Kornimate/medical-research-clean huggingface dataset:
study of pegph20 with initial dexamethasone premedication given intravenously to patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

a study of pegylated recombinant human hyaluronidase (pegph20) administered on a twice weekly schedule for 28 days followed by a weekly dosing schedule in patients with advanced solid tumors who have either failed to respond to standard therapy or for whom no standard therapy exists.

Eligibility criteria:
inclusion criteria: * written, signed, irb-approved informed consent form. * pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor. * patients must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy. * one or more tumors measurable by recist criteria. * karnofsky performance status ≥ 70%. * ejection fraction ≥ 50%, determined by echocardiogram. * life expectancy at least 3 months. * age ≥ 18 years. * acceptable organ function; normal hepatic, renal and hematopoietic function. * negative serum or urine pregnancy test result in women of childbearing potential. exclusion criteria: * known brain metastasis. * new york heart association class iii or iv cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy. * active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. * patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy. * heparin therapy. * known infection with hiv, hepatitis b, or hepatitis c. * known allergy to hyaluronidase. * women currently breast feeding.

Keywords: pegph20 pegylated recombinant human hyaluronidase metastatic or locally advanced solid tumors
neuromarker s-100b as diagnostic tool

Conditions: Spinal Injury

Summary: the hypothesis of this study is to find evidence if there is an influence of spine surgery on the serum levels of two proteins secreted from neuronal cells.

the question, if there is an effect on the cerebrospinal system during spine surgery, which can be traced by monitoring serum levels of neuromarkers is not yet answered. this study has its background from other studies on patients with traumatic brain injury (tbi), in whom elevated serum levels of the two neuromarkers s-100b and nse are associated with injury severity, neuronal damage, brain, tissue damage, and outcome. patients undergoing spine surgery with or without pre-existing traumatic neurologic symptoms are planned to be the study cohort. pre- and postoperatively the serum levels of s-100b and nse are obtained and are statistically compared with patients undergoing other types of bone-related surgery.

Eligibility criteria:
inclusion criteria: * spine fracture exclusion criteria: * additional traumatic brain injury * fractures of the long bones * polytrauma * severely injured patients

Keywords: s-100b nse
vortioxetine for treatment of depressive mood and alcohol use

Conditions: Depressive Disorder, Major; Alcoholism

Summary: this is a randomized, double-blinded, placebo-controlled, multicenter study. a total of 128 subjects will be randomly assigned to a test group or placebo group in a 1:1 ratio. subjects will receive vortioxetine (or placebo) and acamprosate for 6 weeks according to the treatment group. four visits will be made (weeks 0, 2, 4, 8), and on visit 2-4 (weeks 2, 4, 8) compliance, depression symptoms, and alcohol craving will be assessed.

investigational product * baseline: vortioxetine 10mg (or placebo) qd + acamprosate\* * first 2 weeks: vortioxetine 5-10mg (or placebo) qd+ acamprosate\* * last 6 weeks: vortioxetine 5-20mg (or placebo) qd + acamprosate\* * acamprosate 666 mg bid for bodyweight \< 60 kg; acamprosate 666 mg tid for bodyweight ≥ 60 kg

Eligibility criteria:
inclusion criteria: * subjects who are able to understand the study and comply with all study procedures and willing to provide written informed consent prior to screening * male and female subjects aged 19 to 65 years old * diagnosed to have major depressive disorder and alcohol use disorder based on dsm(diagnostic and statistical manual of mental disorders)-5 by two separate psychiatrists. * madrs(montgomery åsberg depression rating scale) ≥ 26 at baseline exclusion criteria: * subjects considered not safe to participate in the study (e.g. who has suicidal thoughts) * pregnant or breastfeeding * subjects with serious or unstable disease * clinical or laboratory signs of on-going hypothyroidism * history of organic mental disorder, schizophrenia spectrum disorder, bipolar disorder, or substance abuse within 12 months (except for alcohol or nicotine abuse) * administration of antidepressant (maois, ssris, snris, tcas) including vortioxetine and anti-craving medications (acamprosate, naltrexone) within 2 weeks from screening * administration of antipsychotic, anti-manic drugs, dopamine antagonists, anxiolytics (zolpidem more than 10mg, benzodiazepine lorazepam equivalent dosage more than 2mg or used as alcohol withdrawal treatment) within 2 weeks from screening * administration of anti-depressant, fluoxetine, within 5 weeks from screening * subjects in need of an alcohol detoxification treatment * subjects in need of a hospitalization care
joint outcome study

Conditions: Hemophilia A

Summary: this study examines the progression of joint disease in children with hemophilia assigned to either standard treatment or enhanced therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with hemophilia a * factor level less than 2% exclusion criteria: * more than 2 bleeds into the same joint
lavage of the uterine cavity for the diagnosis of ovarian and tubal carcinoma and their premalignant changes.

Conditions: Ovarian Epithelial Cancer

Summary: epithelial ovarian cancer (eoc) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in europe and the us of 752,600 in 2007 and 59,828 deaths annually. state-of-the-art diagnostic tests for eoc include transvaginal ultrasonography and serum cancer antigen (ca-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting eoc early enough to improve clinical outcomes. definitive diagnosis of eoc still relies on histological or cytological confirmation. these findings underline the importance for an effective test for early detection of eoc. in the current project we will obtain a lavage of the uterine cavity. it will be investigated whether cells from eocs or genetic material from those cells can be detected in the lavage fluid. aim of this study: there is a clear clinical need for a diagnosis test to detect eoc at an earlier stage.

epithelial ovarian cancer is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in europe and the us of 752,600 in 2007 and 59,828 deaths annually. treatment and survival of the patients depend primarily on the stage of the disease. of all eoc patients only 25% are diagnosed at an early stage while the tumour is confined to the pelvis. in these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy. unfortunately, almost 75% of women affected have advanced stage disease with metastatic spread throughout the abdominal cavity or to retroperitoneal lymph nodes at the time of diagnosis; five-year survival rates drop to 10%-30% for advanced disease, despite maximum surgical effort and combination chemotherapy. state-of-the-art diagnostic tests for eoc include transvaginal ultrasonography and serum cancer antigen (ca-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting eoc early enough to improve clinical outcomes. definitive diagnosis of eoc still relies on histological or cytological confirmation. these findings underline the importance for an effective test for early detection of eoc. in the current project we will obtain a lavage of the uterine cavity. it will be investigated whether cells from eocs or genetic material from those cells can be detected in the lavage fluid. aim of this study: there is a clear clinical need for a diagnosis test to detect eoc at an earlier stage.

Eligibility criteria:
inclusion criteria: * suspected ovarian cancer * verified ovarian cancer exclusion criteria: * pregnant * incapacitated persons

Keywords: neoplasms glandular and epithelial ovarian neoplasms ovarian cancer
legdeb2 global registry for use of legflow in peripheral arteries

Conditions: Peripheral Arterial Disease; Superficial Femoral Artery Stenosis; Iliac Artery Stenosis; Arterial Occlusive Diseases; Popliteal Artery Stenosis; Critical Limb Ischemia

Summary: legdeb2 is a global registry for the treatment of superficial femoral and/or popliteal or below-the-knee or iliac artery lesions using the legflow drug-eluting balloon

legdeb2 is a global registry aimed to prospectively collect and assess global safety and efficacy data on the legflow drug eluting balloon (deb) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal and/or below-the-knee and/or iliac arteries in "real world" patient population.

Eligibility criteria:
inclusion criteria: age ≥ 18 years or minimum age as required by local regulations. * subject with documented diagnosis of lower extremities arterial disease (lead). * angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days. * positive diagnostic indication for pta with a deb in accordance with the instructions for use (ifu) of the legflow deb. * adequate distal run-off to the ankle (at least one native calf vessel \[posterior tibial, anterior tibial, or peroneal arteries\] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment. * adequate inflow (≤ 50% diameter stenosis) either pre-existing or successfully re-established prior to target lesion treatment. * female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before enrollment. * signed and dated patient informed consent (pic) form. * ability and willingness to comply with the clinical investigation plan (cip). * life expectancy, in the investigator's opinion, of at least 12 months exclusion criteria: * high probability of non-adherence to cip follow-up requirements. * failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). * lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm. * acute or sub-acute thrombus in the target vessel. * target lesion also requires treatment with alternative drug eluting technology-based therapy or other antiproliferative therapy (cryoplasty, brachytherapy). * plan for surgical or interventional procedure within 30 days after the study procedure (except for bilateral target limb treatment). * known allergies or sensitivities to heparin, aspirin, other anti- coagulant/anti-platelet therapies, and/or paclitaxel.

Keywords: stenosis drug coated balloon paclitaxel artery disease
effectiveness of dry needling as a treatment of shoulder myofascial pain syndrome in spinal cord injury patients

Conditions: Spinal Cord Injuries; Myofascial Pain Syndrome; Shoulder Pain; Puncture

Summary: shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices. this study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.


Eligibility criteria:
inclusion criteria: * at least one year after spinal cord injury (chronic patients). * spinal cord injury under c5-c6 spinal level with american spinal injury association (asia) classification. * patients with shoulder pain and at least one active trigger point in infraspinatus muscle. exclusion criteria: * be apprehensive to the needles (belonephobia). * immunosuppression. * drug instability. * other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.

Keywords: spinal cord injury shoulder pain myofascial pain syndrome dry needling
resistance training and milk supplementation

Conditions: Muscular Hypertrophy

Summary: post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains. the investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men.

the aim of this investigation was to compare the effects of high protein milk supplementation (daily and after training sessions) during 6 weeks of resistance training on skeletal muscle regulatory markers, hormonal responses and body composition in resistance-trained men. specific aims of the study are to: to investigate the extent to which high protein milk supplementation will improve anabolic factors, lean body mass, fat mass and decrease catabolic markers after 6 weeks of resistance training in resistance-trained men.

Eligibility criteria:
inclusion criteria: * aged 18-35 years of age * healthy males * experienced at resistance training (at least 1 year of prior structured resistance training 3 x week). exclusion criteria: * smoking * chronic alcohol consumption * having any medical issues and diseases * lactose intolerance * the consumption of any dietary supplements (including vitamins or protein supplements) or medications for 6 months prior to participation

Keywords: hypertrophy body composition milk resistance training
psma-pet/mri unfavorable-risk target volume pilot study

Conditions: Prostate Cancer

Summary: the goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (psma-pet) and multi-parametric magnetic resonance imagining (mpmri) with pet-mr technology to define radiotherapy targets, while meeting all the current planning criteria.

psma-pet is highly sensitive and specific for detecting prostate cancer. psma-pet and mpmri can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpmri and/or psma-pet receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.

Eligibility criteria:
inclusion criteria: * written informed consent obtained to participate in the study and hipaa authorization for release of personal health information. * histologically confirmed prostate adenocarcinoma * unfavorable intermediate or high-risk, based on the national comprehensive cancer network (nccn) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol. * subject has adequate performance status as defined by ecog performance status of 0-2. * subject is willing and able to comply with the protocol as determined by the treating investigator. * subject speaks english (quality of life instrument is validated in english). exclusion criteria: * contraindications for mri * other prior or concomitant malignancies with the exception of: * non-melanoma skin cancer * other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence. * inflammatory bowel disease * absolute contraindications to brachytherapy per american brachytherapy society: unacceptable operative risk, absence of rectum, large turp defects
nonrandomized evaluation of a multidimensional behavioral intervention

Conditions: Subjective Cognitive Concerns (SCC)

Summary: this intervention is designed to promote enhanced use of compensation strategies including calendar and task list use, and organization systems, as well as increased engagement with brain health activities including physical exercise, cognitive activities, and stress reduction.

the purpose of this study is to test the feasibility and efficacy of a 10-week multi-dimensional intervention for older adults with subjective cognitive concerns (scc). the goal of this intervention is to enhance compensation skills related to everyday executive and everyday memory functions through training in the systematic use of a calendar system, goal setting and task list system, and organizational strategies within the context of the individual's daily life. this multidimensional intervention program also targets engagement in healthy lifestyle activities (physical exercise, intellectual stimulation, positive emotional functioning) to further promote brain health and functional resilience. importantly, both treatment components work synergistically as the use of compensation strategies assists in building healthy activities into daily routines (e.g., scheduling exercise into one's calendar and putting it on a task list).

Eligibility criteria:
inclusion criteria: * a diagnosis of subjective cognitive complaints (scc) * age 65+ * english speaking * available informant to complete surveys * ambulatory exclusion criteria: * known neurological condition * severe psychiatric illness (e.g., current depression)
genetic variation and immune responses after injury

Conditions: Sepsis; Pneumonia; Trauma; Burn; Injury

Summary: our overall hypothesis is that genetic variations in innate immunity genes predispose patients to varying responses after injury by altering the systemic and local inflammatory responses. in addition, we hypothesize that these genetic differences are associated with different clinical outcomes

the goal of this research proposal is to identify relationships that exist between specific genetic markers, immune responses to injury and infection (sepsis), and post injury clinical outcomes. specifically, we will investigate the clinical impact of mutations involved in the innate immune response, which likely influence host response. to accomplish this goal we will collect and analyze data from patients with acute thermal injury, the most quantitative inflammatory stimulus experienced by humans. in addition, we propose to further characterize the immunologic response parameters to injury and infection, and their role in complicated sepsis. in this way, we will identify parameters associated with unfavorable clinical outcomes, and determine how these parameters differ among individuals with different genotypes. we propose to 1) evaluate associations between candidate snps within the nod2/rip2 signaling pathway and clinical outcome following burn injury, 2) evaluate the functional effects of alternate alleles at candidate snps; finally 3), we will use genetically engineered animal models to determine whether mutations in the nod2 or rip2 genes alter myocardial signal transduction mechanisms shown to play a role in myocardial inflammation/dysfunction after burn trauma. these approaches should allow us to evaluate more extensively clinically relevant interactions between specific genetic polymorphisms, the cellular expression of immune mediators, and burn-induced immune dysfunction. the proposed research should uncover genetic and/or acute immune-inflammatory parameters that identify patients who are at "high risk" and could as a result make possible the targeted design of pharmacologic intervention strategies that will inhibit the toxic effects of lps and other bacterial pathogen components without paralyzing the host immunity of patients

Eligibility criteria:
inclusion criteria: all burn,trauma, or acute surgery victims admitted to the surgical, burn or trauma units within 24 hours of injury will be considered for inclusion. exclusion criteria:severe immunosuppression, dnr, severe trauma, terminal diseases. -

Keywords: polymorphisms innate immune response immunomonitoring immuno paralysis
study of milnacipran added to pregabalin for treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: to evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia defined by 1990 american college of rheumatology (acr) criteria * tolerate at least 300 mg/day of pregabalin * have an incomplete response to pregabalin treatment exclusion criteria: * suicidal risk * substance abuse * pulmonary dysfunction * renal impairment * active cardiac disease * liver disease * narrow angle glaucoma * autoimmune disease * cancer * inflammatory bowel disease * unstable endocrine disease * prostatic enlargement

Keywords: fibromyalgia milnacipran pregabalin treatment forest research institute
evaluation of obstructive sleep apnea with long range 3d endoscopic fourier domain optical coherence tomography (fdoct)

Conditions: Sleep Apnea

Summary: the purpose of this study is to determine whether the optical coherence tomography (oct) can image the structure and geometry of hollow organs of the upper airway in sleep disorder. the research can identify the obstruction sites that help the select the appropriate treatment for potential surgical candidates.

the national commission on sleep disorders research estimated that 18 million americans suffer from obstructive sleep apnea (osa) the majority of them are undiagnosed and untreated at this time. the current diagnostic gold standard for osa is in-laboratory, a full night polysomnography (psg). however, psg is unable to provide information on upper airway structure and anatomy, and cannot identify the obstruction sites. osa can lead to severe health complications including hypertension, heart failure, memory impairment, motor vehicle and work accidents, decreased work productivity, and increased risk of death.

Eligibility criteria:
inclusion criteria: 1. male or female age 18-65 years has no history of obstructive sleep apnea 2. male or female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea 3. male or female age 18-65 years has been diagnose severe obstructive sleep apnea exclusion criteria: 1. pregnant women. 2. breastfeeding women. 3. unable to understand or give consent to the study. 4. currently taking drugs that are sensitive to light. 5. currently taking routine anti-convulsion, sedative or antihistamine drugs. 6. currently taking immuno-suppressive drug therapy.

Keywords: apnea