Kornimate/medical-research-clean huggingface dataset:
virtual reality- working memory retraining

Conditions: Alcohol Use Disorder; Mild Traumatic Brain Injury

Summary: this study will establish the acceptability and feasibility of enrolling and retaining heavy drinking veterans with mild traumatic brain injury (mtbi) in an 8-week, randomized cross-over design trial of active vr working memory retraining (wmr). this study will also seek to establish the efficacy of active vr-wmr to increase performance in executive function.

the investigators will employ a physically active vr working memory retraining (vr-wmr) regimen utilizing components of blue goji vr active gaming. the synthesis of physical activity and an enriched vr environment is expected to yield superior working memory training stemming from greater neurological activation. this enhanced working memory training task will result in greater motivation to engage and complete a training regimen, thus fostering greater improvements in executive function than traditional working memory training tasks; ultimately resulting in increased self-control over alcohol use and other high-risk behaviors.

Eligibility criteria:
inclusion criteria: * must report "heavy" drinking by nih/niaaa criteria (\>7 drinks/week for women; \>14 drinks/week for men) for at least one week in the last 90 days * must meet moderate to severe criteria for current (past year) alcohol use disorder (aud) by dsm-5 * must express a desire to reduce, stop, or maintain cessation of alcohol use * must report a history of tbi as defined by american congress of rehabilitation medicine (acrm), in the chronic, stable phase of recovery (\>6 months from injury) exclusion criteria: * unstable medical or psychiatric disorders judged to be unstable in the clinical judgment of the pi * current or past history of intrinsic cerebral tumors, hiv infection, cerebrovascular accident, aneurysm, arteriovenous malformations, myocardial infarction, cerebrovascular or peripheral vascular disease, type-1 diabetes, any cardiac, hepatic or renal diseases/disorders, surgical implantation of neurostimulators or cardiac pacemakers, medically diagnosed chronic obstructive pulmonary disease, demyelinating and neurodegenerative diseases, history of seizure disorder, and/or any physical disability making it impossible to use exercise equipment * no female participant will be pregnant or attempting to conceive * concurrent participation in an aud, cognitive training, or exercise study * must not require acute medical detoxification from alcohol (ciwa-ad \> 11) within the past week prior to study entry * subjects who, in the opinion of the investigator, are otherwise unsuitable for a study of this type will be excluded

Keywords: alcohol use disorder traumatic brain injury working memory training virtual reality physical exercise
impact of rehabilitation in quality of life in pd

Conditions: Parkinson Disease

Summary: this study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative program on quality of life in patients with parkinson's disease.

parkinson's disease (pd) is a progressive neurodegenerative disease clinically characterized by rigidity, bradykinesia and resting tremor. beyond these symptoms the principal feature of this condition is the lost of habitual automatic movements and the disruption of different cognitive-motivational processes. these features are related to a pathological dopaminergic tone that alters the cortico-striatal pathways with several consequences on motor and emotional behaviours. given its complexity pd impact very seriously on patients' quality of life (qol). dopamine replacement therapy (drt) is the standard treatment for the motor symptom of pd and previous studies have demonstrated its positive effect on qol. however drt does not reduce axial pd symptoms such as freezing of gait, postural instability and balance disturbances. further, long-term drt could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects. in the last years, rehabilitation has been proposed as an effective and complementary treatment for the management of pd and several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results. to evaluate the impact of an intensive, multidisciplinary rehabilitation treatment (mirt), on qol of subjects with pd. literature data showed that this type of treatment determine a positive effect on both motor and non-motor symptoms. starting from these evidences, in this study the investigators have examined whether mirt act positively on qol and for how long this potential positive effect is maintained. 250 pd patients with parkinson's disease hospitalized for a 4-weeks mirt were enrolled. pdq39 was administered at enrolment, and at three points after discharge: at 1, 3 and 6 months. the investigators decided to evaluate qol after homecoming in order to avoid an inpatient state bias. other outcome measures were considered and assessed at the enrolment and at discharge: unified parkinson's disease scale (updrs), parkinson disease disability scale (pdds), berg balance scale (bbs), fog (freezing of gait questionnaire), 6mwt (6 minutes walking test), time up and go test (tug). cognitive and psychopathological status of patients was also assessed using mini mental state examination (mmse), frontal assessment battery (fab), state trait anxiety inventory (stay i-ii), beck depression inventory (bdi).

Eligibility criteria:
inclusion criteria: * parkinson disease * mmse ≥ 24 exclusion criteria: * co-morbidity with other neurological disease * visual and auditory dysfunctions

Keywords: parkinson disease quality of life rehabilitation
effects of salt intake on the nervous systems of patients with salt-sensitive high blood pressure

Conditions: Hyperaldosteronism; Hypertension

Summary: some patients with high blood pressure can experience an increase of blood pressure by 10 percent or more by taking in salt. these patients are referred to as having "salt-sensitive" (ss) hypertension. previous studies conducted on patients with salt sensitive hypertension suggest that their portion of the nervous system responsible for maintaining normal blood pressure (autonomic nervous system) may respond differently to salt than patients with non-salt sensitive (nss) hypertension. this study is designed to examine the response of the nervous system to high doses of salt in patients with salt-sensitive hypertension and patients with non-salt sensitive hypertension.

a subset of patients with idiopathic hypertension shows an increase in blood pressure of 10 percent or more in response to salt-loading and have been termed "salt-sensitive" (ss). limited studies of adrenergic function in response to salt-loading suggest that the response of ss patients may differ from that of non-salt sensitive (nss) patients. the present studies were designed to examine the response of the adrenergic and dopaminergic systems to salt-loading in ss and nss patients with idiopathic hypertension.

Eligibility criteria:
eligibility criteria not identified in protocol.

Keywords: adrenergic nervous system dopaminergic nervous system salt-sensitive hypertension hypertension primary aldosteronism
whole-body vibration therapy in the gait of children with cerebral palsy

Conditions: Cerebral Palsy; Neurologic Disorder; Gait Disorders in Children; Hemiplegia

Summary: observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution


Eligibility criteria:
inclusion criteria: * diagnosis of neurological developmental disorder: cerebral palsy. (according to dsm-v) * age between 2 to 11 years. * gmfcs i and ii. * assessed and/or intervened in or from centers, institutions, etc. who collaborate with the university of almería or participate in them. specifically from the "interactúa" child development and early care center. * the subject, father/mother/legal guardian of each subject, prior to inclusion in the study, must have signed the informed consent for the participation of himself or his/her child in it, leaving a record that it could be abandoned if at any time they deem it appropriate and without having to justify it. exclusion criteria: * diagnosis of epilepsy. * serious blood circulation problems. * recent operations. * prosthetics. * start of another type of therapy different from the current one. * not having indication for physiotherapy.

Keywords: cerebral palsy whole-body vibration
proton radiotherapy for recurrent tumors

Conditions: Tumors

Summary: the purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.

patients will be stratified by treatment site (head and neck, thorax, abdomen, pelvis, extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. this study will be done in two phases. in the first phase, feasibility will be established using the primary objectives set below. the second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified. the secondary objectives will serve as the objectives for the second phase of the study.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed, non-cns solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence. * patients must have a karnofsky performance status of 60. life expectancy of 3 months . * age greater or equal to 18. * patients must be able to provide informed consent. * women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, iud, condoms or other barrier methods, etc.) * hysterectomy or menopause must be clinically documented. exclusion criteria: * prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume. * pregnant women, women planning to become pregnant and women that are nursing. * actively being treated on any research study.

Keywords: adults with non-cns recurrent tumors who have been previously irradiated and have a tumor recurrence in or near prior radiation fields
combined treatment for generalized anxiety disorder (gad)

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (gad). the general goals of the current study are to conduct a late stage treatment development study. the goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.

the specific aims of this study are to collect preliminary data relevant to the following hypotheses: 1. primary hypothesis: acute phase improvement for combined cognitive behavioral therapy (cbt) plus medication will be superior to medication alone. 2. secondary hypotheses: combined cbt plus medication will be superior to medication alone on a number of secondary outcome measures, including the core feature of gad (worry), depressive symptoms, functional impairment, and quality of life. 3. additional exploratory aim: we will explore the comparative relapse rates for the combined cbt plus medication treatment and the medication alone treatment condition at 6-month follow-up.

Eligibility criteria:
inclusion criteria: * gad diagnosis by structured interview * hamilton anxiety scale score of 18 or less * clinical global impressions scale score of at least 4 * hamilton depression scale score of 18 or less * hamilton depression scale suicide item score less than 2 * use of an effective form of contraception throughout the s exclusion criteria: * hypersensitivity to venlafaxine xr * history of seizures * episode of major depressive disorder in the previous 6 months * history of any psychotic illness, bipolar disorder, or dementia * substance abuse and dependence during the past 6 months * other anxiety disorders with the exception of social phobia as long as gad is primary * regular use of anxiolytics or antidepressants within 7 days of study onset * use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation) * use of other psychotic medication besides benzodiazepines

Keywords: generalized anxiety disorder cognitive behavioral therapy psychotherapy plus medication combined treatment
an open-label study to characterize the incidence and severity of diarrhea in patients with early-stage her2+ breast cancer treated with neratinib and loperamide

Conditions: Early Stage HER2+ Breast Cancer

Summary: an open-label study to characterize the incidence and severity of diarrhea in patients with early-stage her2+ breast cancer treated with neratinib and loperamide or other prophylactic measures.

this is an open-label, phase 2 study that will investigate the incidence and severity of diarrhea in early-stage her2+ breast cancer patients receiving neratinib with loperamide, alone and in combination with an anti-inflammatory treatment or a bile acid sequestrant treatment, or neratinib dose escalation, who have previously undergone a course of trastuzumab therapy in the adjuvant setting. patients will receive: * neratinib 240 mg orally once daily with food for thirteen 28-day cycles. * loperamide daily for two 28-day cycles and then as needed. * amendment 3, an anti-inflammatory treatment for one cycle and loperamide to be administered daily for two 28-day cycles and then as needed. closed to enrollment. * amendment 4, colestipol for one cycle and loperamide to be administered one cycle and then as needed. closed to enrollment. * amendment 5, colestipol for one cycle and loperamide as needed. closed to enrollment. * amendment 6/6.1, 120 mg neratinib for week 1 (c1d1-c1d7), followed by 160 mg neratinib for week 2 (c1d8-c1d14), followed by 240 mg neratinib for week 3 and thereafter (c1d15 to end of treatment). loperamide as needed. closed to enrollment. * amendment 7/7.1, 160 mg neratinib for the first 2 weeks (c1d1 - c1d14), followed by 200 mg neratinib for the next 2 weeks (c1d15 - c1d28), followed by 240 mg neratinib thereafter (c2d1 to end of treatment). loperamide as needed.

Eligibility criteria:
inclusion criteria: * age ≥18; male or female * early breast cancer (stage i-3c) * documented her2+ tumor: her2 immunohistochemistry (ihc) 3+ or ish+ * prior course of adjuvant trastuzumab given \>2 weeks and ≤1 year from enrollment * no evidence of local/regional recurrence or metastatic disease * eastern cooperative oncology group (ecog) status of 0 or 1 * male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception * left ventricular ejection fraction (lvef) ≥50% measured by multiple-gated acquisition scan (muga) or echo exclusion criteria: * major surgery \< 30 days * chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) \< 14 days * corrected qt interval (qtc) \>0.450 seconds (males) or \>0.470 (females) or other active cardiac disease * significant chronic gi disorder with diarrhea as a major symptom * active, unresolved infections * currently pregnant or breast-feeding

Keywords: her2 + breast cancer neratinib nerlynx loperamide colestipol budesonide
pre-approval expanded access study for tar-200 treating physician use

Conditions: Non-Muscle Invasive Bladder Neoplasms

Summary: the purpose of this pre-approval access program is to provide access to tar-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (hr-nmibc).


Eligibility criteria:
inclusion criteria: * participant has exhausted all clinically appropriate alternative forms of treatment and is not eligible for, or does not have access to, a clinical trial * histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle-invasive bladder cancer (hr-nmibc), carcinoma in situ (cis) (or tis) with or without papillary disease (t1, high-grade ta), within 12 months of completion of the last dose of bcg therapy, in participants who have received adequate bacillus calmette-guérin (bcg) * all visible papillary disease must be fully resected (absent) prior to initiation of treatment * participants must be ineligible for or have elected not to undergo radical cystectomy (rc) * have an eastern cooperative oncology group (ecog) performance status grade of 0, 1, or 2 exclusion criteria: * presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, t2, t3, t4, and/or stage iv) * presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of tar-200. participants with tumors involving the prostatic urethra in men will be excluded * evidence of bladder perforation during diagnostic cystoscopy * a history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 ml) * active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than hr-nmibc
pet imaging of brain amyloid using [11c]mes-impy

Conditions: Alzheimer's Disease; Healthy

Summary: alzheimer's disease is associated with accumulation in the brain of a protein called amyloid. the purpose of this study is to test the ability of a research drug to measure amyloid in brain using positron emission tomography (pet) and a research drug called \[11c\]mes-impy.

alzheimer's disease (ad) is characterized pathologically by the presence of beta-amyloid plaques in brain. a substantial body of research indicates that the presence of increased beta -amyloid peptide is neurotoxic, and may initiate further pathology observed in ad including neurofibrillary tangles, synaptic loss and dysfunction, and neurodegeneration. there are multiple binding sites available on beta-amyloid plaques. three clearly identified sites are congo-red type, thioflavin-t type, and fddnp type. radioligands currently under development using positron emission tomography (pet) for studying beta-amyloid in clinical research or drug development are based on thioflavin-t site, such as \[11c\]pib and \[11c\]sb-13. though variously effective, these radioligands have one or more drawbacks with respect to measuring relative regional beta-amyloid densities. therefore, we have recently developed \[11c\]mes-impy as an alternative radioligand for imaging beta-amyloid, which will allow a more accurate quantification of amyloid plaques in ad brain. in the current protocol, we wish to evaluate \[11c\]mes-impy in both healthy subjects and ad patients to determine the kinetics of brain imaging beta-amyloid plaques in ad patients.

Eligibility criteria:
* inclusion criteria: healthy control subjects aged 18-90 years and ad patients aged 50-90, with history/physical exam, ecg, and laboratory tests. informed consent. ad patients: mini-mental state examination (score greater than or equal to 10). ad patients: meet nincds-adrda criteria for probable ad. exclusion criteria: 1. current or prior history of any alcohol or drug abuse. 2. severe systemic disease based on history and physical exam. 3. positive result on urine screen for illicit drugs. 4. laboratory tests with clinically significant abnormalities. 5. prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits. 6. pregnancy or breast feeding. 7. claustrophobia. 8. presence of ferromagnetic metal in the body or heart pacemaker. 9. history of brain disease other than alzheimer's disease. 10. unable to lay on one's back for the pet/mri scan.

Keywords: alzheimer's disease positron emission tomography brain neurochemistry beta-amyloid plaques pet mes-impy alzheimer disease ad dementia healthy volunteer hv
study of biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: studying samples of blood and tumor tissue in the laboratory from patients with cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. it may also help doctors predict how patients will respond to treatment. purpose: this phase iv trial is studying biomarkers in patients undergoing chemotherapy for metastatic colorectal cancer.

objectives: primary * research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects. secondary * study the correlations between the pharmacogenetic and pharmacokinetic parameters. * study the predictive value of these parameters on disease-free and overall survival. outline: this is a multicenter study. patients receive 1 of 4 chemotherapy regimens: * regimen 1: fluorouracil and leucovorin calcium * regimen 2: capecitabine and leucovorin calcium * regimen 3: irinotecan hydrochloride * regimen 4: oxaliplatin tumor and blood samples are collected before the start of chemotherapy and are examined by pharmacogenetic analysis. clinical and biological parameters are also studied. blood samples are also collected during the first course of chemotherapy for pharmacokinetic studies. after completion of study therapy, patients are followed periodically for 3 years.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic colorectal cancer * unresectable metastatic disease must be confirmed histologically if \> 2 years since primary diagnosis * measurable metastatic disease \> 1 cm by spiral ct scan or \> 2 cm by other methods * scheduled to receive first-line chemotherapy for metastatic disease * chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin * no inadequate or unusable tissue as the only tissue available * no known brain metastases or meningeal disease patient characteristics: * who performance status 0-2 * no contraindication to chemotherapy * not pregnant or nursing * fertile patients must use effective contraception * no other severe pathology that is likely to worsen during therapy * no dementia or severely impaired mental condition * no geographical or psychological reasons that would preclude treatment prior concurrent therapy: * see disease characteristics * no prior therapy for metastatic cancer * prior adjuvant chemotherapy allowed * concurrent bevacizumab or other monoclonal antibody therapy allowed

Keywords: recurrent colon cancer stage iv colon cancer recurrent rectal cancer stage iv rectal cancer