Kornimate/medical-research-clean huggingface dataset:
fluselenamyl - beta amyloid pet imaging for alzheimer disease

Conditions: Alzheimer Disease

Summary: the purpose of this research study is to determine the safety of a radiotracer 18f-fluselenamyl using positron emission tomography (pet) imaging. the investigators will first complete whole-body pet dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a pet scan. second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18f-fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. amyloid is a protein related to dementia of alzheimer's disease. 11c-pib pet imaging along with mri will also be completed in the same participants and the data will be compared with 18f-fluselenmayl. 11c-pib and 18f-fluselenamyl both bind to beta-amyloid plaques. finally, a comparison of the normal control participants to patients with alzheimer's disease will be completed.


Eligibility criteria:
inclusion criteria: * male or female, any race * age ≥ 18 years * healthy volunteers or volunteers with alzheimer's disease exclusion criteria: * has hypersensitivity to 18f-fluselenamyl or any of its excipients ; * has hypersensitivity to 11c-pib or any of its excipients ; * incapable of providing written informed consent or lacking a legally authorized representative (lar) to provide informed consent ; * unwilling or unable to undergo pet scans tracer injections ; * unwilling or unable to undergo mri (aim 2 and aim 3); * any condition that, in the investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer); * women who are currently pregnant or breast-feeding; * current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the u.s. code of federal regulations (cfr) title 21 section 361.1.
oral isotretinoin for photoaging: results of a randomized controlled phase ii trial

Conditions: Photoaging; Epidermal p53 Expression

Summary: a clinical and histological randomized controlled phase ii trial to evaluate the efficacy and safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or sterilized women aged 40-55y. the subjects were included in two randomly selected groups: a- 21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen spf 60 during three months; b- 11 women received only same moisturizer/sunscreen.

clinical assessment ranging from -2=very bad to +2=very good for all patients. also, profilometry, corneometer and skin elasticity tests in periocular regions and left forearm; skin biopsy on left forearm before/after treatment in b and in 10 randomly selected patients from a. microscopic evaluation of corneal layer and epidermal thickness, dermal elastosis, new collagen and p53 epidermal expression performed by quantitative digital image analysis. blind evaluations (group/time) conducted by two independent observers. clinical evaluation results showed no alterations (0) or slight improvement (+1) for all patients; profilometry, corneometer and skin elasticity measurements presented a significant difference in pre and post treatment values (p=0,001 to 0,028) with no differences between a/b. regarding histological findings and p53 expression no previous differences between groups before the treatment were observed (p\>0,1).quantitative microscopic digital analysis demonstrated no differences between groups at the end of the study for the majority of variables. however, slight but significant difference between a/b subjects was found for p53 with major expression reduction for those treated with oral isotretinoin \[0,66±0,31 vs 0,94±0,34 respectively (p=0,04)\]. the main side effects were cheilitis in 15 patients (75%) and xerophthalmia in 5 (25%). no significant alterations occurred in biochemical tests.

Eligibility criteria:
inclusion criteria: * menopausal or sterilized women exclusion criteria: * woman at risk of pregnancy, with alterations on liver function or lipid profile

Keywords: photoaging isotretinoin profilometry digital analysis
telephone-linked home-based exercise training in pd

Conditions: Parkinson's Disease

Summary: this project is investigating whether a home-based exercise program will reduce depression in patients with parkinson's disease.

background/rationale: nonmotor symptoms in parkinson's disease (pd) are thought to be present from the early stages of disease and are often more disabling and resistant to treatment than motor symptoms. one of the most important and serious of these symptoms is depression. however, there is no consensus on best pharmacological treatment for depression in pd as efficacy is lacking and there is much concern about polypharmacy and safety of various antidepressant medications. therefore, it is essential that the investigators characterize the effects of nonpharmacological interventions on depression in pd. a number of studies have shown significant benefits of exercise in reducing depressive symptoms. emerging studies indicate similar benefits of exercise in the form of resistance training in limiting depression in older adults as well as in those with pd. objective: the investigators hypothesize that a home-based exercise intervention will reduce depression in veterans with depression in pd. methods: the proposed study is a randomized, controlled trial of a structured exercise intervention, evaluating effects on depression. community-dwelling veterans with depression in pd will be randomized to the exercise intervention or a health education control intervention. participants will be male and female veterans with a physician diagnosis of idiopathic, typical pd, with at least 2 of 3 cardinal signs of pd, response to dopaminergic medication, and depression. the interventions will last 6 months.

Eligibility criteria:
inclusion criteria: * physician diagnosis of idiopathic, typical parkinson's disease (pd) * at least 2 of 3 cardial signs of pd * response to dopaminergic medication * depression exclusion criteria: * angina pectoris * history of myocardial infarction within 6 months * history of ventricular dysrhythmia requiring current therapy

Keywords: parkinson's disease exercise therapy quality of life
enhancing the secondary prevention of coronary artery disease

Conditions: Coronary Disease; Ischemic Heart Disease

Summary: people with coronary artery disease can reduce their chance of having a heart attack by making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). there are also many medications that have been proven to reduce the risk of heart attacks and may even help people live longer. this study will look at different ways of improving the use of these beneficial medications to enhance the quality of care for people with this condition.

background: despite the abundant evidence base for secondary prevention, practice audits consistently demonstrate substantial "care gaps" between this evidence and clinical reality such that many patients with coronary artery disease (cad) are not offered all possible therapies for the prevention of myocardial infarction or death. for example, even after an acute myocardial infarction, almost one fifth of patients continue to smoke; over half with hypertension or hyperlipidemia have poorly controlled pressure or lipid levels; and proven therapies such as statins, ace inhibitors, beta-blockers and antiplatelet agents are under-prescribed. multiple barriers are often responsible for the lack of implementation of proven efficacious therapies and traditional means of educating practitioners (journal articles, cme, conferences, etc) are usually ineffective in altering practice. clearly novel interventions to improve the quality of prescribing are needed. local opinion leaders are trusted by their peers to evaluate medical innovations and thus influence practice patterns within their community. few controlled studies, however, have evaluated their effect on changing prescribing practices for common conditions such as cad. hypothesis: this trial will test 2 quality improvement interventions. the principle hypothesis is: does a one-page evidence summary endorsed by local opinion leaders increase the provision of secondary prevention therapies in patients with cad compared to usual care? the secondary hypotheses are: does the same intervention but without local opinion leader endorsement improve the provision of secondary prevention strategies in patients with cad compared to usual care? does local opinion leader endorsement increase the effectiveness of the quality improvement intervention?

Eligibility criteria:
inclusion criteria: * alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (\> or equal to 50% stenosis in at least one vessel). exclusion criteria: * no fasting lipid panel within the previous 6 weeks * on a statin at maximal dose * on a statin/lipid lowering drug and ldl-c is 2.5 mmol/l or less (prior to sept 2006) and ldl-c is 2.0 mmol/l or less (after sept 2006) * not on a statin and ldl-c is 1.8 mmol/l or less * acute myocardial infarction or cardiogenic shock * require emergency bypass surgery following catheterization * contraindication to statins (e.g. cirrhosis, inflammatory muscle disease)

Keywords: coronary disease quality improvement knowledge translation
thera-band resisted treadmill training for chronic stroke patients

Conditions: Chronic Stroke

Summary: the purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. this study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.

this study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . functional balance (berg balance scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and fugl-meyer lower extremity motor scale will also be conducted for subject characterization.

Eligibility criteria:
inclusion criteria: 1. the diagnosis of first time unilateral stroke more than 6 months before 2. the ability to walk for at least 15 m without person assistance 3. apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed \< 0.8 m/s 4. resting blood pressure lower than 150/90 mmhg. exclusion criteria: 1. older than 75 years 2. inability to follow the experimental instructions or procedures 3. any pain, inflammation, or other conditions that could affect walking 4. medically unstable.
effectiveness and side effects of pegylated interferon alpha-2a (pegaferon®) plus ribavirin in the patients with chronic hepatitis c

Conditions: Hepatitis C

Summary: pegylation of interferon prolongs the medication half-life which has resulted in pegylated interferon (peg-ifn) as the new modality for treatment of chronic hepatitis c. we current this clinical trial to assess the efficacy and safety of domestic peg-ifn alpha-2a (pegaferon®) in the patients with chronic hepatitis c.

we enroll 50 patients in to the study. the patients receive pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. the patients are visited every 4 weeks with biochemistry lab tests. they are checked with quantitative hcv pcr on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. the patients with undetectable hcv rna are considered as responders.

Eligibility criteria:
inclusion criteria: * hcv rna: positive * biopsy approved in genotype 1 * age older than 18 yrs exclusion criteria: * ongoing pregnancy or breast feeding * hx of hemochromatosis * hx of metabolic liver dis. * hx of hcc * hx of autoimmune hepatitis * hx of alcoholic liver dis. * hx of bleeding from esophageal varices * ongoing systemic anti-viral or anti-neoplasmic treatment * hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time * hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time * hx of hospitalization for psychiatric dis. * hx of suicidal attempt * hx of ibd * hx of sle * hx of scleroderma * hx of rheumatoid arthritis * hx of itp * hx of autoimmune hemolytic anemia * hx of severe psoriasis * hx of chronic pulmonary dis. associated with functional limitation * hx of mi or unstable angina * hx of arrhythmia requiring ongoing treatment * hx of functional class iii or iv * hx of severe seizure dis. or current anti-convulsant use * hx of organ transplantation with existing functional graft * hx of severe retinopathy * hx of thalassemia * hx of spherocytosis * hx of cerebrovascular dis.
magnetic resonance imaging to assess changes in meniscus vascularity

Conditions: Meniscus Tears

Summary: the menisci in the knee joint are important for normal functioning of the knee. meniscus tears are amongst the commonest of injuries to the knee. the pattern and blood supply of the meniscus tears determines the treatment plan and outcome. the surgeon identifies the blood supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the treatment option ie repair versus partial meniscectomy. this study aims to identify any changes that occur in the meniscus blood supply. the following are the main aims of the 'move'study- 1. use of non-invasive methods ie mrimaging to assess meniscus vascularity to preoperatively plan treatment and advice patient on recovery. 2. the study would assess changes in meniscus blood supply depending on age of the patient. 3. the study aims to assess the alteration in meniscus blood supply following an arthroscopic(key hole) meniscal repair operation.


Eligibility criteria:
inclusion criteria: inclusion criteria for group i,ii 1. patients should be aged 18-20 years or 35-45years 2. asymptomatic knee for past 6 months. 3. painless flexion-extension movements at knee joint. inclusion criteria for group iii 1. patients should be aged 75 or older 2. knee x-ray showing no more than kellgren-lawrence grade ii osteoarthrtis 3. no clinical suspicion of meniscus tear 4. painless flexion-extension movements at knee joint. inclusion criteria for group iv 1. patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair. exclusion criteria: 1. proven polyarthritis / polyarthralgia secondary to rheumatoid arthritis, gout, lupus, ankylosing spondylosis, psoriatic arthritis 2. any previous surgical procedure(open or arthroscopic) involving the knee joint.(baring the current meniscus repair in group iv participants) 3. patients unable to give informed consent. 4. patients with contraindication for mr imaging - metal implants, prosthetic heart valves, pacemakers, metal foreign bodies, vp shunts, pregnancy, cochlear implant, metal clips in the brain, patients with static tremor i.e. parkinson's disease. 5. patients with contraindications for contrast agent - renal impairment, previous allergic reaction.

Keywords: musculoskeletal system
single-dose pk and safety study of gbt440 in subjects with hepatic impairment

Conditions: Hepatic Impairment

Summary: a phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of gbt440 administered in subjects with mild (child-pugh a), moderate (child-pugh b), or severe (child-pugh c) hepatic impairment disease and healthy subjects with normal hepatic function.

approximately 24 to 28 subjects will be enrolled. safety and pk assessments will be performed at selected time points throughout the study.

Eligibility criteria:
inclusion criteria: all subjects: * males or females, 18 to 75 years old * willing and able to give written informed consent patients with hepatic impairment: * mild hepatic impairment (child-pugh a \[5-6 points\]) * moderate hepatic impairment (child-pugh b \[7-9 points\]) * severe hepatic impairment (child-pugh c \[10-15 points\]) healthy subjects: * match in age, gender and body mass index with hepatic impaired subjects * healthy and without clinically significant abnormalities in vital signs, ecgs, physical exam, clinical laboratory evaluations, medical and surgical history exclusion criteria: all subjects: * participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half-lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device) * any signs or symptoms of acute illness at screening or day -1 * history or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease patients with hepatic impairment: * history of liver transplantation, hepatic mass suggestive of hepatocellular carcinoma or acute liver disease * screening serum alt or ast \>5 times the upper limit of normal
preoperative systemic therapy vs upfront surgery in her2 positive early breast cancer

Conditions: Breast Cancer; HER2; Preoperative Systemic Treatment

Summary: preoperative systemic treatment can make patients getting more opportunity for breast-conserving surgery, down-staging and new drugs developing. it is particularly common in human epidermal growth factor receptor 2 (her2)-over expressing subtype for as high as 40%\~60% pcr rate of such a population. even though, in nsabp b18/27 trials, it had been proved that pst could not improve either disease-free survival (dfs) or overall survival (os) comparing with postoperatively systemic treatment in total population. we designed a real-world study to investigate the prognosis of anti-her2 treatment combined with chemotherapy preoperatively versus postoperatively in her2-positive early breast cancer

patients with a diagnosis of her2 positive early invasive breast cancer (ct1-3n0-1m0), from january 2012 to december 2014 were identified and enrolled continuously. the conditions of her2-positive expression of primary breast cancer were defined as follows: her2 3+ by immunohistochemical (ihc) method or her2 2+ by ihc with a further positive result by fluorescence in situ hybridization (fish). according to the real upfront treatment, all eligible patients were classified as pst group and surgery group. all the patients accepted standard one-year trastuzumab as anti-her2 treatment combined with chemotherapy. in the pst group, the effect was evaluated according to recist1.1 every two cycles, the patients with clinical complete response (ccr) or partial response (pr) would receive the whole course of chemotherapy, those with stable disease (sd) or progressive disease (pd) would receive surgery promptly. after surgery, all patients underwent irradiation and endocrine therapies if necessary. the pcr was defined as the absence of infiltrating residual invasive disease in the breast and axillary nodes. for those non-pcr patients after pst, intensive adjuvant chemotherapy was not routine treatment except patients with progressive disease.the primary endpoint was dfs defined as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer. patients suffered disease progress becoming inoperable before surgery were counted as local treatment failures. the second endpoint was os defined as the time from study entry to death from any cause. all the endpoints were compared between pst group and upfront surgery group, also further analysis according to pathological response status stratified in pst group.

Eligibility criteria:
inclusion criteria: 1. her2 positive 2. early invasive breast cancer (ct1-3n0-1m0) 3. using one-year trastuzumab as anti-her2 treatment exclusion criteria: 1. exclude metastasis and recurrent breast cancer 2. using trastuzumab less than a year

Keywords: breast cancer her2 preoperative systemic treatment
bpl-003 efficacy and safety in treatment resistant depression

Conditions: Treatment Resistant Depression

Summary: this is a phase 2 study randomized, quadruple masked, multi-center study , with a open label extension, designed to investigate the efficacy and safety of bpl-003 combined with psychological support in patients with treatment resistant depression (trd).

approximately 200 eligible participants will receive a single dose of either low, medium, or high doses of bpl-003, given intranasally, with 8 weeks of follow up assessments. following this participants may receive a second dose of either monophasic or biphasic dose of bpl-003, given intranasally, with another 8 weeks of follow up assessments. psychological support will be given before, during and after each dosing.

Eligibility criteria:
inclusion criteria: 1. at least moderate major depressive disorder. 2. diagnosed with trd defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments based on the mgh atrq assessment. 3. hamilton depression rating scale score ≥19 at screening and baseline. 4. cgi-s ≥4 at screening and baseline. 5. if currently taking antidepressant medications, willing and able to discontinue current antidepressants. exclusion criteria: 1. current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder. 2. current personality disorders. 3. first-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder. 4. current alcohol or substance use disorder (other than caffeine or nicotine). 5. a participant who at any time has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation. 6. suicidal ideation or behavior within the 12 months prior to the start of screening or on day 1 prior to dosing. 7. suicide attempt and/or self-injurious behavior within the last 12 months prior to screening. 8. uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure. 9. history or current uncontrolled hypertension. 10. seizure disorder or any seizure in the 2 years prior to screening. 11. has clinically significant results on ecg during the screening. 12. any nasal obstruction, blockage, or symptoms of congestion at the time of dosing that in the investigator's opinion may interfere with the administration of the study medication. 13. female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study. 14. male participants who are sexually active and not willing to use adequate forms of contraception during the study.