Kornimate/medical-research-clean huggingface dataset:
clear vision study

Conditions: Posterior Vitreous Detachment; Vitreous Floaters

Summary: vitreous floaters are tiny, cloudy, clumps of cells that appear in the otherwise clear fluid (vitreous) that fills the back 3/4 of the eye. floaters are commonly caused by eye conditions such as posterior vitreous detachment (pvd), vitreous syneresis and asteroid hyalosis. while these symptoms are considered physiological in nature, they can be of considerable inconvenience to many patients which affect essential activities. the investigators wish to assess the safety and efficacy of floater treatment in patients with highly symptomatic floaters using an fda approved nanosecond infrared yttrium aluminum garnet (yag) lasers.


Eligibility criteria:
inclusion criteria: * have been diagnosed with symptomatic floaters lasting more than 2 months * willing to proceed with intervention * be able to provide informed consent * diagnosed with posterior vitreous detachment * accept a 1% risk of complications exclusion criteria: * less than 19 years of age * is a high myope (greater than -6 diopters) * has monocular vision * diagnosed with asteroid hyalosis * diagnosed with acute on-set of floaters (less than two months and may clear spontaneously) * has corneal or lenticular opacities or any media opacity which may interfere with treatment * has any concomitant ocular disease or pathology * has elevated intraocular pressure (iop) or on iop lowering medication * has floaters that are deemed to require more than five treatment sessions, where surgical intervention is the best treatment course * has floaters inaccessible with current lasers and lenses * has floaters located less than 2mm from the crystalline lens or the retina * found to have retinal tears or retinal detachment on initial examination or has had a history of retinal detachment repair within the last two years * has psychiatric problems that may recur or worsen * incapacity to provide informed consent
efficacy study to evaluate buprenorphine hcl buccal film in opioid-experienced subjects

Conditions: Low Back Pain

Summary: the purpose of the study is to determine if buprenorphine hydrochloride (hcl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (clbp), who require continuous around-the-clock (atc) pain relief for an extended period of time.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe low back pain for ≥6 months * treating clbp with a stable daily maintenance dose of atc opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (mse) per day for ≥4 weeks. (additional as needed \[prn\] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg mse opioid analgesic, but must be included in the total daily mse calculation and in combination with the stable daily maintenance dose not to exceed 160 mg mse per day) * stable health, as determine by principal investigator * females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year * willing and able to comply with all protocol required visits and assessments exclusion criteria: * current cancer related pain or received chemotherapy within 6 months of screening * subjects with history of other chronic painful conditions * reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis * allergy or contraindications of any opioid or acetaminophen * surgical procedure for relief of pain within 6 months * hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia * qt interval corrected using fridericia's formula (qtcf) of ≥450 milliseconds on the 12-lead electrocardiogram (ecg) * history of long qt syndrome or a family member with this condition * moderate to severe hepatic impairment * moderate to severe renal impairment * current or past history of alcohol abuse * positive urine toxicology screen for drug of abuse * history or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values

Keywords: clbp chronic low back pain chronic pain back pain
a phase i/ii study to evaluate the safety, pharmacokinetics and efficacy of prj1-3024 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor; Advanced Solid Malignancies

Summary: this is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (mtd) or maximum administration dose (mad) and recommended phase 2 doses (rp2d) of prj1-3024 in subjects with relapsed/refractory solid tumors. the study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of rp2d.

using dose escalation, the study will evaluate the safety, tolerability, pk, and pharmacodynamics of prj1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors. participants with advanced solid tumor will receive prj1-3024 daily as an oral therapy and test the impact of of prj1-3024 on tumors. this study will find the safe and tolerable recommended dose in subjects with advanced solid tumors in a open-label, 3+3 dose escalation study and use the rp2d to assess the preliminary efficacy of prj1-3024 in a long-term extension study.

Eligibility criteria:
- key inclusion criteria: * histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable. * male or non-pregnant, non-lactating female subjects age ≥18 years. * ecog performance status 0\~1. * has at least 1 measurable lesion as defined by recist 1.1 criteria . * life expectancy of \>3 months, in the opinion of the investigator. * able to take oral medications and willing to record daily adherence to investigational product. * adequate hematologic parameters unless clearly due to the disease under study. * adequate renal and hepatic function * able to understand and willing to sign a written informed consent form. key exclusion criteria: * history of another malignancy * known symptomatic brain metastases requiring \>10 mg/day of prednisolone. * significant cardiovascular disease. * known active hbv, hcv, aids-related illness. * has received a live vaccine within 30 days. * history of active autoimmune disorders, or ongoing immunosuppressive therapy or ongoing . * continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to \< grade 2. * receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome p450 3a (cyp3a) . * prior treatment with hematopoietic progenitor kinase 1 (hpk1) inhibitors.

Keywords: maximum tolerated dose recommended phase 2 dose dose escalation hematopoietic progenitor kinase 1 prj1-3024
suturable duragen™ pmcf study

Conditions: Cerebrospinal Fluid Leak

Summary: the primary goal of this study is to retrospectively collect data on the safety and efficacy of suturable duragen™.

this is a multicenter, non-randomized, non-interventional, retrospective post-market clinical follow-up (pmcf) study to evaluate the occurrence of post-operative cerebrospinal fluid (csf) leaks within 30 days (and up to 90 days) after use of suturable duragen™ for a supratentorial, infratentorial, or spinal procedure.

Eligibility criteria:
inclusion criteria: 1. subject is between 18 and 80 years of age 2. subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of suturable duragen™ prior to trial initiation 3. availability of post-operative assessment results. exclusion criteria: 1. there are no exclusionary criteria for this study population
correlation of the clinical behaviour of renal cell carcinoma (rcc) after debulking nephrectomy with tumor gene expression in nephrectomy specimens

Conditions: Renal Cell Carcinoma

Summary: the objective of the study is to determine whether a specific immune microenvironment in the primary tumor is associated with a favorable clinical course after nephrectomy and in the absence of adjuvant treatment.

renal cell carcinoma (rcc) is a tumor with clinically apparent immunologic phenomena, such as response to immunotherapies (interferon, interleukin-2, immune cellular therapy etc), spontaneous regression, and sometimes indolent behaviour. nephrectomy itself influences the prognosis of advanced rcc patients as shown in 2 randomised trials, and could have an immune basis. we previously reported on the variability of clinical behaviour in advanced rcc patients who had not received systemic treatment after debulking nephrectomy (debulking nephrectomy followed by a "watch and wait" approach in metastatic renal cell carcinoma .wong a, et al. urol oncol, in press). the clinical significance of this includes the avoidance of toxic systemic therapies after nephrectomy, or the possibility of using non-toxic vaccine approaches in metastatic patients after cytoreductive nephrectomy. in this research proposal we would like to analyse the immune related gene expression profile on nephrectomy tumor samples and correlate them with the clinical course of the patient after the nephrectomy. this will be an exploratory and retrospective study of 15 patients in whom debulking nephrectomy for advanced rcc had been done, who did not receive any adjuvant treatment, and in whom the clinical course had been monitored after the nephrectomy. we will first carry out a feasibility study during which we will isolate rna from 3 ffpe (formalin-fixed,paraffin-embedded) samples using commercially available rna isolation kit and we will determine if their quality is compatible with quantitative polymerase chain reaction (qpcr) or microarray studies. upon successful feasibility study, the analysis will be extended to 15 patients. rna will be isolated from ffpe samples and the gene expression profiles will be evaluated by qpcr and/or microarray. emphasis will be placed on the expression profile of immune-related genes. finally, transcriptome analysis results will be extended at the protein and cell level using immunohistochemistry assays.

Eligibility criteria:
inclusion criteria: * advanced rcc who had a cytoreductive nephrectomy done. * patients did not receive specific anti-cancer systemic therapy after the nephrectomy, except after clinical disease progression. * tumor samples available.
effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome

Conditions: Metabolic Syndrome; Hypertension

Summary: the purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * male and female europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation * blood pressure greater than or equal to 130/85 mmhg and * hs-crp greater than or equal to 1.0 and less than 10.0 mg/dl and at least two (2) of the following traits of the metabolic syndrome (atp iii criteria): * abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women; * triglyceride level greater than or equal to 150 mg/dl; hdl less than 40 mg/dl for men and less than 50 mg/dl for women * fasting blood glucose greater than or equal to 110mg/dl exclusion criteria: * insulin depended diabetes or type-1 diabetes * severe or resistant hypertension * patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or cushing's syndrome * any acute or chronic inflammatory disease * constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start * pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception); * patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)

Keywords: inflammatory markers vascular protection om effect metabolic syndrome hypertension
flexible dose, long-term safety study of asenapine for the treatment of schizophrenia in adolescents (p05897)

Conditions: Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated

Summary: this study is designed to evaluate whether asenapine, which is approved by the united states food and drug administration (us fda) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. this is an extension of base study p05896 (nct01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study p05897. participants in this extension study will receive open-label asenapine for 26 weeks. throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.


Eligibility criteria:
inclusion criteria: * each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (p05896 \[nct01190254\]) who reach 18 years of age while on p05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met. * must have completed the 8-week efficacy and safety trial (p05896 \[nct01190254\]) and, according to the investigator's judgment, would benefit from long-term treatment. * must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (p05896 \[nct01190254\]), in the opinion of the investigator. exclusion criteria: * a female participant must not be pregnant and must not have the intention to become pregnant during the trial. * a participant must not be at imminent risk of self-harm or harm to others. * a participant must not currently be under involuntary inpatient commitment.
from molecules to cognition: inhibitory mechanisms in asd and nf1

Conditions: Autism Spectrum Disorder; Neurofibromatosis 1

Summary: this study aims to investigate synaptic physiology and behavioral inhibition in patients with nf1 and asd and to answer whether inhibitory deficits at these levels are modulated by lovastatin. structure: (1) visit 1: baseline assessment- participant's characterization, baseline outcome measures and additional evaluations, (2) 3 consecutive days of physiologically probing drug/placebo intake, (3) visit 2: outcome measures and additional evaluations in the day after the last drug/placebo intake, (4) washout period of 4 to 6 weeks, (5) 3 consecutive days of drug/placebo intake, (6) visit 3: outcome measures and additional evaluations in the day after the last placebo/drug intake.

the literature has shown synaptic inhibitory dysfunction in both asd and nf1. here the investigators aim to test whether a mechanistic link can be established between that synaptic inhibitory dysfunction, systems levels changes in oscillatory synchrony and regulation of inhibition and treatment with lovastatin in these two neurodevelopmental disorders. the investigators will explore this link through the application of complementary quantitative measures (putative biomarkers), such as magnetic resonance spectroscopy (mrs) transcranial magnetic stimulation (tms) and electroencephalogram (eeg) applied to the same group of adult patients before and after the lovastatin or placebo intake during three days. the intervention comprehends three sessions: the first two visits will occur in the same week and the third visit will take place 4 to 6 weeks later. in the first visit (baseline assessment), participants will perform neuropsychological, eeg, mrs and tms assessment. in the other two visits participants will repeat eeg, mrs and tms assessments to study possible post- intervention effects. participants will intake 60mg of lovastatin or placebo during three consecutive days before the second and the third visits.

Eligibility criteria:
inclusion criteria: * positive diagnostic results for asd in: the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria. * positive diagnostic results for nf1: clinical diagnosis based on the well-established clinical criteria exclusion criteria: * global intelligence quotient \< 80 * associated medical condition such as epilepsy, neurologic conditions, genetic syndromes, or other usual comorbidity in asd and nf1 populations * medication capable of interfering with the intervention and/or study results * pregnancy * drug use and/or alcohol abuse * contra-indications to mr and tms

Keywords: inhibition gaba molecular imaging functional magnetic resonance imaging autism spectrum disorder neurofibromatosis 1
desensitization and cognitive therapy in general anxiety.

Conditions: Generalized Anxiety Disorder

Summary: this study will test the feasibility and safety of adding interpersonal and emotional processing techniques to standard cognitive behavioral therapy for generalized anxiety disorder.

generalized anxiety disorder (gad) is characterized by chronic worry that interrupts normal functioning. some research has shown cognitive behavioral therapy (cbt) as an effective treatment for gad, but only half of people treated with cbt for gad experience treatment benefits long-term. standard cbt for gad may lose effectiveness over time because it does not address interpersonal and emotional processing problems. this study will determine the safety and feasibility of training therapists to deliver a version of cbt with additional therapeutic techniques for addressing interpersonal interactions and emotional processing. participation in this study will include 14 weekly, 2-hour, individual therapy sessions. during the first hour of each session, all participants will receive standard cbt for gad. participants will be randomly assigned to receive one of two therapies during the second hour: training in interpersonal and emotional processing techniques or listening therapy. participants taking medications will be required to maintain a fixed dosage and keep a daily dairy of medication use, starting 2 weeks before study entry and lasting throughout treatment. in-depth study assessments will take place at baseline and after completing the 15 weeks of therapy. assessments will include clinical interviews, self-report questionnaires, and a physiological measurement session. questions will pertain to anxiety symptoms, self-perceptions, emotional experience, and perceptions of the world. the physiological measurement session will involve recording bodily reactions, including brain waves, heart rate, eye movement, and breathing, while performing simple perceptual tasks. brief psychological assessments will also follow each hour-long portion of each therapy session. follow-up assessments conducted 6, 12, and 24 months after completing treatment will involve interviews and questionnaires as well as recording a week's worth of medication diaries.

Eligibility criteria:
inclusion criteria: * principal diagnosis of generalized anxiety disorder (gad), as defined by the dsm-iv and agreed on by two diagnostic interviewers exclusion criteria: * concurrent psychosocial therapy or past adequate dosage of cbt * medical contributions to anxiety * current substance abuse, psychosis, or organic brain syndrome

Keywords: cbt emotional-focused therapy interpersonal therapy
evaluation of an algorithm for length based weight estimation in comparison to known devices

Conditions: Weight-Estimation

Summary: the purpose of this prospective single center study is to investigate if a developed algorithm is more accurate than the broselow tape (bt). for this study 500 patients are required to collect anonymized data (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of 80% during statistical analysis. the main hypothesis ist that the algorithm has a better accuracy than the bt.

this prospective single center study is performed at the university children's hospital zurich. patients planned for surgery in general anaesthesia with intubation, aged 0 to 16 years and with a body length suitable for the emergency tapes can be included in this study. patient and parental information is performed during the pre-anaesthetic visit. after written consent the patient will be included. patient ́s length and weight will be measures earliest one day before data collection. data collection during anaesthesia has no influence on the daily anaesthesia routine and has no impact on patient safety and anaesthesia. patient's data is made anonymous for further inspection. data is documented in microsoft excel and statistical analysis calculated with spss. 500 patients are needed for a power of 80%. primary outcome parameter is length- based weight estimation, secondary outcome parameters are length-based age estimation and the correctness of recommended anaesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). both tools (algorithm and bt) will be compared with each other regarding primary and secondary outcome parameters.

Eligibility criteria:
inclusion criteria: * body length suitable with the investigated emergency tapes * all patients aged 0 -16 years * receiving general anaesthesia with intubation or laryngeal mask exclusion criteria: * already included in this study once * missing patient or parental consent

Keywords: broselow tape weight estimation patient safety