Kornimate/medical-research-clean huggingface dataset:
amplatzer™amulet™ post-market study (amulet™pms)

Conditions: Atrial Fibrillation; Thromboembolism; Stroke

Summary: this was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the amulet™ device in non-valvular atrial fibrillation (nvaf) subjects. the study was designed to follow the instructions for use (ifu) to gather data on the implant procedure through two years of follow up with the amulet™ device in a commercial clinical setting."

a total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the united states. the study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. no formal hypothesis were tested for this observational post-market study. each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."

Eligibility criteria:
inclusion criteria: 1. subject with history of paroxysmal, persistent or permanent nvaf 2. subject who is 18 years or older, or of legal age to give informed consent specific to state and national law 3. subject who is eligible for an amulet laa occluder device according to current international guidelines and per physician discretion 4. subject who is willing and capable of providing informed consent, participating in all associated study activities exclusion criteria: 1. subject with evidence of an intracardiac thrombus 2. subject with active infection or active endocarditis or other infections producing bacteremia 3. subject where the placement of the device would interfere with any intracardiac or intravascular structures 4. subject with any medical disorder that would interfere with completion or evaluation of clinical study results 5. women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion) 6. subject with laa anatomy that does not accommodate a device per the sizing guidelines
remote monitoring with health-coaching to improve quality of life in older patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this clinical trial tests the effectiveness of a home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching to decrease fatigue and improve quality of life in older patients with multiple myeloma (mm). studies have shown that mm patients have the highest symptom burden among all blood cancers, with older patients experiencing more symptoms and problems, such as fatigue and decreased quality of life, compared to younger patients. there is some data to support that physical activity may have beneficial effects on fatigue, physical function, and quality of life in older cancer patients. studies have also shown that older patients prefer activities that are gentle, holistic, and home-based. mindfulness-based interventions have been shown to have positive effects on sleep, depression, anxiety and cancer-related fatigue. health coaching is a patient centered behavioral change intervention that is delivered by various healthcare professionals and involves goal-setting, self-discovery, and accountability. health coaching interventions have been shown to increase physical activity levels and improve quality of life. a home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching may decrease fatigue and improve the quality of life in older patients with mm.

primary objective: i. to assess the effect-size of a novel combined home-based mindfulness physical activity program with telephonic health coaching on 1) patient-reported fatigue assessed by the brief fatigue inventory (bfi) and functional assessment of chronic illness therapy-fatigue (facit-f) questionnaires and 2) health-related quality of life assessed by the patient-reported outcomes measurement information system global-10 (promis global-10) questionnaire, and 3) physical activity levels measured by steps per day. outline: patients participate in remote monitored home-based physical activity sessions including flexibility practice, slow walking and breathing exercises daily on 6 out of 7 days a week and receive telephone health coaching over 5-20 minutes once a week for 12 weeks. patients also participate in a brief telephone interview at the end of 12 weeks. additionally, patients wear a monitor on the wrist to monitor physical activity for 7 days during enrollment and at 3 months.

Eligibility criteria:
inclusion criteria: * diagnosed with mm and has received treatment with \>= 1 prior lines of treatment, and currently on maintenance treatment with a proteasome inhibitor and/or immunomodulatory agent, and/or anti-c38 antibody * the ability to read and respond to questions in english * age ≥ 65 years * moderate or higher fatigue ( \> 4) on a scale of 0-10 based on fatigue rating to question: - rate your average fatigue over the last week, where 0 is no fatigue and 10 is extreme fatigue * have wi-fi connection, as the program requires wi-fi to operate exclusion criteria: * does not meet listed inclusion criteria
validation of clinical assessment of spinal stiffness

Conditions: Hyperkyphosis; Adolescent Idiopathic Scoliosis

Summary: this study aims to validate and verify the reliability of the clinical measures used in the daily routine by doctors and therapists that allow assessing the spinal stiffness in all spatial planes. the secondary objective is the verification of the diagnostic accuracy of the most reliable tests in identifying the subjects at risk of failure, using as a radiographic standard the examinations performed by the patients during the treatment (data retrieved retrospectively) using as a control group those patients who did not obtain a correction of the spine curvature.


Eligibility criteria:
inclusion criteria: * scoliosis \> 10°cobb or hyperkyophosis \>50° cobb * age between 10 and 17 years old * risser between 0 and 5 exclusion criteria: * history of spinal surgery * presence of back pain * diagnosis of congenital scoliosis or scoliosis secondary to neurological or muscular diseases
feasibility of chemotherapy de-escalation in early-stage her2 positive breast cancer

Conditions: HER2-positive Breast Cancer

Summary: the main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage her2 positive breast cancer.

assess the feasibility of four cycles of neoadjuvant docetaxel carboplatin trastuzumab and pertuzumab (tchp) in women with early-stage (local/locally advanced) her2+ breast cancer with a selective escalation of targeted her2 directed therapy in the high risk group in the adjuvant setting. participants with any residual disease after four cycles of tchp will receive trastuzumab emtansine (tdm1) plus pertuzumab while those with complete pathological response will receive trastuzumab in the adjuvant settings.

Eligibility criteria:
inclusion criteria: * women ≥18 years of age * biopsy proven her2+ early breast cancer * ecog performance status 0-1 * should be a candidate for neoadjuvant chemotherapy using standard guidelines of tumor size of 2cm or more and /or axillary lymph node-positive disease. * adequate cardiac, bone marrow, kidney, and liver functions per treating physician's discretion. * women of childbearing potential who are sexually active must agree to use highly effective methods of contraception during treatment and for three weeks after the last dose of chemotherapy or anti-her2 therapy. the women currently using hormonal contraceptives must agree to change to an alternative highly effective method of contraception * willingness and ability to comply with study and follow-up procedures and give written informed consent. exclusion criteria: * any evidence of stage iv breast cancer * participant deemed unsuitable for clinical trial enrolment by treating physician based on the participants' compliance, location and commute requirements, or tolerance of therapies involved * any invasive malignancy within the last two years of study enrollment except for adequately treated basal cell carcinoma, squamous cell carcinoma, or non-melanoma skin cancer. * women who are pregnant or breastfeeding.

Keywords: her2-positive breast cancer de-escalation
treatment of nevus flammeus with alexandrite laser

Conditions: Nevus Flammeus

Summary: nevus flammeus is a congenital vascular malformation. nevus flammeus is traditionally treated with pulsed dye lasers (pdl); however, around 20 percent of patients are poor responders and do not get satisfactory results from pulsed dye laser treatments. small studies with alexandrite lasers indicate that this may be an alternative treatment for individuals with nevus flammeus. this study assesses the clinical effect and side effects of alexandrite laser treatment for nevus flammeus using different treatment settings.


Eligibility criteria:
inclusion criteria: * 10 or more years of age * fitzpatrick skin type i-iii * previously untreated or pulsed dye laser-insufficiently treated nevus flammeus * nevus flammeus size minimum 8 x 2 centimeter within one anatomical region * written and oral informed consent exclusion criteria: * known light sensibility toward visible light * tendency to develop hypertrophic scars or keloids * fitzpatrick skin type iv-vi * individuals, that are obviously pigmented due to recent sun exposure or sun beds * treatment with systemic retinoids within 6 months * pregnancy and lactation * unwillingness to complete protocol
effects of the combining physical exercise and cognitive training for the community-based elderly

Conditions: Cognitively-normal; Mild Cognitive Impairment; Subjective Cognitive Decline

Summary: this study aims to (1) determine the intervention effects of sequential and simultaneous training on cognitive function and health-related function for cognitively-normal elderly and elderly with mild cognitive impairment(mci) and subjective cognitive decline(scd); (2) compare which combination approach is more advantageous for improvement on outcome measures.

the investigators will recruit 30 cognitively-normal elderly and 30 elderly with mild cognitive impairment(mci) and 30 elderly with subjective cognitive decline(scd). participants will be randomly assigned to one of three groups: sequential training (first perform physical exercise followed by cognitive training), simultaneous training (perform physical exercise and cognitive tasks simultaneously), and control group (perform body stretching and health education courses). all participants will receive trainings for 120 minutes per day, one day per week for 12 weeks. the outcome will include measurements that evaluate the cognitive, physical, daily functions, quality of life, and social participation. participants will be assessed at baseline, after the intervention, and at 3-month follow-up. repeated measures of analysis of variance (anova) will be used to evaluate the changes in outcome measures at three different time points for the elderly with cognitively-normal, mild cognitive impairment(mci) and subjective cognitive decline(scd), respectively. the investigators also use the analysis of covariance (ancova) to investigate the differences between the mild cognitive impairment(mci) and subjective cognitive decline(scd) groups on the outcome measures.

Eligibility criteria:
cognitively-normal elderly inclusion criteria: 1. age≥60 2. able to follow instruction 3. moca\>26 4. not scd or mci or dementia exclusion criteria: 1. concomitant neurological conditions such as dementia, parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema); 2. have unstable cardiovascular status such as uncontrolled hypertension scd inclusion criteria: 1. age\>=60 2. scd(from ecog-12) 3. moca≥26 4. not mci or dementia exclusion criteria: 1. concomitant neurological conditions such as dementia, parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema); 2. have unstable cardiovascular status such as uncontrolled hypertension mci inclusion criteria: (1)age\>=60 (2)20 ≦moca \< 26 (3)mci (3)not dementia exclusion criteria: 1. concomitant neurological conditions such as dementia, parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema); 2. have unstable cardiovascular status such as uncontrolled hypertension

Keywords: aerobic exercise cognitive training
prospective metabolic monitoring of youth and adults with bipolar disorder

Conditions: Bipolar Disorder; Youth; Adults

Summary: background: most psychotropic medications that are effective in the treatment of bipolar disorder (bd) are associated with endocrine-metabolic changes (emcs). to date, there is no long-term study in bd that has examined specifically the association of inflammation with emcs in bd. specific aims: 1) to identify predictors of emcs among adolescents and adults with bd who are being started on a medication ; 2) to compare change in emcs in youth and adults treated for bd; 3) to measure change in emcs associated with use of different medications for bd. research design: participants: 30 adolescents (14-18 years old) with bd and 30 adults (19-65 years old) with bd. measures: blood levels of biomarkers that are associated with emcs will be measured.


Eligibility criteria:
inclusion criteria: 1. provision of written informed consent 2. diagnosis of bd type i, ii, or nos as determined by dsm-iv diagnostic criteria (confirmed using scid or k-sads) 3. both females and males, age14 to 65 years 4. decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic 5. able to understand and comply with requirements of the study 6. proficient in english. exclusion criteria: 1. a primary psychiatric disorder other than bipolar disorder i, ii or nos (comorbid axis i or ii disorders are permitted, as long as clinician judges that bipolar disorder is the primary condition) 2. initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit 3. patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit 4. significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics 5. patients who are receiving pharmacological treatment for diabetes mellitus (dm), hyperlipidemia, or obesity 6. acute or chronic medical illness (e.g. urinary tract infection, bronchitis, rheumatoid arthritis) that, as judged by the investigator, would significantly alter inflammatory, metabolic, or endocrine indices 7. screening bloodwork that identifies any other clinically significant deviation from the reference range in clinical laboratory test results, as judged by the investigator.

Keywords: bipolar disorder youth adults endocrine-metabolic changes
clinical outcomes of patients with resectable non-small cell lung cancer receiving neoadjuvant nivolumab plus chemotherapy in france

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in france.


Eligibility criteria:
inclusion criteria: * having a diagnosis of resectable non-small cell lung cancer (nsclc) * being 18 years or above at the time of their nsclc diagnosis * having initiated a neoadjuvant treatment with nivolumab and chemotherapy outside a clinical trial * being indexed in the site database * being followed at the site for at least 5 months, except for patients with a record of death exclusion criteria: • having any primary tumor other than nsclc on or before the date of nsclc diagnosis that required a treatment ending less than 12-months before the nivolumab plus chemotherapy neoadjuvant treatment

Keywords: non-small cell lung cancer (nsclc)
dead space evaluation in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion mismatch on the genesis of exercise induced hyperventilation in pulmonary hypertension patients. so the investigators tested the chemoreceptor response at rest, both with hypoxic and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two components, alveolar and dead space ventilation.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤ 80 years * ability to understand the research protocol and willing to sign the study informed consent * diagnosis of pulmonary arterial hypertension belonging to class i and iv * stable haemodynamic status and optimized medical treatment since at least 2 months * ability to perform maximal cardiopulmonary exercise test and pulmonary diffusing capacity for carbon monoxide evaluation exclusion criteria: * relevant comorbidities * usual contraindications for cardiopulmonary exercise test * pulmonary hypertension associated to left heart and pulmonary disease, congenital heart diseases with evident cardiac shunts.
serum neurofilament light in multiple sclerosis

Conditions: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis

Summary: this prospective cohort study is designed to characterize the utility of snfl as a biomarker in clinical practice. this study also aims to understand how access to snfl measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. while there is strong evidence in support of snfl as a potential biomarker, literature regarding the application of snfl in a real-world clinical practice setting is lacking. understanding the utility of this test to clinicians and patients as a biomarker of ms disease activity is essential. additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. given recent advances in the treatment of ms, there is increasing need for convenient and accessible measures of treatment efficacy.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with rrms 2. adults aged 18+ at time of screening 3. patients who are able to consent 4. patients who agree to be reasonably compliant with study protocol for the duration of the study 5. any subject who is currently being treated with an ms dmt or any subject initiating a new ms dmt throughout the duration of their participation in the study will be initiated and/or treated according to local label exclusion criteria: 1. patients with current diagnosis of a neurodegenerative or autoimmune disease other than ms that may impact snfl levels, in the opinion of the investigator (including but not limited to: alzheimer's disease, huntington's disease, amyotrophic lateral sclerosis, or parkinson's disease, systemic lupus erythematosus, rheumatoid arthritis) 2. inability to complete blood draws 3. pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study 4. patients who have taken an investigational medication within five half-lives prior to screening or who plan to take an investigational medication during the study 5. patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator
phase 3, randomized, placebo-controlled, double-blinded trial of the combined lysis of thrombus with ultrasound and systemic tissue plasminogen activator (tpa) for emergent revascularization in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (us) as an adjunctive therapy to tissue plasminogen activator (tpa) treatment in subjects with acute ischemic stroke.

the primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial us and systemic tpa (target group) compared to systemic tpa alone (control group) in subjects with acute ischemic stroke. the primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified rankin score ordinal shift analysis). the primary safety endpoint is the proportion of subjects in the target vs control group experiencing symptomatic intracranial hemorrhage (sich) within 24 hours of treatment.

Eligibility criteria:
inclusion criteria: 1. males or females 18 - 80 years of age 2. subjects presenting within timeframe for intravenous tpa treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms 3. no signs of intracranial bleeding on assessment by non-contrast ct 4. subjects with neurological deficits of a total nihss score ≥ 10 points 5. subjects that in the opinion of the treating physician require treatment with full dose iv tpa as standard of care per institutional standards 6. sbp \< 185 mmhg and dbp \< 105 mmhg at baseline or after treatment of hypertension with medications prior to tpa bolus 7. pre-morbid modified rankin score of 0-1 8. provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the informed consent form in accordance with all local and national regulations 9. co-signature on the informed consent form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations 10. for subjects in the optional arterial recanalization substudy: 1. occlusion located in the intracranial carotid tee through mid m2 or proximal a2, or intracranial vertebrobasilar or p1/proximal p2 segments or tandem lesions 2. estimated glomerular filtration rate (egfr) ≥ 60 ml/min for patients undergoing cta or mra exclusion criteria: 1. subjects with primary intra-arterial thrombolysis 2. females who are pregnant or breast feeding 3. subjects receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment 4. subjects with any standard contraindication for intravenous tpa therapy 5. significant concurrent medical/neurological conditions or test values that, in the opinion of the investigator, pose significant risk to the subject and warrant exclusion from the study