Kornimate/medical-research-clean huggingface dataset:
prazosin as an antimanic agent in severe mania or mixed states

Conditions: Bipolar, Mania; Bipolar, Mixed State

Summary: mania has been considered to be, in part, a hyperadrenergic state. one focus of treatment of mania involves directly targeting this hyperexcitable state by reducing arousal with antiadrenergic agents. this can be achieved by decreasing norepinephrine release by stimulating presynaptic inhibitory receptors. prazosin, fda approved for the treatment of high blood pressure works in part by blocking postsynaptic alpha-adrenergic receptors. prazosin has been found to be clinically useful for the treatment of post traumatic stress disorder. it is reasonable, therefore, to anticipate that prazosin might be helpful in the treatment of mania.


Eligibility criteria:
inclusion criteria: * age 18-60 * primary diagnosis of bipolar disorder with severe mania or mixed episode * ymrs score of \> 20 * documented medical evaluation without acute or serious medical illness * negative pregnancy test * healthy functioning liver exclusion criteria: * lack of capacity to provide informed consent * involuntary commitment * low blood pressure * history of adverse reaction or allergy to prazosin or other quinazolines * informed consent not given or retracted during study * history of narcolepsy * unstable or acute medical illness

Keywords: treatment of bipolar, mania double-blind, placebo-controlled study drug intervention add-on study prazosin alpha-1 adrenergic antagonist
comparing the efficacy of tiotropium + olodaterol fixed dose combination (fdc) over tiotropium in improvement of lung hyperinflation, exercise capacity and physical activity in japanese copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol fdc or tiotropium (both delivered by the respimat inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in japanese patients with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * all patients must sign an informed consent consistent with international conference on harmonization - good clinical practice (ich-gcp) guidelines prior to participation in the trial, which includes medication washout and restrictions. * all patients must have a diagnosis of chronic obstructive pulmonary disease (copd) and must meet the following spirometric criteria: patients must have relatively stable airway obstruction with a post-bronchodilator forced expiratory volume in one second (fev1) \< 80% of predicted normal and post-bronchodilator fev1/forced vital capacity (fvc) \< 70% at visit 1. * male or female patients, aged \>= 40 years. * patients must be current or ex-smokers with a smoking history of more than 10 pack years. patients who have never smoked cigarettes must be excluded. * patients with score on the modified medical research council (mmrc) \>= 1. * patients who walk \ = 4 at the end of 6 minute walk test (6mwt) at visit 2. * patients must be able to perform technically acceptable pulmonary function tests (spirometry), to use the physical activity monitor and must be able to complete 6mwt during the study period as required in the protocol. * patients must be able to inhale medication in a competent manner from the respimat inhaler and from a metered dose inhaler. exclusion criteria: * patients with a significant disease other than copd; a significant disease is defined as a disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study, influence the results of the study and cause concern regarding the patient's ability to participate in the study. * patients with clinically relevant abnormal baseline haematology, blood chemistry,urinalysis or creatinine \> x2 upper limit of normal (uln) will be excluded regardless of clinical condition (a repeat laboratory evaluation can be conducted if deemed necessary by the investigator). * patients with a current documented diagnosis of asthma. for patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. * further exclusion criteria apply
the 001-dior multicenter registry

Conditions: Coronary Artery Disease

Summary: the 001 dior study is a prospective, multicenter registry of percutaneous coronary intervention (pci) to assess the clinical success, efficacy and safety of the paclitaxel-eluting balloon dior (eurocor gmbh, germany) for the treatment of de novo ostial bifurcated lesions (001 of medina classification). the dior balloon will be used to treat the stenotic site branch.


Eligibility criteria:
inclusion criteria: * de novo bifurcated lesions 001 of medina classification, with significant stenosis only in the ostium of the side branch and a reference vessel diameter is bigger or equal 2.0mm; the dior balloon will be used to the treat the side branch. * the patient has clinical evidence of myocardial ischemia (stable or unstable angina, acute and non acute myocardial infarction, silent ischemia: ecg, exercise test, etz...) * as the maximal length of the diortm balloon is 30 mm, all eligible lesions should be no longer than 25 mm to ensure an adequate drug elution in the treated segment, avoiding the phenomenon of "geographical miss" . * target lesion(s) stenosis is more or equal 50% by visual estimation. exclusion criteria: * cardiogenic shock * any serious disease that might limit patient survival to less than one year * inability to perform clinical follow-up for a period of 1 year * left main bifurcation lesions: ostial left circumflex or ostial left anterior descending artery stenosis. * lesion length \> 25 mm * target vessel reference diameter \< 2mm * stenosis \< 50% of the reference luminal diameter * severe angiographic calcification at the level of the target lesion
study comparing inotuzumab ozogamicin in combination with rituximab versus defined investigator's choice in follicular non-hodgkin's lymphoma (nhl)

Conditions: Lymphoma, Follicular

Summary: this protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. subjects will be randomized to one of these two arms of the study.

on january 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. the decision was not prompted by the identification of any safety signals in this or other studies. active treatment and follow-up of the already enrolled subjects was continued. on july, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of cd20 and cd22-positive, follicular lymphoma, who have received 1 or 2 prior regimens, at least 1 of which should have contained administration of rituximab (either as a single agent or in combination). * age 18 years or older. * ecog performance status \<= 2. * anc \>= 1.5 x 10\^9/l (1500/ml) and platelets \>= 75 x 10\^9/l (75,000/ml), serum creatinine \<= 1.5 x uln and urine protein to creatinine ratio of \<= 0.5, total bilirubin \<= 1.5 x uln, ast and alt \<= 2.5 x uln. * at least 1 measurable disease lesion that is \>= 1.5 cm x 1.5 cm by ct or mri, in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated. exclusion criteria: * subjects with clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma. * subjects whose disease is rituximab refractory, meaning that they did not have a cr or pr, or that they experienced disease progression within 6 months from the initiation of the rituximab or rituximab containing treatment regimen administered immediately preceding study enrollment.
a phase ii trial to evaluate the efficacy and safety of ql1706 in patients with cervical cancer

Conditions: Cervical Cancer

Summary: this is a single-arm, open-label, multicenter, phase ii trial to evaluate the efficacy and safety of ql1706 in patients with recurrent or metastatic cervical cancer.

this is a single-arm, open-label, multicenter, phase ii trial to evaluate the efficacy and safety of ql1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy. the study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. efficacy evaluation and safety monitoring should be performed throughout the study.

Eligibility criteria:
inclusion criteria: * the subject will participate voluntarily and sign the informed consent form. * female, aged ≥18 years when signing the informed consent form. * recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy. * at least one measurable lesion is needed. * the eastern collaborative oncology group (ecog) physical status score was 0 or 1. * adequate reserves of organ function is needed. exclusion criteria: * active autoimmune disease. * central nervous system (cns) metastasis. * concomitant diseases such as cardiovascular and cerebrovascular diseases. * fistula of female genital tract. * diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment. * previous recipients of immune checkpoint inhibitors. * received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; received proprietary chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug. * received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug. * history of immunodeficiency. * history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
lateral ankle sprain study

Conditions: Lateral Ankle Sprain

Summary: the purpose of this study is to compare the short term treatment outcome measures of the standard of care air cell stirrup brace to that of a high tide fracture boot in patients with lateral ankle sprains.

100 patients with grade ii-iii lateral ankle sprains requiring crutches will be invited to participate. patients will randomly be assigned to be treated with either the air cast stirrup brace (n=50) or the high tide fracture boot (n=50). all patients will be given instructions to use the fracture boot or air cell brace at all times of ambulatory activity until follow-up and to use nsaids as needed. at their 2 week post-sprain follow-up the following outcomes measures will be assessed: modified karlsson score (disease specific survey) pain vas patient satisfaction with treatment vas smfa (general health measure) ability to walk without crutches

Eligibility criteria:
inclusion criteria: * age 18 \& over * lateral ankle sprain (grade ii or iii) presenting within 48 hours of initial injury without prior treatment exclusion criteria: * patients less than 18 years old * those not able to give consent * women who are pregnant or are expecting to become pregnant * \> 48 hrs from injury at time of presentation * prior treatment for injury * fracture at time of current ankle injury or previous ankle fracture * deltoid ligament injuries * other orthopaedic injuries at time of presentation * intoxication * workman's compensation injury * mental illness * dementia

Keywords: lateral ankle sprin air cast stirrup brace high tide fracture boot
the correlation between b-type natriuretic peptide (bnp) and global end diastolic volume

Conditions: Critically Ill

Summary: the investigators hypothesized that the serum b-type natriuretic peptide (bnp) level may be correlated with global end diastolic volume (gedv) as measured by transpulmonary thermodilution technique (picco). the rationale is that some animal studies have proven that bnp is released from ventricular myocardium in response to physical expansion. such physical expansion can be measured by gedv. if the hypothesis can be confirmed with our study, the serum level bnp can be used to monitor volume status of critically ill patient, instead of the invasive monitoring system.


Eligibility criteria:
inclusion criteria: * critically ill patients who required hemodynamic monitoring using picco exclusion criteria: * patients with renal dysfunction * those older than 80 years * pregnant women

Keywords: b-type natriuretic peptide global end diastolic volume
specified drug-use survey of alogliptin and metformin hydrochloride combination tablets "survey on long-term use in type 2 diabetes mellitus patients with renal or hepatic impairment or advanced age"

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.

the drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. this tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more). this survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. the planned number of observed patients will be approximately 600. this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: * participants should meet one or more of the following: 1. have renal impairment (mild) 2. have hepatic impairment (mild or moderate) 3. elderly (aged 65 years or more) exclusion criteria: * participants with any contraindication for study drug.
measurement of intestinal permeability in intensive care patients with single or multiple organ failure

Conditions: Multivisceral Failure Syndrome; Monovisceral Failure; Infection in ICU

Summary: multivisceral failure syndrome (mvfs) in humans is associated with a very high risk of mortality, ranging between 30 and 50%. this syndrome is associated with significant systemic inflammation and a high risk of bacteremia, the origin of which is not always identified. among the possible causes of bacteremia, digestive translocation is the most probable but has not been formally proven to date. this translocation is made possible by the numerous cellular and metabolic alterations secondary to mvfs, which can lead to increased intestinal barrier permeability. intestinal permeability is currently not systematically evaluated in clinical practice in humans. this increased intestinal permeability, associated with the presence of inflammatory markers and a septic state, has been studied in several animal models ranging from the fruit fly (drosophila) to the mouse. these studies have shown a high risk of mortality associated with increased intestinal permeability. we propose to use this methodology in intensive care patients with at least one organ failure to investigate the link between increased intestinal permeability and survival chances.


Eligibility criteria:
inclusion criteria: patient with single organ failure, secondary to sepsis, hospitalized in intensive care for a foreseeable duration of \> 48 hours * saps2 between 20 and 40 at the sixth hour after the diagnosis of organ failure. * consent from the patient or their trusted person. * affiliation to a social security system. * functional digestive tract and possible feeding (per os or via a nasogastric tube whose indication was determined independently of the study's needs). second group of patients with multi-organ failure: * multi-organ failure syndrome with at least 2 organ failures, secondary to sepsis. * saps2 between 60 and 80 at the sixth hour after the diagnosis of organ failure. * consent from the patient or their trusted person. * affiliation to a social security system. * functional digestive tract and possible feeding (conscious patient able to swallow or with a nasogastric tube whose indication was determined independently of the study's needs). exclusion criteria: * pregnant and breastfeeding women; * minors; * persons under administrative and judicial supervision; * absence of a functional digestive tract (patient unable to swallow and absence of a nasogastric tube, contraindication to enteral feeding); * patients with gastroparesis; * refusal of the patient or their trusted person; * patient with a saps2 at the sixth hour after the diagnosis of organ failure \ 80.
irinotecan combined with cisplatin as 1st line treatment for esophageal squamous cell cancer : a single center prospective clinical trial

Conditions: Advanced Esophageal Squamous Carcinoma

Summary: irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. different with westerns, squamous carcinoma is the main pathological type in china patients. the investigators then initiated a prospective phase ii clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.


Eligibility criteria:
inclusion criteria: * having signed informed consent * age 18 to 70 years old * histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy * unresectable recurrent or metastatic disease * measurable disease according to the recist criteria(diameter of the lesion should be more than 10mm by spiral ct or mri, more than 20mm by common ct, the date of image should be less than 15 days before enrollment) * karnofsky performance status ≥70 * life expectancy of ≥3 month * no prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases)(within 7 days before enrollment) * serum akp \< 2.5 times uln (within 7 days before enrollment) * serum creatinine \<1.0 times uln (within 7 days before enrollment) * bilirubin level \< 1.0 times uln (within 7 days before enrollment) * wbc\>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl(within 7 days before enrollment) * no sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃； * good compliance exclusion criteria: * previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy * known hypersensitivity to irinotecan * only with brain or bone metastasis * tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung * no measurable lesions, eg. pleural fluid and ascites * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry * heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or * pregnancy or lactation period * other previous malignancy within 5 year, except non-melanoma skin cancer * chronic diarrhea * mentally abnormal or disable cognition,including cns metastasis
web-based support to caregivers in heart failure

Conditions: Heart Failure; Family Caregivers

Summary: caregivers of people with heart failure experience a lack of support from health care in their caring role. they often want to become more involved in care, receive education and have the opportunity to share experiences with other caregivers. objectives and hypothesis: our hypothesis is that an internet-based support program that is developed in collaboration with caregivers of people with heart failure will increase preparedness to care (preparedness for caregiving scale). we will also evaluate the effects of the support program on the experiences of caring including positive experiences and the impact of care on health and lifestyle (caregiver competence scale, rewards of caregiving scale, heart failure-caregiver questionnaire) and their management of heart failure (knowledge of heart failure, support for heart failure self-care and perceived control over heart disease). we will also explore if the patients' healthcare consumption is altered when caregivers receive more support. method: the project is a randomized controlled study where 300 caregivers from four health care regions will be randomised to either receive a support program via 1177 care guide or to a control group waiting list who receive standard support from health care and municipalities. after the termination of the study participants in the control group will also be offered access to the support program. data will be collected with questionnaires at baseline and after 3 and 6 months. a process evaluation with semi-structured interviews to describe the relatives' experiences of using the program with be conducted. relevance: caregivers have been involved in all stages of the development of the internet-based support program. the evaluation focuses on both the effects of the intervention and factors that affect implementation and equality. caregiver support that is delivered through 1177 care guide enables a more equal, efficient and accessible support for caregivers.


Eligibility criteria:
inclusion criteria: * a close relative identified by the patient who cares for, supports or helps this patient with a verified heart failure diagnosis icd codes within i42 or i50 (i.e. all types of heart failure). exclusion criteria: * relatives who are unable to carry out the data collection or participate in intervention (e.g. non-swedish speaking, cognitive problems, severe mental illness, addiction) * the patient or the close relative have a serious disease with expected short survival of \< 6 months.

Keywords: heart failure caregiver carer preparedness perceived control