Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy and safety of lnz101 and lnz100 for the presbyopia

Conditions: Presbyopia; Near Vision; Miosis; Eye Diseases

Summary: a multi-center, randomized, double-masked, placebo-controlled phase 3 evaluation of the efficacy and safety of lnz101 and lnz100 for the treatment of presbyopia

a multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . to evaluate the efficacy and safety of lnz101 (aceclidine 1.75%/brimonidine 0.08%)/lnz100 (aceclidine 1.75%) compared with placebo for the treatment of presbyopia.

Eligibility criteria:
inclusion criteria: 1. be able and willing to provide written informed consent prior to any study procedure being performed; 2. be able and willing to follow all instructions and attend all study visits; 3. be 45-75 years of age of either sex at visit 1; 4. have +1.00 to -4.00 diopter (d) of sphere calculated in minus cylinder in both eyes determined by manifest refraction documented at visit 1; 5. have ≤2.00 d of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at visit 1; 6. have +1.00 d to -4.00 d manifest refraction spherical equivalent（mrse）of spherical equivalent (se) determined by manifest refraction documented at visit 1. 7. be presbyopic as determined at visit 2 baseline exclusion criteria: 1. be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy; 2. have known contraindications or sensitivity to the use of any of the study medications or their components; 3. have an active ocular infection at visit 1 or at visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye; 4. have moderate or severe dry eye at visit 1, assessed by corneal fluorescein staining; 5. have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of visit 1 or at visit 1;

Keywords: presbyopia pharmaceutical solutions opthalmic solutions eye drops miotic
a study to prospectively assess disease progression in male children with x-ald

Conditions: X-Linked Adrenoleukodystrophy

Summary: this is a non-interventional, multi-center study that follows general principles of periodic assessment of x-ald patients in routine practice. no study drug treatment will be given and no changes to patient treatment are necessary.

this is a non-interventional, multi-center study that follows general principles of periodic assessment of x-ald patients in routine practice. no study drug treatment will be given and no changes to the patient treatment are necessary. patients with x-ald will be recruited and invited to attend a baseline visit. after eligible patients are enrolled, retrospective and baseline data will be collected. after enrollment, patients will be seen approximately every 6 months until they meet withdrawal criteria or the sponsor terminates the study.

Eligibility criteria:
inclusion criteria: * signed informed consent by patient's parent(s)/legally acceptable representative(s). in addition, signed children's assent form according to local requirements. * males patients 2-13 years of age with a confirmed diagnosis of x-ald that fall into one of the following: * asymptomatic patients without mri evidence of cerebral involvement * patients with mri evidence of cerebral involvement (loes score ≥0.5) with or without clinical symptoms * patient who have hsct within 3 months from enrollment exclusion criteria: * patients who are 14 years of age or older * patients who are in a vegetative state * patients (or their guardians) who are unwilling or unable to comply with the study procedures * patients who received hsct more than 3 months before enrollment

Keywords: adrenoleukodystropy x-ald ald
an open trial of allopurinol in patients with poorly responsive schizophrenia

Conditions: Schizophrenia

Summary: this is a four week open label trial of allopurinol to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. no change in medication is required.


Eligibility criteria:
inclusion criteria: * subjects with schizophrenia and poor response (no prospect of discharge because of symptoms) exclusion criteria: * over 65 * renal or liver disease * diabetes * hypertension * taking thiazides or ace inhibitors
necessity of aspiration in the ventrogluteal site

Conditions: Nursing; Injection Site

Summary: h1: aspiration is not necessary for im injections applied from the ventrogluteal region. h2: aspiration procedure increases pain in im injections applied from ventrogluteal region. h3: the duration of the aspiration procedure on im injections applied from the ventrogluteal region is effective on pain.


Eligibility criteria:
inclusion criteria: * patient who came to the emergency service care unit for "diclofenac sodium" injection * have no vision and hearing problems, * who have no disease that may affect their perception of pain * who can evaluate the "visual analog scale" correctly, scoring 5 points or less from the vas, * body mass index is between 18.5-24.9 kg / m2, * who do not have any discomfort in the extremities that will prevent them from taking the desired position, * no complications due to intramuscular injections such as abscess, infection, tissue necrosis and hematoma in the ventrogluteal region * no nodules or masses in the area exclusion criteria: * patients who refuse the injection are excluded.

Keywords: ventrogluteal area aspiration
quality of life in children with cancer

Conditions: Childhood Cancer; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Summary: childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers and lymphomas are the most common ones among them. during medical treatment children with cancer are at risk of neuromuscular and musculoskeletal complications such as reduced muscle strength, gross and fine motor performance impairment, decreased energy consumption. these neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and quality of life of the children. childhood cancers have negative effects on sleep. the aim of this study is to identify the status of sleep, fatigue, and quality of life in children with various types of cancer and to examine the relationship between these conditions.the general situation of children will be determined according to findings from this study.

childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers and lymphomas are the most common ones among them. acute lymphoblastic lymphoma (all) is the most common childhood cancer and 78% of leukemia's reported to be all. during medical treatment children with leukemia are at risk of neuromuscular and musculoskeletal complications such as reduced ankle range of motion, reduced muscle strength, gross and fine motor performance impairment, decreased energy consumption, osteonecrosis and osteoporosis. these conditions can develop as a result of cancer or its treatment. these neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and quality of life of the children. childhood cancers have negative effects on sleep; sleep complaints can develop with the diagnosis and continue even after recovery period.the aim of this study is to identify the status of sleep, fatigue, and quality of life in children with various types of cancer and to examine the relationship between these conditions. in addition, families will be assessed about their children's conditions and satisfaction with the health care they receive.the general situation of children will be determined according to findings from this study.

Eligibility criteria:
inclusion criteria: * diagnosis of childhood cancer and having medical treatment at the hospital exclusion criteria: * having any other health condition (neurologic, developmental or metabolic disorders)

Keywords: cancer leukemia
social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission

Conditions: Inflammatory Bowel Diseases; Remission; Fatigue

Summary: the aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission. secondly, the objectives of the study are to: * assess the impact of fatigue on the quality of life of patients with inflammatory bowel disease in remission. * to determine the profile of patients with inflammatory bowel disease in remission who are fatigued. to this end, during a consultation or hospitalization, participants will be asked to respond independently to various questionnaires (facit-f, dipcare, ssq6, questionnaire on socio-demographic determinants and ibd disk). characteristics of the type of chronic inflammatory bowel disease will be collected from medical records. there will be no patient follow-up as part of the study. participants may be contacted by telephone by the center's investigator within 2 weeks of the interview in the event of a partial or imprecise response.


Eligibility criteria:
inclusion criteria: * patient in clinical remission for at least 6 months: * for crohn's disease patients: harvey bradshaw index (hbi) score ≤ 4 * for patients with ulcerative colitis: a partial mayo score (pms) ≤ 2 with each subscore of 1 or less) * patient in biological remission for at least 6 months fecal calprotectin \<250 μg/g and crp \<5 mg/ * documented diagnosis of crohn's disease or ulcerative colitis based on standard clinical, endoscopic and histological criteria * facit-f score \< 40 (defining significant fatigue) * subjects at least 18 years of age at the time of study inclusion exclusion criteria: * severe acute colitis * active infection with hiv, hepatitis b, hepatitis c, or untreated tuberculosis * patient(s) objecting to the use of their data for research purposes
albumin dialysis in end-stage renal disease: detoxification capacity and impact on vascular endothelial function

Conditions: Chronic Kidney Disease

Summary: the uremic syndrome is mainly related to the retention of a host of compounds, due to altered glomerular filtration and other factors of renal dysfunction, e.g. tubular secretion. uremic retention solutes are arbitrarily subdivided in three different categories according to their physicochemical characteristics and their subsequent behaviour during dialysis: (i) the small, water-soluble, non-protein bound compounds, (ii) the larger middle molecules, mainly peptides and (iii) the small protein-bound compounds (1). although direct proof is lacking, several lines of evidence indicate that albumin is the most important carrier protein. removal of protein bound uremic retention solutes is limited. the prometheus® system fractionates blood into plasma and cellular components, using an albumin-permeable polysulfon filter (albuflow®) with a specially designed sieving coefficient curve (1.0 for 2-microglobulin, \>0.6 for albumin, \<0.3 for igg, \<0.1 for fibrinogen and \<0.01 for igm). due to the high sieving coefficient of the filter for large molecules (i.e. cut-off at about 250 kd) molecules up to the size of albumin (69 kd) easily pass from blood into the secondary circuit which is filled with isotonic sodium chloride solution, whereas larger molecules like fibrinogen (340 kd) cannot pass through the filter. in the secondary circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers in a row with maximized adsorption capacity for putative liver toxins that are directly adsorbed ('fractionated plasma separation and adsorption' or fpsa). the purified plasma is then returned to the blood side of the albumin filter. in order to eliminate water-soluble toxins, blood thereafter undergoes hemodialysis using a conventional high-flux dialyser. we hypothesise that removal of protein bound uremic retention solutes can be improved by fpsa as compared to standard hemodialysis.


Eligibility criteria:
inclusion criteria: * \> 18 years of age * maintenance (\> 3 months) hemodialysis patient * stable access, blood flow at least 250 ml/min exclusion criteria: * known hemodialysis-related hypotension

Keywords: hemodialysis, urmeic retention solute, biocompatibility
hypokalemia and intravenous patient controlled analgesia

Conditions: General Anesthesia; Laparoscopic Cholecystectomy

Summary: the increase in stress hormone level and hyperventilation caused by the postoperative pain may contribute to the development of hypokalemia during postoperative period. therefore, if the postoperative pain is well controlled by the iv-pca,the plasma potassium level during the postoperative period may be not affected by stress response. the researchers tried to investigate the effect of iv-pca on potassium regulation during the postoperative period.

intravenous patient controlled analgesia(iv-pca) has been widely used to control postoperative pain. the increase in stress hormone level and hyperventilation caused by the postoperative pain may contribute to the development of hypokalemia during postoperative period. hypokalemia is a risk factor for postoperative arrhythmia. therefore, if the postoperative pain is well controlled by the iv-pca, the plasma potassium level during the postoperative period may be not affected by stress response, and the incidence of hypokalemia may be reduced. the researchers tried to investigate the effect of iv-pca on potassium regulation during the postoperative period. the researchers divided the patients undergoing laparoscopic cholecystectomy into two groups of iv-pca group and control group. the researchers compared the plasma potassium concentration from the preoperative to postoperative period.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic cholecystectomy * asa class i or ii exclusion criteria: * any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, cushing syndrome * patients with recent exogenous steroid administration or previous diuretics therapy

Keywords: hypokalemia intravenous patient controlled analgesia
pilot trial on efficacy of single dose perioperative intravenous dexamethasone for pain relief after endoscopic submucosal dissection

Conditions: Early Gastric Cancer or Gastric Adenoma

Summary: besides major esd-related complications, minor adverse events after esd are also commonly noticed. pain is one of minor esd-related complications. . the causes of pain associated with esd or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. how control localized pain for patients who suffered from pain after esd is appearing as new medical interests. there are few studies about management strategy for pain after esd. glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. the efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. if pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after esd based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after esd.


Eligibility criteria:
inclusion criteria: * 20 years of age or older * pathologically diagnosed gastric adenoma or cancer that was eligible for esd * patients who gave written informed consent from patients or responsible family members. exclusion criteria: * patients who take pain killer within 48 hours or regularly at enrollment * confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease * multiple gastric lesions for esd * history of gastric surgery at enrollment * severe underlying disease including infection, cardiopulmonary disease, and diabetes.

Keywords: endoscopic submucosal dissection early gastric cancer pain relief intravenous dexamethasone present pain intensity
infliximab for the prevention of graft-versus-host disease following allogenic hematopoietic stem cell transplantation

Conditions: Graft-Versus-Host Disease

Summary: this study will evaluate the efficacy of infliximab in reducing the incidence of grade ii-iv acute graft versus host disease by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplant.

rationale: acute graft host disease (gvhd) remains a barrier to successful hematopoietic stem cell transplantation (hct) used for the treatment of cancers in some patients. gvhd can result from a lack of compatibility between the donor and recipient. research suggests another primary cause of gvhd comes from cytokines, or a substance produced by cells of the immune system that affect the immune response in both positive and negative ways. infliximab is an antibody that directly targets the cytokine associated with gvhd. this study is building upon previous research to assess infliximab's ability to prevent gvhd after hct. purpose: this study is evaluating the efficacy of infliximab in reducing the incidence of gvhd after hct. the safety of this approach, along with changes to specific cytokines from this treatment, will also be measured. treatment: patients in this study will receive infliximab through intravenous infusion. infliximab will be administered in six doses, including one day before chemotherapy or radiotherapy, after the stem cell infusion, and then on days 7, 14, 28 and 42. standard post-transplant treatments of cyclosporine (neoral) and methotrexate (methotrexate) will also be given through intravenous infusion. cyclosporine will be given on day 1, and the subsequent schedule will be determined on an individual basis. methotrexate will be administered on days 1, 3, 6, and 11. several tests and exams will be given throughout the study to closely monitor patients.

Eligibility criteria:
inclusion criteria: * patients undergoing allogeneic hct for the following disorders: * acute myelogenous leukemia * acute lymphoblastic leukemia * non-hodgkin's lymphoma * hodgkin's disease * multiple myeloma * chronic lymphocytic leukemia * chronic myeloid leukemia in accelerated or blast crisis at time of transplant. * age \>20 yrs exclusion criteria: * patients undergoing allogeneic stem cell transplantation for chronic myelogenous leukemia and aplastic anemia are excluded. * pregnant or breast-feeding females.

Keywords: hematopoietic stem cell transplantation
a study of protein metabolism, microbiome and investigational probiotic use in patients with als

Conditions: Amyotrophic Lateral Sclerosis; ALS

Summary: als, also known as "lou gehrig's" disease, is a neurodegenerative disease which is fatal. treatment for als is limited and currently consists of primary symptom relief or support. in addition, time from diagnosis to death averages 3-5 years. new biotic, llc has submitted an orphan drug designation application for an investigational probiotic and have indicated the need for more study of this orphaned drug in als patients.

this will be an exploratory protocol of 10 patients and expect to screen approximately 25-30 patients. the purpose of our study is to examine amino acid levels in plasma pre and post prandial as well as longitudinal gut microbiome in als patients taking the investigational probiotic. 1. purpose: evaluate the clinical outcomes of muscle strength, clinical global assessments and spasticity in patients taking an investigational probiotic. 2. measure changes in questionnaires relating to subjective functional assessments, quality of life, and pain levels over 24 weeks. 3. describe plasma amino acid levels before and after a protein food challenge in als patients of spinal and bulbar type. 4. evaluate and describe the gut microbiome of patients with als. design: this is a non-randomized, open-label, two-group pilot study of plasma amino acid levels, gut microbiome, and of investigational probiotic use in patients with als. participants will be placed into two groups based on certain post-prandial amino acid levels. patients will be stratified for eligibility based on the results of their amino acid profiles.

Eligibility criteria:
inclusion criteria: * diagnosis of sporadic als, definite or probable disease,-revised el escorial criteria * patient must be able to understand the purpose and procedures of the study, sign informed consent and comply with requirements of the protocol. * age 18 and older. * normal serum magnesium (1.7 - 2.3 mg/dl) and manganese (4.7 - 18.3 ng/ml) levels or adequate supplement to obtain normal serum mg (if manganese levels are low (\<1.7 mg/dl), hair manganese will be evaluated before starting probiotic, and inclusion to the protocol will be at the principal investigators discretion). exclusion criteria: * need for consumption of frequent antibiotics, gut ph increasing medications, and/or alkaline water. * patient unable to maintain regular follow up or submit to informed consent * stool ph \>7.5 - the ideal stool ph for growth and function of the investigational probiotic is 6-6.5. * patients who are judged to be ineligible for study entry by investigator or sub-investigator.

Keywords: als amyotrophic lateral sclerosis