Kornimate/medical-research-clean huggingface dataset:
variable approaches of intradiscal o3-o2 injection

Conditions: Low Back Pain

Summary: cost intradiscal injection of ozone-oxygen mixture (o3-o2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain. does change of injection approach make a difference?

low back pain (lbp) mostly is induced by disc herniation (dh), or degeneration and has a burden upon social and economic aspects of life. medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost intradiscal injection of ozone-oxygen mixture (o3-o2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief. a lot of injection approaches are available, but which offers the best results, is the question.

Eligibility criteria:
inclusion criteria: * radicular leg pain * low back pain * non-responsive to conservative treatment exclusion criteria: * patient refusal * infection at injection site * coagulopathy * uncontrolled or degenerative spine disease * pregnancy * multilevel disk involvement

Keywords: low back pain , ozone
cosopt versus xalatan

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.


Eligibility criteria:
inclusion criteria: * adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion * intraocular pressure should be 22 to 30 mm hg inclusive on timolol bid at the 08:00 h * etdrs visual acuity must be 1.0 or better in both eyes exclusion criteria: * any contraindications to study medications * any anticipated change in systemic hypertensive therapy during the trial
a phase 3 study to evaluate the efficacy of lifitegrast in subjects with dry eye

Conditions: Dry Eye Disease

Summary: the purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.


Eligibility criteria:
inclusion criteria: * willing and able to read, sign and date the informed consent and hipaa documents * willing and able to comply with all study procedures * be at least 18 years of age * patient-reported history of dry eye in both eyes * a negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period * artificial tear use within the past 30 days exclusion criteria: * any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy * unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the duration of the study * any blood donation or significant loss of blood within 56 days of visit 1 * any history of immunodeficiency disorder, positive hiv, hepatitis b, c, or evidence of acute active hepatitis a (anti-hav igm), or organ or bone marrow transplant. * use of any prohibited medications at any time during the study unless otherwise specified * any significant illness that could interfere with study parameters * history of laser assisted in situ keratomileusis (lasik) or similar type of corneal refractive surgery within 12 months prior to first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; or any scheduled ocular surgical procedure during the study period. * known history of alcohol and/or drug abuse * subjects with dry eye secondary to scarring or destruction of conjunctival goblet cells (as with vitamin a deficiency)

Keywords: sar 1118
acalabrutinib in patients with relapsed/refractory and treatment naïve deletion 17p cll/sll

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll).

to investigate the safety and efficacy of acalabrutinib for patients with cll/sll that have relapsed/refractory disease or treatment naive deletion 17p.

Eligibility criteria:
inclusion criteria: * men and women 18 years of age and older with histologically confirmed disease. * active disease as defined by at least one of the following (iwcll consensus criteria): * weight loss ≥10% within the previous 6 months * extreme fatigue * fevers of greater than 100.5ºf for ≥2 weeks without evidence of infection * night sweats for more than one month without evidence of infection * evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia * massive or progressive splenomegaly * massive nodes or clusters or progressive lymphadenopathy * progressive lymphocytosis with an increase of \>50% over a 2 month period, or an anticipated doubling time of less than 6 months * compensated autoimmune hemolysis * relapsed/refractory cll or treatment naïve cll patients with 17p deletion, tp53 mutation, or notch1 mutation * agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children. * willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies. * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations). exclusion criteria: * radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational products in the last 4 weeks. * richter's transformation. autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy. impaired hepatic function

Keywords: relapsed/refractory cll btk leukemia lymphocytic lymphoma chronic lymphocytic leukemia (cll) small lymphocytic lymphoma (sll) acp-196 acalabrutinib treatment naive cll 17p deletion tp53 mutation notch1 mutation
competence ability study in people with schizophrenia

Conditions: Schizophrenia; Competence

Summary: the goal of this research is to understand whether schizophrenic patients are capable of comprehending clinical trial consent form or influenced by disease, also after intensified educational illustration for "understanding of consent form", their comprehension increased or not, in order to protect patient's right.

the goal of this research is to understand whether schizophrenic patients are capable of comprehending clinical trial consent form or influenced by disease, also after intensified educational illustration for "understanding of consent form", their comprehension will increase or not, in order to protect patient's right. first week, inform the patient a putative goal and method of clinical trial medicine research, then using macarthur comprehension evaluation tool-clinical research ed., evaluate the understanding of all patients for this putative clinical trial research consent form. for experimental group schizophrenic patients, using panss score evaluate seriousness of their symptom. 2 weeks later, randomly stratify schizophrenic patients into 2 groups, one give educational intervention for consent form, the other does not, then evaluate again with macarthur comprehension evaluation tool-clinical research ed. and panss score.

Eligibility criteria:
inclusion criteria: experimental group 1. age between 20 to 60, all genders. 2. psychiatry doctor diagnosed who met dsmiv-tr criteria schizophrenia. 3. participants require adequate ability to have a interview about 60-70min (include panss and macarthur comprehension evaluation tool-clinical research ed.). control group 1. age between 20 to 60, all genders. 2. psychiatry doctor diagnosed who exclude dsmiv-tr axis. i and ii. 3. participants require adequate ability to have a interview about 30min (include panss and macarthur comprehension evaluation tool-clinical research ed.). exclusion criteria: experimental group and control group participants have no adequate ability to have a interview about 60-70min (include panss and macarthur comprehension evaluation tool-clinical research ed.).

Keywords: schizophrenia panss
long term effects of diabetes of very young children

Conditions: Type 1 Diabetes

Summary: to investigate neurocognitive and behavioral measures in 25 children aged 6-10 years diagnosed with diabetes for \> 5 years who have received long-term insulin pump therapy (\> 3 years) compared to a group of children matched for age, sex, glycemic control, and diabetes duration treated with insulin injections. outcome measures will assess: clinical variables, cognitive status (intelligence, neuropsychological functioning), academic achievement, behavior, parenting stress, and quality of life. it is hypothesized that long term insulin pump therapy initiated during early childhood can delay the progression of neurocognitive complications of diabetes, decrease parental stress, and improve school performance and quality of life, as compared to insulin injections.


Eligibility criteria:
inclusion criteria: * subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age of 5 years * children recruited on pumps must have used pump therapy for at least 3 years * parents/guardians must be understand the protocol and be able to give consent, with assent obtained from all children over the age of 7 years. exclusion criteria: * children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or l-asparaginase. * children must not have any other chronic illness in addition to diabetes with the exception of treated autoimmune hypothyroidism.

Keywords: type 1 diabetes neurocognitive measures behavioral measures
accuvein measure before ultrasound as a facilitatation tool for venous marking

Conditions: Other Diseases of Veins and Lymphatics

Summary: ultrasound marking of saphenous veins before varicose vein surgery or for saphenectomy for vascular or coronary artery bypass grafting is a long, tedious, low-grading examination, generating overconsumption of many consumables including marking markers that may damage the probes, of the modern and expensive ultrasound doppler. augmented reality devices can visualize the superficial veins and hope to simplify the investigation, improve the comfort of the patient during the examination by significantly reducing the time of the examination. there is few data in the literature on the value of using augmented reality devices of this type. the accuvein® system is a patient-friendly, non-contact, non-invasive technique that minimizes discomfort due to standing time and thus improves patient comfort.

at admission eligible patients are proposed to participate. written consent is signed after complete oral and written explanation of the protocol is signed. no register of non-included patients will be kept. in included patients, in parallel to the standard ultrasound investigation for marking of saphenous veins for which the patient is referred, accuvein® system will be performed as explained later in arm description. usual ongoing treatments are obtained by history and recorded. the end of the visit is the end of the participation of the subjects.

Eligibility criteria:
inclusion criteria: * patients referred for venous marking * affiliation to the french national healthcare system * french speaking patients exclusion criteria: * pregnancy * inability to understand the study goal * patients protected by decision of law

Keywords: venous disease peripheral vascular disease vascular surgery ultrasound imaging
a comparison of outcomes in patients in new york heart association (nyha) class ii heart failure when treated with eplerenone or placebo in addition to standard heart failure medicines

Conditions: Heart Failure

Summary: in an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. however, it is not known how patients with established mild-to-moderate heart failure (nyha class ii), who have the additional risk of sudden death, will respond if treated with eplerenone. in this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients. the data safety monitoring committee (dsmc) observed during its conduct of the protocol-specified second interim analysis on the 6th of may, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. as a result of the discussion between the dsmc and the executive steering committee (esc), the esc recommended that emphasis-hf should be terminated, based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the esc recommended that all the patients in the trial should be transferred to open-label eplerenone. the open label extension eplerenone arm will last for 12 months. eplerenone is not currently approved for the indication studied in this patient population. on may 26, 2010, further enrollment into emphasis-hf was stopped. the amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the emphasis-hf trial can be offered treatment with eplerenone


Eligibility criteria:
inclusion criteria: * history (hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration; currently, new york heart association (nyha) functional class ii and on optimal dose, or maximally tolerated dose of standard heart failure medicines (advisable to include ace-i/arbs; beta-blockers) and diuretics if indicated for fluid overload. should have participated in the double-blind phase of the emphasis-hf trial exclusion criteria: * severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2.

Keywords: open-label single arm mortality/morbidity trial eplerenone chronic systolic heart failure
rct comparing 19ga vs 22ga ebus-tbna needles in carcinoma.

Conditions: Lung Neoplasm

Summary: ebus-tbna is often the sole diagnostic test applied in patients with stage iv lung cancer. a limitation of the tbna needle when using a 22 gauge needle is the limited ability to procure adequate histological samples. although a larger 19 ga needle can procure histological samples as demonstrated by the conventional 19 ga needle, published data are not existing with respect to molecular diagnostics. a new nitinol-based 19 ga needle has been developed for ebus-tbna. given the frequent usage of 22 ga needles for molecular diagnostics and the recent technical advancements in 19 ga needle technology, we conduct a rct to compare the performance of both needle types.

all patients with (suspected) stage iv lung carcinoma identified on spiral computed tomography scan and requiring an ebus-tbna investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. procedural technique : patients undergo an ebus-tbna procedure with either the flex 19 ga needle or the 22 ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. secondary endpoints are elements relevant to molecular analysis.

Eligibility criteria:
inclusion criteria: * (suspected) stage iv lung carcinoma identified on spiral computed tomography scan * requiring an ebus-tbna investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis exclusion criteria: * uncontrolled coagulopathy * tracheal stenosis

Keywords: ebus-tbna
cyclosporine in treating patients with low blood counts caused by hematologic cancer

Conditions: Anemia; Leukemia; Neutropenia; Thrombocytopenia

Summary: rationale: cyclosporine may improve low blood counts caused by hematologic cancer. purpose: phase ii trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.

objectives: * determine the frequency of cytopenic response in patients with t-cell large granular lymphocytic leukemia treated with cyclosporine. outline: this is a multicenter study. patients receive oral cyclosporine every 12 hours. treatment continues in the absence of disease progression or unacceptable toxicity. patients are followed every 4 months for 1 year and then every 6 months for 9 years. projected accrual: a total of 9-30 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * diagnosis of t-cell large granular lymphocytic leukemia * increased numbers of large granular lymphocytes in peripheral blood smears * cd3+cd8+cd57+ immunophenotype by flow cytometry and * cd3+cd57+ cell count at least 2,000/mm\^3 or * cd3+cd57+ cell count at least 500/mm\^3 with clonal t-cell receptor beta gene rearrangement * patients must have at least 1 of the following: * severe neutropenia (absolute neutrophil count (anc) less than 500/mm\^3) * neutropenia (anc less than 1,000/mm\^3) and recurrent infections * anemia (hemoglobin less than 9 g/dl) * thrombocytopenia (platelet count less than 50,000/mm\^3) patient characteristics: age: * 18 and over performance status: * nci ctc 0-3 hematopoietic: * see disease characteristics hepatic: * bilirubin no greater than 2 times upper limit of normal (uln) renal: * creatinine no greater than 2 times uln other: * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: endocrine therapy: * no concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes) * no concurrent dexamethasone or other steroidal antiemetics other: * no prior cyclosporine therapy for this leukemia

Keywords: stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia t-cell large granular lymphocyte leukemia anemia neutropenia thrombocytopenia
high frequency oscillation in pediatric epilepsy surgery

Conditions: Pediatric Epilepsy; Epilepsy Surgery; High Frequency Oscillation

Summary: high frequency oscillation (hfo) on electrocorticography (ecog) has been identified as a new biomarker for epileptogenic tissue. the purpose of this study is to see if epilepsy surgery guided by the combination of hfo on ecog and standard clinical practice can result in a greater likelihood of seizure freedom, versus standard clinical practice alone, without hfos.

intra-operative electrocorticography (ecog), based on interictal spike and spike patterns, is performed to optimize delineation of the epileptogenic tissue in the operating room during epilepsy surgery. similarly, extra-operative electrocorticography is often recorded over days to weeks with intracranial grids and depth electrodes, when the epileptogenic zone is not clearly localized with non-invasive studies and/or with intra-operative ecog. surgical resection following extra-operative ecog is then "tailored' by the seizure onset zone as the gold standard. high frequency oscillations have been identified as a more precise biomarker for epileptogenic tissue. the aim of this double-blind randomized surgical trial is to determine if hfo- tailored surgery combining hfos and current standard of care, compared to current standard of care alone, will lead to a better seizure outcome.

Eligibility criteria:
inclusion criteria: * age 0-21 years * refractory focal epilepsy * planned resective epilepsy neurosurgery * includes intraoperative or extraoperative electrocorticography with grids * planned resective epilepsy surgery approved by institutional surgery board exclusion criteria: * subjects undergoing non-resective neurosurgery * does not include intraoperative or extraoperative electrocorticography with grids * planned resective surgery is a hemispherectomy/hemispherotomy
duration of hypothermia for neuroprotection after pediatric cardiac arrest

Conditions: Cardiac Arrest; Brain Injury

Summary: in this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours of whole body hypothermia (cooling) during recovery is better to help prevent brain injury and improve outcome. the investigators will also test the safety of cooling patients for 24 and 72 hours. the investigators hypothesize that 72 hours of cooling will be more beneficial than 24 hours without compromising safety.

cooling has been shown to decrease the amount of brain injury that can occur after heart attacks in adults and in newborn babies with birth asphyxia (a lack of blood flow and oxygen to the fetus). it is unknown if cooling is effective in children after cardiac arrest. however, cooling is recommended by the american heart association as a "consideration" for use in children after cardiac arrest to prevent brain injury and has been used by doctors in our intensive care unit since 2002. children will be randomly assigned to receive either 24 or 72 hours of cooling and compare the results of 1) blood-and urine derived markers of brain injury, and 2) brain magnetic resonance imaging and spectroscopy (mri and mrs), which measures the anatomy and chemical patterns in the brain without using ionizing radiation, between the two groups of patients with 24 or 72 hours of cooling. we will also evaluate if cooling has any effect on patient outcome and quality of life at 6 months and one year using telephone or mail questionnaires. a child may take part in this research study if he or she had a cardiac arrest, received help with breathing and chest compressions to get a spontaneous heart rate by a health care worker, and remains unconscious in the intensive care unit (icu). the attending physician in the icu has already decided to cool your child to provide protection for his or her brain function. children invited to participate in this study also are between 1 week and 17 years of age, have access tubes already in place in an artery or vein for blood draws, a urine catheter, are able to undergo mri and mrs brain scans, and, if female, cannot be pregnant. patients can not have had an acute brain injury from other causes (ex., meningitis, trauma), hemorrhage (excess bleeding from any site), congenital heart disease, do not resuscitate status, are undergoing a brain death examination, or have a known coagulation defect that makes them bleed more easily. the study will be performed on a total of 40 children strictly in this hospital.

Eligibility criteria:
inclusion criteria: * chest compressions by a health care worker age 1 wk - 17 yr rosc attained picu attending decides to cool central venous or arterial catheter glasgow coma score ≤ 8 exclusion criteria: other acute brain injury (tbi, meningitis) do not resuscitate status pregnancy absolute contraindication to mri brain death evaluation metabolic disorder active hemorrhage pre-existing coagulation defect

Keywords: pediatric cardiac arrest