Kornimate/medical-research-clean huggingface dataset:
dbs in treatment resistant major depression

Conditions: Resistant Major Depressive Disorder

Summary: this study aims at assessing efficacy and safety of dbs for treatment of patients suffering from resistant major depression, by means of a random, controlled and crossed study.

the first phase of the study will consist of implanting electrodes and applying continuous stimulation until the patients stabilise clinically. this period is anticipated between 6 and 9 months. the next phase will consist of the crossover study. responders will be randomised to either of 2 groups for a period of 3 months: a stimulation-on group and a stimulation-off group. patients will then be crossed over to the other group for a further 3 months. fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance

Eligibility criteria:
inclusion criteria: 1. patients of both sexes aged between 18 and 70 years. 2. patients diagnosed as having an mdd episode according to dsm-iv-tr criteria, resistant to pharmacological treatment with a score of 4 in the thase-rush index, with ect contraindicated or having failed to produce a maintained response. 3. patients with a hrsd-17 score of 18 or more. 4. patients with an intellectual capacity that facilitates adequate communication and who are willing to cooperate with all the examinations and protocols of the study. 5. patients who have not modified their antidepressant treatment in the month prior to the study. 6. women of childbearing age using medically approved contraceptive methods. 7. patients who have granted their informed consent in writing. exclusion criteria: 1. female patients who are pregnant or breastfeeding. 2. patients with acute, serious or unstable illnesses. 3. patients experiencing delirium or hallucinations, congruent or otherwise with their mood. 4. patients with a history of substance abuse (other than tobacco or caffeine). 5. patients with concomitant psychiatric disorders from axes i or ii of dsm iv-tr. h)patients with general contraindications for dbs (pacemaker users, etc).

Keywords: mdd dbs
mobile devices as educational skin history tools

Conditions: Skin Cancer

Summary: part i of this study surveys patients in the penn dermatologic surgery clinic to evaluate if a need exists for increased patient understanding of their skin history and which factors, if any, related to the patient or their skin history are associated with this need. in part ii, the study aim is to evaluate mobile technology as a way of improving patient understanding of diagnoses, treatments, and procedures. in this part of the study, eligible patients from part i will be randomized either to a control group that receives the current standard of care regarding in-clinic counseling, informational handouts, and access to their medical records, or to an intervention group that in addition to the current standard of care, is setup with a mobile app, allowing patients to view a skin history summary report and a reference on their skin ﬁndings and procedures. patients then complete a survey to establish their baseline understanding of their clinic visit. three weeks later the patient is emailed a follow-up survey to assess their understanding of their in-clinic visit. differences in understanding between the two study groups will be assessed by comparing the number of correctly answered survey items regarding their in-clinic visit, both at baseline (immediately following their surgery) and three weeks later. qualitative information regarding satisfaction and areas of improvement will also be collected via survey. patients who have an appointment during the study period at the penn dermatologic surgery clinic for a skin excision will be eligible for inclusion.


Eligibility criteria:
inclusion criteria: * have an appointment in the penn dermatologic surgery clinic for removal of a skin area during the study enrollment period * possession of a mobile device running ios with the study mobile app (intervention) successfully installed (assistance will be provided by research staff if needed) exclusion criteria: * children or adolescents, or if the patient is court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners * patients will also be excluded if they are incompetent to provide informed consent and hipaa authorization. * if the area being operated on is of the genitals or breasts * if the area being operated on is of the face, and photos of the area cannot be cropped or the eyes cannot be covered sufﬁciently such that photos are non-identifying
non-invasive monitoring of traumatic brain injury progression using the infrascanner (mobi-1)

Conditions: Brain Injuries, Traumatic

Summary: mobi-1 is a multicenter clinical trial that will evaluate the use of the infrascanner for the monitoring of traumatic intracranial hematomas.

mobi-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the infrascanner for monitoring traumatic intracranial hematomas. all patients will receive standard care plus hourly infrascanner assessments. this study will test the hypotheses that: 1. the infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas 2. patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone 3. clinical / research staff will be able to attain all data points and relay the assessments to the medical team.

Eligibility criteria:
inclusion criteria: 1. age 15 or older 2. admission ct scan shows intracranial hemorrhage 3. glasgow coma scale less than 15 4. neurosurgery service determines initial care is nonoperative 5. admitted for observation for tbi, to either step-down unit or intensive care unit exclusion criteria: 1. inability to provide informed consent or lack of a legally authorized representative (lar) 2. admitted and observed for \>2 hours prior to screening (i.e., has already received second neurological check) 3. other injuries deemed non-survivable 4. diagnosed with hemorrhagic shock or receives a large volume transfusion (\>3 units of any blood product within any 1 hour) 5. planned surgical interventions/ procedures during study period (before the second ct scan) 6. known prisoner

Keywords: traumatic brain injury, tbi, intracranial hematoma, ich
hatha yoga in breast cancer survivors

Conditions: Breast Carcinoma; Lymphedema

Summary: this pilot clinical trial studies hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage ii-iii lymphedema. yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).

primary objectives: i. to determine the feasibility of a modified yoga program for breast cancer survivors (bcs) with lymphedema. ii. to identify and document required modifications for a safe and feasible practice. iii. to obtain recruitment estimates and determine barriers to recruitment (acceptability). iv. to evaluate implementation fidelity (adherence and competence) and barriers to implementation fidelity. v. to establish safety. vi. to assess satisfaction. vii. to determine the preliminary efficacy of a modified yoga program for lymphedema in bcs, and associated physical and psychological symptoms/symptom burden, and overall health status. outline: patients undergo an initial yoga evaluation for 60 minutes. patients then undergo their first guided yoga practice session for 30-60 minutes and subsequent guided yoga sessions for 30-90 minutes. 3 times a week for 4 weeks, and twice a week for an additional 4 weeks. patients are also encouraged to complete home yoga practice for 30 to 90 minutes every day for 8 weeks.

Eligibility criteria:
inclusion criteria: lymphedema group: * lymphedema, symptomatic of stage ii or iii based upon screening responses; or l-dex reading of ≥ 7 at initial visit, * \> 3 months (mths) post-breast cancer treatment * no active cancer * has compression sleeve * ability to understand english in order to complete questionnaires * willing to do guided and home yoga practice * willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the short portable mental status questionnaire * medical clearance * reliable transportation to the study site no lymphedema group: * no known lymphedema or intermittent swelling, not symptomatic of stage ii or iii lymphedema (l-dex ≥ 7) * \>3 months post- breast cancer treatment * no active cancer * ability to understand english in order to complete questionnaires * willing to do guided and home yoga practice * willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the short portable mental status questionnaire * medical clearance * reliable transportation to the study site. exclusion criteria (both groups): * active cancer * undergoing radiation therapy or chemotherapy * medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status) * active yoga practice \< 3 months * currently undergoing phase i complete decongestive therapy (cdt) * inability to complete study forms
mirror therapy in pos stroke individuals

Conditions: Stroke

Summary: to evaluate the benefits of mirror therapy (mt) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. this is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. participants were randomized into two intervention groups: mt group with motor patterns of movement (mp, n=13) and mt group with specific functional activities (sa, n=14). motor impairment assessments (fugl-meyer assessment - fma), motivation (intrinsic motivation inventory) and functionality (functional independence measure - fim) were performed before and after treatment, and 3 months after the end of sessions (follow-up). in each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to fma. all participants performed 15 mt sessions, 3 times a week for 50 minutes each session.

objective: to evaluate the benefits of mirror therapy (mt) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. methods: this is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. participants were randomized into two intervention groups: mt group with motor patterns of movement (mp, n=13) and mt group with specific functional activities (sa, n=14). motor impairment assessments (fugl-meyer assessment - fma), motivation (intrinsicmotivationinventory) and functionality (functional independence measure - fim) were performed before and after treatment, and 3 months after the end of sessions (follow-up). in each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to fma. all participants performed 15 mt sessions, 3 times a week for 50 minutes each session.

Eligibility criteria:
inclusion criteria: * inclusion criteria were age over 18 years, clinical diagnosis of chronic and unilateral stroke (greater than six months after injury), hemiparesis sequel in the upper limb, absence of severe cognitive impairment with scores for the mini mental state examination (mmse) greater than or equal to 24 points for the educated and 14 for uneducated 17 and good sitting balance, qualified with scores between 20 and 40 on the berg balance scale (bbs) exclusion criteria: * those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded
feasibility of cocooning immunization strategy with influenza vaccine

Conditions: Influenza

Summary: influenza causes epidemics of respiratory infection in young children each winter. young children, particularly those under 6 months of age are most vulnerable to suffering from complications secondary to influenza infection. consequently, influenza vaccine has been recommended for children 6-59 months of age. influenza vaccine is not approved for use in children under 6 month of age who are at highest risk. therefore, the centers for disease control and prevention advisory committee on immunization practices has recommended vaccination of household contacts of children under 6 month of age - a cocooning strategy. the current study is a hospital-based study to assess the effectiveness of a program to vaccinate birth mothers and household contacts of newborns with influenza vaccine. we propose to study both birth mothers and household contacts of newborns delivered at durham regional hospital and duke university medical center, birthing hospitals serving durham and surrounding counties in central north carolina. we will implement several strategies to increase vaccine coverage rates at durham regional hospital utilizing duke university hospital as a comparison setting. strategies will include: standing vaccine orders for birth mothers, vaccine reminders for household contacts, and a hospital based influenza vaccine clinic to increase vaccine accessibility for household contacts. vaccine coverage rates will be assessed utilizing a survey method (maternal interview at the birthing hospital and a follow-up telephone contact 6-8 weeks later). we hypothesize that influenza vaccine coverage rates for new mothers and household contacts of newborns delivered at the intervention hospital will be higher when compared to coverage rates in the comparison hospital. demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine will also be assessed.


Eligibility criteria:
inclusion criteria: * mother of a newborn delivered at either durham regional hospital or duke university hospital between october 2007 and february 2008 exclusion criteria: * fetal demise or stillbirth * maternal rights relinquished * language barrier

Keywords: influenza vaccine children
a study of alks 3831 in adults with schizophrenia

Conditions: Schizophrenia

Summary: this is a phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. the study duration for each subject will be approximately 33 weeks and will include 25 study visits.


Eligibility criteria:
inclusion criteria: * age 18 to 50 years, inclusive * body mass index (bmi) of 17-30 kg/m2, inclusive * diagnosis of schizophrenia that is clinically stable exclusion criteria: * initiated 1st antipsychotic treatment within the past 12 months and/or has had symptoms lasting \<2 years * current diagnosis of alcohol or drug use disorder, moderate or severe * clinically significant or unstable medical illness, condition, or disorder * pregnant or breastfeeding * significant changes in diet or exercise regimen or plans to join a weight management program during the study * opioid medications taken within 14 days and/or need to take opioid medication during the study period * history of hypersensitivity to or intolerance of olanzapine * use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week during the past year

Keywords: schizophrenia olanzapine samidorphan alkermes
sleep disorders in bronchiolitis obliterans syndrome 2&3

Conditions: Bronchiolitis Obliterans; Sleep Disordered Breathing Central

Summary: this study is to determine whether sleep disorders contribute to impaired quality of life and mobility in patients with bronchiolitis obliterans syndrome and whether non invasive positive airways pressure ventilation can improve sleep, quality of life and mobility in this patient group.

patients with bronchiolitis obliterans syndrome (bos) 2 \& 3 (25) will be matched 1:2 bos 0 patients with similar demographics such as age, gender, bmi, time post transplant and renal dysfunction.patients fitting inclusion/exclusion criteria once they have given informed consent will complete questionnaires on quality of life (qol), any sleep issues they may have and be assessed by a doctor. data from standard blood tests, respiratory function tests and physio assessments of daytime activity, mobility and muscle strength will be collected. all participants will undergo an overnight sleep study. if a sleep disorder is identified the participant will be offered appropriate treatment. all assessments with the exception of the sleep study will be repeated at 6 and 12 months post sleep study.

Eligibility criteria:
inclusion criteria: * patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 2 \& 3 * comparative group -patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 0 * identified possible sleep related disorder exclusion criteria: * subjects who do not provide informed consent * subjects unable to understand the study and related procedures * patients with a life expectancy of less than 6 months

Keywords: lung transplantation bronchiolitis obliterans
study of oral treatments for hepatitis c

Conditions: Chronic Hepatitis C

Summary: phase 1 of this study compared the effectiveness of 3 approved daa (direct-acting antiviral) hcv treatment regimens to learn whether they worked equally well under real-world conditions. phase 2 of this study began early 2017 with removal of 1 daa regimen, limiting randomization to just 2 fda approved daa regimens. patients receiving hcv therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.

in phase 1 of this study, consented patients were randomized to 1 of the following 3 hcv daa treatments: 1) harvoni® (sof/ldv) 2) viekira pak™ (prod) 3) zepatier™ (ebr/gzr) with the optional addition of ribavirin (rbv) and the length of treatment determined by the individual provider. in phase 2 of this study, consented patients were randomized to 1 of 2 fda approved hcv treatments: harvoni® or zepatier™. both phase 1 and phase 2 subjects had up to 1 tablespoon of blood drawn for hcv resistance testing and future biorepository testing (following appropriate additional consent). the results of testing determined whether a genotype 1a subject randomized to zepatier would be provided 12 or 16 wks of zepatier. following enrollment/randomization, participants completed patient reported outcome questionnaires (pros) via electronic device or telephone. following baseline/randomization, participants were asked to complete surveys again at wk 4 of treatment, end of treatment, 1 and 3 year post treatment. patients continued standard medical care throughout study. data was abstracted from test results and medical records throughout treatment and for up to 3 years post treatment.

Eligibility criteria:
inclusion criteria: * hcv genotype 1a or 1b * adult patients (age 18 years or older) * patients being prescribed hcv treatment who can begin treatment with any of the three hcv treatments being studied (harvoni (sof/ldv), viekira pak (prod) (phase 1 only), or zepatier (ebr/gzr)) exclusion criteria: * inability to provide written informed consent * harvoni® is not a covered drug on benefits formulary * current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites) * child pugh (ctp) b or c cirrhosis (documented ctp calculation is required) * pregnant or breastfeeding women

Keywords: hepatitis c
gi tract biomarkers in infants with different diets

Conditions: Obesity, Childhood

Summary: childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. the lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. it is not yet known how obesity develops in an individual, specifically in early childhood. further, it is unclear what mechanistic role a child's earliest nutrition or changing intestinal flora has in the etiology of obesity. very young children are developing appetite and satiety patterns early in life. nutrition and gut microbial flora have impact on how these processes unfold, but specific mechanisms are not yet well understood. the investigators hypothesize that formula-fed infants with changes in their microbial flora are more likely to have altered carbohydrate metabolism, evidenced by greater imbalances of fatty acid production, and are more likely to have accelerated growth trajectory due to satiety disruption. the investigators further hypothesize that altered carbohydrate metabolism, e.g. imbalances of short- and long-chain fatty acid levels in the gut, stimulate cellular stress and affect specific gut hormones. this study will compare the microbiome of the intestinal microbial flora in two groups of infants, one breast fed and the other formula fed, using longitudinally collected fecal samples from both groups. samples will be subjected to shotgun metagenomic analysis and simultaneous metabolomic analysis. a bioinformatics approach will elucidate key differences among and between sample groups, and will further analyze bacterial gene expression levels related to carbohydrate metabolism. this study will compare the expression of human proteins involved in cellular stress response and gut peptide signaling by applying quantitative reverse transcriptase-polymerase chain reaction to human messenger rna isolated from the longitudinally collected samples from both groups. finally, this study will monitor the trajectory of growth and feeding over the first 2 years of life. the project's focus on the influence of different early feeding types, microbial flora changes, and altered carbohydrate metabolism leading to disruption of gut-brain signaling will provide critical data for host:microbiome interactions and translational therapeutic targets.


Eligibility criteria:
inclusion criteria: * otherwise healthy, male or female term infants * exclusively breast or formula feeding * never been exposed to oral or intravenous antibiotics or probiotics exclusion criteria: * maternal antibiotic use while breast-feeding * infant or maternal use of probiotics * current or recent (\<14 days) gastrointestinal infection (viral, bacterial, or fungal) * gastrointestinal mucosal disease, or significant constipation * consuming formula that is not standard cow's milk formula * infants on acid suppression medications or infants receiving high-density formula (\>20 calories/ounce) may be enrolled and will be analyzed separately

Keywords: microbiome gut-brain axis satiety hormone obesity metabolome
effects of tele speech therapy on the treatment of stammering in adults who stutter

Conditions: Stammering

Summary: the aim of the study is to determine the effectiveness of telespeech therapy on the treatment of stammering.


Eligibility criteria:
inclusion criteria: * both genders * adults with stuttering 15 to 40 years according to who criteria exclusion criteria: - stammering with any comorbid are excluded eg. visual and hearing impairment