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NCT ID: NCT02023047 Terminated - Anal Fissure Clinical Trials

An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label study. The study will consist of 2 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2). Approximately 30 subjects will participate into this 8-week study. The primary objective is to examine the dose effect of coated Nifedipine suppository on Anal fissure pain and healing.

NCT ID: NCT02022787 Recruiting - Clinical trials for Clear Cell Renal Cell Carcinoma

Value of Various Chemokines in the Detection and Follow up of RCC

Start date: January 2014
Phase: N/A
Study type: Observational

This study was designed as a pilot study to try and find a Chemokine that may be specific for renal cell carcinoma

NCT ID: NCT02021409 Completed - Anemia Clinical Trials

Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934

DIALOGUE 2
Start date: January 28, 2014
Phase: Phase 2
Study type: Interventional

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this research.

NCT ID: NCT02021370 Completed - Anemia Clinical Trials

15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)

DIALOGUE 1
Start date: February 10, 2014
Phase: Phase 2
Study type: Interventional

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.

NCT ID: NCT02021318 Completed - Clinical trials for Anemia in Chronic Kidney Disease in Non-dialysis Patients

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

Dolomites
Start date: March 12, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.

NCT ID: NCT02020811 Recruiting - Sepsis Clinical Trials

Safety and Efficacy of Immages System in Patients Recieving IV Therapy

IV
Start date: November 2013
Phase: N/A
Study type: Interventional

The study will evaluate the functionality of IMMAGES , an intravenous infusion device system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how the IMMAGES system integrates within IV infusion therapy regime and what are the advantages and disadvantages, if any, of using this system within the prescribed setting.

NCT ID: NCT02020746 Completed - Venous Leg Ulcers Clinical Trials

Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds

Start date: July 24, 2014
Phase: Phase 2
Study type: Interventional

The main objective of this study is to assess the safety and the efficacy of EscharEx in preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds. This study will be a multi-center, assessor blinded, randomized, controlled study intended to demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control treatment in patients with hard to heal wounds. 72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between 5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled into the study. Patients will undergo a 1 week screening period (2 visits) which will include: record of demographics, medical history and concomitant medications, vital signs, physical examination, clinical laboratory tests, wound photography and assessments and questionnaires (wound status and quality of life). During this period wounds will be treated by standard treatment per the decision of the physician. During this screening period, subjects whose study wound size (surface area) decreases by more than 20 percent will be excluded. Following completion of the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10 applications or until complete debridement is achieved, whichever occurs first. In stage 2 (24 patients): Treatment will be performed for up to 8 applications or until complete debridement is achieved, whichever occurs first. Following each application the wound will be washed, photographed and assessed for wound size, removal of nonviable tissue and change in granulation tissue (by digital planimetry software), wound status, and safety parameters. Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline gauze (except when successive 24h or 48h treatments are performed, in the second stage). Following completion of the debridement treatment period, patients will be treated according to standard procedures and evaluated (wound assessments) once a week until complete wound closure for up to 12 weeks from last application (up to 12 visits). Only during the first stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits) follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For patients enrolled at the second stage, if wound closure was achieved at the 12 weeks follow-up, additional visit will be performed 2 weeks later to confirm wound closure.

NCT ID: NCT02020369 Completed - Clinical trials for Hemophilia A With Inhibitors

A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX

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

The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX

NCT ID: NCT02020265 Active, not recruiting - Depression Clinical Trials

fMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers

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

EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols, Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference between the groups in regard to their emotion regulation capability will be tested by fMRI with regard to amygdala activation following EEG-NF LMI as well as two stress challenge tests.

NCT ID: NCT02020200 Not yet recruiting - BD Clinical Trials

The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder

Start date: January 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. The investigators hypothesize that MPH will incur improved performance in all measures.