Kornimate/medical-research-clean huggingface dataset:
suprachoroidal injection of triamcinolone acetonide with ivt anti-vegf in subjects with macular edema following rvo

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (sc) cls-ta administered with intravitreal (ivt) anti-vegf agent in subjects with treatment naive rvo is superior to ivt anti-vegf agent used alone.

a randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal cls-ta with intravitreal anti-vegf agent in subjects with retinal vein occlusion

Eligibility criteria:
inclusion criteria: * has a clinical diagnosis of rvo in the study eye * has a cst of ≥ 300 µm in the study eye * has an etdrs bcva score of ≥ 20 letters read and ≤ 70 letters read in the study eye * is naïve to local pharmacologic treatment for rvo in the study eye exclusion criteria: * any active ocular disease or infection in the study eye other than rvo * history of glaucoma, intraocular pressure \> 21 mmhg or ocular hypertension requiring more than one medication * any uncontrolled systemic disease that, in the opinion of the investigator, would preclude participation in the study * any evidence of neovascularization in the study eye

Keywords: rvo me microneedle microinjection triamcinolone choroid choroid injection suprachoroidal anti-vegf subretinal fluid cystoid macular edema optical coherence tomography oct central subfield thickness lucentis avastin ranibizumab bevacizumab triamcinolone acetonide
pivotal study to validate a novel system to non-invasively detect severe neutropenia

Conditions: Diffuse Large B Cell Lymphoma; Multiple Myeloma

Summary: pivotal study to validate the diagnostic performance of pointcheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.


Eligibility criteria:
inclusion criteria: * able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. * male or female aged 10 years or above. * diagnosed with either diffuse large b cell lymphoma or multiple myeloma. * scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to nccn guidelines. * able (in the investigator's opinion) and willing to comply with all study requirements. exclusion criteria: * participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator. * participants with a history of vasculitis, raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold. * participants with circulating tumour cells in previous or current lab determinations. * participants with any condition producing significant tremor (e.g., essential tremor, parkinson´s disease, dystonic tremor). * unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmhg). * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
individual patient expanded access ind for selexipag (uptravi) in participants with non-healing wound, buerger's disease

Conditions: Non-healing Wound; Thromboangiitis Obliterans

Summary: the purpose of this expanded access program (eap) is to provide selexipag (uptravi) for the treatment of participant with non-healing wound, buerger's disease.


Eligibility criteria:
non-invasive ventilation in pulmonary edema

Conditions: Pulmonary Edema; Myocardial Infarction

Summary: this randomized controlled trial is primarily aimed at assessing the rate of acute myocardial infarction with the two noninvasive ventilatory techniques, non-invasive intermittent positive pressure ventilation and non-invasive continuous positive airway pressure.

objective: to determine whether the application of non-invasive intermittent positive pressure ventilation (n-ippv) increases the incidence of acute myocardial infarction (ami) in patients with acute respiratory failure (arf) secondary to acute cardiogenic pulmonary edema (acpe), as opposed to non-invasive continuous positive airway pressure (n-cpap). background both n-cpap or n-ippv are used to treat acpe complicated by arf. two previous studies, however, report an increased rate of ami associated with the use of n-ippv. methods: fifty-two patients with severe arf consequent to acpe were randomized to receive n-cpap (n=27) or n-ippv (n=25), both associated with standard medical therapy. cardiac markers, electrocardiogram and clinical-physiological parameters were monitored at study entry, after 30 and 60 minutes, and every 6 hours for the first two days.

Eligibility criteria:
inclusion criteria: * rapid onset of the symptoms * severe dyspnoea at rest * respiratory rate \> 30 breaths per minute * use of accessory respiratory muscles * oxygen saturation (spo2) inferior to 90% with an inspiratory oxygen fraction of 60% via a venturi mask * radiological findings of acpe exclusion criteria: * acute ischemic heart disease (myocardial infarction, chest pain, st elevation) * hemodynamic instability (i.e. systolic blood pressure \< 90 with dopamine or dobutamine infusion ≥ 5 mcgr/kg/min) or life-threatening arrhythmias * need for immediate endotracheal intubation (respiratory arrest, bradypnea or gasping) * inability to protect the airways * impaired sensorium (i.e. unconsciousness or agitation) * inability to clear secretions * respiratory tract infection * recent oesophageal/gastric surgery * gastrointestinal bleeding * facial deformities * hematological malignancy or cancer with an eastern cooperative oncology group performance status ≥ 2 * chronic respiratory failure necessitating long-term oxygen therapy * diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease, pneumothorax in the previous 3 months * denial or refusal of intubation * claustrophobia * inclusion in other research protocols
health behavior change in chronic disease management

Conditions: Multiple Sclerosis

Summary: the purpose of this pilot trial is to provide preliminary evidence of the effectiveness of a brief behavioral intervention using telemedicine home monitoring to help individuals with multiple sclerosis adhere to medications that slow disease progression.

there is increasing recognition that coordinated approaches to disease management improve medication adherence. intervention in chronic illness may be viewed as a multidisciplinary and collaborative process based upon behavioral principles, including the idea that illness management skills are learned and behavior is self-directed, motivation and self-efficacy can affect self care, monitoring and responding to changes in physical and mental health improves adaptation to illness, and the health care system can support or hinder self care. preliminary findings suggest that telemedicine home monitoring providing cues to medication administration, brief evaluation of potential barriers (e.g., fatigue, cognition, side effects), identification of areas for future education (e.g., additional injection training), and an opportunity for feedback to providers (e.g., side effects) are well tolerated and may improve self monitoring of chronic medical conditions. the proposed study is a six-month, two group parallel-design, controlled trial to evaluate feasibility and obtain effect size estimates for a behavioral intervention to improve adherence to ms disease modifying therapy (dmt) using telemedicine home monitoring. monitoring will include brief weekly text-based prompting to complete a series of approximately 10-15 questions regarding factors that are expected to affect adherence to dmt. areas of assessment will include the development of side effects (e.g., flu-like symptoms), disease specific symptoms (e.g., fatigue), adherence expectation, and dmt self-efficacy. ms clinic staff will examine responses to weekly home monitoring assessment. they will provide telephone follow-up for medical advice, support, specific educational materials, and referral for services if necessary. potential services will also be informed by research project 1, and will follow the general principle that they will be selected from a standardized list (e.g., additional injection training, energy management strategies for fatigue), but tailored to individual patient need based upon information obtained by home monitoring. primary outcome measures to assess feasibility will be the percentage of eligible participants who complete the study protocol, and comparisons between home monitoring recipients and controls regarding the overall benefits of participation. outcomes will be assessed via monthly telephone calls.

Eligibility criteria:
inclusion criteria: - must have multiple sclerosis and be on a disease modifying therapy exclusion criteria: - inability to participate in self-care

Keywords: adherence medication multiple sclerosis
topical penlac nail lacquer for onychomycosis in children

Conditions: Onychomycosis

Summary: five months of therapy is sufficient to treat onychomycosis in children. topical therapy of onychomycosis in children with penlac nail lacquer has comparable efficacy and a superior cost and safety profile compared to systemic therapy.

therapeutic trials for the treatment of onychomycosis have been conducted in the adult population, but there is limited data available in the pediatric population.

Eligibility criteria:
inclusion criteria: * children between the ages of two and sixteen years * clinical diagnosis of toenail onychomycosis involving at least 20% of one nail plate * positive dtm reading or fungal culture for onychomycosis-either dermatophytes or non-dermatophyte mold * consent to participate in the study * women of child-bearing potential must have a negative urine pregnancy test at the baseline visit and be willing to practice effective contraception for the duration of the study. exclusion criteria: * children with allergy to penlac or one of its ingredients * structural deformity of target nail plate * presence of active psoriasis or severe foot eczema * presence of immunodeficiency disorder * concurrent immune suppressive therapy or immune suppressive therapy within the last 3 months * previous systemic antifungal therapy within the last 6 months * previous topical antifungal therapy within the last 14 days * female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study, or who become pregnant
ercp in super-aged patients considering difficult cannulation: challenges and adverse events

Conditions: Post-ERCP Acute Pancreatitis; Cholangitis

Summary: today 11 percent of china's population is over the age of 65, and according to united nations, it will take china just 20 years for the proportion of the elderly population to double to 25%. as life expectancy has increased, application of endoscopic retrograde cholangiopancreatography (ercp) in super-aged (≥80 years of age) is no longer limited with increasing prevalence of choledocholithiasis, and malignancy in advancing age. this increasing may come with more difficulty in cannulation or more complications in senior patients. regarding difficult cannulation, little is known about grading difficulty in the elderly and its relation with adverse events. therefore, it is time to evaluate the risk factors of adverse events in super-aged patients with difficult bile duct cannulation.

aim: to evaluate the incidence, causes, and management of difficult biliary cannulation during ercp in elderly patients and its role as a risk factor for adverse events. methods: a total of 614 patients, with a mean age of 65.3±16.7 years, underwent ercp during the study period, were prospectively managed and divided into two groups based on their age. there were 146 patients aged 80 years or older in group a with the mean age of 84±3.4 years. the primary outcome measurements were the difficulty grade of papilla cannulation, clinical outcomes, and ercp-related complications in the two groups. the adverse events were analyzed by logistic regression about patient age, co-morbidities, indications, and difficult cannulation grading.

Eligibility criteria:
inclusion criteria: * patients who underwent ercp between july 2016 and january 2018. exclusion criteria: * we excluded the patients who underwent ercp for the objectives of follow up, stent removing or taking a biopsy.

Keywords: ercp elderly difficult cannulation
answerability and minimal clinical significance of the pain questionnaires

Conditions: Chronic Low-back Pain

Summary: to investigate the reliability and sensitivity of the turkish versions of the fear-avoidance beliefs questionnaire, tampa scale for kinesiophobia, and the pain catastrophizing scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation.

nonspecific chronic low back pain is a common condition that can have a significant impact on patient's daily lives and beliefs. patients often believe that there is a strong relationship between structural changes in the lower back, pain, and activities of daily living. patients with nonspecific low back pain may have lower expectations for recovery because they tend to believe that their condition is chronic and unlikely to improve significantly. patients' beliefs and perceptions of their condition can influence the clinical management of low back pain. tampa scale for kinesiophobia (tsk), fear-avoidance beliefs questionnaire (fabq), and the pain catastrophizing scale (pcs) are commonly used in patients with non-specific chronic low back pain. the common feature of these scales is that they evaluate issues such as pain perception, pain-related beliefs, and pain coping strategies. the use of these scales can provide important information to better respond to individuals' needs in pain management and rehabilitation processes. however, the minimal clinical relevance and answerability of the surveys were not explicitly discussed in the search results. further research is needed to investigate the clinical consequences of fear-avoidance beliefs and their potential impact on treatment outcomes for patients with chronic low back pain.

Eligibility criteria:
inclusion criteria: * getting diagnosed with chronic non-specific low back pain * being able to read and speak turkish * being between the ages of 18 and 65 * agreeing to participate in the research and signing the voluntary consent form. exclusion criteria: * presence of systemic disease * cognitive impairment status (mini-mental state examination \<24), * recent (\<12 weeks) history of myocardial infarction, cerebrovascular accident * presence of radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the lumbar region * having previously received any exercise therapy and/or training in pain neuroscience. * refusal of treatment or failure to comply with treatment

Keywords: chronic low back pain pain management rehabilitation minimal clinical significance
changes in cerebral blood flow (cbf) in prone and sitting position before and after gsp-block and before and after epidural blood-patch: a substudy of nct03652714

Conditions: Postdural Puncture Headache; Sphenopalatine Ganglion Block

Summary: the purpose of this optional sub-study to gspb-2018 (nct03652714) is to evaluate the changes in cerebral blood flow (cbf) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.


Eligibility criteria:
study population: subjects who have consented to participate in gspb-2018 will be approached for participation in this sub-study. subjects who have consented to participate in gspb-2018 are not required to participate in this sub-study. inclusion criteria: * age \> 18 years * patients with postdural puncture headache defined as moderate to severe postural headache (vas \>= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture. * lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol * patients who have given their written informed consent for participation in the study and substudy after fully understanding the protocol content and limitations. exclusion criteria: * patients who cannot cooperate to the study * patients who does not understand or speak danish * allergy to the drugs used in the study * has taken opioids within 12 hours prior to intervention * no possible transcranial window on transcranial doppler. if not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient.
study on treatment of pegylated interferon alfa 2a(pegasys®) in the korean chronic hepatitis b(chb) adults

Conditions: Chronic Hepatitis B

Summary: patients will receive peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks


Eligibility criteria:
inclusion criteria: * history of hbsag positive for more than 6 months * hbeag-positive or hbeag-negative within 8 weeks * serum ast or alt ≥ 80 iu/l * hbe-ag positive patients: serum hbv dna ≥ 1.0 x 10\^5 copies/ml (or 20,000 iu/ml) * hbeag-negative patients: serum hbv dna ≥ 1.0 x 10\^4 copies/ml(or 2,000 iu/ml) exclusion criteria: * history of antiviral therapy for chronic hepatitis b within 6 months of study enrollment * prior treatment of interferon * presence of viral coinfections (hepatitis c, hepatitis delta, or human immunodeficiency virus) * other chronic liver disease or decompensated liver disease * platelet\<90,000/mm3 or absolute neutrophil count \< 1,500 mm3 * pregnant or lactating woman * history of organ transplantation * treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry
custom molded foot orthoses effect on foot kinematics and lower extremity electromyography during walking and running.

Conditions: Lower Extremity Pain of a Mechanical Origin

Summary: the purpose of this study was to determine the effectiveness of two types of in-shoe custom made orthotics in altering the motion of the foot and muscle activity of select muscles of the lower leg in individuals experiencing lower extremity symptoms of a non traumatic origin. we hypothesized that orthotics would decrease the extent of motion of the during walking and running when compared to a barefoot condition. the investigators further hypothesized that orthotics would decrease the amount of muscle activity seen during walking and running when compared to barefoot walking.


Eligibility criteria:
inclusion criteria: * subjects must have complaints of lower extremity or foot pain of a non-traumatic, mechanical origin. * subjects must have at least 60 degrees of frontal plane forefoot on rearfoot passive range of motion (as determined by a modified gib test in the symptomatic lower extremity. * subjects must be able to walk independently on a treadmill at a speed of 4.8 kmh. * subjects must have been referred by a health care professional for an orthosis fitting. exclusion criteria: * subjects having less than 60 degrees of forefoot on rearfoot frontal plane passive range of motion. * subjects having a history of a fracture of the foot or ankle. * subjects having any previous illness, surgery or other characteristic (e.g., cardiovascular, musculoskeletal or neuromuscular problems) that would affect their lower extremity function or ability to walk independently. * subjects having knee, lower leg or foot pain of a non-mechanical nature.

Keywords: orthoses foot kinematics emg biomechanics
intracoronary adenosine administration to prevent periprocedural myonecrosis in elective coronary angioplasty

Conditions: Coronary Angioplasty

Summary: aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.

this study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo. this is a double-blind randomized trial single-center study. the enrollment will last 10 months.

Eligibility criteria:
inclusion criteria: * patients undergoing elective coronary angioplasty exclusion criteria: marked bradycardia (\< 40 bpm) * previous allergy to adenosine * inability to sign the informed consent * asthma * elevated cardiac enzymes (troponin i o ck-mb)

Keywords: adenosine randomized trial periprocedural myocardial necrosis elective coronary angioplasty
adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin

Conditions: Esophageal Squamous Cell Carcinoma; Positive Circumferential Resection Margin

Summary: the purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.

although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. the existing data shows that the 5-yeal survival rate of stage t2-3n0m0(uicc 7th edition) of thoracic esophageal squamous cell carcinoma(tescc) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. in rectal cancer, the involvement of the circumferential resection margin (crm) is one of the key factors for local recurrence and poor prognosis,based on reports in which crm with \< 1mm was found to be prognostically significant, whereas the clinical and prognostic significance of the crm involvement in ec has been investigated only in a few series showing conflicting results, as some studies suggest a significant influence of crm. there is lack of clear evidence for prophylactic radiation therapy in positive circumferential resection margin(crm) patients of tescc now. in view of this, the randomized controlled trial will determine the clinical efficacy and toxicity of adjuvant radiotherapy in positive circumferential resection margin(crm) for thoracic esophageal squamous cell carcinoma.

Eligibility criteria:
inclusion criteria: patients with esophageal cancer who received r0 operations in fudan university shanghai cancer center and postoperative pathology: squamous cell cancer,positive circumferential resection margin(crm)+ * kps≥70 before radiotherapy; * did not receive neoadjuvant or adjuvant treatment; * no clear recurrent or metastatic lesions before radiotherapy; * intensity modulated radiation therapy(imrt) is accepted; * regular follow-up. exclusion criteria: * exploratory thoracotomy or palliative surgery; * no clear recurrent or metastatic sites; * recurrence or metastasis is not certain; * death of no definite cause. * irregular follow-up;