conditions, unstable cardiovascular disease, significant blood abnormalities) * are pregnant, are trying to become pregnant or are currently breastfeeding * baclofen hypersensitivity .

Keywords: smoking cessation treatment baclofen smoking cessation counselling
a phase iii study of jr-131 in renal anemia patients with chronic kidney disease (ckd)

Conditions: Anemia

Summary: the purpose of this study is to investigate the equivalence of jr-131 to darbepoetin alfa and evaluate the safety of jr-131 in renal anemia patients with chronic kidney disease (ckd).


Eligibility criteria:
inclusion criteria: * patients being treated with darbepoetin alfa. exclusion criteria: * patients having complication or history of a cardiovascular / lung / brain infarction. * patients having a pronounced hemorrhagic lesion.
a study of the effect of short-term structured psychological care in patients

Conditions: Colorectal Cancer

Summary: the study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy.


Eligibility criteria:
inclusion criteria: 1. voluntary participation in the study and ability to cooperate with treatment and care; 2. patients who were to undergo enterostomy; 3. age ≥18 years; 4. consciousness (being able to complete the questionnaire alone or able to answer the questions correctly); 5. social impact scale (sis) score ≥24. exclusion criteria: 1. critically ill and unable to cooperate with the study; 2. impaired cognitive function that affects communication; 3. patients with other organic diseases in combination.
safety and immunogenicity of sars-cov-2 protein subunit recombinant vaccine

Conditions: Covid19

Summary: the study is an observer-blind, randomized, controlled prospective intervention study of phase i. the primary objective is to evaluate the safety of the sars-cov-2 protein subunit recombinant vaccine within 7 days after each dose.

this trial is observer blinded, comparative, randomized, phase i study. approximately 60 subjects will be recruited (18 years and above). the investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated sars-cov-2 vaccine)

Eligibility criteria:
inclusion criteria: 1. clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above. 2. subjects have been informed properly regarding the study and signed the informed consent form. 3. subjects will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. history of vaccination with any investigational product against covid-19 during or 6 months prior to enrollment. 3. subjects who have history of covid-19 in the last 3 months (based on anamnesis or other examinations). 4. evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. the result of rapid antigen test is positive. 6. women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 7. abnormality hematology and biochemical test results. 8. history of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 9. history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 10. patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. 11. subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)). 12. subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as guillain-barre syndrome. 13. subjects receive any vaccination (other than covid-19 vaccine) within 1 month before and after investigational product (ip) immunization. 14. subjects plan to move from the study area before the end of study period.

Keywords: covid19 vaccine
open label extension study of licarbazepine in the treatment of manic episodes of bipolar i disorder

Conditions: Bipolar Disorder

Summary: this extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study clic477d2303.


Eligibility criteria:
inclusion criteria: * written informed consent provided prior to participation in the extension study * successful completion of study clic477d2303 * cooperation and willingness to comply with all study requirements exclusion criteria: * premature discontinuation from study clic477d2303 * failure to comply with study clic477d2303

Keywords: bipolar disorder, manic episode/treatment/licarbazepine
clinical characteristics and outcomes of relapsed follicular lymphoma after autologous stem cell transplantation at rituximab era

Conditions: Patient's Outcome Prognostic Factors

Summary: introduction high dose chemotherapy followed by autologous stem cell transplantation (asct) is a therapeutic option in follicular lymphoma after first line treatment failure. the clinical characteristics and outcome of fl patients who relapsed after hdt+asct and therapeutic management in the rituximab era are not well known and may represent a difficult challenge. patients and methods: the investigators conducted a retrospective analysis of fl patients who relapsed after hdt+asct in four french centers treated between 2000 and 2014. clinical records were reviewed for clinical characteristics and treatment strategy at relapse. the investigators aimed to identify prognostic factors related to patient's outcome.


Eligibility criteria:
inclusion criteria: * they were older than 18 years * presented fl at diagnosis (grade 1, 2, or 3a). * received high-dose therapy (hdt) with asct from 2000 to 2014 exclusion criteria: 1. they had already been treated with a 1st asct, 2. had a previous history of histological transformation before asct 3. if they were rituximab naive prior to asct.

Keywords: autologous stem cell transplantation rituximab follicular lymphoma prognosis
gonyautoxins local periarticular injection for pain management after total knee arthroplasty

Conditions: Knee Arthroplasty; Pain Management

Summary: the aim of this study is to demostrate the eficcacy in pain control management after total knee arthroplasty of gonyautoxin. local administration during surgery of gonyautoxin before wound closure can achieved better pain control and lower morphin use during hospital stay compared to local administration of chirocaine, ketorolac and epinephrine


Eligibility criteria:
inclusion criteria: * patients who required total knee arthroplasty due to knee osteoarthritis ( kellgren and lawrence score of 2 or more), with no response to conservative management. * without known allergies to the drugs used in the study * anesthetic risk: asa score 1,2,3. exclusion criteria: * obesity, defined as body mass index over 35 * previous knee surgery * mellitus diabetes * organic brain damage * rheumatic arthritis * coagulation deficit * liver disease * chronic obstructive pulmonary disease * chronic consumption of opiods * refusal to participate in the study

Keywords: paralytic sellfish toxins gonyautoxin post surgery pain management total knee arthroplasty
observation and prediction of complications after coronary angiography

Conditions: Coronary Arteriosclerosis; Myocardial Ischemia

Summary: coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. to avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2 hours. the investigators apply pressure over the puncture site using a sand bag in the first hour. the patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours (standard observation). in the present study the patients are randomized between standard observation and an alternative observation, where the patients are allowed to lift their head, arms and legs during the 2 hours, otherwise as standard observation. the study has three aims: 1. to establish the incidence of bleeding complications: * frequency of hematoma (\> 5 cm) * frequency of pseudoaneurysms * frequency of bleeding demanding surgery * frequency of bleeding demanding transfusion 2. establish a model to predict in wich patient to expect a bleeding complication. 3. assess if the alternative observation is associated with more bleeding complications compared to standard observation.


Eligibility criteria:
inclusion criteria: 1. coronary angiography by the femoral access, where the arterial lumen is reached. 2. only attempted puncture at one side. 3. age \>= 18 years. exclusion criteria: 1. conditions that makes observation in the department impossible. 2. dementia or other reasons to expect lack of compliance. 3. previous participation in the project. 4. implanted vascular prothesis at puncture site.

Keywords: coronary angiography complications observation
effect of melatonin on sleep disturbances in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: this clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.

after selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. the evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks.

Eligibility criteria:
inclusion criteria: 1. patients who meet the clinical criteria for idiopathic parkinson's disease (united kingdom parkinson's disease brain bank criteria) 2. patients who complain of sleep disturbances such as insomnia, rem sleep behavior disorder, excessive daytime sleepiness (eds), etc. 3. patients who have received drug treatment for at least 6 months since their diagnosis 4. male or female patient aged 55 or older 5. patients who have given voluntary consent after understanding the content of the clinical trial (in the case of elderly patients aged 70 or older, consent must be received from both the subject and the his or her legal representative) exclusion criteria: 1. patients with a serious cognitive disorder, behavioral disorder, or mental illness 2. patients with a serious medical disease * patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease * patients with un-controlled high blood pressure or diabetes 3. patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding 4. patients who have a history of hypersensitivity to the investigational products or a drug similar in component or who have had heavy metal poisoning

Keywords: melatonin sleep disturbances
location of lower extremity deep vein thrombosis by emergency physicians using portable compression ultrasonography

Conditions: Deep Vein Thrombosis

Summary: the main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (v-scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (dvt) in patients with no history of dvt. the gold standard is doppler ultrasound of the lower limbs performed by a vascular exploration expert.

the secondary objectives of this study are: * to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (v-scan®) with that of emergency compression ultrasonography performed with a classic device * to compare the diagnostic performance of emergency compression ultrasonography between patients suspected of having dvt arriving through the emergency department versus similar patients sent in by their generalist * to compare the diagnostic performance of emergency compression ultrasonography among patients with suspected dvt according to pre clinical probability testing based on the wells score (low, medium or high probability). currently, the use of ultra-portable ultrasound in this indication is not part of routine care, and this study is therefore considered interventional in nature.

Eligibility criteria:
inclusion criteria: * the patient must have given informed consent and signed consent * the patient must be a member or beneficiary of a health insurance plan * patient consulting in the vascular exploration and medicine department for suspected first episode of deep vein thrombosis * ambulatory patient: defined as any outpatient coming in for a consult directly from their place of residence or via the emergency department * patient does not have a history of venous thromboembolism exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is an adult under any kind of guardianship * the patient refuses to sign the consent * it is not possible to correctly inform the patient * patient has a history of venous thromboembolism
real-life study of patients after 3-months of leuprorelin 5mg implant in prostate cancer

Conditions: Prostate Cancer

Summary: to improve the management of patients suffering from prostate cancer, laboratoires bouchara-recordati wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. the evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, psa values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.

to improve the management of patients suffering from prostate cancer, laboratoires bouchara-recordati wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. the evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, psa values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies. the psychological dimension of the management of patients with prostate cancer will also be addressed by evaluating the strategies used by patients to cope with their prostate cancer \[(prostate cancer patients' coping strategies questionnaire (pcpcsq)\].

Eligibility criteria:
inclusion criteria: * patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (leptoprol®). exclusion criteria: * patient who have already participated in another study or those who do not wish to participate in this study.