Kornimate/medical-research-clean huggingface dataset:
oral direct factor xa-inhibitor apixaban in patients with acute symptomatic deep-vein thrombosis-the botticelli dvt study

Conditions: Deep-Vein Thrombosis

Summary: the purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin k antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.


Eligibility criteria:
inclusion criteria: 1. subjects must be willing and able to give written informed consent. 2. confirmed acute symptomatic dvt, i.e., proximal vein or extensive calf-vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation area) without concomitant symptomatic pe. 3. women and men, ages 18 (or legal age of consent) to 90. women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 1 week after the study in such a manner that the risk of pregnancy is minimized. wocbp include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea for 12 consecutive months; or women on hormone replacement therapy (hrt) with documented serum follicle stimulating hormone (fsh) level \> 35miu/ml\]. even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. wocbp must have negative serum or urine pregnancy test (minimum sensitivity 25iu/l or equivalent units of hcg) within 24 hours prior to the start of study medication. exclusion criteria: 1. women who are pregnant or breastfeeding. 2. women with a positive pregnancy test on enrollment or prior to study drug administration. 3. more than 24 hours pre-randomization treatment with therapeutic dosages of unfractionated heparin (ufh), low molecular weight heparin (lmwh) or fondaparinux or more than a single starting dose of vitamin k antagonist (vka) prior to randomization. 4. uncontrolled hypertension: systolic blood pressure \> 200 mm hg or diastolic blood pressure \> 110 mm hg. 5. creatinine clearance \< 30 ml/min 6. impaired liver function (alt \> 3 x uln) 7. use of asa \> 165 mg/day 8. wocbp who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 1 week after the study. 9. azole antifungals (e.g., ketoconazole), hiv protease inhibitors (e.g., ritonavir) and macrolide antibiotics (e.g., erythromycin). note: topical azole antifungal agents are permitted.
sorafenib, tamoxifen, and cisplatin in treating patients with high-risk stage iii melanoma

Conditions: Melanoma (Skin)

Summary: rationale: sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. drugs used in chemotherapy, such as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving sorafenib together with tamoxifen and cisplatin after surgery may kill any tumor cells that remain after surgery. purpose: this phase ii trial is studying the side effects and how well giving sorafenib together with tamoxifen and cisplatin works in treating patients with high-risk stage iii melanoma.

objectives: * compare relapse-free and overall survival of patients with high-risk stage iii melanoma receiving adjuvant sorafenib tosylate, tamoxifen citrate, and cisplatin vs historical data from patients treated with tamoxifen citrate and cisplatin. * compare the toxicity of these regimens in these patients. outline: this is a pilot study. patients are stratified according to number of positive lymph nodes identified during surgery. patients receive oral sorafenib tosylate twice daily on days 1-28, oral tamoxifen citrate twice daily on days 1-7, and cisplatin iv over 1 hour on days 2 and 3. treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. after completion of study therapy, patients are followed periodically for at least 5 years.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of melanoma * high-risk, stage iii disease * no measurable metastatic disease * has undergone surgery within the past 8 weeks * surgically rendered disease free patient characteristics: * ecog performance status 0-2 * creatinine clearance ≥ 50 ml/min or creatinine ≤ 1.5 mg/dl * liver function tests ≤ 3 times the upper limit of normal * anc ≥ 1,200/mm³ * hemoglobin ≥ 9.0 g/dl * platelet count ≥ 100,000/mm³ * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no myocardial infarction within the past 6 months * no congestive heart failure requiring medication * no pulmonary disease requiring supplemental oxygen * no dyspnea at rest * no active infection * no chronic underlying immunodeficiency disease * no other serious illness that, in the physicians' opinion, may compromise the safety of the patient * no other cancer within the past 5 years except for nonmelanoma skin cancer and cervical cancer * no thromboembolic disease within the past 6 months prior concurrent therapy: * no prior tamoxifen citrate, sorafenib tosylate, or cisplatin * no concurrent radiotherapy or surgery

Keywords: stage iiia melanoma stage iiib melanoma stage iiic melanoma
evaluation of tele-expertise for inmates with a dermatological lesion

Conditions: Skin Disease

Summary: the purpose of this study is to determine whether tele-expertise would be effective and cost-effective by reducing the number of secure transportations for inmates in need of a dermatological consultation


Eligibility criteria:
inclusion criteria: * dermatological expertise required exclusion criteria: * none

Keywords: inmates skin lesion telemedicine
effectiveness of a home-based pulmonary rehabilitation program in copd patients

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation

Summary: the study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.


Eligibility criteria:
inclusion criteria: * copd diagnose with b or e characterization according to gold criteria; * residence in the area covered by the institution where the study is carried out exclusion criteria: * frequency of a pr programme in the previous six months * copd exacerbation for less than one week; * presence of unstable comorbidities (list of predetermined diagnoses that constitute absolute exclusion criteria); * presence of comorbidities that constitute relative exclusion criteria through a medical evaluation. * score of the clinical frailty scale 2.0 above six or above five in case of not having a responsible caregiver and living alone * spo2 below 85% in the 6-minute walk test

Keywords: copd pulmonary rehabilitation maintenance pulmonary rehabilitation
effects of episodic specificity induction in normal and pathological ageing.

Conditions: Neurocognitive Disorders

Summary: episodic specificity induction (esi) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. but it remains to be determined 1) whether the mechanisms targeted by the esi affect memory or executive functioning and 2) whether amnestic type (amci) or dysexecutive type (dmci) mild cognitive impairment patients would benefit differently from this training, which has never been tested. by comparing the effect of the esi on these patients, this would open up new perspectives for their symptomatic care.


Eligibility criteria:
inclusion criteria: the participant: * has provided informed consent obtained in accordance with good clinical practices. * is affiliated to a social security system. * speaks fluent french. * is between 55 and 85 years of age. for the participants of the control group: * has a montreal cognitive assessment (moca) score equal to or greater than 26; * has neuropsychological assessment performance (rl/ri 16, d080, tmt, vosp, rey's figure) in the norm according to his socio-professional category and age, i.e. less than two deviating scores of -1 standard deviation or less than the 10th percentile per function. for patients in the tcla group: * has at least two scores below the 10th percentile or below -1 standard deviation from the norm on neuropsychological assessment tests that assess memory, based on its socio-professional category and age; * has less than two scores below the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess other functions. this is in accordance with the diagnostic criteria of petersen (2004) and jak and bondi (2009). for patients in the tcld group: * has focal executive dysfunction expressed by at least two scores less than the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess executive functions (tmt, stroop, verbal fluences, free recall in memory), according to his socio-professional category and age; * has less than two scores below the 10th percentile or less than -1 standard deviation from the norm on neuropsychological assessment tests that assess other functions (except for free memory reminders and language fluences). this is in accordance with the diagnostic criteria of petersen (2004) and jak and bondi (2009). exclusion criteria: the participant: * meets the criteria for a major neurocognitive disorder of the dsm-5. * has a neurological disorder of infectious origin. * has a psychiatric illness. * has a severe uncompensated sensory deficit. * is a substance abuser. * has had chronic depression or anxiety that has not stabilized for 3 months. * refuses to participate. * is participating in another intervention research project. * is placed under the protection of justice. * refuses to sign the consent form. * is unable to express its consent. * consumed toxic substances or alcohol at the time of the study.
the association between molecular typing of treponema pallidum and treatment efficacy and clinical findings

Conditions: Syphilis

Summary: the investigators compare the treatment results and clicical presentations of different molecular subtyping of treponema pallidum


Eligibility criteria:
inclusion criteria 1. persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis exclusion criteria: 1. pregnant woman 2. known allergy to penicillin 3. rpr titers were found to be 1:8 or less
stepwise positive end expiratory pressure elevation for lung recruitment in acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: acute respiratory distress syndrome is a severe lung disease caused by a variety of direct and indirect issues. it is characterized by inflammation of the lung parenchyma leading to impaired gas exchange and persistent hypoxemia. this condition is often fatal, usually requiring mechanical ventilation. recruitment maneuver aimed to enhance the effect of mechanical ventilation.the objective of this study was to compare safety and efficacy of two lung recruitment maneuvers.

in patients with acute respiratory distress syndrome (ards), protective lung strategy and positive end expiratory pressure (peep) therapy should be started as early as possible to avoid lung damage by high pressures, volumes and fraction of inspired oxygen (fio2). recruitment is a strategy aiming at re-expanding the collapsed lung tissue and then maintaining an adequate level of peep to prevent subsequent de-recruitment. the objective of this study was to compare safety and efficacy of two lung recruitment maneuvers (rm): stepwise peep elevation with determination of the alveolar collapsing pressure versus sustained lung inflation in ards patients

Eligibility criteria:
inclusion criteria: * ards * lung injury score more than 2.5 * on mechanical ventilation exclusion criteria: * hemodynamic instability * left heart failure * pneumothorax * copd * restrictive lung disease

Keywords: ards peep recruitment maneuver
the safety and efficacy of zoledronic acid in the prevention of cancer therapy induced bone loss

Conditions: Breast Cancer

Summary: this study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment


Eligibility criteria:
inclusion criteria: * female patients with histologically confirmed incident invasive breast cancer (t1-4) with positive hormone receptor status (er and/or pgr positive) and no evidence of regional lymph node metastasis (n0) or distant metastasis (m0) * patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment. * patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (\>10 ng/dl) * patient receives adjuvant standard chemoendocrine or endocrine therapy * bone density at study entry \> -2.5 t-score exclusion criteria: * history of treatment or disease affecting bone metabolism (e.g., paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin d * abnormal renal function * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) * pregnancy or lactation * women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, iud, vaginal diaphragm or sponge, or condom with spermicide) other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer premenopausal bone mineral density cancer therapy induced bone loss zoledronic acid
neurofeedback as a treatment tool for depression

Conditions: Unipolar Depression

Summary: the purpose of the study is to investigate whether neurofeedback delivered via functional magnetic resonance imaging signals can be used to train depressed patients to self-regulate emotion networks and whether this improves clinical symptoms.


Eligibility criteria:
inclusion criteria: * major depressive disorder (mdd) diagnosis * stable antidepressant dose medication exclusion criteria: * other physical or psychiatric disorders * current substance abuse * current psychotherapy or other specific intervention * exclusion criteria applicable to mri
evaluation of ptsd family coach, a mobile phone app for family members of individuals with ptsd

Conditions: Stress Disorders, Post-Traumatic

Summary: the proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the va national center for ptsd (va ncptsd) for use by family members of those with posttraumatic stress disorder (ptsd). the primary objective of the proposed study is to assess whether family members of veterans with ptsd find the ptsd family coach app to be satisfactory and feasible to use. secondary objectives are to determine if use of the app increases family members' self-efficacy and their ability to manage their own life stress, which may in part be the result of living with someone who has ptsd.

ptsd family coach is a mobile phone app for family members of individuals with ptsd. this application provides: * education about ptsd * a self-assessment tool measuring life stress * self-management skills to address acute distress and stress * direct connection to support and * information about va and community resources for family members of individuals with ptsd from this research, the investigators wish to learn whether family members of someone with ptsd find the ptsd family coach to be satisfactory and feasible to use. the investigators would also like to know if use of the app increases family members' knowledge of ptsd, and its treatment, and their ability to manage their own life stress, which may in part be the result of living with a veteran with ptsd. currently, there are very few resources for family members of veterans with ptsd. if this research demonstrates that ptsd family coach is a promising tool for family members, it has the potential to address a tremendous unmet need using a very cost-effective, scalable solution.

Eligibility criteria:
inclusion criteria: * currently living with a veteran with significant ptsd symptoms * age 18 or older * own an iphone, ipad or other ios compatible device * currently experiencing at least moderate symptoms of stress exclusion criteria: * currently enrolled in another study related to ptsd

Keywords: ptsd family caregiver burden
efficacy study of rapid test to prevent hospital transmission of methicillin-resistant staphylococcus aureus (mrsa)

Conditions: Methicillin Resistance; Staphylococcus Aureus; Staphylococcal Infection

Summary: the purpose of this study is to evaluate the efficacy of a novel pcr-based laboratory test for rapid detection of mrsa carriers to prevent transmission of mrsa in the belgian acute care hospital setting.

methicillin-resistant staphylococcus aureus (mrsa) strains have become endemic pathogens in acute and chronic healthcare facilities in belgium. mrsa infection is causing increased public concern as it carries a significant risk of morbidity, mortality and has been linked to substantial excess healthcare costs. efficient control of mrsa transmission within healthcare facilities critically depends on screening for and isolation of mrsa carriers among admitted patients. active surveillance cultures for mrsa are now part of clinical practice recommendations both in europe and the usa. indeed, studies have indicated that up to 70 % of the patient reservoir for mrsa among hospitalized patients can only be detected by active sampling of muco-cutaneous colonization sites. there is an urgent public health need for early and reliable detection of carriers of mrsa among patients admitted to healthcare facilities, to inform patient isolation and decontamination procedures, and thereby more effectively control cross-infection the general objectives of this intervention study to be conducted in two large belgian hospitals are to measure the impact of rapid (\< 3 h) pcr detection of mrsa carriage upon patient admission on shortening the delay to implement contact isolation precautions for carriers and reducing nosocomial mrsa transmission to patients admitted in the same wards.

Eligibility criteria:
inclusion criteria: * all patients admitted for more than 48h to a ward in which evaluation in the previous baseline period met the following: * \> 80 % compliance with admission and discharge conventional culture screening, for the pooled admissions to all study wards; * \> 80 % compliance with additional mrsa contact isolation procedures, based on a sample of 50 patient care contact observations per hospital in all study wards; * pooled incidence of nosocomial mrsa acquisition ≥ 1.5 new cases /100 at risk admissions in the study wards. exclusion criteria: * patients staying 48h or less in the study wards

Keywords: methicillin resistant staphylococcus aureus mrsa cross-infection staphylococcal infection infection control
smoking cessation with smokeless tobacco, nicotine tablets and nicotine patches

Conditions: Tobacco Dependence

Summary: to test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches. also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.

this is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). after ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. every ½ year cholesterol, blood pressure, lung function and bmi will be assessed and used to enhance adherence of the participants in this trial.

Eligibility criteria:
inclusion criteria: * smokers (\>7 cig/day) * healthy * allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases * mild asthma and copd, * motivated to quit smoking * motivated to follow the protocol * motivated to use medication in this trial exclusion criteria: * severe diseases * psychiatric diseases * used nrt or zyban the last 2 weeks * stopped smoking \>2 days during last 3 months * more than 6 alcoholic drinks per day * smokes other products than cigarettes * pregnant of lactating

Keywords: smoking cessation smokeless tobacco nicotine patch nicotine buccal tablets retreatment adherence