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{ "NCT_ID" : "NCT02753712", "Brief_Title" : "A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma", "Official_title" : "A Two-arm, Randomised, Assessor-blind, Parallel Group Study to Evaluate the Effect of Fluticasone/Form...
#Study Description Brief Summary The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI). #Intervention - DRUG : Fluticasone/Formoterol BAI - DRUG : Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
#Eligibility Criteria: Inclusion Criteria for subjects on Seretide Accuhaler 250/50 µg at screening: * Male and female subjects >=18 years. * Adequate contraception * Documented clinical history of asthma for >=6 months prior to screening visit * Using Seretide Accuhaler at a stable dose of 250/50 μg BID at screening ...
NCT02753712
78,096
{ "NCT_ID" : "NCT00857272", "Brief_Title" : "F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects", "Official_title" : "F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects", "Conditions" : ["Colonoscopy"], "Interventions" : ["Drug: PEG electrolyte lavage...
#Study Description Brief Summary To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects. #Intervention - DRUG : PEG electrolyte lavage solution + bisacodyl - reformulation - multi dose formulation (tablet/solution) for oral administration prior to col...
#Eligibility Criteria: Inclusion Criteria: * Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications: * At least 18 years * Otherwise in good health, as determined by physical exam and medical history * If female, and of child-bearing potential, is using an acceptable form of bir...
NCT00857272
114,683
{ "NCT_ID" : "NCT03789968", "Brief_Title" : "The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients", "Official_title" : "The Incidence and Severity of Drug Interactions Before and After Swit...
#Study Description Brief Summary This study will assess changes in the incidence and severity of drug interactions before and after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir alafenamide-based regimens in treatment experienced patients living with HIV infection. Detailed Description Sim...
#Eligibility Criteria: Inclusion Criteria: * HIV diagnosis * 18 years or older * Receiving ART for at least 3 months * ART is switched to bictegravir/emtricitabine/tenofovir alafenamide between 2/7/2018 and 3/30/2019 * Patient is receiving at least one chronic or as needed non-ART medication at the time of the switch ...
NCT03789968
113,099
{ "NCT_ID" : "NCT03684798", "Brief_Title" : "Mental Contrasting With Implementation Intentions for Alcohol Use Disorders", "Official_title" : "Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders", "Conditions" : ["Alcohol Use Disorder"], "...
#Study Description Brief Summary Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality in order to increase goal commitment when expectations of success are high. The study aims to investigate the effects of a motivational training (Mental Contrasting with...
#Eligibility Criteria: Inclusion Criteria: * Diagnosis of alcohol use disorder according to DSM 5 (Diagnostic and Statistical Manual) * Age: >=18 years Exclusion Criteria: * Cognitive deficits that limit the patients' ability to provide informed consent * Inability to follow the procedures of the study * Acute suici...
NCT03684798
268,882
{ "NCT_ID" : "NCT00866502", "Brief_Title" : "A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease", "Official_title" : "A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031...
#Study Description Brief Summary This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump...
#Eligibility Criteria: Inclusion Criteria: * Male or female. Females should either be post-menopausal (at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with FSH levels >40 mIU/mL), be surgically sterilized (bilateral oophorectomy w/o hysterectomy), or use adequate contraception (oral ...
NCT00866502
175,008
{ "NCT_ID" : "NCT01690676", "Brief_Title" : "Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function", "Official_title" : "The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (F...
#Study Description Brief Summary Effect of apple polyphenols on FMD. Detailed Description The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves ...
#Eligibility Criteria: Inclusion Criteria: * Borderline hypertension * Otherwise healthy * Aged 40 <= age <= 65 years (inclusive) * Not consuming high amounts (over 20 mg daily) of flavonoids Exclusion Criteria: * BMI >32 kg/m2 * Total serum cholesterol >= 8 mmol/l * Any abnormal safety laboratory parameter or abnor...
NCT01690676
2,672
{ "NCT_ID" : "NCT00643734", "Brief_Title" : "A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients", "Official_title" : "A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azith...
#Study Description Brief Summary The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety...
#Eligibility Criteria: Inclusion Criteria: Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included. Exclusion Criteria: Key exclusion criteria were treatment with any systemic antibiotic of greater than one dos...
NCT00643734
100,607
{ "NCT_ID" : "NCT03956186", "Brief_Title" : "Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?", "Official_title" : "Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?", ...
#Study Description Brief Summary Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who ar...
#Eligibility Criteria: Inclusion Criteria: * singleton parturient * planned for elective LSCS under spinal anesthesia Exclusion Criteria: * gestational age < 36 weeks * emergency cases * placenta previa, pre-eclampsia * BMI>40 * Reynauld disease * patient refusal * cardiovascular disease Sex : ALL Age...
NCT03956186
81,008
{ "NCT_ID" : "NCT01448317", "Brief_Title" : "Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacod...
#Study Description Brief Summary Primary Objective: To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects. Secondary Objectives: * To assess the pharmacodynamics effect of a single SC dose of alirocumab o...
#Eligibility Criteria: Inclusion Criteria: * Healthy male subject, between 20 and 65 years inclusive. * Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive. * Serum LDL-C levels >100 mg/dL Exclusion Criteria: * Subject indicated for the use of statins according to cr...
NCT01448317
260,869
{ "NCT_ID" : "NCT04490616", "Brief_Title" : "TMS Treatment of Social Cognition Skills in Mild Cognitive Impairment", "Official_title" : "EFFECTS of RTMS TREATMENT on SOCIAL COGNITION DYSFUNCTIONS in MILD COGNITIVE IMPAIRMENT: an PROSPECTIVE, DOUBLE-BINDING, RANDOMIZED, SINGLE CENTRE, EXPLORATIVE STUDY", "Conditions" ...
#Study Description Brief Summary Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairments in theory of mind (ToM) and facial emotion recognition. Moreover, in amnesic MCI p...
#Eligibility Criteria: Inclusion Criteria: * Subjects aged 50 <= age <= 85 old, inclusive, at the time of informed consent; * Must have at least 5 years of education or work experience to exclude mental deficits other than MCI; * Must meet Petersen's criteria for mild cognitive impairment, and must have: * Clinical de...
NCT04490616
95,986
{ "NCT_ID" : "NCT01711034", "Brief_Title" : "A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer", "Official_title" : "A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Dail...
#Study Description Brief Summary The primary objective of this study is to determine the safe and tolerable dose level of OPB-111077 for patients with advanced cancer. Detailed Description The secondary objective of this study is to investigate the pharmacokinetic properties of OPB-111077; the pharmacodynamic effec...
#Eligibility Criteria: Inclusion Criteria: * Pathologically and/or cytologically confirmed advanced malignancy that is refractory to standard therapy or for which there are no standard treatment options available * For oral or intravenous anticancer therapies, at least 4 weeks or 5 half-lives, whichever is shorter, ne...
NCT01711034
101,028
{ "NCT_ID" : "NCT00304239", "Brief_Title" : "Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp", "Official_title" : "A Multicenter, Double Blind, Vehicle-controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream and Aktilite CL12...
#Study Description Brief Summary The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-da...
#Eligibility Criteria: Inclusion Criteria: * Clinical diagnosis of 4 <= age <= 10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate. * Males or females ...
NCT00304239
102,603
{ "NCT_ID" : "NCT03249038", "Brief_Title" : "Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.", "Official_title" : "Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.", "Conditions" : ["Blood Loss, Surgical", "Blood Loss", "Blood Loss, Postoperative"], "Study_Design" : { "Stud...
#Study Description Brief Summary Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluat...
#Eligibility Criteria: Inclusion Criteria: * Patients scheduled for elective urologic laparoscopy surgery. Exclusion Criteria: * Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoa...
NCT03249038
188,427
{ "NCT_ID" : "NCT01393340", "Brief_Title" : "Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma", "Official_title" : "Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma", "Conditions" : ["Nasal Poly...
#Study Description Brief Summary This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). During the tre...
#Eligibility Criteria: Inclusion Criteria: * Subjects must be at least 18 years, of either gender and any race. * Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system ...
NCT01393340
65,078
{ "NCT_ID" : "NCT02184091", "Brief_Title" : "Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine", "Official_title" : "An Open-Label, Single Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VI...
#Study Description Brief Summary Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients ...
#Eligibility Criteria: Inclusion Criteria: * Male or female patients of any race between the ages of 18 and 75 years with weight within 30% of normal for gender, height and frame as specified by the Metropolitan Life Insurance Table * For patients in the renal group: stable creatinine clearance based on two estimation...
NCT02184091
46,930
{ "NCT_ID" : "NCT05575687", "Brief_Title" : "Brain and Glycemic Responses to Sweet Soft Drinks", "Official_title" : "Brain and Glycemic Responses to Soft Drinks With Different Sweeteners", "Conditions" : ["Normal Physiological Response to Sweet Drinks"], "Interventions" : ["Other: Monk fruit", "Other: Allulose + ste...
#Study Description Brief Summary The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and...
#Eligibility Criteria: Inclusion Criteria: * Age between 18 and 30 years * BMI between 18.5 and 25 kg/m2 * Apparently healthy (self-reported) * Right-handed (because brain responses may differ between right- and left handed individuals) * Sufficient blood hemoglobin (Hb) levels (women > 7,5; men > 8.5 g/dl) and having...
NCT05575687
217,327
{ "NCT_ID" : "NCT00781092", "Brief_Title" : "A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes", "Official_title" : "A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane ...
#Study Description Brief Summary The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions. Detailed Description This comparison will be made between bilateral eyes of the same patient following exc...
#Eligibility Criteria: Inclusion Criteria: * Subjects must be a suitable candidate for FDA Approved LASIK. * Subjects must have a stable refraction as documented by previous clinical records. * Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery. * Subjects...
NCT00781092
74,892
{ "NCT_ID" : "NCT02700009", "Brief_Title" : "Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care", "Official_title" : "Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care", "Conditions" : ["Depression"], "Interventions" : ["Other: Treatment as Usual (T...
#Study Description Brief Summary Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective in previous studies in psychiatric settings, will be disseminated into primary care - a health care setting where there are significant problems in receiving adequate treatment for depression...
#Eligibility Criteria: Inclusion Criteria: * Patient Health Questionnaire score of 10 or above * Age 18 or above Exclusion Criteria: * Refusal to provide informed consent * Inability to read English text on computer screen * Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severi...
NCT02700009
211,106
{ "NCT_ID" : "NCT04139811", "Brief_Title" : "Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD", "Official_title" : "Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment", "Conditions" : ["Retinal Det...
#Study Description Brief Summary Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion. The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been r...
#Eligibility Criteria: Inclusion Criteria: * All eyes with recent macula-off rhegmatogenous retinal detachment (RRD). Exclusion Criteria: * Complicated cases with advanced proliferative vitreoretinopathy (PVR). * Patients with retinal vascular disorders and other macular disorders. * Combined tractional and rhegmato...
NCT04139811
257,686
{ "NCT_ID" : "NCT04593095", "Brief_Title" : "Nurturing and Quiet Intervention: NeuroN-QI", "Official_title" : "Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial", "Conditions" : ["Neurodevelopment"], "Inter...
#Study Description Brief Summary The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. Howev...
#Eligibility Criteria: Inclusion Criteria: Infants: * born between 26 and 316/7 WGA. Mothers * agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation; * express breast milk for their infant; * speak, read, or write French or English. Nurses: * have at least 6 months of work ex...
NCT04593095
125,683
{ "NCT_ID" : "NCT05977010", "Brief_Title" : "Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count", "Official_title" : "Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count", "Conditions" : ["HIV"], "Location_Countries" : ["Indonesia"], "Study_Design" : { ...
#Study Description Brief Summary This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of Tangerang District Hospital. The participant will be interviewed and retrieved for their demographics, treatment history, CD4 and viral load history. Blood will be drawn for HIV-1 viral load examinat...
#Eligibility Criteria: Inclusion Criteria: * HIV positive patient by the HIV Diagnoses Guideline in the Tangerang District Hospital. * Patient older than 18 years and above. * Willing and signed the informed consent (ICF). * Willing to comply with the study procedures. Exclusion Criteria: * Suffered from a disease o...
NCT05977010
8,125
{ "NCT_ID" : "NCT05433233", "Brief_Title" : "Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension", "Official_title" : "Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension", "Conditions" : ["Hypertension", "Aging"], "Interventions" : ["Behavioral: Walking", "O...
#Study Description Brief Summary Eight out of ten older adults have hypertension in the US, which is a strong risk factor for cardiovascular events. To manage hypertension, regular and structured exercise is effective and strongly recommended regardless of drug therapy. However, structured exercise is often performed...
#Eligibility Criteria: Inclusion Criteria: * Men and women aged 65+ * Systolic/diastolic blood pressure of 130 <= age <= 159/80 <= age <= 99 mmHg. Participants will be allowed to be on blood pressure medication. * Body mass index of 25 <= age <= 40 kg/m2 * Non-smokers * Sedentary/inactive individuals: not meeting the ...
NCT05433233
230,127
{ "NCT_ID" : "NCT00165542", "Brief_Title" : "A-protein Levels in Adult and Pediatric Brain Tumor Patients", "Official_title" : "Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients", "Conditions" : ["Malignant Childhood Central Nervous System Neoplasm"], "Interventions" : ["Other: A PROTEIN ...
#Study Description Brief Summary The purpose of this study is to evaluate the sensitivity and specificity of 'A-PROTEIN' levels in patients with brain tumors. A-PROTEIN levels will be analyzed both pre and post treatment. Levels in blood and/or cerebrospinal fluid (CSF) will be analyzed and correlated with the underl...
#Eligibility Criteria: Inclusion Criteria: * All patients with possible malignant or benign lesions of the central nervous system will be included. * There are no restrictions with respect to treatment protocols or prior therapy. * Patients will be identified after presentation to the neurosurgical, neurological or on...
NCT00165542
203,285
{ "NCT_ID" : "NCT05433519", "Brief_Title" : "Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age", "Official_title" : "Z 32104 - Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age", "Conditions" : ["Gestational Age", "Machine Learning", "Pregnancy R...
#Study Description Brief Summary This is a prospective cohort study of women enrolled early in pregnancy, with randomization to determine the timing of three follow-up visits in the second and third trimester. At each of these follow-up visits, investigators will assess gestational age with the FAMLI technology and c...
#Eligibility Criteria: Inclusion Criteria: * 18 years or older * viable intrauterine pregnancy at less than 14 0/7 weeks of gestation * ability and willingness to provide written informed consent * intent to remain in current geographical area of residence for the duration of study * willingness to adhere to study pro...
NCT05433519
189,490
{ "NCT_ID" : "NCT04068961", "Brief_Title" : "New Strategies of Genetic Study of Patients With Oculocutaneous Albinism", "Official_title" : "New Strategies of Genetic Study of Patients With Oculocutaneous Albinism", "Conditions" : ["Oculocutaneous Albinism", "Mutation"], "Study_Design" : { "Study_Type" : "OBSERVATION...
#Study Description Brief Summary The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients. De...
#Eligibility Criteria: Inclusion Criteria: *Oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic consultation and did not show mutations of the TYR, OCA2, TYRP1, SLC45A2 genes) Exclusion Criteria: None Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ...
NCT04068961
235,973
{ "NCT_ID" : "NCT03714100", "Brief_Title" : "Use of Tele-Exercise for Translating an Evidence-Based Fall-Prevention Program for Older Adults in West Virginia", "Official_title" : "Use of Tele-Exercise as an Alternative Delivery Channel for Translating an Evidence-Based Fall-Prevention Program Into Practice for Older A...
#Study Description Brief Summary West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, Centers for Disease Control and Prevention (CDC)-approved, community-delivered, p...
#Eligibility Criteria: Inclusion Criteria: * Adults age 55 and older * Community-dwelling * Able to attend 2, 1-hour Tai Ji Quan: Moving for Better Balance classes a week for 16 weeks * Able to attend 2 testing sessions for data collection (Testing sessions will be scheduled the week before classes begin and the week ...
NCT03714100
256,806
{ "NCT_ID" : "NCT03583060", "Brief_Title" : "Interoceptive Engagement", "Official_title" : "Interoceptive Engagement in Response to Mindful Awareness in Body-oriented Therapy: A Pilot Test Comparison", "Conditions" : ["Stress"], "Interventions" : ["Behavioral: Mindful Awareness in body-oriented therapy"], "Location...
#Study Description Brief Summary The proposed project is the first pilot test to examine interoceptive function as a mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an empirically-validated and manualized protocol is explicitly designed to teach interoceptive awareness skills...
#Eligibility Criteria: Inclusion Criteria: * adult (over 18) * Perceived Stress Scale scores indicating moderate stress levels * naive to mindfulness-based approaches (no prior experience) * agrees to forgo (non-study) manual therapies (e.g., massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months...
NCT03583060
79,240
{ "NCT_ID" : "NCT00210470", "Brief_Title" : "A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer", "Official_title" : "A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in...
#Study Description Brief Summary This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC). Detailed Description IRX-2 is a primary cell-derived biologic that reduces the immune suppressio...
#Eligibility Criteria: Inclusion Criteria: * Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. * No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care. * Clinically stage...
NCT00210470
164,018
{ "NCT_ID" : "NCT01972711", "Brief_Title" : "Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics", "Official_title" : "A Randomized, Double-blind, Placebo-controlled, Single-dose, Study of the Effects of SEP 363856 and Amisulpride on BOLD-fMRI Signal in Healthy Male and...
#Study Description Brief Summary This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics. Detailed Description The study is a randomized, double-blind, placebo-controlled functional magnetic resonance imaging (fM...
#Eligibility Criteria: Inclusion Criteria: * Male or female aged 18 <= age <= 45, inclusive, at Day 1. * Subject must be healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring within four weeks of randomisation. ...
NCT01972711
228,836
{ "NCT_ID" : "NCT01447485", "Brief_Title" : "Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients", "Official_title" : "A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age", "Conditions" : ["Hypert...
#Study Description Brief Summary This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome. #Intervention - DRUG : Valsartan (VAL489)
#Eligibility Criteria: Inclusion Criteria: * Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome Exclusion Criteria: * GFR < 30 mL/min/1.73 m2 * Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenol...
NCT01447485
207,057
{ "NCT_ID" : "NCT02551341", "Brief_Title" : "Lung Protective Ventilation During Robotic Assisted Prostatectomy", "Official_title" : "Randomized Study To Study the Effect of Lung Protective Ventilation (PEEP) Compared With Normal Ventilation (ZEEP) on Lung Function, Kidney Treatment of Sodium and Water, Vasoactive Horm...
#Study Description Brief Summary Randomized study investigating the effects of lung protective ventilation (PEEP), as compared with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water, vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing assiste...
#Eligibility Criteria: Inclusion Criteria: * Age> 18 years * Men * Indication for robot-assisted radical prostatectomy acc. the department's instructions Exclusion Criteria: * Lack of desire to participate * EGFR <15 ml / min * BMI> 35 kg / m2 * Former lung surgery * Known requiring treatment lung disease * Known he...
NCT02551341
131,313
{ "NCT_ID" : "NCT02579954", "Brief_Title" : "Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension", "Official_title" : "Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension", "Conditions" : ["Pulmonary Arterial Hypertension"], "Interventions" : ["Behavioral: Rehabilitation"]...
#Study Description Brief Summary Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluate...
#Eligibility Criteria: Inclusion Criteria: * Adult patients * Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens), * Prevalent cases of pulmonary artery hypertension (>= 6 months) confirmed by right heart catheterism, * Stable for at least 3 months, * Written consent. Exclusion...
NCT02579954
276,317
{ "NCT_ID" : "NCT03154957", "Brief_Title" : "Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path", "Official_title" : "Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg ...
#Study Description Brief Summary The analysis of professional practices in the emergency department of the Strasbourg CHRU in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. Thus, the objectives are two...
#Eligibility Criteria: Inclusion Criteria: * Adult patient consulting for acute shoulder dislocation Exclusion Criteria: * Patient refusing to participate in the study Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volu...
NCT03154957
57,856
{ "NCT_ID" : "NCT04633668", "Brief_Title" : "Impact of Cognitive Behavioral Therapy on Parasomnias", "Official_title" : "Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias", "Conditions" : ["Parasomnia"], "Interventions" : ["Behavioral: Self-Monitoring", "Behavioral: CBT for parasomnias (CBT-p)"]...
#Study Description Brief Summary This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety...
#Eligibility Criteria: Inclusion Criteria: * DSM 5 Parasomnia Disorder * at least one parasomnia event per week * daytime fatigue or sleepiness * 6 months in duration Exclusion Criteria: * current use of agents known to triggers parasomnias such as Lithium carbonate, Thioridazine, Chlorpromazine, Perhphenazine, Meth...
NCT04633668
62,733
{ "NCT_ID" : "NCT04016480", "Brief_Title" : "HFNC During Bronchoscopy for Bronchoalveolar Lavage", "Official_title" : "High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage", "Conditions" : ["Acute Respiratory Failure", "Bronchoscopy",...
#Study Description Brief Summary The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to acute respiratory failure (ARF). In particular, the risk of hypoxemia is greater during broncho-alveolar lavage (BAL). For this reason, oxygen therapy is administered at low or high...
#Eligibility Criteria: Inclusion Criteria: * need for bronchial endoscopy for bronchoalveolar lavage Exclusion Criteria: * life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks * need for invasive or non invasive ventilation * presence of pneumothorax or pulmonary enphisema or bullae * rece...
NCT04016480
50,905
{ "NCT_ID" : "NCT06478654", "Brief_Title" : "Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries", "Official_title" : "Ultrasound Guided Bilateral Modified Pectoral Nerve (PECS II) Block Vs Bilateral Thoracic Erector Spinae Plane (ESP) Block for Postoperati...
#Study Description Brief Summary The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries. Detailed Description Preoperative settings: All ...
#Eligibility Criteria: Inclusion Criteria: * Females aged >=21 years' old. * BMI <=35. * Patients with ASA I & II. * Scheduled for one of the aesthetic breast surgeries. Exclusion Criteria: * Patients refusal. * Contraindications to regional anaesthesia as bleeding disorders, spine deformity and local infection. * P...
NCT06478654
276,084
{ "NCT_ID" : "NCT00638079", "Brief_Title" : "Evaluating the Effect of Food on Absorption of Megace ES", "Official_title" : "Single-center, Randomized, Open-label, 2-way Crossover Bioavailability Study, Evaluating the Effect of Food on Megace ES (Megestrol Acetate 625 mg/5 mL Oral Suspension) Following a 625 mg Dose in...
#Study Description Brief Summary To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals. #Intervention - DRUG : Megestrol acetate oral suspension 625 mg/5 mL - Megestro...
#Eligibility Criteria: Inclusion Criteria: * Body weight ranging from 60 <= age <= 100 kg (132 <= age <= 220 lbs) and body mass index >=18 and <=32 * Healthy Exclusion Criteria: * History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450...
NCT00638079
160,240
{ "NCT_ID" : "NCT00122447", "Brief_Title" : "Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance", "Official_title" : "CVD Risk and Prevention in Early Glucose Intolerance", "Conditions" : ["Impaired Glucose Tolerance", "Prediabetic State"], "Interventions" : ["Drug: Placebo", "Drug: Aspiri...
#Study Description Brief Summary The purpose of this study is to determine whether cardiovascular disease (CVD) risk markers, β-cell function, and insulin sensitivity can be improved by targeting mechanisms of both diabetes and CVD - using an antioxidant, an angiotensin II receptor blocker (ARB), or an anti-inflammat...
#Eligibility Criteria: Inclusion Criteria: * Impaired glucose tolerance Exclusion Criteria: * Diagnosis of diabetes * Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin * Have systolic blood pressure >140 mm Hg * Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflamm...
NCT00122447
264,247
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