Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of monotherapy with noradrenaline and terlipressin in patients of cirrhosis with septic shock admitted to intensive care unit

Conditions: Cirrhosis With Septic Shock

Summary: the patient evaluated in emergency room since admission and detailed history and clinical examination done .the in hospital cases where sepsis is the culprit and shifted to intensive care unit (icu) in view of septic shock were included since onset of shock. initial fluid resuscitation done and if the patient were no fluid responsive they were randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the primary objectives. at the same time the strict vitals monitoring and standard medical therapy for sepsis including antibiotics and other supportive therapy continued. the patients were followed up till discharge, death or up to 28days after enrollment into the protocol (whichever the longest). the detail methodology has been explained in column 14 later.


Eligibility criteria:
inclusion criteria: * patient of cirrhosis or aclf (acute on chronic liver failure) with septic shock (defined later). * age 18-70yrs * an informed consent from the patient or relative exclusion criteria: * pronounced cardiac dysfunction( valvular heart disease, coronary artery disease), * acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. reynaud's syndrome or related diseases). * pregnancy * previous history of transplantation on immunosuppressant. * acute gastrointestinal bleed.(defined later)
ezetimibe (+) simvastatin vs. atorvastatin comparative study in dm or metabolic syndrome patients (0653a-093)

Conditions: Hypercholesterolemia

Summary: an efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in korea.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypercholesterolemia * drug naive or statin treated but inadequately controlled patients against ncep atp iii guideline goal exclusion criteria: * hypersensitivity to hmg-coa inhibitor or ezetimibe
sanofi pasteur quadrivalent influenza vaccine (qiv) pregnancy registry

Conditions: Pregnancy; Influenza

Summary: the sanofi pasteur quadrivalent influenza vaccine (qiv) pregnancy registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

pregnant women will be enrolled in the registry prospectively (after exposure to qiv in routine clinical settings but before knowledge of the pregnancy outcome). women exposed to qiv with or without adverse events will be recorded in the global pharmacovigilance database and medically reviewed. pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. descriptive statistical methods will be the primary approach for summarizing data. no vaccine products will be provided or administered as part of this registry protocol.

Eligibility criteria:
inclusion criteria: * pregnant women will be enrolled in the registry prospectively (after exposure to quadrivalent influenza vaccine (qiv) but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). if the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. retrospective reports are also eligible for the registry but they will be analyzed separately from prospective reports. exclusion criteria: * n/a

Keywords: quadrivalent influenza vaccine pregnancy registry influenza
study comparing adjunctive risperidone versus placebo in major depressive disorder that is not responding to standard therapy

Conditions: Major Depressive Disorder

Summary: the purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with major depressive disorder with sub-optimal response to antidepressant therapy.

many patients who suffer from major depressive disorder (mdd) do not benefit or show only partial benefit from current psychotropic therapy. this clinical trial seeks to study the efficacy and safety of adjunctive treatment with risperidone in patients with mdd who failed to adequately respond to standard antidepressant treatment prior to this trial and who prospectively do not respond to adequate treatment with standard antidepressant therapy (sad). patients entering the open label phase of the study will have already taken a commercially available sad for a minimum of 4 weeks, and provided the dose was optimal, will continue on this dose of sad throughout the four-week open-label and six-week double-blind phases of the trial. if the dose in the four weeks prior to entering the study was not optimal (as per standard clinical practice), the dose will be increased to be within the optimal range and continued at that dose through the entire open-label sad and double-blind phases. during the double-blind phase, subjects receive an adjunctive dose of risperidone or placebo, once daily, added to their stable dose of sad. the starting dose of risperidone or placebo is 0.25 mg for the first three days of the double-blind phase, and is increased to 0.5 mg for days 4 through 14. on the 15th day of this phase, the dose is increased to the target dose of 1.0 mg/day. if response to this dose is not optimal by day 29, it is increased to 2.0 mg/day and is maintained for the duration of the 6-week double-blind phase. this dose may be reduced once to 1.0 mg/day, but then must be maintained at that dose for the remainder of the study.

Eligibility criteria:
inclusion criteria: * understand and sign the informed consent form * age 18-65 * healthy on the basis of physical exam * treatment with a single antidepressant 4 weeks prior to study start and willingness to maintain on stable dose of the same antidepressant throughout the study * current diagnosis of major depressive disorder * judgement of the clinician that the subject has shown a sub-optimal response to the antidepressant exclusion criteria: * presence of other serious medical illness(es)
antimicrobial hernia repair device clinical study

Conditions: Ventral Hernia; Incisional Hernia

Summary: this prospective clinical study will evaluate the safety and efficacy of the cook® antimicrobial hernia repair device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., class ii, class iii, and class iv) surgical fields. up to 30 patients will be treated with the cook® antimicrobial hernia repair device and patients will be followed for 12 months.


Eligibility criteria:
inclusion criteria: * patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique exclusion criteria: * body mass index (bmi) \< 25. * body weight \< 45 kg * glycosylated hemoglobin (hgb a1c) \> 10% * albumin \< 2.5 g/dl or pre-albumin \< 5.0 mg/dl * renal insufficiency, as determined by an estimated glomerular filtration rate (gfr) \< 60 ml/min/1.73 m2 * known allergies to study device components * other relevant exclusion criteria apply
esketamine and butorphanol for post-lobectomy pain

Conditions: Esketamine; Pain; Post-thoracotomy Pain Syndrome; Thoracic Diseases

Summary: post-thoracotomy pain syndrome (ptps) affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. the analgesic effect of esketamine combined with butorphanol in ptps is still unclear, so this study focused on this aspect.

post-thoracotomy pain syndrome affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. esketamine, the left-handed optical isomer of racemic ketamine, acts as an antagonist of the n-methyl-d-aspartate (nmda) receptor, reversing central sensitization and improving postoperative pain. butorphanol, an opioid receptor agonist-antagonist, can alleviate visceral pain, reduce the risk of respiratory depression, and decrease postoperative morphine consumption. however, research on the analgesic effects of esketamine combined with butorphanol in thoracoscopic surgery remains limited. therefore, this study investigated the impact of esketamine combined with butorphanol on acute pain, chronic pain, and related side effects during the perioperative period in patients undergoing video-assisted lobectomy.

Eligibility criteria:
inclusion criteria: * aged 20-70 years * classified as american society of anesthesiologists i-iii * undergoing video-assisted lobectomy exclusion criteria: * operative duration \< 1 hour * significant comorbidities affecting vital organs such as liver, kidney, and heart * severe infections * immunodeficiency * coagulation disorders * history of analgesic drug abuse * severe dementia or communication barriers * mental illnesses.
clinical trial of zuoqing san in treating ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: the exact efficacy of zuoqing san enema in the treatment of ulcerative colitis (uc) has been clinically verified. in this study, zuoqing san was used to treat uc patients with large intestine damp-heat syndrome, and the traditional chinese medicine (tcm) syndrome type was large intestine damp-heat syndrome. the changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of zuoqing san in the treatment of uc large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. by replicating the rat uc model, the effects of zuoqing san on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (ppar-γ) /nuclear factor kappa-b（nf-κb) /signal transducerand activator of transcription 1 (stat1) pathway, macrophage m1, m2 phenotype and microangiogenesis were observed in uc rats. thus, the specific mechanism of zuoqing san in the treatment of uc was revealed. in this study, the therapeutic effect of zuoqing powder on uc was investigated through clinical and animal experiments, and the specific mechanism of action was studied.


Eligibility criteria:
inclusion criteria:① clinically diagnosed uc; ② the severity of uc is mild to moderate. - exclusion criteria:① the severity of uc is severe; ②patient with severe liver, kidney, heart and brain diseases; ③ patients with chinese medicine allergy; ④ pregnant or lactation patients. -
shockwave assisted large bore access

Conditions: Vascular Diseases

Summary: annually, 150-200 tavr with unilateral large bore access and 200 combined tevar/evar/fevar with bilateral large bore access are performed at our institution. nearly 50 percent of patients fall outside ifu for access vessel size. adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging. the intervention the use of the shockwave medical, inc. peripheral lithoplasty® system to achieve large bore access in patients whose vessels fall outside of the ifu suggested dimensions.


Eligibility criteria:
inclusion criteria: * age \>18 years * indicated for planned procedure requiring large bore (\>12 french sheath) access * mental capacity to provide informed consent * iliac access vessel demonstrates \>50% circumferential calcium * iliac access vessel demonstrates maximum inner lumen diameter less than ifu for device required * iliac access vessel demonstrates maximum outer wall diameter greater than or equal to ifu for device required * preoperative ct angiogram, \</= 5mm slices * preoperative abi/tp * unsuccessful delivery of large bore sheath without adjunctive intervention o definition of unsuccessful = operator assessment of the following * visible distortion of iliac artery calcification under fluoroscopy without forward progress of device * adverse forward pressure application by operator * failure of device to track with external pressure applied to abdomen * patient intolerance of advancement (pain response) in awake patient exclusion criteria: * contraindicated for antiplatelet therapy (aspirin or plavix) * planned iliofemoral surgical reconstruction in next 30 days * prior common or external iliac artery stent placement * prior aorto-iliac, aorto-femoral, or iliofemoral bypass present * iliac access vessel demonstrates maximum outer wall diameter less than ifu for device required * inability to obtain preoperative cta (contrast allergy, ckd, etc) * inability to traverse iliac segment with wire * emergent procedure

Keywords: vascular surgery
assessment of health-status of patients with chronic obstructive pulmonary disease (copd) on maintenance therapy with spiriva hh measured by copd assessment test (cat) test

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to evaluate the early (3-month) impact of the long-acting anticholinergic spiriva hh maintenance treatment on the copd symptoms using the novel copd assessment test (cat) in the real life setting of copd patients, previously treated with short-acting bronchodilator on regular or as-needed basis.


Eligibility criteria:
inclusion criteria: * male and female ambulatory outpatients being seen in a participating physicians office for routine care, * patients with a clinical diagnosis of copd (all stages according to global initiative for chronic obstructive lung disease (gold) guidelines 2010) being treated with long-acting anticholinergic (tiotropium, spiriva® handihaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before visit 1), * patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment, * patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone. exclusion criteria: * uncooperative patients as judged by the physician, * patients with any conditions excluded as per country specific package insert, * patients currently enrolled in any clinical trial, * patients with copd exacerbation or any acute disease in the last 3 months before visit 1.
caring for vets and service members: caring contacts for stressed and distressed veterans and service members

Conditions: Stress; Distress, Emotional

Summary: the goal of this clinical trial is to study stressed or distressed veterans and service members. researchers will compare caring contacts plus best available resources to best available resources alone to see if reduces distress and prevents thoughts of suicide.

the objective of this study is to evaluate whether caring contacts via text message are beneficial to veterans and service members experiencing stress or distress. in the past, caring contacts interventions have focused on individuals who are already suicidal and not a more general population. in addition, a core objective of this study is to understand the mechanisms of action of caring contacts and thus has included an ecological momentary assessment (ema) component that will allow us to determine when and how caring contacts is making an impact. study aims are to evaluate if stressed or distressed veterans receiving caring contacts are at greater or less risk of suicidal ideation or behavior as evidenced by: decreased mean and reduction in variability of indicators of suicide risk (motivation to live, passive ideation, active ideation, suicide intent, and urges to harm self) acquired during ecological momentary assessment periods. reduced risk of suicidal ideation (hass-i) and cognitions (scs-r) during follow-up. examine diverse veterans' experiences with caring contacts (i.e., access, satisfaction, preferences, potential mechanisms) evaluate if veterans receiving caring contacts will show a decrease in distress (i.e., isolation, depression, substance use, loneliness, defeat, hopelessness, and psychological pain) identify potential mechanisms of action for caring contacts by exploring the relationship between potential mechanisms (i.e., mattering, connectedness, social responsibility, and entrapment), distress, and suicide risk observed during ecological momentary assessment periods to identify potential mechanisms of action of caring contacts on decreasing distress and suicide risk

Eligibility criteria:
inclusion criteria: * us service member or veteran * 18 years or older * lives in the united states * stressed (recent separation from or in transition out of the military, unemployment, financial strain, unhoused, or suicide loss, etc.) or distressed (isolation, depression, substance use, loneliness, defeat, hopelessness, psychological pain, or suicidal ideation, etc.) * willingness to be contacted periodically by text message and either email or postal mail exclusion criteria: - unable to consent due to inability to understand the consent form due to cognitive limitations or insufficient english (as determined by inability to pass the consent quiz items)

Keywords: suicidal ideation suicide cognitions
intervention of air pollution and acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: to determine the effect of intervention of ambient air pollution on acute coronary syndrome patients.

to investgate the effect of wearing facemasks to decreasing levels of exposure to ambient air on acute coronary syndrome patients.

Eligibility criteria:
inclusion criteria: 1. non-smoker of any type during past six months and living in a non-smoking household. 2. a diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent. exclusion criteria: 1. unstable cv disorders including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension. 2. a history of infection with human immunodeficiency virus. 3. history of malignancy including leukemia and lymphoma and/or any severe, life-threatening disease and/or history of drug abuse within the last 2 years. 4. pregnancy or intent to get pregnant during the study period.
emergency pharmacist safety study

Conditions: Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures

Summary: the emergency department (ed) is a unique environment in medicine, and many safety mechanisms used in other hospital settings cannot be applied in the ed. for example, clinical pharmacists have traditionally provided extra layers of protection to hospital inpatients by cross-checking provider orders for appropriate dosing, contraindications, and interactions. because medications in the ed must be accessed immediately and are often one-time doses, the use of central pharmacy services would introduce an unacceptable delay to the administration of medication. although some hospitals have programs in place in which a pharmacist responds to the ed for cardiac arrests or trauma team activations, few have reported programs which involve a clinical pharmacist assigned exclusively to the emergency department. nonetheless, published reports have asserted that ed-based pharmacists can increase patient safety. although this concept appears logical, no study has attempted to show that these programs reduce potential adverse drug events in the ed. we propose to implement and optimize an ed pharmacist (edp) program as a safe practice intervention in a large ed. the hospital has provided funding for two permanent full time positions starting at the beginning of the award period. in the initial phase interviews of physicians, nurses, pharmacists, and patients will be conducted and the results will be used to optimize the edp role. a large-scale chart review study will then be conducted to evaluate whether there is a reduction in frequency of potential and adverse drug events during times that the edp is on duty. staff perceptions of the effectiveness of this program will also be evaluated. the overall goal of this initiative is to create an effective edp program that will decrease the rate of adverse drug events in ed patients, and to create a "toolkit" to facilitate the introduction of similar programs into other eds. this toolkit will include a description of the formal, optimized role of the edp, challenges and solutions in implementation, and evidence to support the efficacy of such a program.


Eligibility criteria:
inclusion criteria: * pediatric (less than 19), geriatric (\>64), or critically ill (all ages) exclusion criteria: * investigator involved or incomplete chart

Keywords: emergency pharmacist emergency medicine emergency department medical error adverse event pharmacist patient safety
a phase 3 study to evaluate the efficacy and safety of ivacaftor and vx-661 in combination with ivacaftor in subjects aged 12 years and older with cystic fibrosis, heterozygous for the f508del-cystic fibrosis transmembrane conductance regulator (cftr) mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the efficacy and safety of vx-661 in combination with ivacaftor (iva, vx-770) and iva monotherapy in participants with cystic fibrosis (cf) who are heterozygous for f508del-cftr allele and a second allele with a cftr mutation predicted to have residual function.


Eligibility criteria:
inclusion criteria: * heterozygous for f508del-cftr and a second allele with a cftr mutation predicted to have residual function * forced expiratory volume in 1 second (fev1) greater than or equal to (≥) 40 percent (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height during screening * sweat chloride value ≥60 millimole per liter (mmol/l) during screening or as documented in the participant's medical record * stable cf disease as judged by the investigator exclusion criteria: * history of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant * an acute upper or lower respiratory infection, pulmonary exacerbation * history of solid organ or hematological transplantation * ongoing or prior participation in an investigational drug study (including studies investigating vx-661, lumacaftor \[vx-809\], and/or ivacaftor) within 30 days of screening * pregnant and nursing females * sexually active participants of reproductive potential who are not willing to follow the contraception requirements