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NCT ID: NCT03566069 Recruiting - Clinical trials for Severe Mental Illness

Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness

Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

Intranasal administration of Oxytocin (OT) has been found to improve social communication skills and encoding of social cues. Studies indicate that the provision of OT enhances the ability to develop trust 1, to improve the benefits of social support during social stress induction tasks 2 and to increase positive communication during couples' conflict discussions 3. These studies, and many others, point to the potential beneficial effects of OT as a facilitator of relationship-focused processes such as psychotherapy. Studies assessing the effect of OT as a possible outcome enhancer in psychotherapy for clinical populations are scarce, and their findings are largely inconsistent 4. Reasons for this state of affairs include the complexity of recruitment in this population; the provision of single-dose OT, which tends to cause a lower and insufficient effect 5; and methodological constraints, such as the lack of a control group 6 or insufficient probing of interpersonal factors 7. In this study we intend to overcome these constraints by evaluating the impact of intranasal administration of OT in patients suffering from acute stages of anxiety and depression disorders and undergoing intensive, relationship-focused psychotherapy during psychiatric hospitalization. One-hundred-and-twenty admitted patients with anxiety and depression disorders will be randomized and double-blindly allocated to two groups: (a) psychotherapy + OT (n=60), and (b) psychotherapy + placebo (n=60). Patients will be followed for three weeks, beginning at the start of their hospitalization, and will be assessed for the severity of their anxiety and depression symptoms; their working alliance with their therapist; and their treatment outcome after each session. Psychotherapy will be delivered twice a week. Intranasal OT will be administered twice a day. This study can provide insights regarding the potential involvement of OT in the trajectories leading to the production of detectable changes in brain activity following psychotherapy. Additionally, it can support the development of an integrating model combining recent findings in psychotherapy research pertaining to the significant role of therapeutic alliance in psychotherapy outcome, and findings from neuroimaging studies. Finally, provision of OT as a psychotherapy enhancer can facilitate a rapid therapeutic response and subsequently replace aggressive psychiatric medication usage, needed to create a rapid decrease of distress during psychiatric admissions.

NCT ID: NCT03564340 Recruiting - Clinical trials for Recurrent Ovarian Cancer

Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

Start date: May 21, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this study is to: - Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus - The study will also look at the levels of REGN4018 and/or cemiplimab in your body and measure how well your body can remove the study drug(s). This is called pharmacokinetics - The study will also look at any signs that REGN4018 alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus - To find out how safe and tolerable the sarilumab pretreatment is, in combination with REGN4018 and cemiplimab

NCT ID: NCT03560388 Recruiting - Quality of Life Clinical Trials

Acupuncture and Integrative Care in Gynecological Surgery

Start date: June 24, 2018
Phase: N/A
Study type: Interventional

Patients undergoing surgical procedures for gynecological cancer are frequently challenged by intense anxiety prior to surgery, reflecting the accompanying uncertainty regarding the diagnosis, treatment and prognosis of their illness.The purpose of the proposed study is to explore the impact of complementary and integrative medicine (CIM) treatments (including acupuncture) on anxiety, pain, and general QOL of patients referred to gynecological oncology surgery. The investigators working hypothesis is that an intensive CIM treatment program, provided to patients within 24 hours prior to and during surgery will reduce perioperative anxiety and pain, and will reduce the need for intra-operative and post-operative analgesia.

NCT ID: NCT03560375 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Mediterranean Diet, Circuit Resistance Training, Empagliflozin in Elderly With Type 2 Diabetes: a Study Protocol

Start date: May 9, 2018
Phase: Phase 4
Study type: Interventional

Primary objective: To assess the effects of a modified plant-based Mediterranean diet (vegeterranean diet), circuit resistance training (CRT) and empagliflozin alone or in combination on body composition and physical function in elderly subjects with type 2 diabetes. The rationale for this study is to assess three interventions associated with a negative energy/caloric balance (increased caloric use in exercise, caloric restriction in the vegeterranean diet and caloric wasting by glycosuria with empagliflozin), their interaction and effect on body composition and physical function. Methods and analysis: One hundred and twenty men and women ≥ 65 years of age with type 2 diabetes, and low levels of physical activity will be randomized (1:1:1 manner, gender-stratified) for 10 weeks to one of 3 parallel arms: CRT consisting of 3 home sessions/week; ad-libitum plant-based Mediterranean diet (limited consumption of eggs, dairy and fish, avoidance of red meat and poultry) or empagliflozin 10mg/day. After 10 weeks CRT will be added to the empagliflozin or diet arms for an additional 10 weeks. Allocation concealment and blinding of primary outcome assessors will be implemented. Efficacy will be determined by assessment of lean body mass, body weight, frailty status, sarcopenia, HbA1c and quality of life questionnaires. Safety will be evaluated by routine monitoring of adverse events. This study was approved by the Tel-Aviv Sourasky Medical Center Institutional Review Board

NCT ID: NCT03558269 Recruiting - Clinical trials for Congenital Heart Disease

Autologous Umbilical Cord Blood Treatment of Neonate With CHD

Start date: February 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA). Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process. Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems

NCT ID: NCT03552952 Recruiting - Premature Infants Clinical Trials

Development of Preterm Infant Gut Microbiome

Start date: March 8, 2018
Phase:
Study type: Observational

This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

NCT ID: NCT03551223 Recruiting - Clinical trials for Phosphopyruvate Hydratase

Neural Damage and Anesthetic Treatment in the Preeclamptic Parturient; a Prospective Observational Study.

Start date: August 1, 2018
Phase:
Study type: Observational

Objectives: Our primary objective is to evaluate the effect of anesthetic method (general versus regional anesthesia) on neural outcomes in the preeclamptic population undergoing cesarean delivery. Secondary outcome is to examine the fetal cerebral outcomes associated with the anesthetic method. Methodology: This prospective, observational study, will include 50 preeclamptic parturients undergoing cesarean section under general and regional anesthesia. Neuron specific enolase and S100B Protein are neuronal injury biomarkers. Increased levels of these biomarkers in serum indicate neuron damage. Following enrollment venous blood will be drawn from the participants and assessed for NSE and S100B serum levels at the following points; Upon hospital admission and one day postpartum. Furthermore in order to evaluate fetal outcomes upon fetal delivery, umbilical cord blood will be examined for NSE and S100B. Study significance: While spinal anesthesia is the preferred anesthetic method for the preeclamptic parturient undergoing cesarean delivery, it remains uncertain which anesthetic method is neuroprotective. This study will be the first study, to our knowledge, to examine the effect of anesthetic method on neuronal outcomes for a parturient with preeclampsia undergoing cesarean delivery, by the use of noninvasive cerebral biomarkers.

NCT ID: NCT03527615 Recruiting - Safety Issues Clinical Trials

Clinical Pharmacist Anticoagulant Stewardship

Start date: January 1, 2017
Phase:
Study type: Observational

Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.

NCT ID: NCT03522493 Recruiting - Aging Clinical Trials

The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "

Start date: July 2016
Phase: N/A
Study type: Interventional

20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

NCT ID: NCT03519945 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Start date: July 18, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.