Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of flamboyant 125/12 association in the treatment of adults with moderate asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the efficacy and safety of flamboyant 125/12 association in adults with asthma.


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * participants aged 18 years or more; * diagnosis of uncontrolled moderate asthma; * participants with forced expiratory volume in 1 second (fev1) \> 60% of predicted; exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * known hypersensitivity to the formula components used during the clinical trial; * history of alcohol and/or substance abuse within 12 months prior to screening visit. * current smoking or smoking history equivalent to "10 pack years" * participants with untreated oral candidiasis; * pulmonary disease history (e.g., chronic obstructive pulmonary disease \[copd\], cystic fibrosis, bronchiectasis, tuberculosis); * participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks; * known hiv-positive status or active hepatitis b or c virus test result * participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia; * participants with current medical history of cancer and/or cancer treatment in the last 5 years; * participants using medications that would have an effect on bronchospasm and / or lung function.

Keywords: asthma
self-confidence study in patients with argus ii artificial retina

Conditions: Pigmentary Retinopathy

Summary: to evaluate whether the use of the argus ii retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa


Eligibility criteria:
inclusion criteria: * major patient (≥18 years old) * patient already operated in france with artificial retina and having 1 year of follow-up * patient who has agreed to use his medical data for research purposes exclusion criteria: - refusal to participate in the study

Keywords: pigmentary retinopathy argus ii retinal prosthesis self-confidence
psa versus stn dbs for dt

Conditions: Dystonic Tremor

Summary: the aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (psa) versus the subthalamic nucleus (stn) for the treatment of dystonic tremor (dt) in a randomized, double-blinded, cross-over manner.

this is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of psa and stn dbs in treating dystonic tremor. enrolled patients will undergo bilateral dbs surgery, targeting both psa and stn with single trajectory. three months post-implantation, patients enter a 4-month double-blinded crossover phase with psa and stn dbs in randomized order. after 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.

Eligibility criteria:
inclusion criteria: * diagnosed with dystonic tremor based on the mds 2018 consensus * duration of dt symptoms: ≥3 years of motor symptoms * if the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent * good compliance and written informed consent exclusion criteria: * any intracranial abnormalities that would prevent dbs surgery * any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, cluster b personality disorders) * severe cognitive impairment, moca score \<24 * any current substance or alcohol abuse according to dsm-v criteria * any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints * any terminal illness with a life expectancy of \<1 year

Keywords: dystonic tremor deep brain stimulation posterior subthalamic area subthalamic nucleus
endostatin in combination with chemotherapy for metastatic nasopharyngeal carcinoma

Conditions: Effects of Chemotherapy; Stage IVC Nasopharyngeal Carcinoma

Summary: the investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (npc).

to evaluate the progression free survival (pfs), overall survival (os), acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (npc).

Eligibility criteria:
inclusion criteria: * metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ecog ps 0-1，electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up. exclusion criteria: * to give local treatment,clinical severe infection(\>grade 2),with the central nervous system metastases,ecog ps≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.

Keywords: nasopharyngeal carcinoma recombinant human endostatin chemotherapy gemcitabine and cisplatin
the correlation of heart hemodynamic status between 320 multidetector computed tomography, echocardiography and cardiac catheterization in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: with the advances in multidetector computed tomography (mdct) technology, ct angiography (cta) of the coronary arteries using 64-slice or dual-source ct systems has evolved into a robust, alternative, noninvasive imaging technique to rule out coronary artery disease (cad). reported sensitivities and specificities of coronary cta can compete with those of catheter angiography. because ct is the major source of ionizing radiation in medicine, dual isotope myocardial perfusion scintigraphy and coronary cta 16-, 64-slice mdct and dsct scanners are associated with the highest amount of radiation dose. recently, a new generation of mdct machines with even more detector row (320) has become clinically available. the maximum detector width of 16 cm enables the entire heart to be examined in a single rotation and within a single heartbeat and is expected to substantially reduce artifacts from breathing and body motion. due to high volume coverage, 320-slice ct machines are able to perform a nonspiral, ecg-gated examination of the heart within a single breath-hold. the purpose of this study was to investigate the correlation of hemodynamic status of 320 mdct, echocardiography, and coronary catheterization in patients who suspected coronary artery disease.


Eligibility criteria:
inclusion criteria: 1. intermediate or high risk for coronary artery disease 2. healthy volunteers exclusion criteria: 1. unstable angina 2. acute myocardial infarction 3. active cancer status 4. renal failure(creatinine \> 1.5 mg/dl) 5. contrast allergy history 6. pregnancy

Keywords: cad
comparison of caudal block and erector spinae block for postoperative analgesia

Conditions: Circumcision; Lower Abdominal Surgery

Summary: caudal block (cb), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. however, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. one of these blocks, the erector spina plane (esp) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients.

circumcision and any lower abdominal surgery in the pediatric population result in a very painful postoperative period, even when each procedure is evaluated separately. caudal block (cb), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. however, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. one of these blocks, the erector spina plane (esp) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients. as far as we know, there is no previous study in the literature comparing cb and esp block in pediatric patients.

Eligibility criteria:
inclusion criteria: * 1-7 years of age * asa (american society of anesthesiologists) i-ii group * scheduled for circumcision and unilateral lower abdominal surgery at the same session * able to communicate in turkish * willing to participate to the study (parents and children) exclusion criteria: * less than 1 or more than 7 years of age * a neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital lumbar anomaly, liver and/or kidney disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination * unwilling to to participate to the study ((parents or children)

Keywords: ultrasound pain caudal block erector spinae block
quality of life of patients with glioblastoma (gbm) treated with tumor-treating fields

Conditions: Malignant Glioma

Summary: this purpose of this study is to describe the effect of tumor treating fields (novottf) on quality of life (qol), including exercise, sleep quality, and mood, in patients with world health organization (who) grade iv malignant glioma who have been prescribed and approved to receive optune™. this is an observational, longitudinal study, meaning that information about qol will be collected over time while the patient is using the novottf device (for example, optune™).

patients will be provided with a fitbit charge hr™, which they will begin wearing immediately to collect baseline information. the study team will teach the patients how to use the fitbit and the associated smart phone application. patients will also set an account with a platform that will provide information from the fitbit (number of steps, sleep behaviors, and exercise log) to the study team. patients will also have blood drawn, do a 6-minute walk test, and complete questionnaires at clinic visits 1, 8, 16, and 24 weeks after receiving the fitbit. at the end of the study, patients will return the fitbit to the study team.

Eligibility criteria:
inclusion criteria: * written informed consent prior to beginning specific protocol procedures * histologically proven world health organization (who) grade iv malignant glioma * completed standard-of-care treatment for newly diagnosed who grade iv malignant glioma, consisting of temozolomide (tmz) and radiation therapy (rt) * signed optune™ prescription form indicating intention of initiating novottf therapy * stable disease status * patients ≥ 18 years of age * karnofsky performance status (kps) ≥ 70 * patient must be able to ambulate and complete the 6-minute walk test without use of a walker, cane, or any assist device * technology requirement: * patients need to own a smart phone that can interface with the fitbit charge hr™. * patients must be willing to provide their own internet access for this study. this will include either a data plan or wi-fi access on the patient's smart phone for use of the fitbit charge hr™ app. they will also need internet access (through their smart phone or home computer) for setting up a sghix account. patients are welcome to use the free guest wi-fi access within the duke outpatient clinic area for the purpose of this study. * patients will need a home computer or adaptor with usb port to charge the fitbit charge hr™. exclusion criteria: * non-english speaking or inability to read and understand english. * presence of cardiovascular disease that would make physical activity risky, at the discretion of the provider. * any patient who is unable to comprehend and operate the activity tracker, at the discretion of the enrolling provider.

Keywords: pro000888900 katherine peters optune novottf action quality of life tumor treating fields glioblastoma
asthma in the elderly: the effect of montelukast

Conditions: Asthma

Summary: this is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. montelukast is a leukotriene receptor antagonist u.s. f.d.a. approved for the treatment of asthma in subjects who are 12 month old and older. this study is being done because there has been no placebo controlled study of montelukast focused on this group of patients. elderly asthmatics have been mostly ignored in asthma studies. they are more likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger asthmatics. the pathophysiology of asthma in the elderly is typically different than in younger patients. this is a double-blind, placebo-controlled, crossover study. investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco products in their lifetime. after a run-in period of one week, the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa. primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores, the asthma control test and the number of puffs of albuterol, and spirometric values (fev1). secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum ige levels.


Eligibility criteria:
inclusion criteria: * asthma diagnosed for at least one year; * able to swallow small capsules. exclusion criteria: * tobacco smoking for more than 10/pack years; * previous adverse reaction to montelukast or other leukotriene inhibitor; * history of hypereosinophilic disorder other than atopic disease; * treatment with montelukast within 4 weeks from randomization; * asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.
mechanisms of fronto-subcortical dysfunction: comparing pd and ocd

Conditions: Parkinson's Disease; Obsessive-Compulsive Disorder

Summary: the purpose of this study is to characterize and compare irregularities in dopaminergic function in fronto-subcortical circuits, between parkinson's disease patients (on and off medication) and patients with obsessive-compulsive disorder, by examining performance on cognitive tasks involving cognitive flexibility, decision-making, and attentional bias.


Eligibility criteria:
inclusion criteria: * idiopathic pd or * ocd * for control group - age-matched to study groups exclusion criteria: * psychotic symptoms (past or present) * head injury with loss of consciousness * other neurological conditions (excepting pd in pd group) * for ocd group - use of dopaminergic medications
french observatory of electroconvulsive therapy (ect)

Conditions: Mental Disorders

Summary: since the 30s, ect has been a psychiatric treatment mainly used for drug-resistant depressive illnesses. clinical studies have shown its therapeutic efficiency compared to standard treatments also in other psychiatric illnesses. although efficient, ects also induce side effects. in france, there is currently no consensus on providing the suitest medical care. it is therefore important to review our nowadays health care models in order to maintain and improve the recommendations of the french national agency for accreditation and evaluation in health, the last of which date from 1997! within this context, this project has the dual objective of (1) identifying ect medical procedure in france and (2) developing research to evaluate and to improve the effectiveness of this treatment.


Eligibility criteria:
inclusion criteria: * patients consecutively referred for ect. exclusion criteria: * not specified
studying stored samples from patients with localized prostate cancer treated on clinical trial nci-00-c-0154

Conditions: Prostate Cancer

Summary: rationale: studying samples of blood in the laboratory from patients before and after treatment may help doctors learn more about the effects of the treatment on cells. purpose: this clinical trial is studying samples collected from patients with localized prostate cancer who received treatment on clinical trial nci-00-c-0154.

objectives: primary * evaluate the formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy in prostate cancer patients previously enrolled on clinical trial nci-00-c-0154. * evaluate immunologic response. secondary * clone the underlying tumor antigens discovered through serex. outline: samples previously collected on clinical trial nci-00-c-0154 (whole blood, serum, and peripheral mononuclear blood cells) are analyzed for immunologic responses and evidence of formation of anti-tumor antibodies. western blot is used to detect any evidence of vaccine-induced autoantibody responses. if there is an indication of response, serex is used to clone the underlying antigens.

Eligibility criteria:
disease characteristics: * diagnosis of localized adenocarcinoma of the prostate * received treatment on clinical trial nci-00-c-0154 patient characteristics: * consented the use of their collected blood cells for future research while enrolled on nci-00-c-0154 prior concurrent therapy: * see disease characteristics

Keywords: stage i prostate cancer stage ii prostate cancer stage iii prostate cancer adenocarcinoma of the prostate
exoskeleton impact on the quality of life on patients with spinal muscular atrophy

Conditions: Spinal Muscular Atrophy Type II

Summary: the purpose of this study is to evaluate the impact of the use of a pediatric exoskeleton on the quality of life of children, specifically in the psychological and care dimensions. other objectives are to evaluate changes at the physical and functional level.


Eligibility criteria:
inclusion criteria: * patients between 4 and 9 years old * patients with a confirmed diagnostic of spinal muscular atrophy type ii exclusion criteria: * weight over 40 kg * hip-knee distance less than 22 cm or greater than 38cm * knee-ankle distance less than 21 cm or greater than 37cm * distance between trochanters less than 24 cm or greater than 40cm * joint range limit greater than 20º

Keywords: exoskeleton spinal muscular atrophy care quality of life robotics
evaluation of a nutritional supplement for people with type 2 diabetes.

Conditions: Diabetes

Summary: the objective of this trial is to evaluate a nutritional supplement for people with diabetes.


Eligibility criteria:
inclusion criteria: * subjects will be eligible for the study if they meet all of the following inclusion criteria: 1. diagnosis of type 2 diabetes. 2. age between 18 and 75 years. 3. hba1c \> 6.0 but ≤ 8.5 4. if female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration. 5. bmi \> 18.5 kg/m2 and \< 40.0 kg/m2. 6. chronic medication dosage must be stable for at least two months prior to screening visit. 7. subject states that they are a habitual consumer of a morning meal. exclusion criteria: * subjects will be excluded from the study if they meet any of the following criteria: 1. use of exogenous insulin or glp-1 agonists for glucose control. 2. diagnosis of type 1 diabetes. 3. history of diabetic ketoacidosis. 4. current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks. 5. active malignancy. 6. significant cardiovascular event \< 12 weeks prior to study entry. 7. end stage organ failure or status post organ transplant. 8. active metabolic, hepatic, or gastrointestinal disease. 9. chronic, contagious, infectious disease. 10. currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose. 11. history of fainting or other adverse reactions in response to blood collection. 12. clotting or bleeding disorders. 13. allergy or intolerance to study product ingredient.
a study of severe uterine bleeding following exposure to direct oral anticoagulants

Conditions: Uterine Hemorrhage

Summary: the purpose of this study is assess the: (a) incidence of severe uterine bleeding (sub) following exposure to individual direct oral anticoagulant (doacs) (rivaroxaban, apixaban, dabigatran) and warfarin, (b) individual doacs (rivaroxaban, apixaban, dabigatran) association with risk of sub compared with warfarin, and (c) individual doacs (rivaroxaban, apixaban, dabigatran) associated with risk of sub compared with other individual doacs - among women with prior diagnoses for doac and warfarin indications (non-valvular atrial fibrillation \[nvaf\], venous thromboembolism \[vte\], total hip replacement \[thr\] or total knee replacement \[tkr\]).


Eligibility criteria:
inclusion criteria: * non-valvular atrial fibrillation (nvaf) diagnosis any time prior and no venous thromboembolism (vte) (deep vein thrombosis \[dvt\] or pulmonary embolism \[pe\]) in the past 183 days and no knee or hip replacement surgery in the past 35 days * vte (dvt or pe) in the past 183 days and no nvaf diagnosis any time prior and no knee or hip replacement surgery in the past 35 days * total hip replacement (thr) or total knee replacement (tkr) in the past 35 days and no non-valvular atrial fibrillation any time prior and no venous thromboembolism (deep vein thrombosis of pulmonary embolism) in the past 183 days exclusion criteria: * participants were excluded for edoxaban exposure, exposure to other exposures of interest (example: direct oral anticoagulant \[doacs\] for warfarin exposure cohort), hysterectomy, vaginal bleed, and medical, surgical, or transfusion management for vaginal bleeding any time prior to the index exposure