Kornimate/medical-research-clean huggingface dataset:
a study of ak-01 (ly3295668) in solid tumors

Conditions: Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Head and Neck Neoplasms; Breast Neoplasms; Solid Tumor, Adult; Small Cell Lung Carcinoma

Summary: this two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.


Eligibility criteria:
inclusion criteria: * have received at least 1 but no more than 4 prior systemic therapies * have adequate organ function * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * have estimated life expectancy greater than or equal to (≥)12 weeks * have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies * have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-c or nitrosoureas at least 6 weeks prior * female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months * male participants must use a barrier method of contraception during the study and for the following 3 months phase 1 * have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor) phase 2 * have disease measurable by response evaluation criteria in solid tumors (recist) v.1.1 * have evidence of a solid tumor that is locally advanced and/or metastatic, and in: * small cell lung cancer (sclc), must have failed platinum-containing therapy * breast cancer, be estrogen receptor positive and/or progesterone receptor positive, but human epidermal growth factor receptor 2 (her2) negative, and must have failed a hormone therapy and a cyclin-dependent kinase 4/6 (cdk4/6) inhibitor * triple negative breast cancer (tnbc) and failed standard therapy * squamous cell cancers of the head neck associated with the human papilloma virus (hpv), and have failed standard therapy * other solid tumor type that has been approved by the sponsor exclusion criteria: * have symptomatic central nervous system (cns) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the cns * have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, hiv, active hepatitis b or c, cardiac disease, history of major surgery in upper gastrointestinal (gi) tract or gi disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)
telemedicine in high-risk cardiovascular patients post-acs

Conditions: Cardiovascular Diseases; Acute Coronary Syndrome

Summary: this is a non-ctimp randomised controlled trial looking at the utilisation of telemedicine devices to provide remote, clinically necessary, diagnostic information, without the need for hospital attendance that patients will take home with them following admission to hospital with a heart attack.

following hospital admission with a heart attack, telemedicine equipment can provide patients with remote, clinically necessary diagnostic information without the need for hospital attendance, which they can take home when they discharge from the hospital. in this project, patients known to be at high risk of acs are equipped and empowered to seek urgent medical attention without visiting the hospital, if they experience symptoms, and to determine whether or not to seek emergency treatment, with an immediate remote specialist consultation, as assessed by validated technology. those enrolled in the intervention group will be offered telemedicine packages upon discharge from the hospital. those enrolled in the active arm will have their telemedicine package provided to the trial team when they conduct an ecg and seek medical attention. in contrast, in the control group, routine clinical care will be provided, as well as follow up by phone over 9 months.

Eligibility criteria:
inclusion criteria: * 1 acs patients diagnosed with elevated hs-ctni i who have undergone coronary intervention for nstemi or stemi or unstable angina. * 2 in addition, the participant should have at least one additional cardiovascular risk factor: * current or ex-tobacco use * hypertension * diabetes * hypercholesterolaemia. * male aged \> 50 years. * 3 access to a smartphone or smart device. exclusion criteria: * 1 the inability to apply/use the telemonitoring equipmentt * 2 life expectancy of 9 months or less.

Keywords: myocardial infarction acute coronary syndrome telemedicine heart attack
pilot study of the felix system in patients with essential tremor and parkinson's tremor

Conditions: Essential Tremor; Parkinson Disease

Summary: a prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the felix system in the relief of upper limb tremors in adults with essential tremor and parkinson's disease.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. willing to provide written, informed consent to participate in the study. 3. for subjects with essential tremor (et): 1. a clinical diagnosis of et. 2. for either upper limb, a tremor severity score of 2 or higher as measured by one of the tetras items and a total score of 6 or higher across all tetras tasks. 4. for subjects with parkinson's disease (pd): 1. a clinical diagnosis of pd (mds-pd criteria). 2. a tremor score of 2 or higher on mds-updrs question 3.15 (postural tremor) or 3.16 (kinetic tremor), or 3. a rest tremor score of 2 or higher on mds-updrs question 3.17 (rest tremor amplitude) in one upper extremity and a score of 2 or higher on mds-updrs question 3.18 (constancy of tremor). 5. stable dosage of any medication, if applicable, for 30 days prior to study entry. 6. familiar with operating a touch-screen smartphone and connecting to wi-fi internet at home. 7. if necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc. 8. willing to comply with study protocol requirements including: 1. remaining on a stable dosage of current medications, if applicable, during the course of the study. 2. remaining on stable caffeine consumption, if applicable, during the course of t the study. 3. no alcohol consumption on the day before a study visit. exclusion criteria: 1. prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity. 2. any current drug or alcohol abuse. 3. current unstable epileptic conditions with a seizure within 6 months of study entry. 4. pregnant or nursing subjects and those who plan pregnancy during the course of the study. 5. swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site. 6. known allergy to adhesives. 7. history of alzheimer's disease or dementia (montreal cognitive assessment (moca)≤19). 8. botulinum toxin injection for hand tremor within 4 months prior to study enrollment. 9. subject is currently participating or has participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the sponsor. 10. subject is unable to communicate with the investigator and staff. 11. any health condition that in the investigator's opinion should preclude participation in this study.
intervention to improve asthma management/prevention

Conditions: Asthma; Lung Diseases

Summary: to implement and evaluate a comprehensive asthma education and prevention program in all 54 public elementary schools in the predominantly minority birmingham, alabama school system.

background: the study was part of an initiative "interventions to improve asthma management and prevention at school". the broad agency announcement was released in june, 1994. design narrative: the study had several objectives. the first was to demonstrate that a comprehensive school-based asthma education program could be implemented, using existing resources, in a largely poor, inner city educational environment. the second objective was to provide broad information on asthma and its management to elementary school faculties in order to help reduce fear and anxiety due to lack of knowledge about asthma. the third was to provide curriculum-based information about asthma to the general student bodies of elementary schools. the fourth objective was to institute a cost effective screening program that would identify elementary school students with asthma. the fifth was to provide an education program designed to improve knowledge and prevention. the sixth was to develop an individual asthma action plan for students with asthma that would improve their management and prevention skills and to coordinate the individual asthma action plan with school personnel and activities in order to improve support for the students in following their management plans. the program was evaluated through a randomized controlled design with the schools as the unit of randomization and the students the unit of analysis. the birmingham public schools were divided into three cohorts of 18 schools each on the basis of geographic location. schools were randomly assigned within cohorts so that nine schools were experimental and nine were control. the research protocol was implemented in the first cohort in the fall of 1995, in the second cohort in the fall of 1996, and in the third cohort in the fall of 1997. students with asthma were followed for three school terms following collection of baseline data and implementation of the education program. outcomes were assessed in terms of school absences and performance, health care utilization, quality of life and asthma morbidity during school.

Eligibility criteria:
no eligibility criteria
mechanisms of ramipril reduction in the onset of type 2 diabetes

Conditions: Metabolic Syndrome

Summary: the study will be focused on determining the integrated in-vivo mechanisms responsible for ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels) glycemia in patients with impaired glucose tolerance. hypothesis - ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.

several studies have demonstrated that therapeutic agents used to reduce glucose levels and/or weight can delay the onset of type 2 diabetes. intriguingly, angiotensin converting enzyme (ace) inhibitors or angiotensin receptor blockers (arb) also result in reduction in the onset of type 2 dm. the most striking effect was found with ramipril in the hope study. the onset of new type 2 dm was reduced by 34% (p\<0.001) as compared to placebo. furthermore, the results of the dream trial demonstrate that ramipril at a dose of 15 mg can significantly reverse impaired glucose tolerance. however, the mechanisms underlying ramipril effects to delay type 2 diabetes are not known. the proposal will be focused on determining the integrated in-vivo mechanisms responsible for ramipril's effects on delaying type 2 dm and restoring normal glycemia in patients with impaired glucose tolerance. the specific aims of the project are: * to determine the effect of ramipril on insulin resistance at the level of the liver and peripheral tissues, * to determine the effect of ramipril on endothelial function, * to determine the effects of ramipril on insulin secretion, and * to determine the effects of ramipril on substrate flux, lipolysis and inflammatory cytokines.

Eligibility criteria:
inclusion: * 48 (24 male / 24 female) with impaired glucose tolerance. * impaired blood glucose values as outlined by the american diabetes association guideline. fasting plasma glucose between 100 and 126 mg/dl or 2 hour post prandial glucose between 140 and 200 mg/dl * bmi \> 25 kgm2 * age: 20-65 years * treated or untreated hypertension defined as measurement of seated bp at screening visit of systolic bp 120 to 150 and/ or diastolic bp 80 to 100. exclusion: * patients receiving agents that can increase or lower blood glucose, i.e., metformin, thiazolidinediones, sulfonylureas, glitinides, acarbose, glp-1 receptor agonists * untreated or treated while seated systolic blood pressure \>150and/or diastolic blood pressure \>100 * taking hypertensive medications of hctz or ace/arb * allergy to hctz, heparin, nitroglycerin or lidocaine * history of allergy or unacceptable side effects from ace inhibitors * pregnancy or intent to become pregnant during the study * smoking * subject unable to give voluntary informed consent physical exam exclusion criteria * clinically significant cardiac abnormalities (e.g. heart failure, arrhythmia) from history or ecg in subjects \> 40 years old * pneumonia * hepatic failure/jaundice * renal failure * acute cerebrovascular/ neurological deficit * fever greater than 38.0 c screening laboratory tests exclusion criteria according to protocol
lidocaine patch versus intravenous lidocaine in pain relief after laparoscopy

Conditions: Infertility

Summary: to evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.

postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. the inflammatory response to surgery plays a crucial rule in inducing postoperative illus. systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. the lidocaine patch evaluated in many types of pain with promising results. the study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.

Eligibility criteria:
inclusion criteria: * female undergoing elective gynecologic surgery exclusion criteria: * known allergy to lidocaine, * respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs, * inflammatory bowel disease (crohn's disease or ulcerative colitis) * hepatic, renal * chronic use of analgesics or corticosteroids
rspr-007 mannitol challenge trial

Conditions: Asthma

Summary: this is a double-blind, randomised, placebo-controlled, cross-over, phase 2 trial evaluating two doses (a low and a high) of crd007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment.

the present trial will include subjects with diagnosed asthma in a provocation model which mimics assessments of asthma control. mannitol challenge is an indirect asthma provocation test, which requires the presence of inflammatory cells, particularly mast cells, in the airways. the trial involved in total 5 subject visits and will last for a maximum of 30 days for each subject from visit 2 (randomisation) to visit 5 (follow up). visit 2,3, and 4 will be treatment visits where investigational medicinal product (imp) is administrated 3 hours before the mannitol challenge.

Eligibility criteria:
inclusion criteria: * written informed consent * age ≥18 and \<50 years * diagnosis of asthma exclusion criteria: * clinical significant comorbidities * lower respiratory tract infection \<6 weeks prior to visit 1 * others, as specified in the protocol
evaluation of the clinical benefit of the hearing aids tinnitus feature.

Conditions: Hearing Loss, Sensorineural; Tinnitus

Summary: participants with hearing loss and tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.

2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (ha) amplification-only, and 2. fit with ha amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.

Eligibility criteria:
inclusion criteria: * hearing loss * candidate for hearing aid amplification * bothersome chronic tinnitus (3 months+) exclusion criteria: * age less than 18 years * normal hearing * tinnitus presence for less than 3 months * tinnitus not bothersome enough to warrant intervention * non hearing aid candidates
factors associated with complications of cervical necrotizing fasciitis

Conditions: Cervical Necrotizing Fasciitis

Summary: cervical necrotizing fasciitis (cnf) is a rare but severe complication of pharyngeal or dental infections. the infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. recently, a single-center study demonstrated that pharyngeal source of cnf and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis. the aim of the study is to assess the incidence and factors associated with cnf complications, in particular mediastinitis. secondary outcome is to describe patient characteristics, medical and surgical management. methods: a retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in france from january 2005 to december 2016.


Eligibility criteria:
inclusion criteria: - patient admitted in icu for management of cervical necrotizing fasciitis between 2005 and 2016. exclusion criteria: * patients admitted in icu for management of cervical abscess without cervical necrotizing fasciitis * age \< 18 years

Keywords: cervical necrotizing fasciitis mediastinitis
ole of phase 2b/3 study anavex2-73-ad-004

Conditions: Alzheimer Disease

Summary: this is a phase 2b/3 open-label extension study to evaluate the effects of anavex2-73 on safety and effficacy of daily treatment.

this is a phase 2b/3 open-label extension study to evaluate the effects of anavex2-73 on safety and effficacy of daily treatment.

Eligibility criteria:
inclusion criteria: * previous completion of participation in the anavex2-73-ad-004 double-blind study. * participants may be either outpatients, or residents of an assisted-living facility. * participants must have a designated study partner, who spends at least 10hrs per week with the participant, in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant. * no suicidal ideation of type 4 or 5 in the columbia suicide severity rating scale (c-ssrs) in the past 3 months (i.e. active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) or suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior). * confirmation from the participant that, if of childbearing potential is not pregnant through urine pregnancy testing. exclusion criteria: * adverse events (aes) from the previous study (anavex2-73-ad-004) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation * any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study * significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in dsm-v or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (pcp), amphetamine or marijuana at screening. prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants (e.g. amitriptyline, amoxapine, desipramine, (norpramin) doxepin, imipramine (tofranil), nortriptyline (pamelor), protriptyline (vivactil), trimipramine (surmontil)). * any known hypersensitivity to any of the excipients contained in the study drug formulation.
study of sta-9090, administered once-weekly in patients with solid tumors

Conditions: Solid Tumors

Summary: an open-label dose escalation study of patients with solid tumors treated with sta-9090 (ganetespib)


Eligibility criteria:
inclusion criteria: * patients must be documented to be refractory or not candidates for current approved therapies. * must have an ecog status 0-2. * peripheral neuropathy \< or = 2. * must have acceptable organ and marrow function per protocol parameters. * no clinically significant ventricular arrythmias or ischemia. exclusion criteria: * must not be pregnant or breastfeeding. * chemotherapy or radiation within 3 weeks. * previous radiation to \>25% of total bone marrow. * previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation. * primary brain tumors or active brain metastases. * use of any investigational agents within 4 weeks. * treatment with chronic immunosuppressants. * uncontrolled, intercurrent illness.

Keywords: metastatic cancer solid tumor histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable for which no standard therapy exists sta-9090 ganetespib
the usefulness of coronary ct scan after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease

Conditions: Coronary Disease

Summary: the purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.


Eligibility criteria:
inclusion criteria: * patients treated withbioresobable vascular scaffold for coronary disease exclusion criteria: * history of allergy to contrast * serum creatinine \> 2.0 mg/dl * severe arrhythmia * pregnancy or breast feeding

Keywords: bioabsorbable scaffold computed tomography