Kornimate/medical-research-clean huggingface dataset:
duke conte center for the neuroscience of depression in late life

Conditions: Major Depression

Summary: the proposed silvio o. conte center for neuroscience of depression will focus on understanding the neurobiological mechanism of depression. a total of 5 projects are proposed. the center is focused on a single hypothesis. the first project examines localization of lesions, structural changes in critical regions subserving the circuit, alterations in the white matter tracts relevant to the circuit and changes in glutamate. the second project uses post mortem cell counting and cellular localization in serotonin receptors and assessment of the type of cell loss in the orbitofrontal cortex. the third project uses cognitive paradigms and functional mri to probe the circuit and the role of brain lesions and serotonin on the functioning of this circuit. the fourth project uses transgenic and knockout mice to examine to role of norepinephrine and serotonin as it relates to the circuit. the final project is designed to assess in these transgenic mice using multielectrode array of single neuron recordings of the firing pattern of the circuit neurons in various states and tasks and the role of monoamines in modulating this circuit.

three shared resources, administrative, research and assessment and data management/statistics are proposed to facilitate the conduct of these projects and to ensure integration at the conceptual, analytical and resource availability level, and flow to the various projects. findings from the center should greatly enhance our understanding of the biology of depressive disorders and help improve the treatment of these disorders. in addition, the technological innovations developed in the context of this project are likely to be of major importance and relevant to other studies of brain function.

Eligibility criteria:
inclusion criteria: for depressed group: 1. age \> 60 years 2. major depression, single episode or recurrent 3. ability to read and write english 4. mmse \>25 5. willingness to participate in the follow-up study for at least two years. for non-depressed group: 1. age \> 60 years 2. ability to read and write english 3. mmse \>25 4. willingness to participate in the follow-up study for at least two years exclusion criteria: 1. lifetime alcohol or drug dependence 2. conditions associated with mri abnormalities such hydrocephalus, benign and cancerous brain tumors, epilepsy, parkinson's disease, huntington's chorea, dementia, demyelinating diseases, etc. 3. endocrine disorder (other than diabetes mellitus) 4. any physical or intellectual disability that may affect completion of self rating instruments 5. established clinical diagnosis of dementia 6. other primary psychiatric disorders, including panic disorder, social phobia, ocd, non-affective psychosis (including schizo-affective disorder), schizophrenia, bipolar disorder 7. any metal or pacemaker in the body which precludes mri.

Keywords: depression elderly neuroimaging postmortem knockout mouse
radiologic criteria for round window visibility prediction in cochlear implantation

Conditions: Cochlear Implantation

Summary: the aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.

whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. this procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area. ct scan of temporal bone is part of systematic preoperative assessment. technological advances in radiology during the last decades now provide inframillimetric resolution. thus, otologic surgeons wish they could anticipate round window exposure from these ct scan. this could decrease the procedure duration, complication occurrence, or improve surgical strategy. several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone ct scan. however, these diagnostic tests performances have not been assessed for most of them, or compared between them.

Eligibility criteria:
inclusion criteria : * patients undergoing cochlear implantation in reims universitary hospital during the inclusion period * patients who agree to participate in the study * patients who had preoperative temporal bone ct scan exclusion criteria : patients who have : * temporal bone malformation on temporal bone ct scan or mri * chronic otitis media (except simple middle ear effusion) * middle ear surgery antecedent * cochlear implant in the context of a reimplantation

Keywords: sensorineural hearing loss round window ear surgery cochlear implantation
effect of lactulose on minimal hepatic encephalopathy and health-related quality of life

Conditions: Minimal Hepatic Encephalopathy; Hepatic Encephalopathy

Summary: minimal hepatic encephalopathy (mhe) has a negative effect on patients' daily functioning. no study has so far investigated the effect of treatment related improvement in cognitive functions on health related quality-of-life (hrqol). this study was carried out to determine the influence of treatment on psychomotor performance and on hrqol in patients with mhe. the mean number of abnormal np tests decreased significantly in patients in treated group compared with patients in untreated group manova for time and treatment, p =.001). mean total sip score improved among patients in the treated group after 3 months compared with patients in untreated group after 3 months (manova for time and treatment, p=.002). improvement in hrqol was related to the improvement in psychometry. in conclusion, treatment with lactulose improves both cognitive functions and hrqol in cirrhotic patients with mhe.

the study has been published in march 2007 in hepatology lactulose improves cognitive functions and health-related quality of life in patients with cirrhosis whohave minimal hepatic encephalopathy.srinivasa prasad, radha k. dhiman, ajay duseja, yogesh k. chawla, arpita sharma, and ritesh agarwal. (hepatology 2007;45:549-559.)

Eligibility criteria:
inclusion criteria: * all the patients diagnosed as having cirrhosis of liver exclusion criteria: * overt he or a history of overt he; * history of recent (\< 6 weeks) alcohol intake; * infection, recent (\< 6 weeks) antibiotic use or gastrointestinal bleeding; * history of recent (\< 6 weeks) use of drugs affecting psychometric * performances like benzodiazepens, antiepileptics, psychotropic drugs; * history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; * electrolyte imbalance; * renal impairment; * presence of hepatocellular carcinoma; * severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement; * inability to perform np tests and to complete the sip questionnaire due to bad vision.

Keywords: minimal hepatic encephalopathy hepatic encephalopathy subclinical hepatic encephalopathy health related quality of life
evaluation of the effectiveness of safe nutrition program applied to acute stroke patients with dysphagia

Conditions: DYSPHAGIA

Summary: it was planned in a quasi-experimental design with a non-randomized control group. the study was planned to be completed in three stages: control, preparation and intervention periods. question 1: does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? question 2: is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? question 3: does a safe nutrition program shorten the hospital stay and ng tube duration in acute stroke patients with dysphagia?

introduction: dysphagia is a common complication in acute stroke patients. although there are treatment options, healing takes time. managing this process in the safest way is important for the physical and mental health of the patient. purpose: this study aimed to evaluate the effectiveness of a safe nutrition program applied to acute stroke patients with dysphagia.

Eligibility criteria:
inclusion criteria: * acute stroke patients * 18 years and over exclusion criteria: * those who do not want to be involved in the study

Keywords: dysphagia stroke
bevacizumab and trastuzumab with weekly paclitaxel followed, after surgery, by encapsuled liposomal doxorubicin, cyclophosphamide and trastuzumab as adjuvant treatment after surgery on women with her2+ breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the efficacy of the combined therapy bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer her 2+ followed by surgery and adjuvant therapy (cyclophosphamide, trastuzumab and doxorubicin liposomal).


Eligibility criteria:
inclusion criteria: * older than 18 years * pre or post menopause patient with histology confirmation of breast cancer status ii or iii, her2+ confirmed by fish technique. * lesion bigger than 2cm. * life expectancy \> 12 weeks. * normal heart function (lvef\>55%) * patient should give his/her signed, written informed consent. exclusion criteria: * previous chemotherapy treatment. * previous treatment with her2 or vegf inhibitors. * pulmonary disease not controlled. * hypertension not controlled (systolic \> 150 mmhg and/or diastolic \> 100 mmhg) or significant cardiovascular disease (cva/cerebral hemorrhage (6 months before inclusion), myocardial infarction (6 months before inclusion), unstable angina, congestive cardiac disease ≥ nyha 2, or serious cardiac arrhythmia requiring medication. * antecedents of coagulopathy or clinically significant thrombosis. * major surgery, open biopsy or significant trauma 28 days before the inclusion in the study or planned major surgery during the study. * peripheral neuropathy \> ctc 2 at inclusion. * altered renal function a. creatinine \> 2.0 mg/dl or 177 mmol/l. b.proteinuria \> 2+ with reactive stick(dipstick). if screening proteinuria 2+, collection of 24h urine must show a value of proteins of 1 g/24h. * daily chronic treatment with corticosteroids * daily chronic treatment with aspirin (\> 325 mg/day) o clopidogrel (\> 75 mg/day) * antecedents or heritage evidence of bleeder diathesis or coagulopathy with risk of hemorrhage. * antecedents of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months previous to the inclusion. * active infection to be treated with iv antibiotics * serious injury not curing, peptic ulcer or bone fracture. * pregnant or active sexual patient not using contraceptive methods. or lactating woman * current or recent treatment with another imp or participation in another clinical trial (30 days before inclusion) * another primary tumor (including primary brain tumors)within 5 years to the study inclusion, apart from in situ cervix carcinoma, skin squamous carcinoma, both if they are appropriately treated, or skin basal cell cancer if controlled.
eye movement desensitization and reprocessing (emdr) in non-specific chronic back pain

Conditions: Non-specific Chronic Back Pain

Summary: the study explores the feasibility of eye-movement-desensitization and reprocessing (emdr) in non-specific chronic back pain.

the study explores the feasibility of eye-movement-desensitization and reprocessing (emdr) in non-specific chronic back pain in a randomized controlled trial (rct) with 6 months follow-up. the treatment consists of 12-sessions emdr a 60 minutes using eye-movements for bilateral stimulation in addition to treatment as usual (tau) that is compared to tau alone.

Eligibility criteria:
inclusion criteria: * \>= 18 years * non-specific chronic low back pain \>= 45 days/3 months * high emotional distress caused by psychological trauma * german language skills exclusion criteria: * specific causes of chronic back pain * application for retirement pension pending * ongoing psychotherapy * severe physical or psychiatric comorbidity

Keywords: eye-movement-desensitization and reprocessing emdr chronic back pain cbp treatment
smoking onset in a biethnic population

Conditions: Cardiovascular Diseases; Heart Diseases; Lung Diseases

Summary: to conduct a prospective study of the determinants of smoking onset in adolescents attending memphis city schools and to determine the unique predictors of smoking onset in black versus white adolescent females.

background: although many smoking prevention programs have been implemented on a large-scale basis, the effectiveness of these programs varies greatly. while these programs have undoubtedly prevented many young adults from starting to smoke, recent smoking initiation rates among females have consistently exceeded the rates of males and smoking initiation rates among afro-americans remain at high levels. more information is needed on the reasons for smoking initiation among adolescents, particularly females. despite considerable interest in this area, virtually nothing is known regarding the reasons for adoption of smoking in black or white females. not a single prospective study has evaluated race-and gender-specific models for the prediction of smoking onset. for example, while it is commonly assumed that the weight-reducing qualities of smoking are associated with smoking onset among female adolescents, not a single prospective study has been conducted that documents that weight-related concerns at one age predict smoking onset at a later age. the study was part of the collaborative projects on women's health initiative which was proposed by the nhlbi staff, given concept clearance at the february 1992 national heart, lung, and blood advisory council, and released as a request for applications in april 1992. design narrative: the study was part of a two grant project on the collaborative projects on women's health. dr. robert klesges conducted a longitudinal study to assess whether weight concerns of adolescent girls predict smoking onset at a later age. his collaborator, dr, linda eck (r01hl50946), evaluated the role of smoking in dietary intake, physical activity, and metabolic rate and determined the differential effects of smoking and race on the energy balance of african american and white women. dr. klesges' study was renewed in fy 1998 to continue longitudinal observation of factors relating to the onset of smoking in a biracial population of 6,967 boy and girl students first surveyed as seventh graders in 1993-94. the cohort was tracked through the end of high school and two years after high school in order to investigate the determinants of smoking onset both in high school and into the young adult years. the study was renewed in february 2001 through january 2005 to follow-up participants for four years post-high school to assess the extent of young adult smoking onset and cessation, to determine predictors of smoking onset, and identify predictors of cessation for both early onset and late onset smokers.

Eligibility criteria:
no eligibility criteria
a study of paliperidone palmitate 6-month formulation

Conditions: Schizophrenia

Summary: the main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month pp6m (dose 1 or dose 2 \[milligram\] mg eq.) and to provide access to pp6m in participants with schizophrenia completing the r092670psy3015 study without relapse.


Eligibility criteria:
inclusion criteria: * completed the double-blind phase of study r092670psy3015 without relapse and continue to be willing to be treated with paliperidone palmitate 6 month injection (pp6m) * must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the double-blind phase of study r092670psy3015 at the time of screening for this study * a woman of childbearing potential: a) must have a negative pregnancy test on day 1; b) use contraception consistent with local regulations. a man must agree that during the study and for a minimum 12 months after receiving the last dose of the study intervention: a) his female partner(s) will use highly effective method pf contraception * sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study; and must be able to provide his or her own consent (that is, consent cannot be provided by a legal representative of the participant) * in the opinion of the investigator, the patient would be able to participate for the duration of this study exclusion criteria: * has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * completed r092670psy3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant * if a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention
the use of transcranial ultrasound treatment of obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the primary objective of this study is to determine the safety and efficacy of ultrasound as a treatment for obsessive compulsive disorder.

the present study is being undertaken as an open-label study to evaluate the safety and feasibility of focused ultrasound as an intervention for patients with obsessive compulsive disorder (ocd). participants in this study will undergo 8 consecutive weekly sessions of transcranial low-intensity focused ultrasound (lifup) targeting the caudate of the basal ganglia. the safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound for this neurological application. treatment response will be measured using the beck depression \& anxiety inventories, the yale-brown obsessive-compulsive scale, and the global rating of change scale.

Eligibility criteria:
inclusion criteria: * diagnosis of obsessive compulsive disorder * score greater than 15 on the yale-brown obsessive compulsive scale (y- bocs) * failure to remit with 3 ssris, antidepressants and/or anxiolytics * must be willing to comply with the study protocol * english proficiency * at least 18 years of age exclusion criteria: * subjects not english proficient * subjects unable to give informed con-sent * subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep * pregnancy, women who may become pregnant or are breastfeeding * advanced terminal illness * any active cancer or chemotherapy * any other neoplastic illness or illness characterized by neovascularity * macular degeneration * subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer) * advanced kidney, pulmonary, cardiac or liver failure
effects of walking analysis on surgical outcomes

Conditions: Cerebral Palsy

Summary: the purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.

gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. however, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. consequently, the use of gait analysis in clinical practice remains controversial. the purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy. comparison: surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy * able to walk * under evaluation for orthopedic surgery to correct walking problem(s) exclusion criteria: * orthopaedic surgery in past 1 year * injection of botulinum toxin in past 6 months

Keywords: gait walking orthopedic surgery orthopaedic surgery
excimer laser combined with dcb compared with angioplasty alone in the treatment of infrapopliteal lesions.

Conditions: Critical Limb Ischemia; Infrapopliteal Lesions

Summary: this study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

this is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Eligibility criteria:
inclusion criteria: * the treatment vessel is denovo * stenotic (\>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s) * reference target vessel diameter between 2-4.0 mm by visual assessment * documented rutherford class 4 or 5 symptomatic critical limb ischemia * the patient must be \>18 years of age * life-expectancy of more than 12 months * the patient has no child bearing potential or negative serum pregnancy test * within 7 days of the index procedure * the patient must be willing and able to return to the appropriate follow-up times for the duration of the study * the patient must provide written patient informed consent that is approved by the ethics committee anatomic inclusion criteria: * all inflow lesions successfully (\<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications * at least one angiographically visible target at the ankle for establishment of straight line flow. exclusion criteria: * patient refusing treatment * the target vessel segment diameter is not suitable for available catheter design. * unsuccessfully treated endovascular or bypass( \>30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis * lesion lies within or adjacent to an aneurysm * the patient has a known allergy to heparin, aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies. * the patient has a history of prior life-threatening contrast media reaction. * the patient is currently enrolled in another investigational device or drug trial. * the patient is currently breast-feeding, pregnant or intends to become pregnant. * the patient is unable to provide informed consent * the patient has end stage renal disease (currently on any form of dialysis) * known left ventricular ejection fraction \< 35% * the patient has had a myocardial ischemia within 30 days prior to enrollment * the patient has had a cardiovascular accident within 90 days prior to enrollment * serum creatinine \> 150 µmol * the patient has a previous bypass in the target limb * the patient has a current systemic infection

Keywords: excimer laser angioplasty drug-coated baloons