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NCT ID: NCT01815021 Completed - Hypoparathyroidism Clinical Trials

A Study Comparing Amorphous Calcium Carbonate (ACC) Versus Crystalline Calcium CCS) in Hypoparathyroidism Patients

AMCS009
Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Primary objective: Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL). Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL). Secondary objectives: Phase I - ACC dose selection - to confirm the conversion factor of ACC from CCS - To determine the effect of food on ACC absorption Phase II - To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS will not cause an increase in hypercalciuria in patients with hypoparathyroidism - To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the side effects related with high calcium consumption. Amorphical has a strong basis to believe that the ACC product is better absorbed compared to the commercially available CCS products and therefore, can maintain desirable target albumin corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As results, the burden of taking high doses of calcium supplementation along with the side effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be reduced. Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a straightforward method to test this hypothesis. The study is designed to be conducted with extra precaution in order to avoid disturbing the fragile balance between CA levels in serum and calcium levels urine. The crossover design of phase II of the study allows a more accurate and reliable comparison of results attributable to the specific treatment within the same individual. In addition, the subjects will continue consuming all their routine medication throughout the trial. The subjects in the control arm will consume their routine calcium supplement doses thus, will be treated with a standard of care.

NCT ID: NCT01814852 Completed - Clinical trials for Vasculogenic Erectile Dysfunction

Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

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

This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

NCT ID: NCT01814150 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

The Association Between Alpha 1 Acid Glycoprotein Level and Outcome Metastatic Cancer Treated With Docetaxel

Start date: April 2013
Phase: N/A
Study type: Observational

Docetaxel based chemotherapy is a standard therapy in various metastatic cancers including lung cancer, breast cancer, gastric cancer, prostate cancer, and bladder cancer. One of the main plasma protein carriers of docetaxel is Alpha 1 acid glycoprotein. Retrospective data suggests that plasma level of alpha 1 acid glycoprotein is associated with the outcome of docetaxel based therapy in cancer patients. The investigators aim to prospectively study the association between the plasma level of alpha 1 acid glycoprotein and the outcome of docetaxel based therapy in cancer patients.

NCT ID: NCT01813422 Completed - Clinical trials for Hypercholesterolemia

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

GLAGOV
Start date: April 18, 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

NCT ID: NCT01813240 Not yet recruiting - Clinical trials for Spinal Tumors, Trauma Patients, Minocycline.

Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement

Start date: May 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups: 1. Minimizing the neurological damage among trauma patients. 2. Preventing neurological damage through operation in spinal tumors patients. 2.OBJECTIVES The primary objectives of the trial are to determine: 1. Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients? 2. Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients. 3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?

NCT ID: NCT01811797 Terminated - Clinical trials for Vasculogenic Erectile Dysfunction

Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

Start date: October 2013
Phase: N/A
Study type: Interventional

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

NCT ID: NCT01811732 Completed - Clinical trials for Skin and Subcutaneous Tissue Bacterial Infections

Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Start date: April 2013
Phase: Phase 3
Study type: Interventional

This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

NCT ID: NCT01811576 Completed - Clinical trials for Growth Hormone Deficiency

Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

Start date: March 31, 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the clinical effect of TV-1106.

NCT ID: NCT01811173 Active, not recruiting - Chronic Disease Clinical Trials

Comprehensive-Care for Multimorbid Adults Effectiveness Study

CCMAP
Start date: March 2013
Phase: N/A
Study type: Interventional

This study is intended to examine whether directed care of a nurse working jointly with the patient's primary care physician, including a comprehensive assessment, creation of a tailored care plan, proactive follow-up, self management support and caregiver support and care coordination, can reduce hospital admissions for patients with multiple chronic conditions.

NCT ID: NCT01810796 Not yet recruiting - Clinical trials for Coronary Artery Disease,

Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

Start date: December 2013
Phase: Phase 3
Study type: Interventional

Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood pressure or heart rate, prevents postoperative myocardial injury.