Kornimate/medical-research-clean huggingface dataset:
evaluate the efficacy of xuebijing injection in acute exacerbations of copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: objective: a prospective multicenter randomized controlled trial to assess the efficacy and safety of xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(aecopd). methods: 254 aecopd inpatients will be recruited in 6 hospitals in china over 2 years. they will be randomly assigned to experimental group and placebo group，experimental: xuebijing injection 50ml in 100ml of normal saline iv, in 80mins, per 12 hours. administration of the agent for consecutive 5 days；placebo comparator: normal saline 150ml iv, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. compare the following index between the two groups: invasive mechanical ventilation rate, length of hospital stay, treg cell,th1,th2,hla-dr,crp,pct,il-4,il-6,il-10,tnf-α，ifn-γ, apacheⅱ, caps score.

a prospective multicenter randomized controlled trial to assess the efficacy and safety of xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(aecopd).

Eligibility criteria:
inclusion criteria: 1. body weight≥40kg and ≤100kg 2. diagnosis of copd :(following global initiative for chronic obstructive lung disease，gold2016) 3. forced expiratory volume in 1 second of less than 70% predicted value after bronchodilator 4. acute exacerbation of copd: the clinical presentation of the patient complaining of an acute change of symptoms(baseline dyspnea,cough,and/or sputum production)that is beyond normal day-to-day variation. 5. assessment of copd exacerbations: medical history:severity of copd based on degree of airflow limitation;duration of worsening or new symptoms;number of previous episodes (total/hospitalizations); comorbidities; present treatment regimen;previous use of mechanical ventilation; 6. sign the informed consent exclusion criteria: 1. pregnant women, lactating women； 2. be allergic to xuebijing； 3. acute exacerbation of copd onset of more than 72 hours； 4. aecopd with severe hypoxemia：oxygenation index \<150 or received endotracheal intubation invasive mechanical ventilation； 5. participation in another experimental protocol within 30 days of study entry 6. primary diseases：asthma，cystic fibrosis，lung cancer，tuberculosis，pulmonary sarcoidosis，pulmonary interstitial fibrosis，malignant neoplasms，blood system diseases，hiv； 7. complications：pulmonary embolism，shock，dic，unstable cardiovascular disease，upper gastrointestinal bleeding，pneumothorax，severe liver and kidney dysfunction； 8. mental incompetence or active psychiatric illness 9. used the following drugs within 72 hours days of study entry：ulinastatin，tanreqing， reduning，qingkailing； 10. the investigator judged that the subject could not be completed or should not participate in the trial：hemodialysis more than 1 mouth，organ transplant patients with potential medical dispute.

Keywords: pulmonary disease, chronic obstructive xuebijing
personalized integrated alcohol and sexual assault prevention among college students

Conditions: Alcohol Drinking; Sexual Assault

Summary: heavy episodic drinking and sexual assault are problematic on college campuses. this study includes a randomized controlled trial of positive change (+change), an integrated alcohol and sexual assault prevention program, compared to an attention-matched control condition across two universities in reducing alcohol use, sexual assault victimization, sexual assault perpetration, and increasing sexual assault bystander intervention. this study will also test the efficacy of +change plus booster session, an identical version of +change delivered 6 months after the baseline, compared to +change alone in long-term reductions in alcohol use, sexual assault victimization, sexual assault perpetration, and increases in sexual assault bystander intervention. this research is the next step of a niaaa-funded planning grant (r34aa025691).

aim 1: test the efficacy of positive change (+change) among college students in each risk group (cisgender heterosexual men; cisgender heterosexual women; lgbtq). students aged 18-25 who engage in heavy episodic drinking will be recruited from 2 large public universities (n = 3,300) and will be randomly assigned to +change, +change plus +booster, or an attention control. alcohol use, sexual assault (victimization and perpetration), and bystander intervention will be assessed at baseline, 3-, 6-, 9-, and 12-month follow-ups. h1a: +change conditions (+change and +change plus booster) will result in less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to the control condition at 3-month follow-up and maintained at 6 months. h1b: +change plus booster at 6-months will maintain less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to +change over 9- and 12-month follow-ups (i.e., less decay of change). aim 2: investigate theoretical mechanisms through which +change conditions impact alcohol use (e.g., descriptive drinking norms, drinking to cope with minority stress for lgbtq students), sexual assault victimization and perpetration (e.g., sexual assault-related norms, sexual assault resistance self-efficacy, hypergender ideology), and bystander intervention (e.g., bystander intervention self-efficacy). exploratory aim: examine +change efficacy among lgbtq subgroups (lesbian, gay, bisexual, trans, non-binary gender, gender queer, queer/questioning, intersex, asexual).

Eligibility criteria:
inclusion criteria: * 18-25 years old * current student at university of study * valid email address at university of study * endorse engaging in heavy episodic drinking at least once in the past month on the screening survey exclusion criteria: • there are no exclusion criteria other than not meeting inclusion criteria
ginkgo biloba extract and the insulin resistance syndrome

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to examine whether the ingestion of the herbal dietary supplement ginkgo biloba extract has any effect on the efficacy of three classes of diabetic medications - (glucotrol, glucophage and actose). additionally, the study will examine the effect of ginkgo biloba extract on pancreatic insulin production in non-diabetic subjects between the ages of 20 and 75 years old.

herbal remedy is popular among those with chronic diseases, who may already be taking several prescription medications, thereby increasing the risk of drug-herb interactions. ginkgo biloba extract is a popular dietary supplement that is ingested by the general population to enhance mental focus and by the elderly to delay onset of age-acquired loss of cognitive function. in subjects with non-insulin dependent diabetes (niddm), ingestion of ginkgo biloba may decrease efficacy of the hypoglycemic agents and increase whole body insulin resistance. because aging is a significant risk factor for the development of niddm as a result of a progressive decline in pancreatic function, and because the elderly chronically take multiple prescription medications, the increased use of ginkgo biloba in this population may increase drug-herb interactions. therefore, we shall examine the effect of ginkgo biloba on the pancreatic function in the elderly to determine whether it may produce pancreatic dysfunction and a potential for the development of insulinopenia. the results of this study should provide valuable information for designing new therapeutic strategies for the treatment of diseases in the insulin resistance syndrome.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus and taking oral diabetes medications - glucotrol, glucophage and actose or avandia * must be able to swallow * healthy individuals without diabetes aged 20 to 80 years of age exclusion criteria: * type 1 diabetes mellitus * type 2 diabetes mellitus taking insulin injections * regular use of anti-inflammatory drugs * chronic anemia

Keywords: ginkgo biloba type 2 diabetes platelet function antioxidant
acupuncture on post-stroke overactive bladder

Conditions: Overactive Bladder

Summary: this study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms. participants will be put into groups randomly and compared. there are two groups: traditional acupuncture and usual care. the ratio of group allocation is 1:1.

current practice in management of oab is quite limited. acupuncture, which is a major treatment modality of traditional chinese medicine, has also claimed to have favourable therapeutic effect on oab. previous study found that acupuncture at the bl-33 point was effective for controlling the overactive bladder. although acupuncture has been shown to be effective in treating oab, there has been no randomized controlled trial examining the efficacy of acupuncture on patients with post-stroke. given the high incidence of oab in post-stroke patients, potentially effective alternative treatments should be investigated.

Eligibility criteria:
inclusion criteria: 1. chinese aged 18 or above 2. patient suffering from first ever stroke or recurrent stroke with no urinary symptom in previous episode(s); 3. patient with classic symptoms, i.e. urgency, urinary frequency or urge incontinence and overactive bladder symptom score (oabss) score ≥3 and the urgency item rated as at least 2-point; 4. not taking any medication for oab 5. able to communicate 6. no current acupuncture or transcutaneous electrical nerve stimulation treatment exclusion criteria: 1. urinary retention with post-void urinary volume \> 100ml; 2. current urinary tract infection; 3. preexisting history of oab or bladder outlet obstruction or underactive bladder; 4. significant cognitive impairment with mmse \< or =19; 5. coexisting alzheimer's disease, parkinson's disease, spinal cord disorder or progressive neurological disease such as multiple sclerosis; 6. active skin lesion or open wound over the needle placement areas; 7. having valvular heart defects, severe cardiac diseases, or bleeding disorders, 8. being fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation; 9. pregnant; 10. malignancies at the sites of selected acupoints; 11. receiving acupuncture treatment 1 month before baseline.

Keywords: post-stroke
software-based modification of hand tremors in xr

Conditions: Tremor

Summary: the following trial evaluates the effect of tremor stabilization algorithms on involuntary hand tremors suffered by parkinson's patients. these algorithms will be implemented in virtual reality (vr). approximately 300 study subjects are to be randomized to experimental (vr plus algorithms, i.e., intervention) and active comparator (vr only, i.e., control) study arms. study subjects will perform a postural tremor test (ptt) to elicit postural parkinsonian tremors. our primary outcome is whether the intervention modifies tremor severity.

the following trial evaluates the effect of tremor stabilization algorithms on involuntary hand tremors suffered by parkinson's patients. these algorithms will be implemented in virtual reality (vr). approximately 300 study subjects are to be randomized to experimental (vr plus algorithms, i.e., intervention) and active comparator (vr only, i.e., control) study arms. study subjects will perform a postural tremor test (ptt) to elicit postural parkinsonian tremors. our primary outcome is whether the intervention modifies tremor severity. secondary outcomes include determining whether tremor severity is reduced long-term. these measurements will occur 5 minutes to 30 days post-intervention and will not involve vr. other secondary outcomes include determining age-of-onset impact on tremor severity, and online self-report surveys for functionality in life in general and in the context of parkinson's disease. subjects will perform tremor-recordings on-site. self-reports will be remote.

Eligibility criteria:
inclusion criteria: * candidates eligible for our study will be 35 - 85 years, diagnosed with parkinson's disease, with no falls within 6 months prior to the study, are able to walk for 5 minutes unassisted, have adequate hearing and vision capabilities, can comply with study requirements, have the ability to fill online questionnaires, and provide written informed consent to participate in the study. exclusion criteria: * candidates that are ineligible for our study have visual-perceptual deficits that limit capacity to be in vr, have clinical diagnosis of dementia or other severe cognitive impairment as determined by a mini-mental state examination score (mmse) of less than 24, or have a history of stroke, traumatic brain injury or other neurological disorders
effect of idea-070 on pain and inflammation induced by pdt

Conditions: Actinic Keratosis

Summary: primary objectives: effect of idea-070 compared to placebo on pain and inflammation induced by pdt. the primary objective is to detect a statistically significant difference of pain and inflammation induced by pdt in test areas treated with idea-070 compared to placebo-treated areas.


Eligibility criteria:
inclusion criteria: diagnosis ot actinic keratosis to be treated with pdt affecting equal sized areas of both sides of the head affecting at least 10% of the area of photoexposure exclusion criteria: morpheaform basal cell carcinoma, major hypertrophy of lesions, porphyria, topical treatment with 5-fu, cryotherapy, pdt, diclophenac sodium, and other less common treatments on the treatment area or systemic treatment within 3 month prior to screening, concomitant use of other analgesics including topical nsaids
effect of structured training program in diabetic patients

Conditions: Diabetic Peripheral Neuropathy

Summary: diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. in such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.

the goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with dpn, despite the existence of various individualized exercise programs designed for dpn patients. the main questions this study aims to answer is: what is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with dpn on pain, sensory symptoms, balance, vibration sense and quality of life? group 1: patients in group 1 will receive a structured exercise program. group 2: patients in group 2 will receive a non-structured exercise program. this group will allow us to compare the effects of a structured and a non-structured exercise program.

Eligibility criteria:
inclusion criteria: * diabetes mellitus with moderate to severe dpn * subjects of both gender * age from 40 to 70 years * independent walking * mnsi score more than 2 out of 13 exclusion criteria: * presence of an active planter ulcer * history of surgery during intervention period * neurological diseases other than dpn
salt reduction on blood pressure and cardiovascular organ damage

Conditions: Hypertension

Summary: the purpose of this study is to determine the effect of a modest reduction in salt intake on blood pressure in white, black and asian individuals with hypertension or prehypertension, and also to determine whether a modest reduction in salt intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease.

the average salt intake for adults in the uk is approximately 10-12 g/day. the current recommendations are to reduce salt intake to 5-6 g/day or less. many randomised trials have shown that this reduction in salt intake has a significant effect on blood pressure, however, most previous trials were carried out in white individuals, fewer in blacks, and none in asians. increasing evidence from epidemiological studies in humans and experimental studies in animals suggest that that our current high salt intake may have other harmful effects on cardiovascular health e.g. a direct effect on stroke, left ventricular hypertrophy, progression of renal disease and proteinuria independent of and additive to salt's effect on blood pressure. however, no well-controlled trials have studied whether a modest reduction in salt intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease. we propose to carry out a double-blind randomised trial to study the effects of a modest reduction in salt intake, as currently recommended, on blood pressure and target organ damage assessed by the measurements of 24 hour urinary albumin excretion, left ventricular mass, left ventricular diastolic function, pulse wave velocity and capillary density, in white, black and asian individuals with hypertension or prehypertension. comparisons: usual salt intake compared to reduced salt intake.

Eligibility criteria:
inclusion criteria: * patients with untreated essential hypertension or prehypertension (sitting systolic blood pressure between 120 and 170 mmhg and/or sitting diastolic blood pressure between 80 and 105 mmhg) * age 18 - 75 years. exclusion criteria: * individuals younger than 18 or older than 75 years * individuals with severe hypertension i.e. blood pressure \> 170/105 mmhg * individuals with any secondary cause of hypertension * individuals with impaired renal function with plasma creatinine greater than 150 umol/l * individuals with diabetes mellitus * individuals with malignancy or liver disease * individuals with ischaemic heart disease or heart failure * females who are pregnant or breast feeding or on the oral contraceptive pill.

Keywords: blood pressure sodium dietary hypertension or prehypertension
rct of progesterone to prevent preterm birth in nulliparous women with a short cervix

Conditions: Preterm Delivery; Cervical Length

Summary: the purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.

preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. recently the nichd did a study in women who were pregnant again after having delivered preterm. it showed that giving 17 alpha-hydroxyprogesterone caproate (17p) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. this placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17p initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?

Eligibility criteria:
inclusion criteria: * nulliparous * cervical length as measured on transvaginal examination \< 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days * gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization exclusion criteria: * multifetal gestation * progesterone treatment after 14 weeks 6 days during current pregnancy * vaginal bleeding, heavier than spotting, after 15 weeks 6 days * amniotic membranes prolapsed beyond external os * preterm rupture of membranes * fetal anomaly * pregnancy without a viable fetus * current or planned cervical cerclage * congenital mullerian abnormality of the uterus * contraindication to intra-muscular injections * hypertension requiring medication * diabetes managed with insulin or oral hypoglycemic agents * des exposure * cervical surgery such as cold knife conization * planned indicated preterm delivery * participation in another interventional study that influences age at delivery * participation in this trial in a previous pregnancy * prenatal care or delivery planned outside a mfmu network center

Keywords: nulliparous pregnancy short cervix progesterone
a safety and efficacy study of a recombinant fusion protein linking coagulation factor ix with albumin (rix-fp) in patients with hemophilia b

Conditions: Hemophilia B

Summary: this study will examine the safety, pharmacokinetics and efficacy of rix-fp for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia b.


Eligibility criteria:
inclusion criteria: * male subjects, 12 to 65 years old * severe hemophilia b (fix activity of ≤ 2%) * subjects who have received fix products (plasma-derived and/or recombinant fix) for \> 150 exposure days (eds) * no history of fix inhibitor formation, no detectable inhibitors at screening and no family history of inhibitors against fix * written informed consent for study participation * on-demand subjects only, who have experienced a minimum average of 2 non-trauma induced bleeding episodes requiring treatment with a fix product during the previous 6 or 3 months exclusion criteria: * known hypersensitivity to any fix product or hamster protein * known congenital or acquired coagulation disorder other than congenital fix deficiency * hiv positive subjects with a cd4 count \< 200/mm3 * low platelet count, kidney or liver dysfunction * recent life-threatening bleeding episode
a long-term extension study of tch346 and placebo administered once daily in patients with amyotrophic lateral sclerosis(als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a study to evaluate the safety and clinical effects of 4 oral doses of tch346 compared to placebo in patients with mild or mild to moderate stages of als.

this is a study to evaluate the safety and clinical effects of 4 oral doses of tch346 compared to placebo in patients with mild or mild to moderate stages of als.

Eligibility criteria:
inclusion criteria: * completed original protocol, study no. ctch346a2211 * be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained exclusion criteria: * exclusion criteria as described in the original protocol will remain applicable into the extension protocol other protocol-defined exclusion criteria may apply.

Keywords: amyotrophic lateral sclerosis; als