Kornimate/medical-research-clean huggingface dataset:
effectiveness of care management in alzheimer patients

Conditions: Alzheimer Disease or Associated Disorder; Mild to Moderately Severe Dementia

Summary: context: the french alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of alzheimer disease or associated disorder. however, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence. objective: to evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of alzheimer disease or associated disorder. design and setting: multicentric cluster randomized control trial. patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in france are included. intervention: in addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. this social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. patient in the control group have absolutely no intervention and are followed-up as usually. in order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation. main outcome measure: neuropsychiatric inventory (npi) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of alzheimer's disease or other dementia (diagnostic and statistical manual of mental disorders, fourth edition \[dsm iv\] criteria of dementia) * presence of an informal caregiver * mild to moderately severe dementia (mmse \[10-28\]) * diagnosis of dementia made by a specialist ≤ 6 months * patient affiliated to the national health insurance system exclusion criteria: * institutionalized patient * patient on legal guardianship * behavioural problem with important clinical repercussion * psychotic syndrome * severe and unstable general pathology

Keywords: alzheimer dementia mild to moderately severe new diagnosis prevention of behavioural problems
a study of clofarabine in older patients with acute myeloid leukemia (aml) for whom chemotherapy is not suitable

Conditions: Acute Myeloid Leukemia

Summary: the purpose of the study is to determine if treatment of older patients indicated with untreated acute myeloid leukemia (aml) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with clofarabine.

note: this clinical trial was conducted by bioenvision ltd. bioenvision ltd. was acquired by genzyme corporation oct 2007.

Eligibility criteria:
inclusion criteria: * provide signed, written informed consent * have untreated aml according to world health organization (who) classification * male or post-menopausal female ≥ 65 years of age * unsuitable for intensive chemotherapy * be able to comply with study procedures and follow-up examination * male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies * have adequate liver and renal function as indicated by certain laboratory values exclusion criteria: * received previous treatment with clofarabine * are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed) * have received prior treatment for leukemia. growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine * have a psychiatric disorder that would interfere with consent, study participation, or follow-up * have an active, uncontrolled systemic infection * are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days * have symptomatic central nervous system (cns) involvement * blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia

Keywords: acute myelogenous leukemia acute myeloid leukemia clolar evoltra clofarabine untreated acute leukemia adult acute leukemia
impact of an increased restrictive factor of one anastomosis gastric bypass on metabolic outcomes type 2 diabetes.

Conditions: Obesity, Morbid; Diabetes Mellitus, Type 2

Summary: the purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (oagb) using a "fundoring" fundoplication on metabolic outcomes in type 2 diabetes mellitus. the randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the oagb.

the randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the oagb. the purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (oagb) using a "fundoring" fundoplication on metabolic outcomes in type 2 diabetes mellitus. the main hypothesis is that an increase in the restrictive effect will lead to an increase in the metabolic effect and an increase in its persistence over time.

Eligibility criteria:
inclusion criteria: * bmi 25-55 kg/m2 * patients with diabetes mellitus, type 2 exclusion criteria: * bmi \ 55 kg/m2 * patients without diabetes mellitus, type 2 * history of surgery on the stomach * less than 18 or more than 60 years of age * psychiatric illness * patients unwilling or unable to provide informed consent

Keywords: obesity metabolic surgery fundoring one anastomosis gastric bypass fundoplication diabetes mellitus, type 2
dose-finding study of mt-1303 in subjects with moderate to severe chronic plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the primary objectives of the study are: * to evaluate the safety and tolerability of three dose levels of mt-1303 in subjects with moderate to severe chronic plaque psoriasis. * to evaluate the efficacy of three doses levels of mt-1303 in subjects with moderate to severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on psoriasis area and severity index (pasi).


Eligibility criteria:
inclusion criteria: * have been diagnosed with plaque psoriasis for at least 6 months prior to screening * have moderate to severe chronic plaque psoriasis as defined by pasi score ≥ 12 and bsa ≥ 10% at baseline * in the investigator's opinion is a candidate for systemic therapy exclusion criteria: * non-plaque forms of psoriasis (e.g., guttate, erythrodermic or pustular) * current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate) * history of any of a list of pre-defined cardiovascular diseases * history or known presence of any significant infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study. * previous exposure to any other s1p receptor modulator * receipt of a live vaccine within 28 days prior to randomisation * need, or likely need for, treatment with class i or iii anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate * clinically significant findings electrocardiogram (ecg) findings.

Keywords: psoriasis plaque psoriasis
blood collection for development and validation of point-of-care diagnostic liver function tests

Conditions: Liver Diseases; Healthy; Liver Cirrhosis; Liver Fibrosis

Summary: this is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. blood samples will be collected from participants to further development and validation of the testing platform to support fda review. the diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.

the nature of outpatient diagnostics delays diagnosis and proper treatment due to the need to travel to a sample collection site that is designed for volume testing adding the individual's sample to the testing que. the physical and temporal separation of diagnostic testing from medical office or virtual care visits delays physician decision-making until results are available. many patients even skip the recommended testing due to time and financial costs. many acute and chronic conditions result in disruption of normal liver function. common prescription and over-the-counter medications also affect liver function when taken over extended periods or at elevated doses. having multiple rapid, easy-to-use diagnostic tests on a single platform could improve condition diagnosis and medication monitoring by ensuring current test results are available every time and anywhere they could be useful for immediate medical decision-making. this study will provide fresh blood samples for further development and validation of a novel point-of-care diagnostic testing platform. tests for liver function biomarkers such as bilirubin, alt (alanine transaminase), and ast (aspartate aminotransferase) will be characterized and validated using fresh whole blood, freshly prepared serum, and frozen serum. enrolled participants will have a standard venous and a standard finger stick blood collection. enrolled participants can return once weekly for blood draws or can chose to have only a single study visit. the study will continue until sufficient data has been generated to support review of the tests by the fda.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * able to read and understand an informed consent form written in english exclusion criteria: * pregnancy * participated in the present study within the last 6 days * subject is subjectively unwell at the time of enrollment visit * subject previously participated and has asked to be withdrawn from the study

Keywords: liver function diagnostic test point of care
study of home-based exercise to alleviate postpartum depression

Conditions: Postpartum Depression

Summary: the purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.

postpartum depression occurs in 10-16% of women, with depressive symptoms lasting up to one year post delivery. women affected by depression in the postpartum have been shown to be at higher risk for developing a recurrent depressive disorder. while the direct and indirect costs associated with postpartum depression are unknown, those associated with depression have been found to exceed 43 billion dollars in the united states alone. moreover, maternal depression can negatively impact the mother-infant relationship and infant development. despite the high prevalence of postpartum depression, the condition often goes undiagnosed and untreated by primary care providers. alternative non-medical interventions for treating postpartum depression have not been widely investigated, leaving women and health care providers with few evidence-based options for treatment. if this exercise program is shown to be effective, then this intervention can be an alternate treatment option for alleviating depressed mood for women in the postpartum period. this nonpharmacological approach may be particularly attractive as many women are reluctant to take medication in the postpartum.

Eligibility criteria:
inclusion criteria: * women 4 to 38 weeks following childbirth * score of 10 or more on the edinburgh postpartum depression scale * understand english or french * no current alcohol or substance abuse, * not currently participating in regular moderate or high intensity exercise (30 minutes, at least 3 times per week) exclusion criteria: * obstetrical or concomitant diseases which would have precluded participation in an exercise program.

Keywords: postpartum depression exercise
evaluate the efficacy and safety of andrographolide sulfonate in patients with acute tonsillitis

Conditions: Acute Tonsillitis

Summary: a multicenter, randomized, single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute tonsillitis

the patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group and control group. experimental group: on the basis of conventional therapy,combined with xiyanping injection(andrographolide sulfonate) 10-20ml/d, with 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: xiyanping injection simulation(0.9% normal saline) 10-20ml/d,the treatment method is the same as the experimental group. treatment cycle: less than 7 days (the longest period of treatment is 7 days, if the clinical symptoms were relieved in the treatment, patients were stoped treatment).

Eligibility criteria:
inclusion criteria: * 1.18-65 years, males or females; * 2.patients met the acute tonsillitis diagnosis; * 3.patients'all symptoms (including cough) appeared no longer than 72 h before inclusion to the trial * 4.patients compliance is good, written informed consent was obtained from all participants before the study. exclusion criteria: * 1.patients had a history of andrographolide sulfonate or andrographolide allergy. * 2.pregnancy, lactation, and absence of contraception in women of fertile age. * 3.judging by the researchers, past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases. * 4.after checking, patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases * 5.patients using systemic steroids or other immunosuppressive therapy * 6.patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases. * 7.patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year. * 8.patients were participated in any study of drug trials in the last 30 days. * 9.according to the researchers' judgment, anyone who are not suitable for the study.
phase i study to investigate the effect on the blood pressure after oral administration of sk3530 and amlodipine

Conditions: Hypertension

Summary: to assess the pharmacodynamic effects of co-administrated sk3530 (pde5 inhibitor) and amlodipine, phase i study in hypertensive patient was designed.


Eligibility criteria:
inclusion criteria: * male subjects 19-65 years of age inclusive * subjects with hypertension as defined 100 mmhg ≤ sbp\<140 mmhg and 65 mmhg ≤ dbp \< 90 mmhg after more than 5 minutes in the supine position * written informed consent * willing and able to comply with the requirements of the protocol exclusion criteria: * subjects with acute or chronic disease within 4 weeks of study initiation. * subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.) * subjects with any clinically significant allergic disease or with a known allergy to the pde5 inhibitors * subjects with clinically significant abnormalities on laboratory tests * subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmhg or diastolic blood pressure of at least 10 mmhg when a person assumes a standing position * subjects with abnormal qtc interval(≥440ms) * subjects with color-blindness or weakness * subejcts with alcohol, drug or caffeine abuse * diet known to alter drug absorption, distribution, metabolism or elimination processes * subjects who participated in other clinical studies within 2 months before an administration * other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
cappa-2: cisplatin added to gemcitabine in poor performance advanced nsclc patients

Conditions: Non-Small Cell Lung Cancer

Summary: the primary objective of this study is to evaluate the impact on overall survival (os) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced nsclc in poor clinical condition (ps 2), not previously treated.

performance status is one of the most important prognostic factors for patients with advanced non-small cell lung cancer (nsclc), regardless of treatment received. chemotherapy is recommended for advanced nsclc patients in good clinical condition, but it is not clear how much benefit is gained from giving chemotherapy to patients in poor general condition (performance status 2). this category of patients represents about 20% of all patients at initial diagnosis of nsclc, and remains a treatment challenge for the clinician. there have been very few studies that have evaluated the impact of chemotherapy for this group of patients, and there is no established standard therapy. studies evaluating single agent and combination two-agent chemotherapy regimens' impact on survival and improving symptoms are needed.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage iiib or iv); * no prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment); * ecog performance status 2; * age: \> or = 18 and \< 70 years; * life expectancy at least 4 weeks; * normal bone marrow, hepatic and renal function defined as: neutrophils \> or = 2000/mm3, plt \> or = 100,000/mm3, hb \> or = 10.0 g/dl, bilirubin \> or = 1.5 times the upper normal limit (unl), ast and alt \< or = 3 times the unl (5 times in the presence of liver metastases), creatinine within normal limits; * signed informed consent. exclusion criteria: * active systemic infections; * severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus); * inadequate hepatic or renal function; * radiation therapy ongoing or concluded within two weeks prior to enrollment; * symptomatic cerebral metastases; * previous chemotherapy for advanced disease; * any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures; * pregnant or nursing females; * any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)

Keywords: stage iiib stage iv chemotherapy monotherapy combination chemotherapy poor performance status
the effectiveness of ologen® collagen matrix in preventing intraocular pressure (iop) spikes after ahmed glaucoma valve surgery (agv-fp7)

Conditions: Glaucoma

Summary: the purpose of this study is to investigate whether placing ologen over the posterior plate of the ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of iop elevation during the postoperative period.

uncontrolled glaucoma may require surgical intervention. glaucoma drainage implants such as agv-fp7 are in wide use upon glaucoma and comprehensive surgeons. the success of aqueous shunt surgery depends on the formation and maintenance of a thin permeable capsule around the posterior plate of the aqueous shunt. encapsulated bleb formation, where the capsule is thick and elevated, is a common cause of drainage failure in the early post-operative period. this finding is usually accompanied by elevated intraocular pressure (iop), which requires additional intervention, often surgical and therefore reduces the success rate of the initial surgery. recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (ologen), has become available for glaucoma surgery. this device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® cm,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents. this study is to investigate whether placing ologen over the posterior plate of the ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of iop elevation during the postoperative period.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * uncontrolled treated glaucoma requiring agv-fp7 surgery. * subject must be able and willing to cooperate with investigation plan. * subject must be able and willing to complete postoperative follow-up requirements * subject must be willing to sign informed consent form exclusion criteria: * known allergic reaction to porcine collagen * history of uveitis * corneal opacity or irregularity, preventing visualization of patency of tip of tube or accurate applanation * history of scleral buckle