Botulinum Toxin Type A for the Treatment of Male Chronic Pelvic Pain Syndrome
Chronic Prostatitis With Chronic Pelvic Pain SyndromeProstatitisThe aim of this randomized placebo-controlled study is to demonstrate the efficiency and safety of the injection of Botulinum Toxin Type A (200 Units) into the external urethral sphincter for the treatment of chronic prostatitis/chronic pelvic pain.
Pulmonary Rehabilitation in Functional Outcomes and Its Relationship With Morbidity and Mortality...
Pulmonary DiseaseChronic ObstructiveBackground: The pulmonary rehabilitation effects on various outcomes of COPD are well known. However, they may be lost over time due to poor adherence to therapy with absence of regular exercise maintenance in long term, disease progression, comorbidities, falls incidence and higher exacerbations frequency. Currently, the main focus is to make the patient more active and ensure the benefits maintenance. However, few studies have been concerned with the aim of to investigate the long-term effect of this intervention and the relationship of the change promoted in important outcomes of the disease with its morbidity and mortality. Design: Non-controlled clinical trial, prospective and longitudinal. Setting: Outpatient pulmonary rehabilitation program in Florianopolis, Brazil Subjects: Patients with COPD (GOLD II-IV). Interventions: Pulmonary rehabilitation program (PRP) based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and resistance training for upper and lower limbs. Main measures: Before, post-PRP, 6 months post-PRP and 12 months post-PRP will be measured Spirometry or Total Body Plethysmography, Triaxial Accelerometry by Dynaport Activity Monitor, Glittre ADL-Test to evaluated functional capacity and functional performance, Six-Minute Walk Test distance on tracks of 20 and 30 meters, muscle oxygenation variables by NIRS PortaLite®, force platform NeuroCom® SMART Equitest®, Timed Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale - International - Brasil, London Chest Activity of Daily Living score, Modified Medical Research Council score, Saint George Respiratory Questionnaire score, COPD Assessment Test score and Hospital Anxiety and Depression Scale, Behavioural Regulation in Exercise Questionnaire-2, Basic Psychological Needs in Exercise Scale, General self-efficacy scale, COPD self-efficacy scale, Pulmonary Rehabilitation Adapted Index of Self-Efficacy. The death cases and numbers of exacerbations and hospitalizations will be measured by monthly phone calls after PRP.
A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors
LymphomaLarge B-Cell36 moreThis study is a dose escalation, and cohort expansion study in subjects with advanced cancer for which no standard therapy exists. Subjects must have received prior treatment for cancer that has not worked, or has stopped working.
Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With...
AnemiaIron Deficiency3 moreThe HOPE-Hb trial is a phase II study to determine the feasibility and impact of a combination treatment (intravenous iron plus erythropoietin) versus intravenous iron treatment alone on preoperative hemoglobin concentration before hip or knee arthroplasty.
Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
DepressionAnxiety Disorders3 moreThis study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care[MTPC]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Secondary outcomes include sustained attention/response inhibition and interoceptive awareness. A secondary analysis will investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation.
The Integrated Population (I-POP) Health Trial
DiabetesHypertension3 moreThe primary aim of this study is to determine whether community health worker (CHW) navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income, primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months.
Jumping Exercises Approach in Individuals With Chronic Ankle Instability
Joint InstabilityChronic Disease1 moreThe aim of this pilot study is to analyze the effect of a 12-week specific jump training compared with conventional therapy in patients with chronic functional instability of the ankle. It is to be evaluated to what extent the symptoms in of chronic functional instability of the ankle can be influenced in everyday life.
A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD
Anemia of Chronic DiseaseThe trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10 subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses, followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have stable Hgb levels will start the washout period of one to eight weeks. During the washout period, 30 subjects whose Hgb are < 10.0 will complete the baseline assessment to confirm their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a 1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day 29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period, the trial subjects will be observed for an additional 28 days to allow safety and immunogenicity assessments.
JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome...
Benign Prostatic HyperplasiaChronic ProstatitisBenign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45 associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms and is in part related to prostate enlargement and obstruction. The standard medical therapy for this condition includes 5-alpha reductase inhibitors -5ARI (eg dutasteride) or alpha blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset of patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS (organ specific phenotype) is the third most prevalent prostate disease after prostate cancer and BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant percentage of urology outpatients (3-8% of male outpatient visits)resulting in a major impact on quality of life of patients and economic costs to society. Clinical phenotyping allows for prediction of the patients with CP/CPPS most likely to respond to dutasteride and tamsulosin (age, Lower Urinary Tract Symptoms [LUTS] and prostate related phenotypes [BPH]). It can be estimated that up to 30% of men currently diagnosed with CP/CPPS will include men with co-existing Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of JALYN (dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in men diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg. BPH and CP/CPPS).
Family Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting
Chronic DiseaseWomen with chronic medical conditions have been found in multiple studies to use birth control less often compared to women without chronic medical conditions. The investigators hypothesized that approaching women with chronic medical conditions who were admitted to the hospital and having a bedside conversation about pregnancy intention and counseling regarding birth control usage along with offering to start birth control before discharge would increase the use of birth control in this population. As a separate intervention, the investigators hypothesized that having a brief conversation with the participants and then giving them a flyer that recommended talking with their doctor about birth control could also increase the use of birth control in this population.