Kornimate/medical-research-clean huggingface dataset:
effect of deep brain stimulation on depression and quality of life in parkinson's patients

Conditions: Parkinson's Disease

Summary: we will evaluate the effect of deep brain stimulation on the depression and quality of life in parkinson's disease. we aim to compare depression pre-operatively and post-operatively in parkinson's patients with deep brain stimulation to parkinson's patients evaluated and approved for deep brain stimulation but who did not complete surgery. we will also compare quality of life measures between patients with and without deep brain stimulation.

deep brain stimulation is an approved therapy for parkinson's patients, and this procedure is actively performed at vanderbilt university hospital. questions have been raised concerning the effect of deep brain stimulation on the depression commonly seen in parkinson's patients. through this study, we plan to evaluate and compare the incidence and severity of depression in parkinson's patients with deep brain stimulation to those who did not complete the surgery. primary literature has indicated a general increase in quality of life of those patients receiving dbs, but no studies have compared these two specific patient populations.

Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic parkinson's disease. * patients who have received neuropsychological testing in preparation for possible deep brain stimulation. * patients are within the age of 50 and 85. exclusion criteria: * parkinson's patients not approved for deep brain stimulation on the basis of neuropsychological testing. * patients who received deep brain stimulation less than a year ago. * patients who do not consent to the study procedures.

Keywords: parkinson's disease depression quality of life deep brain stimulation
aortic stenosis evaluated via modern ballistocardiography and seismocardiography

Conditions: Aortic Stenosis

Summary: calcific aortic stenosis (as) (formerly "senile" or "degenerative") is a frequent disease of heart valves and is characterized by a thickness and calcification of leaflets with a significant increase of the pressure gradient, defined as an aortic jet velocity of \> 2 m/s. whenever the aortic jet velocity is \> 4 m/s, in association with an aortic valve area of \ 65 years and 12% of those aged \> 75 years. among those aged \> 75 years, it is estimated that 3.5% has severe as. with the aging of population, the prevalence of as is expected to increase in the forthcoming years. transcatheter aortic valve implantation (tavi) has been introduced in 2004 and consists in percutaneous replacement of the aortic valve. it is indicated in those patients with severe as who cannot undergo surgical replacement because of high surgical risk. tavi seems to be a good alternative to surgical intervention also for patients deemed at intermediate risk, especially if they are frail or aged. ballistocardiography (bcg) consists of the measurement of the body's accelerations as a consequence of the recoil forces generated by the blood mass ejection at each cardiac contraction and recorded on the body's surface close to the subject's center of mass. seismocardiography (scg) records the heart-induced accelerations generated at each cardiac contraction and transmitted to the local chest surface. thanks to specific algorithms applied to the scg and bcg waves, it is possible to compute the kinetic energy (ke) and power (p) of a single cardiac contractile cycle. the aims of our study are to demonstrate that: lvot vmax and lvot vti changes obtained with echocardiography can be estimated reliably throught bcg and scg signals, before and after tavi procedure; pmax and ke computed from the bcg and scg signals could predict the severity of the as before the tavi procedure. ke and p computed from non invasively recorded bcg and scg waves may prove useful in the evaluation of as severity and its evolution before and after tavi procedure, respectively.


Eligibility criteria:
inclusion criteria: * severe aortic stenosis, planned to undergo tavi procedure exclusion criteria: * concomitant heart valve disease other than as * c2 and d2 stages of as according to the current definition (see table i for further details) * heart failure regardless to the etiology * arrhythmias * severe kidney disease * denied consent to participate

Keywords: ballistocariodgraphy seismocardiography lv mechanics
pragmatic analysis of vitamin d in anca-associated vasculitis

Conditions: ANCA-associated Vasculitis; Granulomatosis With Polyangiitis; Microscopic Polyangiitis; Eosinophilic Granulomatosis With Polyangiitis

Summary: this prospective study will assess if 12 months of vitamin d3 (cholecalciferol) supplementation, in patients with aav (gpa, mpa, and egpa) who have deficient or insufficient 25(oh)d3 status at enrollment, correlates with improved disease activity and/or lower frequency of relapse (compared to historical data and a previously conducted cross sectional study (part i) that assessed vitamin d status in a cohort of similar patients).

1. subject cohorts: patients with a diagnosis of aav from the msh rheumatology clinic in a cohort of consecutive patients over a 3 month recruitment period. 2. study design, data collection: patients with insufficient and/or deficient vitamin d status at study enrolment will be instructed to take 12 months of vitamin d3 (cholecalciferol) supplementation (1000 iu for those not on vitamin d, or to increase the dose up to 2000 iu per day for those already on vitamin d) vs. those with sufficient status who will be observed for 12-months. 3. study duration: 12 months. 4. study endpoints: vitamin d status vs. disease activity.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age, women and men * followed at the mount sinai hospital, vasculitis clinic, toronto * with a diagnosis of aav (gpa, mpa or egpa) satisfying the modified american college of rheumatology 1990 classification criteria and/or the revised 2012 chapel hill nomenclature definition. exclusion criteria: * current or history of hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis d, williams syndrome, other autoimmune, chronic inflammatory or infectious conditions, malabsorptive disorders, cancer, type 1 diabetes, liver disease * current or planned pregnancy within the next year. * intolerance, allergy to oral vitamin d, and/or contra-indication to take oral vitamin d

Keywords: vitamin d anca vasculitis
an observational study on bevacizumab (avastin) as first-line treatment in colorectal cancer participants with potentially resectable liver metastases

Conditions: Colorectal Cancer

Summary: this observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.


Eligibility criteria:
inclusion criteria: * participants with colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases * first-line treatment with bevacizumab for potentially resectable metastatic disease exclusion criteria: * outright resectable disease * clearly inoperable disease * participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy
combined human milk oligosaccharides (hmos) and probiotics intervention for children with autism

Conditions: Autism Spectrum Disorder; Neurodevelopmental Disorders; Anxiety

Summary: this research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. the study will use a combination of human milk oligosaccharides (hmos, prebiotics) and probiotics as an oral powder.this clinical trial will have two consecutive phases. phase 1a is an 8-week randomised, double-blinded, placebo-controlled trial. participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). phase 1b is an 8-week open-label study. all participants that complete phase 1a will move into phase 1b (n=60). this allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.


Eligibility criteria:
inclusion criteria: 1. aged 5.00 years to 12.99 years. 2. a confirmed diagnosis of asd or pervasive developmental disorders (pdd) including autistic disorder, asperger's disorder (as); pdd not otherwise specified (pdd-nos); and atypical autism. exclusion criteria: 1. organic gi disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the gi tract. 2. bowel surgery or short bowel syndrome 3. participants who have a diagnosed cow milk protein allergy. 4. participants who suffer from the conditions listed below or who are taking any of the following medications or supplements: * antibiotics or antifungals in the last two months * probiotic supplements in the last two months * immunocompromised or severely ill * genetic disorders (e.g. fragile x syndrome) * chronic health conditions such as diabetes, heart disease or an eating disorder.

Keywords: gut microbiome behaviour
tdcs applied to the ofc: effects on decision-making and impulse control

Conditions: Impulsive Behavior; Suicidal Impulses

Summary: in this study the investigators aim to assess whether transcranial direct current stimulation (tdcs; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (ofc) is able to modulate decision-making and impulse control in healthy participants.

in this single-blind, three-arm and sham-controlled study, we will assess whether transcranial direct current stimulation (tdcs; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (ofc) is able to modulate decision-making and impulse control in healthy volunteers. we hypothesize that tdcs applied to the ofc, in comparison to sham tdcs, will significantly enhance decision-making and impulse control. for this study we will enroll 45 healthy individuals aged 18-60 years. these individuals will be assessed with a battery of computerized tasks as well as clinician-administered and self-reported questionnaires on depression and anxiety. assessments will be carried out before and after a single 30-minute tdcs session.

Eligibility criteria:
inclusion criteria: * men or women aged 18 to 60 years exclusion criteria: * presence any psychiatric and/or neurological illness * psychoactive substance abuse/dependence in the past 6 months * current use of medication(s) that might influence cognition and/or affective status * presence of an uncontrolled medical disease (e.g., cardiovascular, renal) * pregnancy and/or lactation * specific contraindication for tdcs (e.g., metallic head implant).

Keywords: decision-making impulse control transcranial direct current stimulation brain stimulation neuromodulation tdcs iowa gambling task stroop word-color task
vinorelbine plus (+) trastuzumab vs docetaxel plus (+) trastuzumab as 1 line treatment for her2 positive (+) metastatic breast cancer

Conditions: Breast Cancer

Summary: in an open-label randomised phase iii-trial patients with metastatic her2-positive breast cancer naive to chemotherapy with normal organ function and who performance status \< 3 are randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks. primary endpoint is time to progression. secondary endpoints include overall survival, time to treatment failure, response rate, duration of response and toxicity. the study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic her2-positive breast cancer * who performance status \< 3 exclusion criteria: * chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months with docetaxel, vinorelbine or trastuzumab * severe dyspnoea * abnormal organ function including cardiac

Keywords: metastatic breast neoplasm
community testing of wearable assistance

Conditions: Cerebral Palsy

Summary: this feasibility study looks to evaluate ankle exoskeleton assistance in community settings for individuals with cerebral palsy.

participants will undergo consent (if not done over the phone), history/physical/activity questionnaire, and orthotic device fitting. following device fitting, the participants will practice walking with powered assistance. next, participants will complete "pre" walking tests with and without the device (order randomized) on a 15-minute pre planned community walk in close proximity with their own home. distance, time, heart-rate, and perceived exertion will be recorded. the expected duration is 1-2 hours. next, participants will be asked to complete (under parental supervision for minors) the pre-determined walking route every day for 1 week with or without ankle exoskeleton assistance (block randomized). following the first week of independent walking practice, participants will complete "post" walking tests with and without the device on the same walking route. distance, time, heart-rate, and perceived exertion will be recorded. the expected duration is 1-2 hours. participants will then have a 2-6 week washout period. following this washout, the pre- and post-assessments will be completed before and after, respectively, another week of identical community walking practice completed under the remaining condition (either exoskeleton or no exoskeleton).

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy * gross motor function classification level i, ii, or iii * able to walk for at least 20 minutes with or without a walking aid * able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking * able to provide verbal assent, if appropriate. if the participant is non-verbal, parental interpretation of gesticulation for assent will be used. exclusion criteria: * any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time. * participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
integrated treatment for smoking cessation & anxiety in people with hiv

Conditions: Nicotine Dependence; Symptoms of Anxiety; HIV

Summary: during the 1-year formative phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable hiv+ smokers. during this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (n = up to 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. the goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. during the two-year pilot rct phase of the above study, we directly develop and test a novel psychosocial/behavioral and pharmacological smoking cessation intervention for hiv+ smokers with interfering psychological distress.

this study represents an important step in treating nicotine dependence in hiv-positive individuals. this study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk hiv+ smokers. the 1-year formative phase of the study will develop an integrated treatment for quitting smoking for anxiety-vulnerable hiv+ smokers. the proposed treatment will include cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and cognitive-behavioral talk therapy for anxiety. the pilot of the proposed treatment will be conducted with a small group of individuals (n = up to 12). this phase will be used to establish feasibility of treatment delivery, and participant acceptability before conducting a pilot randomized trial of the treatment. additionally, this phase will monitor smoking cessation history through point prevalence abstinence (ppa), as well as anxiety symptoms through the anxiety sensitivity index (asi) at the baseline and follow-up assessments. this study represents an important step in treating nicotine dependence in hiv-positive individuals. this study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk hiv+ smokers. the pilot rct phase of the study (years 2 and 3), will test the developed cognitive-behavioral intervention in a pilot randomized-controlled trial format. the outcomes for this trial will be to determine the acceptability and feasibility of the intervention and the potential for an effect on increasing point prevalence abstinence and deceasing psychological distress.

Eligibility criteria:
inclusion criteria: * 18-65 years old * informed consent * daily smoker * motivated to quit smoking exclusion criteria: * use of other tobacco products * untreated or unstable psychiatric disorders * current use of cognitive-behavioral therapy or medication for smoking cessation treatment * insufficient command of english

Keywords: nicotine dependence smoking, cessation quitting anxiety symptoms cognitive-behavioral therapy
study about effect of saxagliptin on circulating endothelial progenitor cells and endothelial function in newly diagnosed type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: in this study, the investigators aim to investigate whether saxagliptin modulate endothelial progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetics (diagnosis were made according to the american diabetes association guideline \[19\] ), treatment naive, age 30-75, hemoglobin a1c (hba1c) ≥6.5%, fasting c-peptide \>1.0ng/l exclusion criteria: * pregnancy or lactation, smoker, acute disease or infection, chronic renal disease (estimated glomerular filtration rate \ 5.6mmol/l), cardiovascular events or surgery within 3 months, taking glucocorticoid, history of acute or chronic pancreatitis, pancreatic tumor, severe cardiac or pneumonic disease.

Keywords: saxagliptin endothelial progenitor cell flow-mediated dilation
reboxetine adjuvant therapy for the treatment of schizophrenia

Conditions: Schizophrenia

Summary: 30 patients will randomly be selected and will be administered either reboxetine or a placebo. changes in cognition and behavior will be assessed by computer tests and scales during a six week study period.

all participants will be administered panss, sans, esrs, calgary, progesterom, sexual functioning scale, ham-a, covy, hamilton depression scale, and cgi and cgi improved rating on the first visit, as well as blood tests, ecg and weight. they will then be tested using a computer cognitive test (cogscan test) that lasts about 45 minutes. next, they will be given either a two week dose of placebo or treatment (2 mg \* 2 daily for first week, then 4 mg. day, 2 mg. night for the second week). after two weeks they the dose is increased to 4 mg. \* 2 daily. at four weeks all tests are readministered, as well as at six weeks. the study is concluded at 6 weeks, following a readministration of tests. physical examination is also administered at the conclusion.

Eligibility criteria:
inclusion criteria: * schizophrenia all types * 18\> exclusion criteria: * uti * \>65 * non organic state * no depression treatment

Keywords: schizophrenia reboxetine cognitive behavior
observation versus post-surgery radiotherapy after complete exeresis in soft tissues members sarcoma

Conditions: Soft Tissue Sarcoma of Members

Summary: soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them. these rare tumors involve complex multidisciplinary care better in centers having expertise. loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. results have been demonstrated equivalent to those of an amputation in terms of local control and survival. the local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%. the main objective is to achieve a low recurrence rate while maintaining the function. the question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.


Eligibility criteria:
inclusion criteria: * soft tissue sarcoma members histologically confirmed * tumor primitive complete excision with margins greater than or equal to 10 mm in the soft tissue in all directions during the initial surgery. a sub-centimeter margin is authorized under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is r0 a margin sub-centimeter depth is allowed for superficial tumors if the underlying fascia resected is not invaded. * primitive tumors without breaking initial tumor and without tumor residue in the systematic recovery in case of incomplete initial excision margins or doubtful * who less than or equal to 2 * age greater than or equal to 18 years * review extension negative (normal chest ct) * information and monitoring possible * patient affiliated to social security exclusion criteria: * previously treated local sarcoma relapse * visceral or lymph node metastases * pre-operative treatment (chemotherapy or radiotherapy) * pnet, alveolar rhabdomyosarcoma, darrier-ferrand sarcoma * excision margins of less than 10 mm in one direction or doubtful or unspecified, except under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is r0 and tumors if the superficial fascia underlying resected is not invaded. * break-tumor during the initial surgery, or residual tumor at second surgery * chemotherapy * delay between surgery r0 margins greater than or equal to 1 cm (initial surgery or recovery) and the start of radiotherapy exceeding 8 weeks * history of radiation on the member * history of cancer (except carcinoma in situ of the cervix and basal cell skin cancer or in complete remission for over 5 years) * pregnant women * patients under guardianship or curatorship

Keywords: sarcoma soft tissue members radiotherapy absence of radiotherapy