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Hyperplasia clinical trials

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NCT ID: NCT02443961 Completed - Clinical trials for Bronchopulmonary Dysplasia

Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies

Start date: April 2, 2019
Phase: Phase 1
Study type: Interventional

Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth, 15-50% of very low birth newborns (<1500 gr.) will develop BPD. The prevalence of BPD is increasing due to the advances in neonatology, with a rise in the survival of smaller and more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These factors lead to a pathological development of the lung and pulmonary vessels, developing secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this generates a important sanitary burden and a decrease in life quality. Multiple experimental models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also recently some clinical trials have tried this therapy on premature newborns with promising results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions. Methods: The investigators have designed a clinical trial to evaluate the feasibility and security of MSC therapy in patients at high risk of developing BPD.

NCT ID: NCT02431754 Completed - Clinical trials for Benign Prostatic Hyperplasia

A Study of Tadalafil (LY450190) in Participants With Benign Prostatic Hyperplasia (BPH)

Start date: April 2015
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.

NCT ID: NCT02425800 Completed - Clinical trials for Benign Prostatic Hyperplasia

Human Prostate Tissue Model to Maintain and Study Prostate Cancer Stem Cells

Start date: July 28, 2015
Phase:
Study type: Observational

This pilot research trial studies the use of a human prostate tissue model to maintain and study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that was removed during surgery from patients with non-cancerous enlargement of the prostate (benign prostatic hyperplasia) and may create an environment similar to the natural environment of the human body. Prostate cancer stem cells are cells that cause cancer to grow. Using real tissue to create an environment to study stem cells may help doctors learn more about how they work and how they respond to treatments.

NCT ID: NCT02423759 Completed - Clinical trials for Benign Prostate Hyperplasia

A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy

Start date: April 2015
Phase: Phase 4
Study type: Interventional

The aim of the study is to evaluate whether changing antibiotic prophylaxis from fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted antibiotic prophylaxis according to rectal swab culture would influence infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.

NCT ID: NCT02417844 Completed - Clinical trials for Prostatic Hyperplasia

Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.

Start date: April 2015
Phase: Phase 1
Study type: Interventional

Two tamsulosin HClformulations will be tested in fed state

NCT ID: NCT02417831 Completed - Clinical trials for Prostatic Hyperplasia

Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.

Start date: April 30, 2015
Phase: Phase 1
Study type: Interventional

A bio-equivalence of 2 different capsule formulations in fasted subjects

NCT ID: NCT02390882 Completed - Clinical trials for Benign Prostate Hyperplasia

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH

Start date: October 2014
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia

NCT ID: NCT02381366 Completed - Clinical trials for Bronchopulmonary Dysplasia

Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study

Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of PNEUMOSTEM® in premature infants at high risk for BPD.

NCT ID: NCT02366975 Completed - Clinical trials for Lower Urinary Tract Symptoms

TRT on BPH Hypoganadal MetS Patients. Florence-PROTEST

PROTEST
Start date: November 2012
Phase: Phase 4
Study type: Interventional

There are many evidences in the literature showing that the metabolic syndrome (MetS) is associated with BPH / LUTS. There are also numerous evidence that hypogonadism is associated with both conditions, thus being one of the most probable pathogenetic factor underlying the association between MetS & BPH / LUTS. Preliminary evidences from observational clinical studies have shown that treatment with testosterone replacement in hypogonadal patients with MetS reduces the symptoms of lower urinary tract symptoms (LUTS) associated with BPH. Preclinical studies performed by the investigators research group show in an experimental model of metabolic syndrome the occurrence of marked inflammation and tissue remodeling of the prostate gland, which is prevented by treatment with testosterone replacement (Vignozzi et al., 2012). There is therefore a need for a clinical trial to demonstrate the effect of treatment with testosterone replacement in reducing the inflammation of the prostate and its effectiveness in improving the symptoms related to inflammation in patients with prostatic BPH associated with metabolic syndrome and testosterone deficiency . The aims of the present study is to evaluate the effectiveness of testosterone replacement therapy compared to placebo in reducing signs and symptoms of inflammation of the prostate and LUTS symptoms in hypogonadal patients with metabolic syndrome and BPH who are candidates for radical prostatectomy simple. For this purpose both clinical (assessment of specific symptoms of prostatitis assessed by questionnaire National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI and assessment of the symptoms of LUTS and questionnaires International Prostate Symptom Score, IPSS), ultrasound (transrectal ultrasound evaluation of markers of prostatic inflammation: macrocalcifications, inhomogeneity etc.), biochemical (evaluation of inflammatory cytokines in the semen), urodynamic and histology (histomorphometric and immunohistochemical analysis of samples prostate derived from patients enrolled in the study or not treated with testosterone) scores will be performed. Along with the symptoms and clinical signs of prostate inflammation and LUTS, the effect of testosterone therapy or placebo on penile erection will be also evaluated.

NCT ID: NCT02352311 Completed - Healthy Clinical Trials

Safety and Pharmacokinetic Characteristics of DKF-313

Start date: January 2015
Phase: Phase 1
Study type: Interventional

This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.