Kornimate/medical-research-clean huggingface dataset:
a long term follow-up study of amg0001 in subjects with critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: subjects from the ag-cli-0206 phase 3 study that received amg0001 will be eligible for the ag-cli-0206-ltfu study

the study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with amg0001. a health questionnaire will be used to collect specific information from the subject every 6 months. only those subjects that were randomized in the ag-cli-0206 study and who received amg0001 are eligible to participate in this long term follow-up study. subjects that received placebo will not be eligible for participation in this study.

Eligibility criteria:
inclusion criteria: * subjects who have been treated with amg0001 in the ag-cli-0206 study. * subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative. * subjects who have provided a release of information to the sponsor. exclusion criteria: * subjects who were not enrolled in the agcli-0206 study. * subjects who enrolled in ag-cli-0206 and who were not treated with amg0001. * subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative. * subjects who have not provided a release of information for the sponsor to contact them directly via phone, email and/or mail.
efficacy and safety of the mometasone nasal gel in the treatment of persistent allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.


Eligibility criteria:
inclusion criteria: * signed consent of the patient; * clinical diagnosis of moderate - severe persistent allergic rhinitis according to aria classification(allergic rhinitis and its impact on asthma); exclusion criteria: * patients with any clinically significant disease that in the investigator is opinion can ´t participate in the study; * patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; * patients with history of hypersensitivity to any of the formula compounds; * participation in clinical trial in the year prior to this study; * pregnancy or risk of pregnancy and lactating patients; * patients who were in use of drugs that can interfere with evaluation; * decongestants dependent patients or patients receiving allergen specific immunotherapy; * patients on treatment with monoamine oxidase inhibitors (maois); * history of hypertension, coronary artery disease, cardiac arrhythmias, glaucoma, hyperthyroidism and / or prostatic hypertrophy.
macroscopic on cite evaluation of eus-fna specimen with 22 g needle

Conditions: GI Cancer

Summary: in order for the diagnosis of digestive system tumors and their appropriate treatment afterward, the type of these tumors should be determined by the pathologist. pathology doctors need sufficient tissue (a small part of the organ thought to be diseased) to make a diagnosis. tissue samples were taken from the patients by biopsy procedure. it is examined with microscopes by performing various staining and occasionally it is reported that sufficient tissue cannot be provided to make a diagnosis. in this case, patients may be subjected to repeated biopsy procedures. the aim of this study is to investigate whether the biopsy material obtained by endoscopic ultrasonography (eus) is sufficient for the diagnosis of the pathology physician with the naked eye. researchers will try to determine to what extent the physician performing the biopsy procedure can predict whether the tissue he has obtained is sufficient for the pathologist. in this way, researchers think that fewer biopsy repetitions will be needed in the future.

this study was designed to improve the acquisition of sufficient tissue (eus-fna) with endosonography-assisted fine needle aspiration biopsy, which has been approved and used worldwide for the diagnosis of digestive system diseases. the procedure to be applied in the study is to determine the visible tissue fragments in the sample to be taken after the standard eus-fna procedure and to compare it with the diagnosis made by the pathologist. patients with a tumor detected in the digestive system and referred to the investigation unit for tissue diagnosis will be included in this study. the data obtained in the study will be collected prospectively and will be analyzed retrospectively.

Eligibility criteria:
inclusion criteria: 1. i̇n the age range of 18-80 years old 2. tumour detected withcross-sectional imagined technics in the digestive system exclusion criteria: 1. refuse to give written informed consent 2. established bleeding disorder 3. inr\>1.5iu plaelet count \<100000/dl
copaxone subcutaneous injection syringe special drug use-result investigation (all-case investigation) "prevention of relapse of multiple sclerosis"

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate the safety and efficacy of copaxone subcutaneous injection syringe (hereinafter referred to as copaxone) in patients with multiple sclerosis in the routine clinical setting.

the drug being tested in this study is called glatiramer acetate is being tested to treat people who have multiple sclerosis. this study will look at the safety and efficacy of glatiramer acetate in patients with multiple sclerosis in the routine clinical setting. the study will enroll approximately 1000 patients. • glatiramer acetate subcutaneous injection syringe this multi-center trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: - all patients treated with copaxone from the first day of market launch of the product exclusion criteria: -none
intranasal oxytocin administration and the neural correlates of social and non-social visual perception

Conditions: Social Perception

Summary: the objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using eeg and the event-related potential (erp) technique. the value of eeg is its high temporal specificity, enabling precision in the timing of social behavior to be addressed. in order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during eeg recording, namely infant and adult faces and houses. brain responses after intranasal oxytocin will then be compared with placebo, to examine the effect of intranasal oxytocin on central nervous system activity. we hypothesize that intranasal oxytocin will enhance the neural response to social stimuli (infant and adult faces) but not to non-social stimuli (houses).


Eligibility criteria:
inclusion criteria: * adults ages 18-64 * good medical health * ability to understand and speak english exclusion criteria: * pregnancy * medical illnesses: moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza). * cardiovascular risk factors: history of hypertension with baseline blood pressure above 140 mm hg (systolic) over 90 mm hg (diastolic). also any history of syncope and/or baseline blood pressure below 100 mm hg (systolic). * cns disease: known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness \> 3 minutes. * medication status: individuals on stable doses of a neuroleptic and/or an antidepressant medication for at least the past 6 weeks will be allowed to participate in this study. the use of other psychotropic medications will not be allowed. females taking contraceptive hormones will not be able to participate in the study. * a history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness

Keywords: intranasal oxytocin social perception eeg/erp
a trial of ferumoxytol for the episodic treatment of iron deficiency anemia in pediatric participants with chronic kidney disease

Conditions: Iron Deficiency Anemia

Summary: study amag-fer-ckd-253 is an extension study of the combined amag-fer-ckd-251 (nct01155375) and amag-fer-ckd-252 (nct01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (ida) with ferumoxytol.

study amag-fer-ckd-251 was a study evaluating the efficacy and safety of intravenous (iv) ferumoxytol in pediatric participants with dialysis-dependent chronic kidney disease (ckd). study amag-fer-ckd-252 was a study evaluating the efficacy and safety of iv ferumoxytol in pediatric participants with nondialysis-dependent chronic kidney disease. due to significant challenges with enrollment for both studies, study amag-fer-ckd-252 was combined with study amag-fer-ckd-251 and enrollment continued under study amag-fer-ckd-251. participants were enrolled by age cohorts in a stepwise manner following a safety review by the data safety monitoring board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest: randomization was stratified by the following age cohorts: 12 to \<18 years, 6 to \<12 years, 2 to \<6 years, and 6 months to \<2 years. participants who completed the combined amag-fer-ckd-251 and amag-fer-ckd-252 studies had the option of participating in this extension study.

Eligibility criteria:
key inclusion criteria include: 1. participants who had completed participation in the combined amag-fer-ckd-251 and amag-fer-ckd-252 studies within 4 weeks of screening 2. female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study 3. participant and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study key exclusion criteria include: 1. experienced a serious adverse event related to iv iron therapy in the combined amag-fer-ckd-251 and amag-fer- ckd-252 studies 2. hemoglobin level ≤7 g/dl

Keywords: iron deficiency anemia feraheme ferumoxytol chronic kidney disease ckd pediatric dialysis-dependent nondialysis-dependent
integrated diagnosis and treatment of adults with attention-deficit/hyperactivity disorder

Conditions: Adult Attention-deficit/Hyperactivity Disorder

Summary: non-interventional study to gain further information about the therapy progression in routine treatment of adults with attention-deficit/hyperactivity disorder (adhd). main focus will be on the improvement of the clinical global impression (cgi) in comparison to the outcome of randomized, controlled studies.


Eligibility criteria:
inclusion criteria: * adult patients with newly diagnosed adhd exclusion criteria: * known sensitivity to methylphenidate or any of the excipients * glaucoma * phaeochromocytoma * during treatment with non-selective, irreversible monoamine oxidase (mao) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis * hyperthyroidism or thyrotoxicosis * diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder. * diagnosis or history of severe and episodic (type i) bipolar (affective) disorder (that is not well-controlled) * pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels) * pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke * a history of pronounced anacidity of the stomach with a ph value above 5.5, in therapy with h2-receptor blockers or in antacid therapy,

Keywords: non-interventional study attention deficit/hyperactivity disorder adhd
study of post-training supports for health workers in benin

Conditions: Malaria; Pneumonia; Diarrhea; Measles; Malnutrition

Summary: the objective of this study was to determine the effectiveness and cost-effectiveness of a package of interventions to support health workers in benin (in west africa) who had been trained to use integrated management of childhood illness guidelines (i.e., guidelines intended to improve the treatment of childhood illnesses).

integrated management of childhood illness (imci) is a child health strategy in developing countries with a goal of improving the treatment of illnesses at first-level health facilities through the use of clinical practice guidelines. the world health organization (who) recommends implementing the guidelines with an 11-day training course. there is a concern that health workers might not master all aspects of the guidelines and that health worker performance may deteriorate over time. in 1999, benin (in west africa) was planning to implement imci. in response to concerns about how well health workers would follow imci guidelines, interventions were designed to support health workers after imci training: 1) regular supervision of health workers; 2) supervision of supervisors; 3) job aids; and 4) non-financial incentives for health workers. these interventions were intended to be used together. the objective of this study was to determine the effectiveness and cost-effectiveness of the package of interventions to support imci-trained health workers in benin.

Eligibility criteria:
inclusion criteria: * inclusion criteria for health facilities were: 1) public and licensed private health facilities providing outpatient services, and 2) the level of care was appropriate for use of integrated management of childhood illness (imci) guidelines. * inclusion criteria for consultations were children 1 week - 59 months old seen for any illness during regular working hours (typically 8am-6pm) on weekdays. exclusion criteria: * health facilities in which the level of care was not appropriate for use of integrated management of childhood illness (imci) guidelines(i.e., one referral hospital and one sub-specialty hospital).

Keywords: benin child health developing country health services research health worker performance integrated management of childhood illness
eflornithine to prevent cervical cancer in patients with cervical intraepithelial neoplasia

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. the use of eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer. purpose: randomized phase ii trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.

objectives: i. compare the efficacy of eflornithine versus placebo in causing regression in patients with cervical intraepithelial neoplasia. ii. compare the qualitative and quantitative toxicities of these treatment regimens in these patients. iii. establish the biochemical tissue markers of dna content, pcna, the ras oncogene, egfr, and keratin and involucrin as intermediate biomarker end points for squamous carcinogenesis in these patients. outline: this is a randomized, double blind, multicenter study. patients are randomized to one of three treatment arms. arm i-ii: patients receive one of two different doses of oral eflornithine daily. arm iii: patients receive oral placebo daily. treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. patients are followed at 28 days, and then at 6, 12, 18, and 24 months. projected accrual: a total of 180 patients (60 per treatment arm) will be accrued for this study.

Eligibility criteria:
inclusion criteria: 1) women with newly diagnosed or recurrent cin grade 2-3, involving an area 3times larger than the biopsy site. patients must be \> 18 years old, with a performance status less than or equal to 2 (zubrod scale) and a predicted life expectancy of greater than or equal to 12 months. patients must have a medically safe form of contraception for the duration of the study. all patients must complete the of pretreatment evaluation, consent to colposcopy and cervical biopsy for histologic evaluation exclusion criteria: 1) patients may not have had a prior malignancy.

Keywords: cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 eflornithine
rural adult and youth sun protection study

Conditions: Melanoma (Skin); Skin Cancer

Summary: the purpose of this study is to help prevent skin cancer by improving the use of sun protective behaviors among youths living in rural communities in utah and west virginia.

children living in rural and under-served communities are at high risk for skin cancer; however, there are no evidence-based sun safety interventions showing durable effects for this vulnerable pediatric population. the objective of this proposal is to rigorously test a novel, multi-level approach to skin cancer prevention among young rural children that is delivered through developmental baseball leagues. to attain this objective, the investigators will conduct a two-arm cluster-randomized trial with the primary outcome being multi-behavior sun protection change among children.

Eligibility criteria:
parent inclusion criteria: i. adults who currently have children ages 3 and older years of age playing on participating sports teams in leagues serving rural areas in utah or west virginia (rural is defined as ≥4 by the ruca or rucc systems) ii. live and/or work in rural communities in utah or west virginia (≥4 as defined by the ruca or rucc systems) coach/leader inclusion criteria: i. adults who serve as coaches or leaders of recreational sports (i.e. baseball/softball, soccer, flag football, etc.) teams or developmental programs serving children ages 3 and older ii. live and/or work in rural areas of utah or west virginia (rural is defined as ≥4 by the ruca or rucc systems) participant inclusion criteria for minor participants (ages 3 and older) are as follows: i. live in rural communities and/or participate in sports leagues serving rural communities in utah or west virginia (≥4 as defined by the ruca or rucc systems). participant inclusion criteria for key informant interviews are as follows: i. adults who serve as leaders or who are affiliated with sports leagues or community groups serving rural youths and/or adults who currently have minor children 3 years of age or older playing on participating sports teams and/or adults who live and/or work in rural communities in utah or west virginia ((≥4 as defined by the ruca or rucc systems) local sports leagues will be eligible to participate if they convene recreational sports (i.e. baseball/softball) teams or developmental programs (i.e. t-ball and coach pitch) for children ages 3 and older. exclusion criteria: * adults and children who do not speak or read english will be excluded. * for individuals asked to complete surveys, individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of these surveys will be excluded.

Keywords: rural melanoma, skin cancer prevention underserved communities youth sports
"iron overload and endocrinological diseases"

Conditions: Iron Overload; Thalassemia Major; Thalassemia Intermedia; Hemochromatosis; Endocrinopathy

Summary: patients with hemochromatosis or thalassemia develop progressive tissue and organs damages secondary to iron overload. iron overload can result both from transfusional hemosiderosis and excess gastrointestinal iron absorption. iron deposition in the heart, liver, and multiple endocrine glands results in severe damage to these organs, with variable degrees of endocrine and organ failure. although patients with iron overload often present endocrine disorders, the pathogenetic mechanisms underlying endocrinopathies are not completely clear. in particular it is not elucidated if the spectrum of endocrinopathies could change with advancing age. all endocrinological comorbidities can develop from a primary damage of the target gland, from pituitary secondary failure or from both. the aim of this study is to investigate the prevalence of endocrinological diseases in adult patients with iron overload due to β-thalassemia or hemochromatosis and their impact on well-being and quality of life. the study design is a prospective cross-sectional clinical study. all subjects enrolled will be evaluated for the endocrine diseases. the study protocol will include data collection from family and patients' history of diseases, physical examination, hormonal assessment for all endocrine axes and instrumental examinations. the results will provide evidence on the prevalence of endocrine diseases in patients with iron overload and will add information to characterize the type and the degree of endocrine deficiencies, and on the pathogenic mechanisms involved, in order to individualize diagnostic and therapeutic approaches.


Eligibility criteria:
inclusion criteria: * certain diagnosis of β-thalassemia major or intermedia * certain diagnosis of hereditary hemochromatosis * adult patients with an age between 18 and 65 years exclusion criteria: * subjects with an age \ 65 years