
Clomiphene Stair-Step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome...
Polycystic Ovary SyndromeThe objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional protocol. Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the inclusion criteria, they were divided into two groups; 65 patients for the stair step protocol and 75 patients for the traditional protocol.

A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short...
Short Bowel SyndromeThis will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive standard of care. Three doses of teduglutide are to be investigated for 12 weeks. All subjects will be screened prior to the start of treatment (SOT) to establish baseline characteristics including safety, eligibility and nutritional support parameters.

Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute...
FLT3 Gene Mutation NegativeFLT3 Internal Tandem Duplication Positive6 moreThis phase I/II trial studies the side effects and best dose of quizartinib when given in combination with azacitidine or cytarabine in treating patients with acute myeloid leukemia or myelodysplastic syndrome that have come back (relapsed) or are not responding to treatment (refractory). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine and cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib with azacitidine or cytarabine may work better in patients with acute myeloid leukemia or myelodysplastic syndrome.

Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
Postoperative Dumping SyndromeDumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this trial is to evaluate : the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying. the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during OGTT). the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during OGTT). the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after an Oral Glucose Tolerance Test (OGTT) with 75g of glucose) the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as measured by the combined Dumping Syndrome score the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured by (a) early and (b) late phase dumping symptom score separately the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL SF-36)

BMN 110 Phase 3B in Australian Patients
Mucopolysaccharidosis IVA (Morquio A Syndrome)There is currently no treatment for MPS IVA other than supportive care for the clinical manifestations of the disease. Enzyme replacement therapy (ERT) with BMN 110 to replace the deficient GALNS is a potential new treatment option for MPS IVA patients. BMN 110, containing recombinant human GALNS (rhGALNS) developed by BioMarin is expected to reduce the progressive, pathologic accumulation of KS, and improve signs and symptoms of the disease. The objective of this Phase 3B open label study (110-502) will be to evaluate the safety and tolerability of 2.0 mg/kg/week (qw) of BMN 110 in Australian patients with MPS IVA. In addition, a number of secondary and tertiary efficacy endpoints will also be investigated. The dose and regimen of BMN 110 have been selected on the basis of data from a Phase 1/2 clinical study with BMN 110, nonclinical and in vitro studies with BMN 110, and clinical and nonclinical data from other enzyme replacement therapies. Extension Phase is included per amendment dated 10Mar 2014: To provide patients enrolled in the Initial Phase access to BMN 110 until commercial product becomes available in Australia and continue to assess long-term safety

Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates...
Respiratory Distress Syndrome in Premature InfantBronchopulmonary DysplasiaBronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection. These conditions initiate an inflammatory response characterized by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the development of significant acute and chronic lung injury. The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10 is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is the most abundant protein in the mucosal fluids in normal healthy lungs. The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated premature infants receiving positive pressure ventilation for treatment of respiratory distress syndrome (RDS) to prevent long term respiratory complications referred to as bronchopulmonary dysplasia, and, more recently, as Chronic Pulmonary Insufficiency of Prematurity (CPIP; asthma, cough, wheezing, multiple respiratory infections). CC10 regulates inflammatory responses and protects the structural integrity of pulmonary tissue while preserving pulmonary mechanical function during various insults (eg. viral infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties suggest that administration of rhCC10 may help to facilitate development of normal airway epithelia and prevent the inflammation that leads to CPIP in these infants. This study is funded by the FDA Office of Orphan Product Development (OOPD).

Long Term Safety Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic...
Myelodysplastic SyndromeThis is an extension study study to investigate long term safety of SyB L-1101 when administered intravenously every 4 weeks to the patients who have completed 8 cycles in the study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome. Antitumor effects will also be investigated in this study.

Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome...
Overactive Bladder SyndromeINTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society as urgency, with or without incontinence, usually with increased urinary frequency and nocturia. It is difficult to estimate the prevalence of this syndrome because many patients do not seek medical help, despite considerable negative impact on quality of life. Lower urinary tract dysfunctions can be treated using electrical stimulation of the posterior tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary frequency and nocturia . Due to lack of consensus on the parameters of this technique, further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will accept up to 145 women with overactive bladder diagnosis for at least six months prior to the beginning of the study. The subjects will be divided into five groups: group TENS 0-1 (placebo group), group TENS 1-1 (electrical stimulation of one leg once a week), group TENS 1-2 (electrical stimulation of one leg twice a week), group TENS 2-1 (electrical stimulation of two legs one a week) and group TENS 2-2 (electrical stimulation of two legs twice a week). Physical evaluation will be done at the beginning and at the end of the treatment. Evaluation will be done using the King "s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for follow-up treatment.

High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome
Polycystic Ovary SyndromeThe aim is to investigate whether strength training or high intensity interval training is effective in improving insulin sensitivity, cardiovascular outcomes, body composition and reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS). Few studies have examined the effect of strength training alone on insulin sensitivity, reproductive outcomes and body composition in women with PCOS. Most previous studies on aerobic exercise in PCOS have applied moderate exercise intensity.

The Effectiveness of a Bladder Training Video for Management of Lower Urinary Tract Symptoms.
Nonneurogenic Lower Urinary Tract DysfunctionDysfunctional Elimination SyndromeChildren with non-neurogenic lower urinary tract dysfunction (NLUTD) represent a significant subgroup of pediatric urology patients, comprising up to 30 percent of some out-patient clinics. These children present with urinary tract infections (UTIs), abnormal voiding habits and various other lower urinary tract symptoms (LUTs) such as incontinence, urinary urgency and urinary frequency. Furthermore, the effects of NLUTD on a child's physical health, mental health and its potential negative clinical sequelae, which includes upper or lower urinary tract damage, must be taken into account when treating these children. These patients have complex needs requiring a significant amount of health teaching and it is imperative to determine the effectiveness of the various modes of delivering urotherapy. To determine the best modality to deliver urotherapy, this trial will compare the effectiveness of a 7 minute bladder training video to the effectiveness of standard urotherapy provided at a pediatric urology clinic at improving NLUTD/DES symptoms and quality of life in children between 5-10 years of age.