Kornimate/medical-research-clean huggingface dataset:
activity levels and rehabilitation outcomes of patients post-stroke

Conditions: Stroke

Summary: patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be recruited into the study. the participants will wear two activity monitors (one commercial grade and one research grade) for the duration of their rehab stay. data from the monitors will be correlated with rehab outcomes, therapy units billed, and length of stay.


Eligibility criteria:
inclusion criteria: * diagnosis of stroke * patient at the brookdale center for healthy aging \& rehabilitation * not greater than maximum assistance to walk 10 feet * walking re-training included in the therapy plan of care exclusion criteria: * primary diagnosis other than stroke * allergy or reaction to the wrist bands of the activity monitors

Keywords: rehabilitation outcomes activity level
brief, scaleable intervention for coronavirus (covid-19) mental health sequelae in college students

Conditions: Emotional Regulation; Affect

Summary: the major aim of this pilot study is to evaluate a brief coping skills intervention for college students, based on an evidence-based treatment and delivered remotely via 14 short daily videos. participants will be 150 rutgers undergraduates who are enrolled in fall 2020. participants in the experimental group (n=100) will receive 4 daily smartphone surveys assessing stress, affect, and other related factors for two weeks before, during, and after the 2-week coping skills intervention. participants in the control group (n=50) will receive assessments over the same time period with no skills intervention. both groups will be assessed weekly throughout the fall semester to monitor the transition to the new semester and longer-term impact of the intervention. the control condition participants will have access to the skills videos at the end of the study.


Eligibility criteria:
inclusion criteria * age 18 years or older * matriculated at rutgers during fall of 2020 (on campus and/or remote) * currently residing in the united states * willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures * ios and android smartphone compatible with metricwire exclusion criteria * non-english speaking * unable to understand or provide informed consent
a study to assess safety & effectiveness of tovinontrine in chronic heart failure with reduced ejection fraction (cycle-1-ref)

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Cardiovascular Diseases; Heart Diseases

Summary: the purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower nt-probnp in patients with chronic heart failure with reduced ejection fraction.


Eligibility criteria:
inclusion criteria: * is an adult male or female patient 18 years of age * has evidence in the medical history supporting a diagnosis of clinical hf syndrome, nyha functional class ii to iii, with the duration of at least 6 months prior to the time of screening. the hf syndrome is defined by documentation of 1 or more of the following: * at least 1 of the typical symptoms due to hf such as dyspnea and/or fatigue limiting exercise capacity; * at least 1 of the typical signs of hf such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or * hospitalization, emergency department visit, or outpatient visit for hf requiring intravenous (iv) or subcutaneous (sq) diuresis within the past 12 months. * has ejection fraction (ef) ≤ 40% by transthoracic echocardiogram (tte) performed and interpreted locally at the time of screening; * has nt-probnp level ≥ 600 pg/ml at the time of screening. patients with atrial fibrillation or flutter at the time of screening are required to have an nt-probnp level of ≥ 1000 pg/ml at the time of screening; * is on stable optimized doses of guideline-directed hf therapy, per investigator's clinical judgement, for a minimum of 4 weeks prior to the time of screening and during screening, with no planned changes after randomization. * has had no addition of new guideline-directed hf therapy within the 3 months prior to the time of screening or during the screening period; exclusion criteria: * has a documented ef \>40% by tte within 6 months of the time of screening or during the screening period; * has evidence of recent hf exacerbation defined by hospitalization or requirement for iv or sq diuretics within 60 days of the time of screening or during the screening period; * has a requirement for routine, scheduled outpatient iv infusions for hf (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration; * has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study; * has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of screening or during the screening period; * has had a prior or planned orthotopic heart transplantation; * has presence of or plan for mechanical circulatory support; note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: pde9 ped9 inhibitor heart failure crd-750 tovinontrine hfref
old red blood cell in renal transplantation

Conditions: Disorder Related to Renal Transplantation; Transfusion Reaction

Summary: kidney transplantation is the treatment of choice for esrd. however, the life expectancy of kidney transplant patients is lower than that of the general population. deaths recipients are due mainly to cardiovascular diseases related to a chronic inflammatory state. in addition, renal transplant patients frequently have anemia, identified as an independent cardiovascular risk factor that can be corrected by blood transfusion. but the relationship between transfusion and inflammatory condition are bidirectional. the patient's inflammatory condition will sound on the effectiveness of transfusion and transfusion could trigger an inflammatory condition. this has been reported with the said blood components "aged", especially with packed red cells in patients hospitalized in intensive care after heavy heart surgery.the main objective of this study is to evaluate the impact of early transfusions on the evolution of renal transplantation (ie death, anti-hla immunization, acute rejection, graft loss, delayed graft function, cardiovascular events ) taking into account in the analysis: patient age at the time of transplantation, the number of incompatibility (s) (hla class i and / or ii) between the graft and the patient and sex of the recipient. this is a multicenter retrospective observational study (descriptive epidemiological study).the impact of early transfusions is determined retrospectively over a period of 6 years from 01 january 2002 to 31 december 2008, in renal transplant patients of all centers of france met the criteria for inclusion. this cohort represents about 12 000-14 000 patients


Eligibility criteria:
inclusion criteria: * male or female patients aged over 18 years * patients who received a first kidney transplant exclusion criteria: * patients who received multiple transplants.
a study to determine the long-term safety, tolerability and biological activity of sar421869 in patients with usher syndrome type 1b

Conditions: Usher's Syndrome

Summary: primary objective: to evaluate the long-term safety and tolerability of sar421869 in patients with usher syndrome type 1b secondary objective: to assess long-term safety and biological activity of sar421869

the total duration of study period is up to 15 years.

Eligibility criteria:
inclusion criteria : provide signed and dated written informed consent (and if appropriate assent) and any locally required authorization eg, health insurance portability and accountability act (hipaa). must have been enrolled in protocol tdu13600. must have received a subretinal injection of sar421869 exclusion criteria: did not receive sar421869 as part of the tdu13600 protocol.
post-covid-19 condition: observational study in vietnam

Conditions: Post COVID-19 Condition

Summary: the primary objective of this study is to estimate the prevalence of the post-covid-19 condition in confirmed mild, moderate, and severe covid-19 adult patients in hai phong, vietnam.

it is a cross-sectional study implemented in hai phong (vietnam) by the infectious and tropical diseases department of viet tiep 2 hospital and the department of public health of the hai phong university of medicine and pharmacy (hpmu). the aim is to enroll moderate and severe covid-19 patients from the 2 following provincial hospitals, viet tiep hospital and kien an hospital, and mild covid-19 patients from the community level in hai phong to assess the burden of post-covid-19 condition in each patient group (mild, moderate or severe acute covid-19). 835 participants are aimed to be interviewed through phone calls: 196 participants with mild disease, 289 participants with moderate disease, and 350 participants with severe disease. in case of suspected post-covid-19 condition, the participant will be proposed to come to viet tiep 2 hospital for a study visit i) to confirm the post-covid-19 condition, ii) to describe symptoms, iii) to evaluate the functional limitations related to the post-covid-19 condition, and iv) to assess the determinants of the post-covid-19 condition in patients with mild, moderate, and severe acute covid-19.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or more; * with a history of documented covid-19 as confirmed by either a positive sars-cov-2 rt-pcr or antigenic test, 3-12 months before inclusion; * hospitalised in viet tiep 2 hospital or kien an hospital (tertiary care hospitals) with moderate or severe covid-19 or registered in provincial cdc health system for mild covid-19; * accepting to participate in the study; exclusion criteria: * not able to understand or answer a quick phone questionnaire; * individuals who refuse or cannot come to viet tiep 2 hospital in case of the suspected post-covid-19 condition.
intracoronary infusion of bm-derived mononuclear cells in patients with large acute myocardial infarction

Conditions: Myocardial Infarction

Summary: large acute myocardial infarctions are the most frequent cause of subsequent systolic heart failure. some evidence exists on the improvement after intracoronary administration of bone marrow cells in patients with a recente acute myocardial infarction. although subgroup analyses suggest that patients with the largest myocardial infarctions have the largest increase in ejection fraction after intracoronary bone marrow administration, there is no published trial including only large myocardial infarctions. therefor we sought to confirm the subgroup analyses by conducting a trial in only large first acute myocardial infarction patients.


Eligibility criteria:
inclusion criteria: * age ≥20 and \<80 years old * acute myocardial infarction \>2 and \<96 hours from start to reperfusion * cumulative st-segment elevation \>6 mm on 12 lead ecg * no functional myocardial impairment outside the myocardial infarction region * succesful pci of infarct related coronary artery * left ventricular ejection fraction \<50% on ventriculography, echo or mri * accepted anticonceptive use during the study for women of childbearing potential * written and signed informed consent exclusion criteria: * cpr \> 10 minuts or persistent cardiogenic shock * complete left bundle branch block without concordant st-segment elevation * need foor cardiac surgery (valvular, coronary or other) * trombocytopenia, coagulation disorders or hematological disease * history or active malignancy * life expectancy (apart from acute myocardial infarction) \<5 years * dialysis or severe kidney insufficiency (creatinin clearance \<30ml/') * severe liver insufficiency * severe respiratory disease * systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction) * symptomatic cerebral or periferal vascular disease * prior myocardial infarction or prior myocardial dysfunction * prior cabg or heart valve surgery * pregnancy, pregnancy wish or lactation \<1 month * psychiatrical illness * physical or psychological inability to adhere to the protocol * participation in other not yet completed study

Keywords: first large acute myocardial infarction
comparison between two types of sedation for elective upper endoscopy procedures

Conditions: Gastro Esophageal Reflux; Gastric Ulcer; Sedation Complication

Summary: sedation is defined as the act of administrating a sedative drug to produce a state of calm or sleep. sedation is commonly given to a patient in hospital settings to provide a tolerable and pleasant experience by relieving anxiety, pain and discomfort, as well as to expedite the duration of the procedure. moderate sedation (conscious sedation) is the preferred state of sedation, whereby self-maintenance of ventilation and hemodynamic stability is achieved. the primary objective of this study is to determine if inhalational sevoflurane is a more superior sedative agent in terms of faster psychomotor recovery and time taken to fulfil discharge criteria when compared with intravenous midazolam sedation. secondary objective is to determine if inhalational sevoflurane sedation has better patient's and endoscopist's satisfaction when compared with intravenous midazolam sedation.

a randomized controlled trial study was done on patients undergoing elective upper gastrointestinal endoscopy in a single tertiary centre in malaysia. the study was approved by university malaya medical centre medical research ethics committee. all patients gave written and informed consent. patients were fasted, and three psychometric tests were performed as a baseline before sedation. patients were randomly allocated to either receive iv midazolam (group m) or inhalational sevoflurane (group s) via nasal mask. standard monitoring was applied. patients in sevoflurane group received the inhalational agent via a nasal mask with stepwise increment until and observed assessment of alertness/sedation scale of 3 or maximum 1.0 minimum alveolar concentration was achieved. patients in midazolam group were given a stat dose of iv midazolam 2.5mg. both groups received 30mcg of iv fentanyl and lignocaine 1% gargle prior to the procedure. the unblinded observer monitored the level of sedation and recorded the patient's vital signs. a second blinded observer performed the psychometric tests before and at the end of the procedure. he also recorded the time to fulfil discharge criteria as well as the satisfaction scores from the patient and endoscopist.

Eligibility criteria:
inclusion criteria: * asa i to ii * patients who are not taking sedative agents prior to procedure. * patients who are able to give consent for the procedure. exclusion criteria: * patients with ischaemic heart disease, respiratory diseases and cerebrovascular disease. * patients who are taking opioid or sedative medications 24 hours before procedure. * patients with previous history of adverse effects to sevoflurane or midazolam. * pregnant patients. * patients with airway obstructions. * patients with features of difficult airway such as limited neck extension, small mouth opening of less than 3 cm, mallampati score of more than 3. * patients who are at risk of aspiration. impaired gag reflex, presence of neurological disorders and impaired physical mobility.

Keywords: sevoflurane midazolam upper endoscopy recovery discharge time
tezspire (tezepelumab) asthma japan post-marketing study (pms)

Conditions: Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)

Summary: the purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of tezspire. 1. development of related aes 2. contributing factors possibly having an impact on the safety and effectiveness 3. development of unexpected related aes

the purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of tezspire. 1. development of related aes 2. contributing factors possibly having an impact on the safety and effectiveness 3. development of unexpected related aes this investigation will be conducted to support the application for re-examination specified in article 14-4 of the act on securing quality, effectiveness and safety of products including pharmaceuticals and medical devices.

Eligibility criteria:
inclusion criteria: * the evaluable patients are those treated with tezspire for the first time due to "bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy) exclusion criteria: none
an open label study to assess the efficacy, safety and tolerability of cozaar plus (losartan potassium 50mg/hydrochlorothiazide 12.5mg) possibly titrated up to cozaar plus-f (losartan potassium 100mg/hydrochlorothiazide 25mg) in patients with essential hypertension (0954a-325)

Conditions: Hypertension

Summary: evaluate blood pressure after 6 weeks of treatment with cozaar plus.


Eligibility criteria:
inclusion criteria: * patient treated with valsartan 80mg or irbesartan 150mg or vandesartan 8mg for at least 4 weeks prior to visit 1 * patient with systolic blood pressure between 140 to 159 mmhg and diastolic pressure between 90 to 99mmhg taken at visit 1 exclusion criteria: * history of angina pectoris that has not been stabilized in the past 6 weeks * history of clinically significant abnormal lab results or diseases * myocardial infarction within the past 6 months * stroke in the past 6 months
custodiol versus ringer: what is the best agent?

Conditions: Thoracoabdominal Aortic Aneurysms

Summary: postoperative renal failure is the most significant risk factor for early mortality after elective surgical repair of thoracoabdominal aortic aneurysms (taaas). to prevent damages related to kidney ischemia during aortic crossclamping and taaa repair, the most recent guidelines recommend the use of cold crystalloid or blood perfusion. since the most studied crystalloid solution is the ringer's lactate solution, this can be considered the standard of care for evaluating the effectiveness of other substrates. an histidine-tryptophan-ketoglutarate enriched crystalloid solution named custodiol (dr. franz kohler chemie gmbh, bensheim, germany) is currently used for organ preservation during transplantation and for cardioplegia during open-heart surgery in most eu countries. this solution may provide a better grade of renal protection to ischemic damage than the standard crystalloid solutions. a recent observational study published by our group suggested a lower incidence of postoperative renal kidney injury in patients undergoing open taaa surgical repair using renal perfusion with custodiol, as compared to those perfused with an enriched ringer's lactate solution. objective of this study is the confirmation of the promising findings about the effectiveness of renal perfusion with custodiol during repair of taaa compared with other crystalloid. the study will be a prospective, single-center, randomized, double-blind, controlled trial, investigating acute kidney injury in patients undergoing taaa open repair using custodiol renal perfusion versus an enriched ringer's lactate solution. it is expected to enroll adult patients undergoing elective taaa open repair. participants will be followed for the duration of hospital stay, an expected average of 2 weeks.


Eligibility criteria:
inclusion criteria: ability to provide written informed consent; patient undergoing open surgical repair of taaa requiring renal perfusion. exclusion criteria: 1. patients who have participated to experimental trials during the previous 3 months 2. intervention under emergency / urgency 3. patient uncooperative and / or affected by mental disease 4. allergy or intolerance to the study drug 5. patient under renal replacement treatment (dialysis) before surgery 6. pregnant or breast-feeding women
the effect of lidocaine on smooth emergence with double lumen tube

Conditions: Cough; Lidocaine

Summary: cough suppression during emergence and tracheal extubation from general anaesthesia has become an important issue as part of patient safety. cough arised from the mechanical irritation of endotracheal tube and cuff could be accompanied by various adverse effects such as laryngospasm, hypertension, tachycardia, arrhythmia and increase of intracranial, intraocular, or intra-abdominal pressure. several cough-preventing strategies have been proposed for smooth emergence, such as opioids, dexmedetomidine or lidocaine. maintenance of remifentanil infusion during emergence has been reported to be an effective method in reducing cough and cardiovascular change without delay of recovery. in previous studies, the effetive effect-site concentraions for 95% of adults (ec95) for preventing cough are a little different depending on anaestheic agent, type of surgery and sex, ranged from 2.14 to 2.94 ng/ml. however, since most of these studies are for sing lumen endotracheal tube, similar preventing effect would not be expected for double lumen tube (dlt) because of its large diameter and long length. another problem is higher concentration of remifentanil more than 2.5 ng/ml could not guarantee the safety after extubation. the efficacy of a single iv bolus of lidocaine for the prevention of cough has been the subject of numerous trials. therefore, combined use of lidocaine and remifentanil could effectively prevent emergence cough for dlt without the risk of high concentration of remifentanil.


Eligibility criteria:
inclusion criteria: * patients needs for double lumen tube intubation for one lung ventilation during surgery with asa (american society of anesthesiologists) class i or ii exclusion criteria: * gastroesophageal reflux disease * obese patients (bmi \> 30) * recent upper respiratory infection history (within 3 weeks) * asthma history * anticipating difficult airway
an observational study of olanzapine coated and orodispersible tablets effectiveness in schizophrenic and bipolar outpatients.

Conditions: Schizophrenia; Bipolar Disorder

Summary: the primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings


Eligibility criteria:
inclusion criteria: * patients suffering from schizophrenic or schizoaffective disorders based on the disease diagnostic criteria dsm iv and being prescribed olanzapine during the 45 preceding days. * patients suffering from bipolar disorders based on the disease diagnostic criteria dsm iv and being prescribed olanzapine during the 45 preceding days for one of the following: * moderate or severe manic episode * relapse prevention in patients with bipolar disorder exclusion criteria: * current treatment with any investigational drug or procedure at entry or during the whole study * hypersensitivity to olanzapine * patients with known narrow angle glaucoma risk