Kornimate/medical-research-clean huggingface dataset:
study on ginkgo biolba extract fifty and mild cognitive impairment associated with csvd

Conditions: Mild Cognitive Impairment

Summary: this study aimed to explore the efficacy and safety of ginkgo biolba extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (csvd). subjects included based on eligibility criteria were randomized into treatment and control groups. patients will receive the drug or placebo for 12 months. patients were followed at baseline and at 3 months, 6 months, and 12 months after randomization. the primary outcome was the difference from baseline in the montreal cognitive assessmen (moca) score at 12 months after randomization.


Eligibility criteria:
inclusion criteria: 1. age 50-75 years old, with no limitation on sex. 2. head mri showed svd lesions. high white matter signal, fazekas score ≥2 and meet one of the following requirements: have ≥2 vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking); combined lacunar foci; combined with a new subcortical lacunar infarction (within 7 days of onset); 3. mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a score of 18 ≤moca score \< 26. 4. insufficient cognitive impairment to affect independence of life (mrs≤2). 5. after enrollment, you can live in the local stable for more than two years. 6. sign the informed consent form. exclusion criteria: 1. known or suspected allergy to the components of the investigational drug or allergic constitution. 2. with other brain diseases: alzheimer's disease, lewy body dementia, parkinson's disease frontotemporal dementia, crohn's disease, as well as other diseases that can lead to cognitive impairment, such as subdural hematoma, communicating hydrocephalus, brain tumors, drug poisoning, alcoholism, thyroid disease, and vitamin deficiency. 3. previous diagnosis of genetic/degenerative/inflammatory related small cerebral vascular diseases, such as cadasil, carasil, etc. 4. concomitant with major depressive disorder (≥24 score in hamd-17) or other transient organic psychosis (e.g., schizophrenia) that meets dsm-v criteria. 5. any medication used to treat cognitive impairment in the 4 weeks prior to randomization. 6. combined with severe neurological impairment, such as convenient hand hemiplegia, aphasia, auditory and visual impairment, the relevant examination or scale evaluation can not be completed. 7. combined with severe gastrointestinal diseases such as indigestion, gastrointestinal obstruction, gastric and duodenal ulcers that can affect drug absorption, or inability to swallow medication. 8. liver enzymes (alt, ast)\>2 times the upper limit of normal value, creatinine\>1.2 times the upper limit of normal value, and decreased glomerular filtration rate (\<90ml/min). 9. life expectancy \< 1 year, or other reasons for not being able to complete follow-up. 10. pregnant or lactating women, or those with fertility plans. 11. has participated in other clinical trials.
capital: carotid artery plaque intravascular ultrasound evaluation

Conditions: Carotid Artery Disease

Summary: to assess the safety and feasibility of volcano corp eagle eye gold catheter system to correlate the presence and characteristic of carotid artery atherosclerotic disease with anatomic and histologic analysis.

a phase , single center, prospective safety and feasibility study in patients diagnosed with carotid artery disease requiring intervention (carotid endarterectomy(cea) or carotid artery stenting (cas) with distal protection) as determined by the attending physician per standard treatment guidelines. at the time of the procedure, patients will undergo peri-operative assessment of their carotid artery disease with the study device.

Eligibility criteria:
inclusion criteria: * \>18 years of age * patient must be: symptomatic with lesions \>/= to 50% stenosis, or asymptomatic with lesions of \>/= to 75% stenosis in at least one carotid artery, specific to the internal carotid artery, common carotid artery or bifurcated region; documented through acceptable ultrasound studies, completed within 30 days of recruitment. * for patients with bilateral carotid disease- procedures need to be staged greater than 30 days apart. the lesion that has a greater degree of stenosis will be considered as the index procedure. * women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment. * the patient is able to give informed consent. exclusion criteria: * the patient is experiencing a new (acute) neurologic event or has experienced a stroke within the last 30 days prior to enrollment. * the patient has intracranial tumors, arterial vascular malformations \>5mm, aneurysms or severe intracranial stenosis distal to the target lesion. * presence of thrombus at the target site or loose 'floating' debris as determined by duplex analysis and/or angiography. * existing hemorrhagic disease or coagulation problems creating inability to obtain homeostasis at entry site. * the patient has an allergy to, or is unable to tolerate, heparin, concomitant medications (clopidogrel or ticlid, aspirin) or to nitinol metal. * the patient has a history of or known reaction to radiocontrast agent (radiopaque dye) and is unable to be premedicated. * coumadin treatment that has continued during the 48 hours prior to enrollment and an inr above hospital normals (i.e. in the event of atrial fibrillation or prosthetic valve replacement). * hemodynamic instability at the time of intervention. * severe chronic renal insufficiency (plasma/ serum creatinine\> 2.5 mg/dl) at the time of intervention, except in patients on dialysis.

Keywords: cad cea cas ivus symptomatic asymptomatic cerebral protection device tia stroke plaque morphology
nonsurgical periodontal treatment associated or not with systemic antibiotics and photodynamic therapy

Conditions: Aggressive Periodontitis, Generalized

Summary: to assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (pdt) in the treatment of generalized aggressive periodontitis (gagp).

the aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (clm) association with photodynamic therapy (pdt) in the treatment of generalized aggressive periodontitis (gagp). sixty periodontal pockets were select and randomly assigned into four groups: periodontal debridement (pd) (n=15): periodontal pockets that received periodontal debridement (pd) with placebo; pd+clm (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; pd+pdt (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; pd+clm+pdt (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. probing depth (pd),gain in clinical attachment level (cal) and bleeding on probing (bop) were evaluated at baseline, 3 and 6 months post- operatively.

Eligibility criteria:
inclusion criteria: * diagnosis of gagp * presence of ≥20 teeth * \<35 years of age * periodontal pockets with probing depth (pd) and clinical attachment level (cal) ≥ 5mm with concomitant bleeding on probing (bop) in single-rooted teeth from different quadrants - agree to participate in the study and sign a written consent. exclusion criteria: * pregnant or lactating * suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease * received antimicrobials in the previous 6 months * taking long-term anti-inflammatory drugs * received a course of periodontal treatment within the last 12 months * smoked

Keywords: clarithromycin photodynamic therapy antimicrobial therapy periodontal pocket
motor signature, falls risk, and home-based interventions in older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Fall

Summary: a single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.


Eligibility criteria:
inclusion criteria: * at least 65 years old * had a fall at least 3 months prior to the baseline assessment * can ambulate independently * has mild cognitive impairment exclusion criteria: * cannot ambulate independently and communicate with researchers * have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia) * have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

Keywords: gait computerized cognitive training falls mild cognitive impairment mobility physical exercise tai chi chuan
investigation of multi-omics technique to predict the efficacy of chemoradiotherapy combined with immunotherapy for r/m npc

Conditions: Multi-omics Technique; Nasopharyngeal Carcinoma; Recurrent and Metastatic Nasopharyngeal Carcinoma; Efficacy of Chemoradiotherapy and Immunotherapy

Summary: the observational clinical study will recruit 50 recurrent and/or metastatic nasopharyngeal carcinoma (r/mnpc) patients, to investigate the prediction values of multi-omics technique for the efficacy of chemoradiotherapy combined with immunotherapy.


Eligibility criteria:
inclusion criteria: * recurrent or metastatic nasopharyngeal carcinoma patients * all genders，range from 18～70 years old * ecog score 0 \~ 1 * inform consent form exclusion criteria: * have or are suffering from other malignant tumors; * participating in other clinical trials; * drug or alcohol addition; * do not have full capacity for civil acts; * mental disorder; * pregnancy or lactation; * severe complication, eg, uncontrolled hypertension.
assessment of the clinical efficacy and acceptability of think positive (t+) in diabetes management

Conditions: Diabetes (Insulin-requiring, Type 1 or Type 2)

Summary: new telemedicine systems have been designed to assist people suffering from diabetes in the management of their chronic disease. more recently the focus has been moving to portable systems equipped with bluetooth. this study consists of evaluating an application called the think positive (t+) diabetes management software. it is a randomized controlled trial designed to compare, over a nine month period, a group of patients receiving usual care with a group of patients using the t+ system. the objectives of the study are to investigate the extent to which this telemedicine application helps patients control their blood sugar levels (hba1c), as well as the extent to which its users consider it to be acceptable. the impact of its use on factors such as diabetes self-care, health status, quality of life, self-confidence in diabetes management, fear of hypoglycemia and illness representations will also be examined. because of the supplementary real-time support and feedback that t+ offers, its use should lead to better outcomes in diabetes management than usual care does.


Eligibility criteria:
inclusion criteria: * type 1 and type 2 diabetes patients * insulin requiring patients * sufficiently fluent in english * hba1c \> 7.5 * last visit with diabetes specialist nurse (dsn) \< 12 months exclusion criteria: * psychiatric disorders * poor vision or/and lack of manual dexterity * prior use of t+ * participation in another ongoing trial * patients with antenatal/gestational * patients who are in transition between the children services and adult services insulin pump users

Keywords: diabetes self- management glycemic control telehealth mhealth
physical exercise and depressive symptoms in moderately or severely depressed adults

Conditions: Depressive Symptoms

Summary: this study is a comparative trial comparing the time course of depressive symptoms between moderately and severely depressed participants over a 10-week long exercise program

sixty depressed french adults (34 with symptoms of moderate intensity and 26 with symptoms of severe intensity as defined by the phq-9 cutting scores) voluntarily participated in our comparative trial. a control group (waiting list) of n = 16 including 8 severely depressed and 8 moderately depressed participants received no physical exercise. for the remaining 44 participants (26 with moderate-intensity depressive symptoms and 18 with high-intensity depressive symptoms), two weekly nordic walking sessions of 1h were performed for 10 consecutive weeks. depressive symptoms were assessed using standard self-report questionnaires at various time points: 1/ enrollment (using the phq-9), and then (2) just before the beginning of the exercise intervention (pre-intervention; using the bdi-ii), 2/ at the end of week 5 (mid-intervention; using the bdi-ii), and 3/ the day following the end of the exercise program (post-intervention)

Eligibility criteria:
inclusion criteria: * phq-9 (kroenke et al., 2001) score of 10 or above exclusion criteria: * medical contraindication to moderate-intensity aerobic exercise * inability to read french language

Keywords: add-on treatment
prevalence of brca1 and brca2 mutations in ovarian cancer patients in the gulf region

Conditions: Ovarian Cancer

Summary: a prospective, multi-centre, epidemiological observational study designed to evaluate the prevalence of brca1 and brca2 (breast cancer gene) mutations in current and newly diagnosed ovarian cancer patients across different countries in the gulf region. this study will also describe the epidemiological features for the disease for the enrolled patients.


Eligibility criteria:
inclusion criteria: 1. subjects willing to sign the informed consent form (icf) 2. female subjects 18 years of age or older 3. have histologically confirmed diagnosis of federation of gynecology and obstetrics (figo) ovarian epithelial, primary peritoneal cancer made by one or more of the following: 1. standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or 2. surgical resection and radiographic evidence consistent with ovarian cancer 3. paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract). 4. have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections. exclusion criteria: patients who meet any of the following criteria are ineligible to participate in the study and hence will not be consented: 1. the diagnosis is not of a primary ovarian cancer; thus, patients will be excluded if a previous cancer has metastasized to the ovary, or if there is a secondary malignancy that is associated with the ovarian cancer. 2. is not able or willing to provide written informed consent. 3. have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study. 4. be a patient who, in the judgment of the investigator, would be inappropriate for enrollment in this study. a rationale will be documented for all patients who are screened and ultimately excluded from the study as a result of meeting any of the aforementioned exclusion criteria
magnevist® injection enhanced mra at two dose levels compared to non contrast mra for the detection of structural abnormalities of the infrarenal aorta and peripheral arteries

Conditions: Peripheral Vascular Disease

Summary: the purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of magnevist (the study drug) used for mri of the infrarenal aorta and peripheral arteries. the results will be compared to the results of mri taken without magnevist, and with the results of your x-ray angiography.

this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc.is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * has known or suspected peripheral vascular disease * is scheduled for x-ray angiography exclusion criteria: * has any contraindication to magnetic resonance imaging * is scheduled for any procedure before the x-ray angiography * had previously had stents placed bilaterally in the region to be imaged

Keywords: structural abnormalities of the infrarenal aorta and peripheral arteries
a safety and tolerability study of dapivirine (tmc120) vaginal microbicide gel

Conditions: HIV Infections

Summary: approximately 112 hiv-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. volunteers will be randomized to dapivirine (tmc120) vaginal gel or matching placebo gel. the volunteers will receive investigational product for a total of 42 days. volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.


Eligibility criteria:
inclusion criteria: * hiv-negative * willing to participate and sign an informed consent * willing to be tested for hiv, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group. * willing to use two forms of contraception during the study. * willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study. * have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses. * willing to abstain from using any vaginal product (other than the study product or placebo). * willing to be sexually abstinent from randomization until completion of day 7 evaluations. exclusion criteria: * currently pregnant or breast-feeding. * clinically detectable genital abnormality on the vulva, vaginal walls or cervix. * laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed genital ulcer disease or active hsv-2 lesions. * breakthrough bleeding or gynecologic surgery within 60 days prior to randomization. * symptomatic bacterial vaginosis and unwilling to undergo treatment. * women who require treatment for tuberculosis (tb) within 21 days prior to randomization.

Keywords: hiv-1 hiv seronegativity
triclosan, triclocarban, and the microbiota

Conditions: Triclosan Effects on Microbial Flora

Summary: triclosan (5-chloro-2 (22,4-dichlorophenoxy)phenol) is a broad-spectrum antibacterial and antifungal agent that is found in thousands of common household products, including deodorants, toothpaste, "antibacterial" soaps, cleaning products, kitchen utensils, bedding, socks, trash bags. the benefits of triclosan have not been proven except in reducing plaque and gingivitis when used in toothpaste. in this study, the investigators intend to look at whether exposure to triclosan changes the colonizing flora of the skin, gut and mouth as well as changes in certain blood hormone levels, including adipocytokines, androgens, and inflammatory markers. changes in the gut microbiota have been associated with a variety of disease states such as inflammatory bowel disease, colorectal cancer. additionally, reductions in the microbiome diversity have been associated with obesity.

hypothesis: exposure to triclosan changes microbial flora and leads to changes in objectives: 1. assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after tc use 2. assess whether tc use correlates with microbial resistance 3. if any, assess time to change in alterations in microbial flora study design: prospective, randomized, double-blinded, cross-over study of 20 subjects here, we propose a pilot study in which we will compare the microbial flora of subjects who use triclosan-containing personal hygiene products and those who use triclosan-free products. we will randomize half the cohort to triclosan-containing personal hygiene products including toothpaste, liquid hand soap, bar soap, and dish soap for half of the cohort for a 5-month period of time. the participants and investigators will be blinded as to whether they are using triclosan-containing products or triclosan-free products by blinding the packaging. after about 5 months, the participants will cross-over to the other arm. during a lead-in period of about 2 weeks, we will collect urine samples for a baseline triclosan level and body weight. we will also collect leptin, resistin, grehlin, il 10, il17, pai-1 plasminogen activator inhibitor -1, tnfa, ifn-g, insulin, igf, glucagon, crp, tsh, free t4t3, estradiol, testosterone free, testosterone total, adiponectin, il6, visfatin, h. pylori, esr. blood, urine, and body weight will be collected at three points in the study: prior to first phase, in between phases, and after completion of second phase. we will collect stool, skin, tooth, and saliva samples multiple times throughout the study and submit for pyrosequencing.

Eligibility criteria:
inclusion criteria: * health subjects * age \>18 years exclusion criteria: * pregnancy * recent travel to the developing world (within 3 months) * recent use of antibiotics (within 3 months) * unwillingness to change personal care/hygiene products * recent gastrointestinal illness (within 3 months) * individuals who are unlikely to be available for the 10 months of the study period.

Keywords: triclosan triclocarban microbial flora obesity
effects of high-dose coenzyme q10 on biomarkers of oxidative damage and clinical outcome in parkinson disease

Conditions: Parkinson Disease

Summary: the investigators hypothesise that measuring biomarkers of oxidative damage could better inform investigators on the potential merits (and pitfalls) of coq10 supplementation in pd subjects.

subjects with idiopathic pd will be recruited to a 10-week dose escalation study. each dosage (400mg/day, 800mg/day, 1200/day and 2400mg/day) will be consumed daily for two weeks. information on safety and fasting blood/urine samples will be collected. primary endpoint is plasma f2-isoprostanes (adjusted for arachidonate) while secondary endpoint is the change in the total unified parkinson disease rating scale (updrs) before and after treatment. serum phospholipase a2 activities, plasma all trans-retinol, plasma total tocopherol (sum of α-, δ- and γ-tocopherol) and serum uric acid will be measured.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson disease * age \>21 years * able to provide written informed consent exclusion criteria: * diabetes mellitus, stroke, cardiac and renal diseases and cigarette smoking * major psychiatric disorder or drug and/or alcohol abuse/dependence * regular use of antioxidants, dietary supplements, traditional chinese remedies, non-steroidal anti-inflammatory drugs or immunosuppressive drugs

Keywords: coenzyme q10, parkinson disease, oxidative damage