Kornimate/medical-research-clean huggingface dataset:
intravitreal injection anesthesia - comparison of different topical agents

Conditions: Age-Related Macular Degeneration (AMD)

Summary: patients with neovascular age-related macular degeneration (amd) scheduled to receive intravitreal (ivt) ranibizumab injection will be randomized to receive one of three topical anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10 seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. a questionnaire will be conducted immediately after and 15 minutes after the injection, to assess for pain.

all patients scheduled to receive intravitreal ranibizumab for the treatment of neovascular amd will be evaluated for inclusion into the study. after a positive evaluation, the study will be explained to the patient, the letter of explanation reviewed with the patient and informed consent approved if patient agrees to participate. demographic data of sex and age will be recorded. as well the number of previous intravitreal injections will be recorded ( none, 2 - 5 and \> 5 ). a nurse will then proceed to select an opaque envelope from a box of identical envelopes. the envelope will contain the topical anesthetic agent to be used. the randomization code linking each patient to their anesthetic will be stored in a secure location, and only accessed at the completion of the trial. the anesthetic procedure will be performed by someone other than the surgeon who will perform the ivt injection. after a minute of the anesthetic application, the surgeon, blinded to the anesthetic intervention, will perform the ivt injection of ranibizumab. immediately following the injection, a blinded observer will first explain the pain questionnaire, and then conduct it. also at this time, the physician who performed the injection will complete the wong-baker pain questionnaire. the patient will then be asked to wait in a room for an additional 15 minutes, where the same observer will return and the pain questionnaire will be conducted a second time.

Eligibility criteria:
inclusion criteria: 1. age greater than 50 2. scheduled to receive ranibizumab for neovascular amd exclusion criteria: 1. history of pars plana vitrectomy 2. any major surgery within the prior 28 days, or one planned within next 6 months 3. history of thromboembolic event 4. previous known allergic response to topical anesthetic(s) (lidocaine, tetracaine, cocaine)

Keywords: amd intravitreal injection anesthesia
collagen crosslinking with ultraviolet-a in asymmetric corneas (2)

Conditions: Keratoconus; Ectasia; Degeneration

Summary: to evaluate the efficacy of ultraviolet-a (uva)-induced cross-linking of corneal collagen (cxl) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using uva light and the photo- mediator riboflavin. the purpose of this study is to generate data for presentation at medical meetings and for peer-review publication


Eligibility criteria:
inclusion criteria: * 8 years of age or older * diagnosis of keratoconus, post-lasik ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration. * diagnosis of ffkc * history of radial keratotomy with fluctuating vision. * ability to provide written informed consent * likely to complete all study visits * minimum corneal thickness of at least 300 measured by ultrasound or pentacam exclusion criteria: * severe corneal scarring that markedly affects vision * contraindications to any study medications or their components * pregnancy or breast feeding * active herpes corneal disease

Keywords: diagnosis of keratoconus, post-lasik ectasia, ffkc, or pellucid marginal degeneration
safety and effectiveness of nintedanib in korean patients

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the objectives of this study are to monitor the safety and effectiveness of ofev in korean patients in a routine clinical practice setting.


Eligibility criteria:
inclusion criteria: * patients who have been started on ofev in accordance with the approved label in korea * patients who have signed on the data release consent form exclusion criteria: * patients for whom nintedanib is contraindicated according local label of ofev * patients with known hypersensitivity to ofev, peanut or soya, or to any of the excipients * women who are pregnant or nursing * patients with moderate(child pugh b) and severe(child pugh c) hepatic impairment
gestational metabolic abnormalities and maternal and infant nutrition and health

Conditions: Gestational Diabetes; Hyperglycemia; Insulin Resistance; Obesity

Summary: childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in life. recent evidence indicates that abnormalities that increase risk for diabetes may be initiated early in infancy. since the offspring of women with diabetes have an increased long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic abnormalities on early nutrition and infant metabolic trajectories is of considerable interest. the purpose of the study is to investigate the impact of maternal nutrition and metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the first year of life.

the current investigation is a prospective study conducted within ongoing cohort studies of women and their offspring. pregnant women attending outpatient obstetrics clinics in toronto, canada are recruited. the overall study protocol includes four study visits between the second half of pregnancy and the first year of infant's life and interim phone call interviews: * pregnant women undergo an oral glucose tolerance test at an expected average of 30 weeks of gestation and complete medical and lifestyle questionnaires including food frequency questionnaires. * infant birth anthropometry measurements and human milk samples are collected at an expected average of 3 days postpartum. the timing of onset of lactogenesis ii is asked at 3d, 5d, 7d postpartum or until the event occurrence up to day 7. * at 3 months postpartum, follow-up assessments including infant anthropometry, medical and lifestyle questionnaires and human milk sample collection are completed. * interim telephone interviews are conducted at 6 weeks and 5, 7, 9 months postpartum to characterize infant feeding and supplementation behaviors. * at 12 months postpartum, infant anthropometric assessments are conducted.

Eligibility criteria:
inclusion criteria: * singleton or twin pregnancy * aged 20 years or older at the time of recruitment * intention to breastfeed exclusion criteria: * pre-existing diabetes

Keywords: gestational diabetes gestational hyperglycemia gestational insulinemia maternal obesity human milk lactogenesis obstetrics nutrition infant growth
smoking cessation for adults with attention deficit hyperactivity disorder (adhd)

Conditions: ADHD; Smoking

Summary: the objective of this study is to evaluate whether osmotic-release methylphenidate (oros mph), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with attention deficit hyperactivity disorder (adhd).

the primary objective of this study is to evaluate whether oros mph (concerta), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with adhd. the study will involve an estimated 252 participants, recruited from approximately 6 sites.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of adhd2 * smoked cigarettes for at least 3 months * currently smoking \> 10 cigarettes/day * have an interest in quitting * negative urine screen for cocaine, methamphetamine, opiates, benzodiazepines, and marijuana exclusion criteria: * have a clinical diagnosis for current abuse or dependence for any psychoactive substance other than nicotine, depression, or anxiety; or a life-time clinical diagnosis of psychosis or bipolar disorder * allergic to oros-mph * pregnant or breastfeeding * abnormal electrocardiogram (ecg) * taking a monoamine oxidase (mao) inhibitor * taking any medication used for treating either adhd or smoking * use of tobacco products other than cigarettes in the past week * blood pressure readings greater than 135/85 and/or a heart rate more than 90 beats per minute on three consecutive clinic visits
short-term preoperative traction method for rigid and severe scoliosis

Conditions: Scoliosis Idiopathic

Summary: the investigators collected retrospective data of severe (\>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018. the first group consisted of patients who underwent cotrel traction exercises and second group underwent continuous-progressively increasing skull tongs femoral traction (stft) traction. posterior fusion was performed in all patients. intraoperative parameters (blood loss, operation time and level instrumented) and radiologic change (initial, post-traction and postoperative cobb angle) was evaluated and analyzed


Eligibility criteria:
inclusion criteria: * adolescence/adult idiopathic scoliosis; * severe and rigid scoliosis (defined as cobb angle more than 80° and flexibility index less than 25%); * either skull tongs-femoral traction or cotrel longitudinal traction used in the preoperative time period exclusion criteria: * other types of scoliosis (neuromuscular scoliosis, congenital scoliosis, etc.) * intradural abnormalities (diastomatomyelia, tethered cord, etc) * history of previous spine surgery
instrumented data exchange for ataxia study

Conditions: Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 3; Spinocerebellar Ataxia Type 6; Friedreich Ataxia

Summary: this research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of ataxia.


Eligibility criteria:
inclusion criteria: * sca 1, 2, 3, 6, and fa with mutations in the pathogenic range confirmed from genetic testing * sca: aged 18-75 years * fa: aged 12-30, diagnosed between ages 5-25 * community dwelling * physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement * able to walk independently 10 yards without an assistive device * able to sit or stand unassisted for 30 seconds * no other neurological or musculoskeletal disorder that could affect mobility * no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility * willing and able to participate in a 2-year study * consent to be video recorded while performing study assessments exclusion criteria: * dementia that limits subjects' ability to follow directions * pain that limits mobility * sca: enrolled in a clinical drug trial
feasibility study: evaluate the effectiveness of using a topical anesthetic prior to ultherapy™ treatment

Conditions: Skin Laxity

Summary: this study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with ultherapy™ treatment.

all subjects will receive a full face and neck ultherapy™ treatment. thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. the subject and investigator or sub-investigator performing ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. pain scores will be collected following treatment of each section of the face and neck on both sides. subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.

Eligibility criteria:
inclusion criteria: * male or female, aged 30 to 65 years. * chosen an ultherapy™ treatment as part of their treatment regimen. * subject in good health. * skin laxity on the face and neck. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study exclusion criteria: * known sensitivity to lidocaine or any other anesthetic of the amide type. * history of anaphylactic shock. * presence of an active systemic or local skin disease that may affect wound healing. * current therapy with class i antiarrhythmic drugs (e.g., tocainide, mexiletine). * known or suspected hypersensitivity to lmx-4 active substance, or any of the amide-type local anaesthetics, or any of the excipients (protocol section 10.3). * severe solar elastosis. * excessive subcutaneous fat in the face and neck. * body mass index of 30 or greater. * excessive skin laxity on the face and neck. * significant scarring in areas to be treated. * significant open facial wounds or lesions. * severe or cystic acne on the face. * presence of a metal stent or implant in the facial area to be treated.
efficacy study of clr3001 in depression

Conditions: Depression

Summary: the purpose of this study is to assess the ability of clr3001 to reverse depressive symptoms relatively quickly in adult patients with major depressive disorder (mdd).

clr3001 is thought to work by helping the body's natural responses overcome depression.

Eligibility criteria:
inclusion criteria: * male or female out-subjects 18-65 years. * single episode or recurrent mdd (to a maximum of 5 prior episodes). * no current therapy for depression as per washout instructions. * able to provide written informed consent. * meet criteria for mdd with current mde through mini questionnaire. * meet criteria for mdd with current mde, as defined by dsm-iv tr. * hamd-17 score ≥ 14 at screening (visit 1) and baseline (visit 2; randomization). * able to understand and complete questionnaires, and communicate with the investigator and study coordinator. * judged to be reliable to keep all appointments and procedures required by the protocol. * female subjects of childbearing potential (who are not at least 2 years postmenopausal or surgically sterile or totally abstinent) must be using a reliable, medically acceptable form of contraception and must agree to continue such use throughout the duration of the study. reliable forms of contraception include oral, implanted, transdermal or injected contraceptives, intrauterine devices, and adequate double barrier methods including use of spermicide. partner's vasectomy is also an acceptable contraceptive regimen. exclusion criteria: * investigators and immediate family members. * treatment within the last 90 days with a drug that had not received regulatory approval at the time of study entry. * persons who had previously withdrawn from this study or previous study investigating clr3001. * a primary diagnosis of panic disorder, social anxiety disorder, obsessive-compulsive disorder within the past year. * the presence of an axis ii disorder, which, in the opinion of the investigator, would interfere with compliance in the study. * history of active substance dependence within the last half-year, excluding nicotine and coffee, or active substance abuse that may interfere with the outcome of the study. * acute suicidal ideation or risk, ≥3 on hamd-17 suicide item. * fall in hamd-17 score greater than 20% between visit 1 and visit 2. * serious concomitant diseases such as cancer, serious metabolic (e.g. insulin dependent diabetes), renal, cardiac, thyroid, immunological, neurological or other significant disease or laboratory abnormality (hematology, blood chemistry, ecg), or treatment for medical conditions which may interact with clr3001. * women who are pregnant or breast-feeding, or men or women who plan to * infirmities or living in an area limiting participation in the study or compliance with study procedures.
signature diagnostic of non-alcoholic steatohepatitis (nash) by infrared light spectroscopy

Conditions: Obesity

Summary: evaluation of the diagnostic performance of an algorithm developed to detect metabolic profiles specific of non-alcoholic steatohepatitis nash and based on the reading of a blood sample's infrared spectra

the study is aimed at patients suffering from severe or morbid obesity and engaged in a bariatric surgery course. an additional blood sample will be taken upstream of the surgical procedure in the fasted subject. the metabolic fingerprint of the patient will be analyzed on serum from spectral data measured at most two hours after collection. the spectra obtained by the spectroscopy platform will be processed by algorithmic analysis to build the diagnostic test. during the surgical procedure, a liver biopsy will be performed. the sample will be sent to the pathology laboratory for preparation and the slides will then be anonymized to be sent to a specialized laboratory for centralized reading by an expert pathologist. this expert will determine the diagnosis of non-alcoholic steatohepatitis (nash) or non-nash after microscopic analysis of the sample without having any information about the patient. the two results obtained by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (nashmir test).

Eligibility criteria:
inclusion criteria: * patient over 18 years old; * patient able to read, write and understand the french language; * patient who has signed an informed consent form before carrying out any procedure related to the study; * patient supported in bariatric surgery; * patient affiliated to a social security scheme or comparable scheme exclusion criteria: * patient who has already benefited from a bariatric surgery (ring, sleeve, bypass ..); * patient taking: corticosteroid for more than 2 months, amiodarone, methotrexate, tamoxifen, 5-fluorouracil, irinotecan, cisplatin, asparaginase, nucleoside reverse transcriptase inhibitors of hiv, tetracycline, valproic acid, perhexilline; * patient with excessive alcohol consumption (\> 210 g/week in men,\> 140 g/week in women) present or past; * patient with infection or coinfection present or passed with hepatitis b virus, hepatitis c virus or human immunodeficiency virus; * patient with known chronic liver disease (including hemochromatosis, autoimmune hepatitis ...); * pregnant, parturient or nursing women; * patient deprived of liberty by judicial or administrative decision; * patient subject to a legal protection measure;
mngs versus blood culture in fn

Conditions: Infections; Hematologic Diseases; Febrile Neutropenia

Summary: blood stream infection (bsi) during febrile neutropenia (fn) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. the new technique of metagenome next generation sequencing (mngs) has the potential of early and more accurate detection of pathogens. however, this technique has not been well validated for bsi diagnosis in patients with hematological disease. therefore, we designed a prospective multicenter study to compare the diagnosis performance in bsi.


Eligibility criteria:
inclusion criteria: * hematologic disease * febrile neutropenia exclusion criteria: * refuse to consent * age\<=14 * not caused by infection
glucocorticoids and bone in graves' ophthalmopathy

Conditions: Graves Ophthalmopathy

Summary: continuous use of systemic glucocorticoids decreases bone mineral density and increases fracture risk. graves' orbitopathy is treated with weekly infusion of high-dose intravenous glucocorticoid. the investigators aim at investigating whether this treatment regimen also affects bone metabolism.

systemic glucocorticoid increases bone resorption and decreases bone formation and thereby decreases bone mineral density and increases fracture risk. this effect is evident with a daily dose of 5 mg for three months or an accumulated dose of 450mg. there is, however, less evidence that intermittent use of glucocorticoids is harmful to bone. graves orbitopathy is treated with a weekly infusion of the glucocorticoid methylprednisolone and the accumulated dose over a 12-week course sums up to 4,500mg. the investigators therefore want to investigate if that treatment regimen affects bone turnover, bone mineral density, or bone structure in 30 patients with graves' orbitopathy.

Eligibility criteria:
inclusion criteria: * graves ophthalmopathy that requires treatment with intra-venous methylprednisolone exclusion criteria: * treatment with osteoporosis medication * primary hyperparathyroidism * hypoparathyroidism * vitamin d \< 20mmol/l * estimated glomerular filtration rate \< 30 ml/min * liver disease * peroral treatment with glucocorticoids within last three months prior to inclusion
optimizing 6-mercaptopurine therapy in pediatric acute lymphoblastic leukemia by using allopurinol

Conditions: Lymphoblastic Leukemia, Acute, Childhood

Summary: the study will investigate, in children with acute lymphoblastic leukemia during maintenance treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. the effect on hematological and liver toxicity parameters in blood will also be investigated as well as clinical toxicity.

after one month of conventional maintenance therapy (mt) children and adolescents, treated for acute lymphoblastic leukemia on nordic protocols and with wild type thiopurine methyltransferase (tpmt) are eligible for the study. they will first receive a 12 week phase with normal mt during which time repeated sampling of 6-mercaptopurine (6mp) metabolite levels and other laboratory parameters will be performed. after 12 weeks, allopurinol at a dose of 50 mg/sqm is added (simultaneously reducing the dose of 6mp by 50%) and during the next 12 weeks patients are monitored closely for toxicity and samples for determination of metabolite levels and hematological and liver toxicity are obtained regularly. if, after 4 weeks of allopurinol treatment, the levels of 6-thioguanine are below 200 nmol/mmol hemoglobin, the dose of allopurinol will be increased to 100 mg/sqm. allopurinol treatment is continued for 12 weeks after which the patients switch to their original maintenance therapy.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of acute lymphoblastic leukemia * treatment according to nordic society for pediatric hematology/oncology (nopho) all2008 based protocols * age 0-18y at time of initial diagnosis * tpmt wild type * written informed consent exclusion criteria: * mature b cell lymphoblastic leukemia * t(9;22) positive acute lymphoblastic leukemia * unknown tpmt status or presence of tpmt mutation (both heterozygous and homozygous) * known intolerance to any of the chemotherapeutic drugs in the protocol * major organ failure precluding administration of planned chemotherapy * severe liver toxicity defined as persistent (≥ two weeks) elevation of either s-bilirubin \> 50 μmol/l or s-gpt \> 20 x upper normal limit (unl) or p-prothrombin complex \> 1.5. * reduced kidney function defined as s-creatinine ≥ 1.5 x unl. * lactating female or female of childbearing potential not using adequate contraception.