Kornimate/medical-research-clean huggingface dataset:
phase 1b study of tizanidine in pediatric patients with cerebral palsy

Conditions: Spasticity Due to Cerebral Palsy

Summary: a single-dose, phase 1b, multicenter, open-label study to assess the pharmacokinetics, safety and tolerability, and pharmacodynamics of tizanidine at 4 different oral dose levels in pediatric subjects 2 to 16 years old with mild to moderate spasticity due to cerebral palsy.

evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of botox injection inclusion; family participation refusal / disinterest and gastric or jejunostomy tube placement. a third protocol amendment to improve enrollment was discussed with the investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. the investigative sites were notified that the study was closed to enrollment march 27, 2012.

Eligibility criteria:
inclusion criteria: * have clinically diagnosed spasticity resulting from cerebral palsy * have a motor disability resulting from a static, nonprogressive brain injury or malformation occurring prenatally or before the age of 2 years * have mild to moderate spasticity at screening * have a parent or legally accepted representative able to understand and comply with study requirements who voluntarily provides informed consent and agrees to be primarily responsible for adhering to the requirements of the study exclusion criteria: * have a history of hypersensitivity or allergic reaction to tizanidine or any of the capsule components * have dietary restrictions or food allergies that conflict with a standardized meal * have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic, endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic intervention * have an ongoing seizure disorder that requires medical therapy
cognitive control training for urgency in a naturalistic clinical setting

Conditions: Impulsive Behavior; Mental Disorders

Summary: this study is designed to test whether computer-based cognitive exercises are helpful for reducing a specific type of impulsivity. also, the study is testing whether these are exercises are associated with specific changes in behavior and in the brain. participants will be psychiatric patients enrolled in a partial hospitalization program. half of these participants will receive usual treatment, and half will complete computer-based cognitive exercises in addition to usual treatment.

impulsivity has different components. one personality trait related to impulsivity, known as "urgency," is strongly related to many different mental health symptoms and risky behaviors. urgency refers to impulsivity specifically in the context of strong emotions. research shows that higher levels of urgency are related to specific deficits in cognition. problems with response inhibition--the ability to cancel or withhold a planned action--are associated with urgency. also, research shows that difficulties in another aspect of cognition--working memory--may moderate the relationship between inhibition deficits and urgency. one previous study found that people who practiced computerized response inhibition and working memory tasks for two weeks reported significant decreases in urgency. it is unknown if these computerized tasks would be helpful for reducing urgency in adults with psychiatric disorders. furthermore, it is unknown if changes in urgency are related to changes in the brain mechanisms that help to support response inhibition. this study will collect data on brain activity while people are completing response inhibition tasks.

Eligibility criteria:
inclusion criteria: * currently receiving treatment at the mclean hospital behavioral health partial hospital program (php) * report an average score of 3.0 or greater on the negative urgency scale, the positive urgency scale, or 3.0 or greater on both scales, upon admission to the php * right-handed (if enrolled in eeg arm) exclusion criteria: * currently undergoing electroconvulsive therapy (ect) * current symptoms of acute mania * current symptoms of acute psychosis * history of traumatic brain injury

Keywords: impulsivity inhibition (psychology) working memory cognitive remediation
drug therapy and surgery in congenital heart disease with pulmonary hypertension

Conditions: Congenital Heart Disease; Pulmonary Arterial Hypertension

Summary: the purpose of this study is to test the hypothesis that treating pah-chd patients preoperatively with pah drugs and keeping them on treatment for six months after surgery reduces the risk of immediate postoperative death and the risk of residual pah at six months following operation to \<10%.

pulmonary arterial hypertension (pah) is a complicating factor in the management of congenital heart disease (chd) with intracardiac or extracardiac communications. in children with moderate to severe pah, the risk of serious complications following the surgical repair of shunts (including right cardiac failure and death) is 15-20% or even higher, and the risk of late, postoperative residual pah is \~25%. we therefore intend to conduct a study aimed at reducing the risk of severe immediate postoperative complications and the risk of residual pah at six months following surgery to less than 10% in children with moderate pah (primary objective). the study is also aimed at promoting a statistically significant reduction in pulmonary artery pressure and pulmonary vascular resistance at six month after surgery, compared with baseline in children with moderate or severe pah (secondary objective). we hypothesized that these goals could be achieved by treating patients preoperatively and for six months postoperatively with sildenafil, either singly or combined with bosentan. both drugs have been approved for treatment of pah on the basis of randomized clinical trials. preoperative and postoperative (on treatment) hemodynamic evaluation will be based on noninvasive and invasive diagnostic procedures. as an additional objective, we intend to analyze possible abnormalities in genes that have been shown to be associated with pah-chd, and inflammatory mediators as well. the idea is to investigate whether changes in these markers correlate with the clinical profile and response to treatments.

Eligibility criteria:
inclusion criteria: * potentially operable patients with congenital cardiac septal defects (bi-ventricular physiology) and pah, must have at least three of the following severity criteria: age \> 18 months; absence of congestive heart failure (pulmonary congestion); down syndrome; bidirectional shunting across the septal defect; periods of systemic (peripheral) oxygen saturation \< 90%. exclusion criteria: * patients with complex cardiac anomalies for whom there are no possibilities of complete repair. patients with uni-ventricular physiology.

Keywords: congenital heart disease pulmonary arterial hypertension sildenafil bosentan pediatric cardiac surgery
chest tube after a video-assisted thoracoscopic surgery pulmonary wedge resection

Conditions: Lung Diseases, Interstitial; Pulmonary Nodule, Solitary

Summary: after performing vats pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. chest tubes after vats pulmonary wedge resections are left in place a minimum of 1 day. however, this practice has no scientific foundations. the investigators believe it is possible to avoid the placement of a chest tube after this procedure in a great amount of patients. this is a randomized controlled clinical trial with analysis blinding in which the investigators want to compare the outcomes between installing a chest tube or not after vats pulmonary wedge resections. the investigators will include consecutively patients with interstitial lung disease or indeterminate pulmonary nodules undergoing this procedure, at the participating institutions. the investigators calculated a sample size of 50 subjects in each group using pneumothorax \< 10% data from luckraz et al and to determine a difference of hospital stay of 2 versus 1 day; ds(1.5), power = 0.9 and alpha = 0.05.


Eligibility criteria:
inclusion criteria: * patients undergoing video-assisted thoracoscopic surgery pulmonary wedge resections at the participating institutions. * no evidence of air leak at the end of the surgical procedure. * no active bleeding at the end of the surgical procedure. exclusion criteria: * pleural effusion previous to the procedure requiring drainage after it. * bullous or emphysematous changes in lung parenchyma. * patients going to positive pressure in the airways after the procedure.

Keywords: chest tubes thoracic surgery, video-assisted lung diseases, interstitial pulmonary nodule, solitary
the decline in walking performance in adults with cerebral palsy - influence of performance fatigability

Conditions: Muscle Spasticity; Paralysis; Cerebral

Summary: due to an early brain injury occurring in antenatal or postnatal, cerebral palsy (cp) causes alteration in motor function with posture and gait disorders. it is commonly observed motor performance degradation during adulthood, and the underlying pathophysiology remains poorly known.

one of the hypotheses to explain the decline in walking capacities in adults with cp is their greater fatigability, that could be related to energy overconsumption (due to the specific biomechanical constraints of their walking pattern) and/or the occurrence of early sarcopenia affecting the compensatory muscle mechanisms commonly seen in children to compensate for architectural disorders and posture alterations. to optimize prevention and/or therapy in these patients, it is crucial to better understand the aetiology of fatigability and its role in the decline in walking performance.

Eligibility criteria:
inclusion criteria: common for cp and healthy volunteers: * capable of walking for six minutes without stopping * capable of consenting to the tests specific for the cp group * gmfcs i or ii at age 18 * spastic diplegic cerebral palsy exclusion criteria: * counter-indications to the test procedures * mental retardation or intelligence quotient (iq) below 80 * accompanying diseases not allowing for the test setup * major surgeries altering performance in the last six months * injection of botulin altering maximal force production in the last three months * refusing to sign the consent form

Keywords: fatigue fatigue-resistance torque power cerebral palsy
first-line treatment with icotinib in elder nsclc egfr mutated patients

Conditions: Non-Small Cell Lung Cancer

Summary: a single arm, open label, phase iv trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (iiib and iv) nsclc and mutated egfr.

a single arm, open label, prospective, phase iv trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (iiib and iv) nsclc and mutated egfr. * primary endpoint to assess progression-free survival * secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.

Eligibility criteria:
inclusion criteria: * recurrent or progressive non-small cell lung cancer stage iv or iiib patients. * positive egfr mutation. * no previous systemic anticancer therapy. * male and female patients aged over 70 years. * measurable lesion according to recist with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. * provision of written informed consent. exclusion criteria: * evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). * known severe hypersensitivity to icotinib or any of the excipients of this product. * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Keywords: nsclc egfr mutation elder patients
heliox and posture in patients with asthma

Conditions: Acute Asthma

Summary: the purpose of this study is to verify that nebulization with bronchodilators associated with heliox gas (helium + oxygen) and the posture of a leaning forward truck is effective in patients with an asthma attack.

when associated with inhaled bronchodilators, the heliox, a mixture of helium and oxygen in obstructive lung diseases with asthma, reduces the turbulence of airflow despite high rates, due to its low density. although the first report of the use of heliox in the treatment of asthma dating to 1935, few controlled studies are available clarify the impact of the use of heliox in hospital admission of patients with acute asthma attacks refractory to standard treatment. the severe airflow obstruction, observed in cases of acute asthma, also leads to lung hyperinflation that favors the increase of respiratory work by increasing the load for the inspiratory muscles by placing them at a mechanical disadvantage. various body positions were studied relating them to muscle activity with mechanical disadvantage. these studies suggest that the influence posture acts mainly in the position of the diaphragm, thus, increasing the stress related to other muscles such as the abdominals and the effect of gravity on these. this study aims to: assess the efficiency of the positioning body associated with nebulization with bronchodilators carried by heliox during acute severe asthma in adults, using as the primary outcomes fev1, fvc and pef and secondary outcomes as the borg scale, inspiratory capacity, rr, hr and spo2.

Eligibility criteria:
inclusion criteria: * reversibility of bronchial obstruction after administration of bronchodilator drugs for at least 10% in fev1 * a clinical diagnosis of acute severe asthma * a history of asthma over 1 year * duration of the crisis of current asthma lasting less than seven days exclusion criteria: * were unable to understand or perform the spirometric maneuver * smoking (within the last 3 years associated with a higher consumption of 100 cigarettes/year) * other pulmonary comorbidities * lower to upper airways * heart failure * heart rate greater than 150 bpm * systolic pressure below 90 mmhg or greater than 150 mhg * pregnancy * inability to stay inline with the trunk forward

Keywords: asthma heliox bronchodilators posture
study to evaluate the efficacy and safety of ctp-543 in adults with moderate to severe alopecia areata (thrive-aa2)

Conditions: Alopecia Areata

Summary: this study evaluates the safety and effectiveness of an investigational study drug (called ctp-543) in adults (18 years and older) who have 50% or greater scalp hair loss.


Eligibility criteria:
inclusion criteria: * clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of screening. total disease duration greater than 10 years is permitted. * at least 50% scalp hair loss, as defined by a severity of alopecia tool (salt) score ≥50, at screening and baseline. * willing to comply with the study visits and requirements of the study protocol. exclusion criteria: * treatment with other medications or agents within 1 month of baseline or during the study that may affect hair regrowth or immune response. * active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the salt assessment, or untreated actinic keratosis anywhere on the body at screening and/or baseline. * treatment with systemic immunosuppressive medications within 3 months of screening or during the study, or biologics within 6 months of screening or during the study. * females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug. * clinically significant medical condition, psychiatric disease, or social condition, as determined by the investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.

Keywords: alopecia hair loss hair disease ctp-543
a phase 2 study of vosoritide in children with idiopathic short stature

Conditions: Idiopathic Short Stature

Summary: the purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hgh), in children with idiopathic short stature (iss).

following a minimum 6 month observational period in which baseline growth is assessed, participants in the vosoritide and placebo groups will complete a minimum of 6 months of randomized treatment (maximum of 6 months of placebo treatment), followed by open-label treatment with vosoritide until they reach near-final adult height, or at least 16 years of age for females or 18 years of age for males, whichever comes later. participants randomized to the hgh group will receive open-label hgh for a minimum of 4 years.

Eligibility criteria:
key inclusion criteria: 1. height assessment corresponding to a height z-score of ≤ -2.25 sds in reference to the general population of the same age and sex, as calculated using the centers for disease control and prevention (cdc) growth charts 2. tanner stage 1, at time of signing the icf (unless too young to stage). key exclusions: 1. known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to laron syndrome, prader-willi syndrome, russell-silver syndrome, turner syndrome, disproportionate skeletal dysplasias, abnormal shox gene analysis, or rasopathy (including noonan syndrome) 2. previous treatment with a growth promoting agent
observational study of tamsulosin in patients with benign prostatic hyperplasia

Conditions: Prostatic Hyperplasia

Summary: study to describe tamsulosin prescription characteristics in a representative population of patients on treatment for benign prostatic hyperplasia


Eligibility criteria:
inclusion criteria: * patients older than 21 years old diagnosed with benign prostatic hyperplasia (bph), who require pharmacological treatment to relieve symptoms and improve their quality of life, according to physician's judgment. the study will include naïve patients and patients not responding to previous therapy who receive secotex as alternative or complementary treatment. the decision to treat a patient with tamsulosin must be based on the best standard accepted in the clinical practice and must be carried out following secotex (tamsulosin) prescription information exclusion criteria: * patients with known hypersensitivity to tamsulosin or any of its ingredients, history of orthostatic hypotension or severe liver failure, or with any missing data required to complete the questionnaire are excluded
short-incubation levulan photodynamic therapy versus vehicle for face/scalp actinic keratosis (ak)

Conditions: Actinic Keratosis

Summary: the purpose of this study is to determine if levulan photodynamic therapy (pdt) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.


Eligibility criteria:
inclusion criteria: * 6-20 grade 1/2 aks on the face or scalp * a history of ak therapy within the treatment area at least twice in the two years prior to study entry exclusion criteria: * pregnancy * grade 3 aks or atypical aks (e.g., ak \> 1 cm2 in size) within the treatment area * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the treatment area * plans to be exposed to artificial tanning devices or excessive sunlight during the trial * subject is immunosuppressed * unsuccessful outcome from previous ala-pdt therapy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * any condition which would make it unsafe for the subject to participate in this research study * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * subject has; * an active herpes simplex infection or * a history of 2 or more outbreaks within the past 12 months, in the treatment area * use of the following topical preparations on the extremities to be treated: * keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment. * cryotherapy within 2 weeks of initiation of treatment * retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment. * microdermabrasion, laser ablative treatments, ala-pdt, chemical peels, 5-fu, diclofenac, imiquimod or other topical treatments for ak within 8 weeks of initiation of treatment. * two or more ala pdt treatments in the past 6 months * use of systemic retinoid therapy within 6 months of initiation of treatment.
neurodevelopmental outcomes in hypoplastic left heart syndrome

Conditions: Congenital Heart Disease

Summary: there have been many improvements in the care of children with hypoplastic left heart syndrome (hlhs). this has helped these children survive longer. because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in children with hypoplastic left heart syndrome. the purpose of this research study is to help the investigators learn more about developmental disabilities in children with hypoplastic left heart syndrome. during the time of your child's first surgery for hypoplastic left heart syndrome, a monitor was placed on your child's forehead to measure the oxygen levels in the brain. this monitor is called near infrared spectrometry (nirs). the researchers involved in this study want to know if oxygen levels in the blood vessels of the brain have any effect on developmental disabilities later in life in children with hypoplastic left heart syndrome. the researchers plan to enroll 60 research subjects.

our study is a cross-sectional, descriptive study to evaluate the developmental outcome for school-age children with hlhs. the general approach of the proposed research is confirmatory study/hypothesis testing. the hypothesis (neurodevelopmental outcome of children with hlhs is inversely correlated with cerebral oximetry values as measured by nirs in the 48 hours following the norwood operation) was formulated based on a meticulous review of the literature, which clearly demonstrates a substantial prevalence of neurodevelopmental deficits in children with hlhs who have undergone surgical palliation. the methodologies for measuring developmental outcome are highly reproducible and have been validated in this population.

Eligibility criteria:
inclusion criteria: 1. hypoplastic left heart syndrome is defined as normal segmental anatomy with mitral and/or aortic atresia or stenosis and a left ventricle too small to sustain the systemic circulation 2. ages 2.5 to 6 years old 3. surgical palliation with the norwood procedure (stage i palliation) at children's healthcare of atlanta after january 1, 2001 exclusion criteria: 1. primary language in the home is not english 2. named genetic syndrome associated with profound developmental delay, such as digeorge syndrome

Keywords: single ventricle hypoplastic left heart developmental