Kornimate/medical-research-clean huggingface dataset:
a randomized, non-inferiority clinical trial of cva telerehabilitation treatments - telephysiotaichi

Conditions: Stroke

Summary: telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home after stroke. the investigators therefore postulate a non-inferiority hypothesis of the telerehabilitation approach compared to home visits to improve balance problem related to stroke. the platform used will be based on a technological infrastructure that was developed and tested in previous telerehabilitation studies. the study is a randomized control trial (rct).the study population of interest will target individuals who have had a stroke who stayed in a hospital or chronic stroke population. participants will be recruited during the hospitalization period at each of the three sites or in the community. the investigators expect to recruit 240 participants, 120 per group. the first evaluation will be conducted at recruitment to establish the baseline measures. the two other evaluations will be conducted 2 months (t2) and four months (t3) following recruitment.


Eligibility criteria:
inclusion criteria: * have had a stroke with a rankin score of 2 or 3; * was not referred to an intensive functional rehabilitation unit (ifru) and returned home following discharge from hospital; * understands instructions to allow participation in evaluations and interventions; * has a balance problem as evidenced by a score between 46 and 54 on the berg balance scale96; * has a caregiver that would be available during the telerehabilitation sessions to ensure safety during exercises; * live in an area serviced by high speed internet. exclusion criteria: * severe body hemineglect; * significant hemianopsia visual problems accompanied by hemineglect; * uncontrolled medical problems; * moderate to severe aphasia

Keywords: telemedicine telerehabilitation acute stroke tai chi tai ji rehabilitation home care services single blind method randomized controlled trial
renal-based optimization of quadruple therapy in patients with heart failure with reduced ejection fraction.

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction

Summary: the goal of this clinical trial is to evaluate guideline-directed medical therapy (gdmt) up-titration in patients with heart failure with reduced ejection fraction.the main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple gdmt in patients with hfref, assessed by a weighed composite score. participants will be randomized towards control (standard of care, soc) or intervention group. researchers will compare soc with protocol-based up-titration to see if the protocolized optimization improves prescription rate of gdmt.


Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction ≤ 40%, assessed lvef with imaging within last three months before randomization (tte/kt/mibi/mri) * nyha ≥ ii exclusion criteria: * hemodynamic instability * recent acute coronary syndrome (\< 1 month before randomisation) * already on quadruple heart failure therapy or on triple gdmt in case of egfr \< 30ml/min/1.73m2 or a potassium above 6mmol/l * egfr \< 20ml/min/1.73², planned for dialysis or already actively treated with chronic dialysis. * implantation of a cardiac resynchronization therapy (crt) within 3 months * adult congenital heart disease * previous heart transplantation or currently/planned for ventricular assist device * women who are pregnant or breastfeeding * unable to participate in 3 months follow-up

Keywords: heart failure heart failure with reduced ejection fraction guideline-directed medical therapy quadruple therapy
international expand lung pivotal trial

Conditions: Lung Transplant

Summary: to evaluate the safety and effectiveness of the ocs™ lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

the ocs™ lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics: * donor pao2/fio2 ≤ 300 mmhg; or * expected ischemic time \> 6 hours; or * donor after cardiac death (dcd donor); or * donor age ≥55 years old

Eligibility criteria:
inclusion criteria: * at least one of the following: * donor pao2/fio2 ≤ 300 mmhg; or * expected ischemic time \> 6 hours; or * donor after cardiac death (dcd donor); or * donor age ≥55 years old exclusion criteria: * • presence of moderate to severe traumatic lung injury with air and/or blood leak * presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or et suction * previous history of pulmonary disease * multiple transfusions of \>10 prbcs units * abo incompatibility * tobacco history of \>20 pack years

Keywords: lung transplantation lung preservation breathing lung transplant
novel pharmacotherapy approaches in smokers with serious mental illness

Conditions: Bipolar Disorder; Schizophrenia; Schizoaffective Disorder; Nicotine Dependence

Summary: approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the fda-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. all smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. all participants will receive ten 30-minute sessions of a behavioral treatment called acceptance and commitment therapy (act). participants will be followed for an additional 12 weeks off study medication. the major endpoint is the feasibility of combining act with the different dosing strategies. investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.

this pilot feasibility trial is a phase iv, 12-week, single center, randomized, double blind, parallel group comparison of low (0.5 mg twice daily with slower titration over one full week) versus standard dose (1.0 mg twice daily with standard titration) varenicline in individuals with dsm-v bipolar disorder (bd) or schizophrenia spectrum disorders (ssd) with a 12-week, post-treatment follow-up. the 16 visits after screening (weeks 0-24) include 11 in-person (with medications dispensed at weeks 0, 2, 4, 6, 8 and 10\] and 5 via telephone. plasma will be obtained at baseline to measure participants' nicotine metabolite ratio (nmr) and to identify slow versus normal nicotine metabolisers. a flexible quit date (between days 8-35) will be employed allowing varenicline preloading to occur prior to the target quit date. ten sessions of acceptance \& commitment therapy (act) for smoking cessation will be delivered by trained counselors.

Eligibility criteria:
inclusion criteria: * 18-70 years of age * outpatients with a dsm-v diagnosis of bipolar disorder or schizophrenia spectrum disorder * smoke at least 10 cigarettes per day and have an expired carbon monoxide (co) breathalyzer of ≥ 10 ppm at screening and baseline visits * are motivated to quit smoking * have access to a mental health provider exclusion criteria: * females who are pregnant, planning to become pregnant, or lactating * test positive for any non-prescribed medications or illicit drugs * have made a suicide attempt or engaged in self-mutilatory behavior in the past year * meet criteria for another substance use disorder in the past month * in the investigators' judgement, are either psychiatrically or medically unstable to safely participate * are currently using any other form of treatment for smoking cessation

Keywords: nicotine varenicline acceptance and commitment therapy schizophrenia schizoaffective bipolar smoking cessation cigarette
anti-inflammatory treatment at the onset of necrotizing enterocolitis (nec) in preterm infants

Conditions: Necrotizing Enterocolitis

Summary: despite modern medical advances, necrotizing enterocolitis (nec) remains a significant problem in neonatal intensive care units (icus). although research has shown nec to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. the investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages ii and iii nec. the investigators will follow c-reactive protein (crp) levels as a marker of systemic inflammation for the primary outcome in this study.

given the extensive inflammatory response inherent to nec, anti-inflammatory treatment may be of benefit, to both reduce inflammation and as a potential therapy to improve outcome. to date, there is no specific therapy for nec that has been found to improve outcome, but corticosteroids have yet to be investigated in that capacity. therefore, we propose to examine the effect of hydrocortisone for treatment of nec in a randomized, blinded, placebo-controlled pilot study, focusing on a primary outcome of c-reactive protein levels at 3 and 7 days of therapy as a measure of inflammation. in addition, we will follow several secondary outcome measures to determine the possibility of improved outcome in those infants assigned to hydrocortisone. the investigators hypothesize that infants diagnosed with nec who receive hydrocortisone will have significantly lower c-reactive protein levels at 3 and 7 days of treatment versus infants who receive placebo.

Eligibility criteria:
inclusion criteria: * infant born at gestational age less than 34 weeks * birth weight less than 2500 grams * diagnosis of stage ii or iii nec made by attending neonatologist, neonatology fellow, or pediatric hospitalist * legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures * consent can be obtained and study drug can be administered within 6 hours of diagnosis exclusion criteria: * congenital gastrointestinal anomaly * subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry * subject has received indomethacin therapy within 48 hours prior to being diagnosed with nec

Keywords: necrotizing enterocolitis nec premature hydrocortisone steroids anti-inflammatory
effects of antihypertensive drug treatment on brain blood flow, cognition, and regulation of nervous system in older adults with hypertension.

Conditions: Essential Hypertension; Older Adults

Summary: high blood pressure (bp) is a public health problem worldwide. nearly three-quarters of older adults (age \~60 years) in the united states have high bp. high bp links to many health problems, like stroke. drug treatments are typically used in clinics to reduce high bp and the risk of associated health problems. however, these drug treatments may not always benefit brain health. for example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high bp. alternatively, reduced brain blood flow may cause high bp due to increased nervous system activity (the so-called "fight or flight response"). thus, monitoring brain blood flow may help to manage high bp during drug treatment. it is unknown if brain blood flow and its control will be altered by drug treatment in older high bp patients. therefore, study team will recruit older adults with high bp, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment. results from this study will provide novel and clinically relevant information on the impact of drug treatment for high bp on brain health. investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for bp control and brain health.


Eligibility criteria:
inclusion criteria: * older men and women with mild-to-moderate essential hypertension (60-85 years, clinic systolic bp 130-159 and/or diastolic bp 80-109 mmhg) exclusion criteria: * any evidence of cardiovascular or pulmonary disease by medical history or by physical examination * severe hypertension (systolic bp ≥160 and/or diastolic bp ≥110 mmhg; for safety reasons) or secondary hypertension * being on ≥3 antihypertensive agents * chronic kidney disease (an estimated glomerular filtration rate \&gt;45 ml/min) or renal failure * diabetes mellitus (fasting glucose ≥126 mg/dl or 2-hour oral glucose tolerance test, glucose level ≥200 mg/dl) or other systemic illness * any history of substance abuse (other than tobacco) * current cigarette smokers * history of gouty arthritis * taking hormonal replacement therapy * endurance-trained athletes * diagnosed alzheimer's disease and related dementias

Keywords: antihypertensive drug cerebral blood flow cognitive function
correlation of motor metrics and neurological data

Conditions: Movement Disorders (Incl Parkinsonism)

Summary: this is a pilot study to collect data with the ceraxis product and standard movement disorders tests in order to prove and codify potential correlations.


Eligibility criteria:
inclusion criteria: * adult with a diagnosis of idiopathic parkinson's disease or essential tremor by a movement disorders neurologist * age greater than or equal to 21 years * hoehn and yahr stage i-iii * ability to ambulate 200+ meters independently * ability to follow 2-step commands * clinically responsive to medication or deep brain stimulation (dbs) * clinically optimized medication or dbs for at least six months * able to tolerate withdrawal of medication and/or dbs exclusion criteria: * any comorbidity which would exclude them from being able to use the ceraxis product * inability to learn how to use the system * diagnosis of dementia or impairment that compromises the ability to provide informed consent * neurological disease other than parkinson's disease or essential tremor (i.e. multiple sclerosis, stroke with residual motor deficits) * musculoskeletal injury that significantly alters gait
multiple-loading dose regimen study in patients with chronic plaque-type psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of ain457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * diagnosis of plaque psoriasis for at least 6 months prior to screening. the patients must meet all of the following criterion: 1. coverage of the body surface area (bsa) of 10% or more with plaques 2. a score of 3 or more on the iga scale 3. a pasi score of at least 12 at baseline exclusion criteria: * have forms of psoriasis other than the required "plaque psoriasis" * women of childbearing potential * recent use of investigational drugs or treatment with other biological therapies (wash-out periods required) * previous treatment with this investigational drug * subjects with active or history of clinically significant cardiac, kidney or liver abnormalities; other protocol-defined inclusion/exclusion criteria may apply

Keywords: plaque psoriasis inflammatory skin disease skin condition, thickening flaking scaly patches skin disease
visone heart failure study: pilot

Conditions: Heart Failure With Reduced Ejection Fraction, HFrEF

Summary: the visone hf pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering asymptomatic diaphragmatic stimulation in medical refractory heart failure patients using the visone™ implantable system for 12 months.

this 12 month study is intended to validate the early benefits observed with asymptomatic diaphragmatic stimulation (ads) as a primary form of heart failure therapy with low rates and severity of adverse effects. medical refractory symptomatic heart failure patients with reduced ejection fraction and no evidence of arrhythmias or ventricular dysynchrony will undergo laparoscopic implantation of the visone™ implantable system comprised of a pulse generator and two leads, programmed to deliver cardiac-gaited diaphragmatic stimulation pulses at asymptomatic outputs. patients will be followed in pre-specified durations of 1,3,6 and 12-months using a series of evaluations of hemodynamic, echocardiographic, heart failure status, diaphragmatic function, implanted system data and standard safety measures including adverse events, for comparison with their baseline values. the results are intended to be used for designing a subsequent larger study for performing statistical power calculations.

Eligibility criteria:
inclusion criteria * nyha class ii/iii medical refractory despite guideline indicated heart failure medications * sinus rhythm with \<10% ectopy * ef ≤ 35% * nt-probnp \> 500 (250 if on loop diuretics) exclusion criteria * 6mhw \>500 m or \< 200 m * resting hr \> 140 bpm * sbp \ 170 mmhg * serum creatine \> 2.5 mg/dl * ventricular dyssynchrony by ecg with qrs ≥ 140ms * unstable angina, ami, cabg, ptca, cva/tia, persistent af, nsvt, sustained vt or vf, or dccv within 3 months * intermittent inotropic drug treatment * existing pacemaker or indications for a pacemaker * severe primary pulmonary disease including pulmonary arterial hypertension or severe copd, or other respiratory or lung diseases where fev \< 50% or any condition with severe diaphragmatic dysfunction * previous open laparotomy within 1 year or contraindications to laparoscopy, as determined by implanting physician * known or active intra-abdominal infections, or known intra-abdominal pathology * previous thoracic or abdominal organ transplant, transplant waiting list * pregnancy

Keywords: implantable heart failure device therapy asymptomatic diaphragmatic stimulation
characterization and functionality of calcium channels cav1.4 of th17 lymphocytes in human with psoriasis

Conditions: Psoriasis

Summary: it's clearly known that lymphocyte activation in particular th17 response, plays a major role in the development of plaque psoriasis. new therapies targeting this pathway are showing great clinical efficacy in patients with moderate to severe plaque psoriasis. pioneering observations have shown that the expression of cav1.4 channels in th17 lymphocytes and they're functional role is supported by the inhibition of il-17 production by a pharmacological inhibitor of cav1 channels that is effective in a mouse model of psoriasis. this data strongly suggest that the cav1.4 channel, via its involvement in the signalling responsible for the production of th17 cytokines represents an interesting therapeutic target in psoriasis. the aim of the study is to explore biological functions related to the activation of the cav1.4 pathway in psoriasis.

* evaluate the expression of cav1.4 calcium channels by th17 lymphocytes from plaque psoriasis. * to assess: * the role of cav1.4 channels on the activation of th17 lymphocytes * the transcriptomic signature relating to the signalling channel cav1.4 * the epigenetic signature, in particular changes in overall methylation and specific promoter methylation

Eligibility criteria:
inclusion criteria: * group 1 : subject with plaque psoriasis (diagnosis confirmed by dermatologist) with a plaque iga score ≥ 3 * group 2 : subject with atopic dermatitis according to the uk working party criteria with an iga plaque score ≥3 exlusion criteria: * group 1 : other chronic inflammatory dermatosis than plaque psoriasis at the sites to be sampled * group 2 : other chronic inflammatory dermatosis than atopic dermatitis at the sites to be sampled * for both groups: ongoing treatment with calcium channel blockers * for both groups: any current topical treatment on the biopsied or systemic plaque for psoriasis or ad (including phototherapy)

Keywords: th17 cav1.4 lymphocyte channel
a phase ii study to evaluate efficacy and safety of dovitinib (tki258) in advanced scirrhous gastric carcinoma patients

Conditions: Adenocarcinoma, Scirrhous; Linitis Plastica; Stomach Neoplasms; Stomach Diseases; Neoplasms by Site; Neoplasms

Summary: this is a prospective, open-label, single-arm, non-randomized, multi-center, phase ii proof of concept (poc) study with a two-stage design and bayesian interim monitoring to evaluate efficacy and safety of single agent tki258 in adult patients with scirrhous gastric carcinoma (sgc) that have progressed after one or two prior systemic treatments.


Eligibility criteria:
inclusion criteria: * diagnosis of advanced/metastatic scirrhous gastric carcinoma * evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion * patients previously treated with one or two systemic lines * documented radiological confirmation of disease progression * ecog performance status of 0 to 2 * male and female patients aged 20 years or greater * adequate liver, renal, and hematologic function exclusion criteria: * patients who received prior treatment with an fgfr inhibitor * patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases * patients with another primary malignancy within 3 years prior to starting study treatment other protocol-defined inclusion/exclusion criteria may apply

Keywords: solid tumors advanced scirrhous gastric carcinoma gastric cancer second-line or third-line treatment vegf fgfr neoplasms gastric neoplasms cancer carcinoma gastric diseases female genital diseases tumors oral administration capsules tki258 tki-258 tki 258
reset-o rct (randomized controlled trial)

Conditions: Opioid-use Disorder

Summary: this randomized controlled trial research study will be evaluating an app, reset-o, owned by pear therapeutics, inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.

this randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (tau) and the app, reset-o (n = 100), and half will be assigned to tau only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. all subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. participants assigned to tau + reset-o will be expected to engage with the app, reset-o, for the full six months. the app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of opioid use disorder (oud) as determined through routine clinical care * recently starting outpatient treatment for oud within the penn state health hub and spoke system of care * initiating mat with buprenorphine-naloxone (suboxone), buprenorphine (subutex), or methadone. since buprenorphine (subutex) is an fda approved mat for pregnant women with oud, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements. * prison inmates are eligible to participate in the study * ability to read, write, and comprehend english exclusion criteria: * initiating maintenance treatment that does not include mat or switching to a maintenance treatment that does not include mat (i.e.: detoxification and counseling treatment only without mat). * planning an outpatient detoxification * judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment) * less than 18 years of age * unable to read, write, and comprehend english