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NCT ID: NCT03304938 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia

Start date: August 20, 2017
Phase: N/A
Study type: Interventional

Considering the high prevalence of sleep disturbance in diabetic patients and the effectiveness of lavender in treatment of sleep disorders in this study the efficacy of Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be investigated. This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

NCT ID: NCT03304899 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Start date: October 23, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death. The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.

NCT ID: NCT03293199 Recruiting - Clinical trials for Pneumothorax Spontaneous Tension

Comparing Efficacy of Chest Tube Drainage and Needle Aspiration in Pneumothorax Treatment

Start date: August 12, 2017
Phase: N/A
Study type: Interventional

Spontaneous pneumothorax is a common condition which is defined as air presence inside of pleural space. Despite, several studies that have been carried on management patients suffering spontaneous pneumothorax, the first step approach on patients is still the topic of debate. Since chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, current study compares the efficacy of abovementioned techniques, as well as long-term outcomes. In current multi-center single-blinded RCT, all patients admitted with spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. Patients randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence. Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow up might be lower in patients who undergo needle aspiration instead of chest tube drainage.

NCT ID: NCT03293108 Recruiting - Osteoporosis Clinical Trials

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Dyenix) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women

Start date: April 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women. Postmenopausal women diagnosed with osteoporosis according to their Bone mineral density result (BMD), aged between 45 to 75 are included in this trial. This is a Phase III, randomized, two armed, double-blind, parallel, active-controlled,non-inferiority clinical trial. The eligible patients are randomized in a 1:1 ratio to receive Dyenix or Prolia® subcutaneous injections, at the beginning of the trial and every 6 months at month 6 and 12, in an 18-month study period. Along with, all women will receive daily supplements containing at least 1000 mg of elemental calcium (divided into two doses) and at least 400 IU vitamin D daily during 18 months of the study. The primary objective of this study is to assess non-inferiority of test- Denosumab 60 mg (Dyenix) to the reference Denosumab 60 mg (Prolia®) in terms of efficacy among osteoporotic postmenopausal women. The secondary objectives of this study are: To further compare efficacy of test- Denosumab 60 mg to reference Denosumab 60 mg; To assess the safety of test- Denosumab 60 mg compared to reference Denosumab 60 mg.

NCT ID: NCT03288987 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

A Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab (AryoGen Pharmed) Compared With Bevacizumab (Avastin®) in Metastatic Colorectal Cancer

Start date: October 5, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, two arms, double-blind (patient and assessor blinded), parallel active non inferiority controlled clinical trial with a 2:1 allocation. This trial was conducted to evaluate the efficacy and safety of bevacizumab (produced by AryoGen Pharmed) plus FOLFIRI-3 compared with bevacizumab (Avastin®) plus FOLFIRI-3 in patients with metastatic colorectal cancer (mCRC). Patients who met the following criteria could be recruited to receive the mentioned intervention randomly. Inclusion criteria: male or female aged 18-75 years, mCRC verified histologically, Having one or more bi-dimensionally measurable lesions as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, Was not felt to be amenable to curative resection, With an (ECOG) performance status of ≤ 1, Life expectancy of longer than 3 months, Adequate organ and marrow function, May have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented, Patients with history of hypertension must be well-controlled (blood pressure less than/equal to 150/100), on a stable regimen of anti-hypertensive therapy.

NCT ID: NCT03273192 Completed - Bioequivalence Clinical Trials

A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects

Start date: April 22, 2017
Phase: Phase 1
Study type: Interventional

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of a single dose (40 mg) of adalimumab. The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to its originator, Humira®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax. The secondary objectives of the study are: - To further compare the PK of CinnoRA® and Humira®. - To assess the safety of CinnoRA®.

NCT ID: NCT03273088 Completed - Bioequivalence Clinical Trials

Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects

Start date: December 4, 2016
Phase: Phase 1
Study type: Interventional

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and tolerability of Altebrel, in a crossover fashion in healthy male volunteers after administration of a single dose (25 mg) of etanercept. The primary objective of this study is to demonstrate that the PK of Altebrel is similar to its originator, Enbrel®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax. The secondary objectives of the study are: To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.

NCT ID: NCT03267797 Recruiting - Clinical trials for Recurrent Implantation Failure

The Effects of Lymphocyte Therapy on Pregnancy Rate of Patient With Recurrent Implantation Failure

Start date: October 7, 2017
Phase: Phase 2
Study type: Interventional

Infertility and miscarriage ordinary events in reproductive failure in humans, as are affected one couple in every six couples of reproductive age and abortion is including in approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains below 30% and Recurrent Implantation Failure in one of the most important limiting factor is the assisted reproductive techniques. According to studies conducted in recent years one of the most important mechanisms of implantation failure is maternal immune system because the fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly associated with implantation failure. Lymphocytes during implantation, in association with endometrium and blastocyst, participate in the production of cytokines, in particular Th1 pre-inflammatory cytokines. TNFα, IFNγ ،LIF ،IL12 ،IL15 Among these are pre-inflammatory cytokines that appear to be necessary in the early stages of implantation. The initial inflammatory response should therefore be selectively reduced to preserve pregnancy. Inflammatory response impairment at the beginning of pregnancy causes fetal implantation failure, while high inflammation leads to acute rejection (spontaneous abortion) or chronic (pre-eclampsia) ). Preserving pregnancy requires a specific cytokine pattern, in particular Th2 cytokines (IL3, IL4, IL5, IL10, IL13, GMCSF), which causes the anti-inflammatory state of pregnancy required. Therefore, maternal immunity seems to be involved in creating and sustaining pregnancy through the Th1 / Th2 Thalassic Balance. An imbalance between the two systems can be an explanation for the implantation failure in some patients. The effect of intra-uterine lymphocyte therapy on the fertility rate of women with RIF in the mouse model has been shown to be controlled by the Th1 system. While the Th2 system has a protective role, two thirds of patients have had an incomplete endometrial admission. Since the immune cells of the uterus are balanced through a broad cytokine pattern, it is important to evaluate the implantation success of RIF patients after intrauterine insemination (IUI) of their own lymphocytes in the uterus in the pre-implantation phase. Laboratory tests on mice show an increase in the number of embryonic implantations with human PMBCs. Considering the importance of TH1 and TH2 cells in the success or failure of pregnancy and the relationship between the function and balance of these cells with pregnancy problems, such as implantation failure (RIF), and the role of factors and inflammatory cytokines in creating proper nesting conditions, by introducing the lymphocytes of a participants infected with RIF into the uterus in order to induce primary inflammation, the investigators will examine its effect on fertility and the success of implantation in women with RIF.

NCT ID: NCT03266913 Recruiting - Clinical trials for Hyperbilirubinemia, Neonatal

Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Start date: August 1, 2017
Phase: Phase 3
Study type: Interventional

Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in Bandar Abbas.

NCT ID: NCT03260803 Enrolling by invitation - Osteopenia Clinical Trials

Oligopin Supplementation and Bone Turnover Markers and Antioxidant Changes in Postmenopausal Osteopenic Women

Start date: August 15, 2017
Phase: Phase 3
Study type: Interventional

Osteoporosis fractures impose a significant economic burden on the health system. There is evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women), and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the prevention of osteopenia progression towards osteoporosis has been considered as an important issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the equilibrium between bone formation and resorption done by simultaneously regulating osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption contributes to reducing bone mineral density and hence increasing the risk of osteoporosis Recently, new therapies have been focused on use of medicinal herbs, especially phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act both on osteoblast and on osteoclast. Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in vitro studies and animal models. Investigators aimed to investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial. Participants are forty four women with osteopenia divided into two groups randomly (22, having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia) receives the same amount of the placebo. At the first and the end of the study, blood sample are taken to measure in order to peripheral blood mononuclear cells isolation and plasma separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.