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NCT ID: NCT01715285 Completed - Prostate Neoplasms Clinical Trials

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

Start date: February 12, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

NCT ID: NCT01713946 Completed - Clinical trials for Tuberous Sclerosis Complex-associated Refractory Seizures

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures

EXIST-3
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].

NCT ID: NCT01713140 Completed - Clinical trials for Osteoarthritis, Knee

Experimental Study of Strength Training to Activate the Quadriceps Muscle After Total Knee Arthroplasty

Start date: October 2012
Phase: N/A
Study type: Interventional

Background: Progressive strength training is a training modality used in rehabilitation after total knee arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be present in the operated leg after TKA, which relates to reduced central nervous system (CNS) activation of the muscle. As increased CNS activation occurs during strength training when muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this also is the case after TKA. The clinical implication is that repetitions performed to contraction failure during strength training, may help reduce CNS activation deficits of the quadriceps muscle after TKA. Purpose: The aim of this study is to investigate CNS activation of the quadriceps muscle during strength training performed with repetitions to contraction failure after TKA. Method: Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure, etc.) of the set to failure. Hypothesis: Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA, the EMG amplitude will increase while the median power frequency will decrease during a strength training set performed to contraction failure after TKA.

NCT ID: NCT01712789 Completed - Multiple Myeloma Clinical Trials

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

STRATUS
Start date: November 6, 2012
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

NCT ID: NCT01711892 Completed - Exercise Clinical Trials

Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy

Start date: March 2012
Phase: N/A
Study type: Interventional

Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC). The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life. Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer. Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health. It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.

NCT ID: NCT01711281 Completed - Heart Failure Clinical Trials

Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

BIODetectHFII
Start date: October 2012
Phase: Phase 4
Study type: Interventional

Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters, physical capacity and quality of life. A continuous measurement of the left-ventricular volume would provide information about heart performance and could be used for both heart failure monitoring and optimization of CRT-therapy.

NCT ID: NCT01710735 Completed - Clinical trials for Myofascial Pain Syndrome

Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs

Start date: April 2011
Phase: N/A
Study type: Interventional

In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.

NCT ID: NCT01708980 Completed - Clinical trials for Osteoarthritis, Knee

Descriptive Study of Strength Training Exercises to Activate the Muscles of the Operated Leg After Total Knee Replacement

Start date: October 2012
Phase: Phase 1
Study type: Interventional

Background: In the early phase after a total knee replacement (TKA), patients experience multi-level weakness in the operated leg, which is caused primarily by reduced central (CNS) activation failure of the muscles - especially the knee extensors. This considerable loss of muscle strength relates to reduced functional performance. The investigators recently reported that early-commenced physiotherapy, including progressive strength training performed in machines, seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the operated leg, elicited during strength training in machines, can be reached during strength training in more simple forms? Many clinicians are faced with the problem of not having strength training equipment at their institution, or having to prescribe simple strength training exercises for home-based training. Purpose and hypothesis: The purpose of this study is to determine which strength training exercises that activate the muscles in the operated leg the most after TKA. The hypothesis is that strength training exercises performed in machines is more effective compared to strength training performed in more simple forms (using elastic bands or own body weight, etc.). Participants and methods: Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first investigation, will be included. The participants are investigated twice. During the first investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a load that can be lifted exactly 10 times) will be determined for all the exercises. At least 72 hours later, the participants will undergo an electromyographic analysis, which determines the neuromuscular activity of the thigh muscles in the operated leg. Ethical issues: From a pilot study, the investigators found that strength training exercises commenced early after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.

NCT ID: NCT01708642 Completed - Clinical trials for Intraoperative Blood Loss

The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.

NCT ID: NCT01707979 Completed - Diabetic Neuropathy Clinical Trials

NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes

NIR
Start date: September 2012
Phase: N/A
Study type: Observational

The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.