Kornimate/medical-research-clean huggingface dataset:
an open-label trial of oxytocin in adolescents with autism spectrum disorders

Conditions: Autism Spectrum Disorders; Pervasive Developmental Disorders; ASD; PDD

Summary: this study is an 8-week open-label trial testing oxytocin nasal spray (syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (asd). we hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of autism spectrum disorders in adolescents ages 11-17.


Eligibility criteria:
inclusion criteria 1. male and female outpatients ages 11-17 years 2. dsm-iv-tr pdd diagnosis of autistic disorder, asperger's disorder, or pdd-nos as established by clinical diagnostic interview and with the aid of the mgh asd symptom checklist (mgh-asd-scl). 3. at least moderate severity of asd impairment as measured by a raw score of ≥80 on the srs and a severity score of ≥4 on cgi-pdd. 4. participants and their parent/guardian must be able to speak and understand english sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol. 5. subjects and their parent/guardian must be considered reliable reporters. 6. each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent. 7. subjects must be able to participate in mandatory blood draws. 8. subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria. exclusion criteria 1. iq \<85 2. total lack of spoken language 3. dsm-iv-tr pdd diagnosis of rett's disorder or childhood disintegrative disorder. 4. clinically unstable psychiatric conditions or judged to be at serious suicidal risk as determined by evaluating investigator. 5. history of substance use (except nicotine or caffeine) within past 3 months 6. serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. 7. subjects with severe hepatic impairment (lfts \> 3 times uln) and those with severely impaired renal function (egfr \< 30). 8. pregnant or nursing females. 9. known hypersensitivity to oxytocin. 10. severe allergies or multiple adverse drug reactions. 11. a non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician. 12. subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy). 13. investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild. 14. currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.

Keywords: autism spectrum disorders pervasive developmental disorders asd pdd oxytocin syntocinon treatment
effects of gait training with and without pnf on balance ,gait and activities of daily living in parkinson's patients

Conditions: Parkinson Disease (PD); Proprioceptive Neuromuscular Facilitation

Summary: proprioceptive neuromuscular facilitation (pnf) and gait training exercises are specifically used to treat balance, gait and functional activities in parkinson s patients. pnf has been compared with gait training and balance training in other conditions like stroke and multiple sclerosis but limited literatures are present in which pnf has been compared with gait training in parkinson patients.


Eligibility criteria:
inclusion criteria: * parkinson's patients. * patients from both gender around the age of 45-65. * patient with a score of 42 above on the berg balance scale. * patients with shuffling gait * patient with good cognitive function minimum score of 20 or more on mini-mental status examination mmse scale * exclusion criteria: * patients with a history of cva. * patient with peripheral vascular disease. * patient with fracture or dislocation of lower limb. * patient with peripheral nerve injury

Keywords: pnf pd bwstt adls
quality of life with testim®

Conditions: Hypogonadism

Summary: the present non-interventional study is to document the testosterone levels in patients with clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone deficiency syndrome). during testosterone replacement therapy with testim®, the changes in the quality of life - especially with respect to motivation, activity and fatigue - of hypogonadal patients will be documented and correlated with the testosterone levels during the course of therapy.


Eligibility criteria:
inclusion criteria: * therapeutic need according to spc * written informed consent exclusion criteria: * contraindications according to spc
a randomized trial comparing a ventilatory strategy to prevent atelectasis versus a lateral decubitus strategy during robotic bronchoscopy (vespa vs. lads trial)

Conditions: Pulmonary; Lung

Summary: to learn if lads is better than vespa at preventing atelectasis during a robotic bronchoscopy.

primary objective: to compare the proportion of patients developing target-obscuring atelectasis when using a lateral decubitus strategy (lads) vs using a ventilatory strategy to prevent atelectasis (vespa) during robotic bronchoscopy for posteriorly-located peripheral lung lesions. secondary objectives: * to compare the proportion of patients with atelectasis in the target lobe in vespa vs. lads during robotic bronchoscopy. * to compare the proportion of patients with atelectasis obscuring 100%, 50% or more, and less than 50% of the target during robotic bronchoscopy using lads vs. vespa. * to compare the proportion of patients in whom a biopsy sample was not taken due to atelectasis using lads vs. vespa. * to compare the diagnostic yield using lads vs. vespa. * to compare the proportion of tool in lesion (til) using lads vs. vespa. * to compare the diagnostic accuracy (sensitivity and specificity) for malignancy using lads vs. vespa. * to compare the proportion of lads-induced vs. vespa-induced complications. * to compare the proportion of bronchoscopy-induced complications in lads vs. vespa. * to compare the accuracy of 3d-2d image registration using lads vs. vespa. * to compare clinical workflow in robotic bronchoscopy with vespa and lads strategies to identify potential improvements in workflow.

Eligibility criteria:
inclusion criteria: 1. adult patients (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia. 2. lung nodules should be up to 3 cm in diameter and located in right or left bronchial segments b2, b6, b9, and b10. greater than 50% of the volume of the lesion needs to be below a horizontal line traced at the most anterior edge of the corresponding vertebral body. 3. chest ct performed \< 45 days prior to bronchoscopy. 4. voluntary informed consent to participate in the study. exclusion criteria: 1. patients with prior lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) as seen on most recent ct 2. lesions outside of the designated lung areas defined as inclusion criteria. 3. known pregnancy 4. vulnerable population 5. ascites 6. known diaphragmatic paralysis 7. smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume \> 150% of predicted 8. history of primary or secondary spontaneous pneumothorax 9. lung bullae \> 5 cm 10. patients with mediastinal or hilar adenopathy with high suspicion for malignancy in whom lymph node sampling is indicated and should occur prior to robotic bronchoscopy of the peripheral lesion. 11. patient with active covid pneumonia.
educational video for improving follow-up after an emergency department visit for asthma

Conditions: Asthma

Summary: the study will assess the efficacy of a three-part emergency department (ed)-based "asthma belief and control" intervention on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an emergency department visit.

inner-city children are particularly at risk for poor asthma treatment outcomes and frequently obtain their asthma care in the ed. prior studies have had limited success in improving primary care follow-up, quality of care, and long-term outcomes after a pediatric ed visit for asthma. prior ed-based interventions have been designed to address barriers to follow-up with a primary care provider (pcp) such as an inability to obtain a follow-up appointment or lack of transportation. focus groups and surveys of inner-city families have found that beliefs about the benefits of follow-up care and the role of preventive asthma medications have a strong impact on adherence to therapy. this study will develop a brief educational video about the benefits of follow-up asthma care using a multi-disciplinary panel of experts at the children's hospital of philadelphia and focus groups of parents of children with asthma. this educational video will then be combined into an intervention along with symptom screening and a reminder phone call that has been demonstrated to improve follow-up rates in a previous study. the combined intervention will be tested using a randomized trial design to determine its efficacy on healthcare utilization, asthma controller medication use, symptoms, and quality of life during the 6 months following an ed visit. the research is conducted as part of a research career development award.

Eligibility criteria:
inclusion criteria: * age 1-18 years * history of asthma: * at least 2 prior episodes of bronchodilator treatment * no underlying cardiac disease * no other chronic lung disease * residence within philadelphia city limits * discharged from ed after treatment for asthma exclusion criteria: * prior study enrollment * parent unable to speak english * no telephone to be reachable for follow-up calls

Keywords: asthma emergency primary care children
aerobic exercise and blood biochemical factors in spinal cord injury

Conditions: Spinal Cord Injury

Summary: background: patients with spinal cord injury (sci) have a higher prevalence of cardiovascular diseases compared to the healthy population. aerobic exercise training is one of the recommended treatments. however, literature regarding the effect of aerobic training on patients with sci is scarce. this study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with sci. method: male patients with sci and age- and sex-matched healthy individuals were recruited. cardio-pulmonary exercise testing (cpet) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. the patients with sci attended aerobic exercise training for 36 sessions within 12-16 weeks. basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with sci post-training.

the patients with sci were invited to undergo a 12- to 16-week exercise training by arm ergometry. the exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.

Eligibility criteria:
inclusion criteria: * age \>20 years, male sex, and onset of injury more than one year exclusion criteria: * known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers
comparison of initial ozurdex (dexamethasone implant) to avastin (bevacizumab) for treatment of macular edema caused by central retinal vein occlusion (crvo)

Conditions: Macular Edema; Central Retinal Vein Occlusion

Summary: the purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (crvo)after initial treatment with ozurdex (dexamethasone implant) or avastin (bevacizumab).


Eligibility criteria:
inclusion criteria: * presence of central retinal vein occlusion (crvo) * age 18 years or older * etdrs (early treatment diabetic retinopathy study) visual acuity between 3 and 72 letters and approximate snellen equivalent of 20/40 to 20/800 * oct central foveal thickness \>250 microns * negative pregnancy test for women of childbearing potential * ability to provide written informed consent * capable of complying with study protocol exclusion criteria: * history of glaucoma in the study eye with intraocular pressure \>21mmhg on more than one topical medication. combination drugs are considered more than one medication * history of steroid-related glaucoma (steroid response) * previous intraocular injection of steroid medication within 90 days * avastin (bevacizumab) or lucentis (ranibizumab) within 60 days * evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician * previous intraocular surgery (e.g. cataract surgery) with in 60 days * concurrent ocular disease that would limit visual acuity in the opinion of the treating physician * dense cataract that precludes clinical examination and retinal imaging of the retina * history of allergy to dexamethasone, bevacizumab, betadine * ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician * unwilling or unable to follow or comply with all study related procedures * current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment

Keywords: macular edema central retinal vein occlusion
tamsulosin hydrochloride 0.4 mg capsules under fed conditions

Conditions: Healthy

Summary: the objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (manufactured by teva pharmaceutical industries ltd.; distributed by teva pharmaceuticals usa) and flomax® (tamsulosin hydrochloride)0.4 mg capsules (manufactured by yamanouchi pharmaceutical co., japan; distributed by boehringer ingelheim pharmaceutical inc. usa), after a single-dose in healthy subjects under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking male subjects, 18 years of age or older. * bmi greater than or equal to 19 and less than or equal to 30. * negative for: * hiv. * hepatitis b surface antigen and hepatitis c antibody. * using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). * urine cotinine test * no significant diseases or clinically significant findings in a physical examination. * no clinically significant abnormal laboratory values. * no clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ecg). * systolic blood pressure between 100-140 mmhg and diastolic blood pressure between 60-90 mmghg. * be informed of the nature of the study and given written consent prior to receiving any study procedure. exclusion criteria: * known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration. * known or suspected carcinoma. * known history or presence of: * hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity. * alcoholism within the last 12 months. * drug dependence and/or substance abuse. * use of tobacco or nicotine-containing products within the last 6 months. * use of any prescription medication within 14 days prior to period 1 dosing. use of any over the counter (otc) medication within 7 days prior to period 1 dosing. * use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to period 1 dosing. * on a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet). * participated in another clinical trial or received and investigational product within 30 days prior to drug administration. * donated up to 250 ml of blood within the previous 30 days or donated from 251 to 500 ml of blood in the previous 45 days or donated more than 500 ml of blood in the previous 56 days (based on the canadian blood services guideline for blood donation. * difficulty fasting or consuming the standard meals. * do not tolerate venipuncture. * unable to read or sign the icf.
a study to evaluate the safety, tolerability and pharmacokinetics of multiple subcutaneous injections of abt-122 in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetics of abt-122 in subjects with rheumatoid arthritis.

this is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. twenty-four subjects with rheumatoid arthritis will be selected to participate. subjects will be randomized to receive either abt-122 or placebo. abt-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) \> 3 months. * on methotrexate (mtx) therapy =\> 3 months and on a stable dose for at least 4 weeks. * except for mtx, must have discontinued all disease-modifying antirheumatic drugs (dmards) for at least 3 months or 5 half-lives, whichever is longer. * body mass index (bmi) is 19 to 38, inclusive. * other than ra, subjects should be in good general health. exclusion criteria: * evidence of anti-abt-122 antibody on a serum sample taken at screening. * history of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any igg containing product. * history of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days. * history or evidence of active tuberculosis (tb) or the subject has evidence of risk factor for latent tb. * subject has any medical condition or illness other than ra that is not well controlled with treatment.

Keywords: tolerability immunogenicity safety rheumatoid arthritis pharmacokinetics
treatment of hemorrhoid with 1940nm laser procedure

Conditions: Hemorrhoids

Summary: patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with aethoxysklerol

prospective randomized, control study. patients with hemorrhoids 2-3 will be randomized in two groups. 100 patient in each. patients will be treated with laser 1940nm or sclerothearapy with aethoxysklerol. follow up for one year. primary end point - recurrence of hemorrhoids desease.

Eligibility criteria:
inclusion criteria: hemorrhoids 2-3st exclusion criteria: acute hemorrhoids ibd psychosomatic diseases previous surgical interventions

Keywords: hemorrhoids, laser, sclerotherapy
oral omadacycline vs. placebo in adults with ntm pulmonary disease caused by mycobacterium abscessus complex (mabc)

Conditions: Mycobacterium Infections, Nontuberculous; Mycobacterium Abscessus Infection; Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterial Pulmonary Infection

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with nontuberculous mycobacterial (ntm) pulmonary disease caused by mycobacterium abscessus complex (mabc)

the total duration of subject participation in the study is approximately 5 months which includes a total duration of study treatment for approximately 3 months (84 days). eligible participants will be randomized 1.5:1 to receive 3 months of treatment with either omadacycline or placebo (monotherapy). the study will use a double-dummy design in order to maintain the study blinding.

Eligibility criteria:
key inclusion criteria: * has a diagnosis of nontuberculous mycobacterial pulmonary disease caused by mabc * has at least 2 of the following ntm-infection symptoms present at screening and baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss. * at least 1 positive pulmonary (sputum) culture for mabc in the 6 months prior to screening and 1 positive culture at screening * radiographic evidence of mabc infection via computed tomography (ct) scan of the chest within 3 months prior to screening * in the opinion of the investigator, guideline-directed antibiotic therapy for treatment of mabc will not be required within the next 3 months, and a delay, in order for the subject to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable * additional inclusion criteria as per protocol key exclusion criteria: * has received antibiotic treatment within 6 months prior to screening for mabc or mac * has received systemic or inhaled antibiotic therapy (other than chronic macrolide therapy) within 4 weeks prior to screening * has any of the following medical conditions: * active pulmonary malignancy, or any type of malignancy requiring chemotherapy or radiation within 1 year prior to screening * active allergic bronchopulmonary mycosis, or any other condition requiring chronic treatment with systemic corticosteroids within 90 days prior to screening * radiologic evidence of cavitary disease * known active pulmonary tuberculosis * cystic fibrosis * history of lung transplantation * another advanced lung disease with a known percent predicted forced expiratory volume in 1 second \< 30%. * disseminated or extra-pulmonary ntm disease * has been previously treated with omadacycline * has a history of hypersensitivity or allergic reaction to tetracyclines * additional exclusion criteria as per protocol

Keywords: nontuberculous mycobacteria (ntm) mycobacterium abscessus complex (mabc) ntm pulmonary disease ntm lung disease