Kornimate/medical-research-clean huggingface dataset:
a trial l of panobinostat given in combination with trastuzumab and paclitaxel in adult female patients with her2 positive metastatic breast cancer

Conditions: HER-2 Positive Breast Cancer; Metastatic Breast Cancer

Summary: the primary purpose of this study is to identify the maximum tolerated dose (mtd) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. the study will evaluate safety and efficacy of the combination in adult female patients with her2+ metastatic breast cancer


Eligibility criteria:
inclusion criteria: * age \> 18 year old * confirmed her2+ metastatic breast cancer * prior treatment and progression on trastuzumab * patients must have adequate organ functions * eastern cooperative oncology group (ecog) performance status of ≤ 1 exclusion criteria: * patients who have had surgery within last 2 weeks prior to starting the treatment * patients who receive concurrent therapy for brain metastases * impaired heart function or clinically significant heart disease * ongoing diarrhea * liver or renal disease with impaired hepatic or renal functions * concomitant use of any anti-cancer therapy or certain drugs * female patients who are pregnant or breast feeding * patients not willing to use an effective method of birth control other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer her2 positive adult-female lbh589 hdac inhibitor panobinostat metastatic breast adult female patients
effectiveness of proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibitor initiation before percutaneous coronary intervention on acute myocardial infarction patients

Conditions: Acute Myocardial Infarction (AMI)

Summary: the goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (ami) scheduled for primary percutaneous coronary intervention (pci). it will also learn about the safety of drug tafolecimab. the main questions it aims to answer are: * does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events? * does drug tafolecimab improve the coronary microvascular dysfunction? * what medical problems do participants have when administering drug tafolecimab by injection? researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat ami. participants will: * administer drug tafolecimab by injection or not every month for 12 months * receive the standard of care of ami * complete the measurement of coronary angiography-derived microcirculation resistance index after pci * complete cardiac magnetic resonance after pci if available * visit the clinic at 1,6,12 months after the first administration for checkups and tests * report any discomfort, event or queries at any time


Eligibility criteria:
inclusion criteria: * adults 18-75 years old * ami diagnosed according to the latest guidelines, including st-segment elevation myocardial infarction (stemi) and non-st-segment elevation myocardial infarction (nstemi) * the requirement for stemi was that primary pci was scheduled within 12 hours of onset. * the requirement for nstemi was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants . * regardless of baseline ldl-c levels * participants voluntarily took part in this study and signed informed consent exclusion criteria: * previous or ongoing treatment for any pcsk9i * allergy to pcsk9i, statins, or any of the drug ingredients used during the trial * history of hemorrhagic cerebrovascular disease * history of old myocardial infarction/chronic heart failure * history of pci or coronary artery bypass grafting (cabg) or preparation for cabg * above killip level ii * prolonged cardiopulmonary resuscitation (\>20min) * definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall) * malignant arrhythmia * severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors * pregnant or lactating women * participate in other clinical trials

Keywords: acute myocardial infarction tafolecimab pcsk9 coronary microvascular dysfunction major adverse cardiovascular events monoclonal antibody against proprotein convertase subtilisin/kexin type 9 ldl-c
bergamo lymphoid cancer registry

Conditions: Hodgkin Lymphoma; Non Hodgkin Lymphoma; Myeloma

Summary: this registry has been established to gain a better understanding of the clinical and biological characteristics and outcome of patients with lymphoid cancer

lymphoid cancer including hodgkin disease, non-hodgkin lymphomas (nhl) and myeloma, represents the most common hematologic malignancy. despite the overall prognosis improved in the last 10 years, there are many open issues that need to be addressed, specifically refractoriness to standard treatment, disease recurrence and outcome with new drug in the so called "real world" setting. since the hematology and bone marrow transplant unit at "ospedale papa giovanni xiii" of bergamo has developed specific tools to collect clinical data thought fully validated electronic charts and biological specimens thanks to a regulatory compliant biobanking program, the aim of this study is to collect clinical and biological information of lymphoid cancer patients. the cohort of patients enrolled will permit to analyze the practice pattern, perform biological correlative studies of great translational potential with relevance to clinical practice.

Eligibility criteria:
inclusion criteria: * male or female patients 18 years or older * written informed consent * confirmed diagnosis of hodgkin disease, non-hodgkin lymphomas or myeloma exclusion criteria: - unconfirmed diagnosis of hodgkin disease, non-hodgkin lymphomas or myeloma
text messaging reminders for influenza vaccine in primary care

Conditions: Influenza

Summary: influenza morbidity and mortality cause a substantial financial burden to the nhs and to the uk as a whole. influenza vaccine is safe and effective but is required annually because the circulating strain of virus changes each year. in the uk in 2012, the chief medical officer (cmo) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65 with certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should be vaccinated. while primary care practices are achieving these targets for elderly patients, those set for younger patients with chronic conditions are not being met, with a third of patients being missed in the 2011/12 flu season and with no substantial improvements in uptake in the past decade. therefore strategies to increase flu vaccine uptake in these patients are required. previous trials have shown that patient reminders can increase vaccine uptake and in particular, text messaging has shown to work in some populations in the united states as a cheap, simple and effective reminder. however, whether the same is true in uk general practice is unclear. the use of text messaging in the nhs for appointment reminders is also increasing as it is cheap, quick and effective. text messaging is already used in roughly 30% of practices to remind patients about their flu vaccine but there has been no trial addressing its effectiveness. therefore, we propose a trial of a text messaging flu vaccine reminder in patients aged under 65 who have a chronic condition. we hypothesise that practices that send a text message will have increased flu vaccine uptake.


Eligibility criteria:
inclusion criteria: * practices must use text messaging software to communicate with patients; * practices must not have used a text message to remind patients aged under 65 about influenza vaccine in the 2012/13 influenza season. * practices will send the text message to eligible patients who are aged between 18 and 65, with one of the following risk conditions: chronic respiratory disease, chronic liver disease, chronic kidney disease, chronic heart disease, chronic neurological disease, immunosuppression exclusion criteria: * practices will not send the text message to pregnant women.

Keywords: text messaging
lipidomic characterization in non-metastatic breast cancer women undergoing surgery: a pilot study.

Conditions: Breast Cancer; Lipid Cell; Tumor; Nutrition Related Cancer; Body Weight

Summary: the goal of this clinical trial is to learn about breast cancer lipodome signature in patients waiting for surgery with different body mass index. the main question it aims to answer are: * to highlight a specific lipidome molecular signature for breast cancer patients overweight and obese (bmi \> 25 kg/m2) compared with patients of normal weight (bmi\<25 kg/m2). * evaluate the effect of the pool of biochemical, nutritional and anatomical-pathological data of breast cancer patients and the correlation between molecular profile and body weight.


Eligibility criteria:
patients * age \<65 years (not to have influence on functioning of desaturase enzymes that decline with older ages). * neoplastic pathology: primary invasive breast cancer or ductal in situ (dcis) newly diagnosed, in the pre-operative phase and which has not already undergone chemo- or radiotherapy. * absence of serious intestinal and hepatic pathologies, diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic affection, thyroid affections in pharmacological treatment. * absence of supplementation with omega-3 based supplements for at least 6 months. * homogeneous distribution by bmi (1:1 ratio subjects with bmi≥25 and bmi\<25, respectively). * informed consent to participate in the study. controls * age \<65 years; * not be affected by cancer; * bmi \<25kg/m2; * informed consent to participate in the study exclusion criteria: patients * age ≥65 years (would affect the functioning of desaturase enzymes that decline with older age). * invasive primary breast cancer or ductal in situ (dcis) previously treated with chemo- or radiotherapy. * metastasis at diagnosis. * presence of serious intestinal and hepatic pathologies. * presence of diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic disease, thyroid disease in pharmacological treatment. * supplementation with omega-3 based supplements for at least 6 months. * failure to sign the informed consent to participate in the study. controls * age ≥65 years; * suffering from tumor pathology; * bmi ≥25kg/m2; * refusal to sign informed consent to participate in the study.
patient-reported autoimmunity secondary to cancer immunotherapy

Conditions: Opportunistic Autoimmune Diseases

Summary: this is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with "checkpoint inhibitors" in mono or combo therapy in real life. the study is based on patients reported experience validated by physician, recruited in cancer centers in france with another data collection from a french healthcare data claims database and a biological collection.


Eligibility criteria:
inclusion criteria: * adult patient (over 18 year old) in france (dom/tom included), starting a monoclonal anti-pd-1 and/or anti-ctla-4 immunotherapy for a cancer, whatever the cancer, within the marketing authorization. * as this research will be funded by bms, for the e-cohort, we will consider only patients treated by a bms monoclonal antibody, to date: ipilimumab (yervoy©), nivolumab (opdivo©) and combo according to smpcs. * all patients (anonymous) with a reimbursed checkpoint inhibitor drug in snds will be included for the healthcare database claims study. * included patients should be able to understand and fill in questionnaires in french and should give informed consent and contact details, they should be able to read and answer emails in french. * french healthcare insurance beneficiary, whatever the scheme is. exclusion criteria: * patients in all interventional clinical trials, with exclusion from other studies specifically mentioned * patients deprived of liberty or guardianship * women of childbearing potential with a desire of becoming pregnant * major patients under tutorship. * patients with dementia or drug addiction * patients with no regular access to internet and phone

Keywords: monoclonal anti-pd-1 immunotherapy monoclonal anti-ctla-4 immunotherapy checkpoint inhibitors autoimmune manifestations patient reported outcome oncology
translating the abcs into hiv care

Conditions: HIV; Cardiovascular Risk Factor

Summary: the overall objective of this project is to develop and rigorously test implementation strategies to address the gap in scientific knowledge of lower use of evidence-based interventions commonly referred to as the abcs (aspirin, blood pressure control, cholesterol control, and smoking cessation)which contributes to the growing cvd morbidity and mortality among plh.

our project has two major aims: aim 1: to assess the impact of the implementation of an evidence-based, multilevel strategy to reduce cardiovascular vascular disease (cvd) among plh. aim 2: to assess the process of implementation of these strategies using re-aim quest. using both quantitative and qualitative methods, we evaluate the process of implementation by assessing reach, \[effectiveness addressed in aim 1\], adoption, implementation and maintenance whilst integrating qualitative evaluation for systematic translation.

Eligibility criteria:
inclusion criteria: sites: * serve a cohort of at least 100 hiv patients * have an electronic health record (ehr) * agree to collaborate on implementing feasible adaptations of intervention strategies patients: * patient of the site with a diagnosis of hiv * age 40-79 years * ≥5% risk for cvd as calculated using the ascvd risk estimator plus * willing to participate * no plans to leave the site in the next 12 months * proficient in either english or spanish * own a cell phone with texting capabilities clinicians: * physicians, physicians assistants, or nurse practitioners who provide direct hiv care to patients * work at a participating site * willing to implement the project's intervention strategies exclusion criteria: patients: * currently participating in another cvd trial * have experienced a prior cardiac or vascular event such as myocardial infarction (mi) or cerebrovascular accident (cva) * have had a cvd procedure such as installation of a stent or angioplasty * have peripheral vascular disease, intermittent claudication or peripheral arterial disease * are pregnant * lacks capacity to consent clinicians: • planning to leave the site within the next 12 months
safety and efficacy of sr-hgh (sustained-release human growth hormone, declage inj.)

Conditions: Growth Hormone Deficiency

Summary: as studies demonstrate, the administration of recombinant human gh (rhgh) in adults with gh deficiency has been known to improve metabolic impairment and quality of life. patients, however, do have to tolerate daily injections of gh (rhgh).


Eligibility criteria:
inclusion criteria: * men and women aged ≥ 20 years with diagnosed gh deficiency (caused by pituitary tumor, trauma, other pituitary disease)

Keywords: adults gh deficiency
study of the effect of imagery rehearsal therapy (irt) of nightmares

Conditions: Nightmares; Anxiety Disorders; Mood Disorders; Personality Disorders

Summary: the purpose of this study is to determine whether imagery rehearsal therapy(irt) is effective in the reduction of the number of nightmares and the nightmare distress in a population of patients with psychiatric disorders.

within the normal population 4-8% of the people suffer regularly from nightmares. clinical observations show that nightmares are a common problem for patients who suffer from all kinds of psychiatric disorders, and not just for the patients diagnosed with ptsd. often nightmares can lead to sleep disorders, which have a negative impact on emotional well-being and cognitive functioning during the day. as well as this a strong relationship between severity of nightmares and severity of psychopathology has been found. this gives a strong argument for treatment of nightmares as a symptom, separate from the psychiatric disorder. a few controlled studies of the treatment of nightmares have been published, in which behavioral therapy, relaxation techniques, exposure and systematic desensitization have been studied, all of which have shown positive results. but these techniques do not seem to reduce the number of nightmares in patients who suffer from ptsd. these last few years more controlled studies of a cognitive behavioral technique called 'imagery rehearsal therapy' (irt) have been published. with irt patients have to change the script of their nightmares into a different outcome, and rehearse this new script using cognitive imagery a few times a day. comparisons: treatment of nightmares with irt compared to a waitlist control group who do not get irt until 6 months later.

Eligibility criteria:
patients referred to ggz centraal (previously symfora groep) by their family doctor/gp for treatment of a psychiatric disorder. patients that suffer from anxiety disorders, eating disorders, mood disorders and/or personality disorders. inclusion criteria: * minimum of 3 nightmares per month * nightmares are associated with distress in daily life * subject wants to get treatment for the nightmares exclusion criteria: * imagery rehearsal therapy for nightmares in the past * psychotic disorders * acute psychiatric crisis * mentally challenged or neuropsychiatric syndrome * severe addiction problems * insufficient mastery of the dutch language

Keywords: nightmare sleep disorder sleep imagery rehearsal anxiety disorders mood disorders personality disorders
patient-reported outcome questionnaire for women with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the goal of the study is to understand the meaning of progression-free survival for women with metastatic breast cancer and to use this understanding to create and distribute a new questionnaire to assess the effect progression has on a woman's functioning and well-being.

this study is being conducted in three stages. stages i and ii are complete. participation in stage iii requires the completion of an online survey. the survey may be accessed at the following link: https://www.surveymonkey.com/s/mbc3survey compensation options for eligible participants are listed at the end of the survey. eligibility will be confirmed in follow-up call/email by study staff.

Eligibility criteria:
inclusion criteria: * female * age 18 and older * clinical diagnosis of metastatic breast cancer * u.s. resident * able to speak and read english * willing to sign and informed consent * willing to self-administer one online questionnaire that will take approximately 15 minutes to complete

Keywords: women stage iv metastatic breast cancer progressed progression
transcutaneous and epidural spinal stimulation for enabling motor function in humans with motor complete paraplegia

Conditions: Paraplegia, Spinal; Paraplegia, Complete; Paraplegia; Traumatic

Summary: the purpose of this study is to compare transcutaneous electrical spinal stimulation (tess) and epidural electrical stimulation (ees); in particular, the motor activity enabled by each method and the potential health benefits of each method.


Eligibility criteria:
inclusion criteria * spinal cord injury due to trauma located between the seventh cervical and tenth thoracic vertebrae * american spinal injury association grading scale of a or b (at least 4 each of a and b) below the level of sci * intact spinal reflexes below the level of sci * at least 1-year post-sci * at least 22 years of age * willing to use medically acceptable methods of contraception, if female and of child-bearing potential exclusion criteria * currently a prison inmate, or awaiting trial, related to criminal activity * pregnancy at the time of enrollment * dexa t score \<-3.5 at spine and femur head * history of chronic and/or treatment resistant urinary tract infection * unhealed decubitus ulcer * unhealed skeletal fracture * untreated clinical diagnosis of depression * presence of joint contractures or an ashworth spasticity score of 4 * active anti-spasticity medication regimen within 3 months prior to study enrollment * presence of transcranial magnetic stimulation-evoked potentials in leg muscles * non mri-compatible implanted medical devices. * undergoing, or planning to undergo, diathermy treatment * active participation in another interventional clinical trial * presence of conditions or disorders which require mri monitoring * for ees cohort subjects, a history of coagulopathy or other significant cardiac or medical risk factors for surgery * current use of a ventilator * clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping * mass \> 113 kg (250 pounds) * history of frequent hypotension characterized by light headedness, or loss of consciousness * history of frequent hypertension characterized by headache, or bradycardia * history of frequent, severe, autonomic dysreflexia * any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
dexamethasone vs. dexmedetomidine for espb in pain management after pediatric idiopathic scoliosis surgery

Conditions: Scoliosis Idiopathic; Scoliosis; Adolescence

Summary: effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

this study is proposed to explore the effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. after scoliosis surgery, children need good analgesia. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. the safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. an effective adjuvant, such as dexamethasone or dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect. there is considerable research where intravenous and perineural dexamethasone and dexmedetomidine use has been compared in adults. however, there is a massive lack of research regarding children. in this study, investigators compare perineural dexamethasone and dexmedetomidine. group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg dexmedetomidine added to the local anesthetic. the investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility criteria:
inclusion criteria: * children scheduled for idiopathic scoliosis surgery * age \>10 and \<18 years exclusion criteria: * age \< 10 years * age \< 18 years * infection at the site of the regional blockade * coagulation disorders * immunodeficiency * asa= or \>4 * steroid medication in regular use
a phase ii study of al-37807 to treat open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to determine whether al-37807 is safe and effective in treating patients with open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * adult patients of either sex and any race with open-angle glaucoma or ocular hypertension; logmar visual acuity not worse than 0.60; additionally clinically relevant ophthalmic or systemic conditions may be excluded exclusion criteria: * under 18