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NCT ID: NCT03836950 Recruiting - Parkinson's Disease Clinical Trials

rTMS to Improve Cognition in Parkinson's

TMSCogReP
Start date: April 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine safety, feasibility, and the behavioral and brain effects of a non-invasive treatment, repetitive transcranial magnetic stimulation (rTMS), for Veterans with Parkinson's disease and mild impairments in their thinking. The hypothesis is that rTMS can improve thinking for people with Parkinson's disease who are experiencing mild problems with their thinking ability.

NCT ID: NCT04004364 Recruiting - Clinical trials for First Episode Psychosis

Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes

ESPRITO
Start date: April 1, 2020
Phase:
Study type: Observational

The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

NCT ID: NCT04048785 Recruiting - Clinical trials for Infant Sleep Problem

Behavioral Sleep Intervention and Infant Sleep and Social-emotional Development

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

An estimated 30-50% of infants have frequent problematic night wakings. Sleep disturbances have been linked to various adverse outcomes in children, including social-emotional development delay. Despite some evidence of the effectiveness of Infant behavioral sleep intervention, the benefits on children's social-emotional development are worthy of further exploration. The aim of this study is to evaluate the efficacy of behavioral sleep interventions on improving infant sleep and social-emotional development. Infants with behavioral sleep disturbances are randomized into one of the two conditions: Behavioral sleep intervention or no treatment. And infant sleep and social-emotional development were assessed for both group at baseline, and four and eight weeks after sleep intervention.

NCT ID: NCT04049357 Recruiting - Colorectal Cancer Clinical Trials

Care for Colon 2015

CFC2015
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The investigatior believe that implementing camera capsule endoscopy as a filter test to colonoscopy will increase screening participation, increase the number of individuals with detected intermediate- high risk adenomas or cancer, reduce the colonoscopy demand and reduce the number of complications.

NCT ID: NCT04085900 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. Screening positive participants will be followed up annually. All subjects will also be followed by record linkage to Cancer Register and Population Register.

NCT ID: NCT04087408 Recruiting - Clinical trials for Effect of Adding GnRHa as Luteal Phase Support in Antagonist ART Cycles

Role of Triptorelin 0.1 mg as a Luteal Phase Support in Assisted Reproductive Technique After Embryo Transfer : a Randomized Controlled Trial

Start date: April 1, 2020
Phase: Phase 3
Study type: Interventional

There is still controversy over the best LPS agent and protocol and its dose and duration as well as the time of initiation and cessation. There are many protocols of luteal support in assisted reproductive technology (ART) cycles. Luteal phase support with progesterone is a standard approach for ART cycles . Initial studies in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) patients have demonstrated that the use of a GnRH agonist (GnRHa) trigger, followed by fresh transfer and a standard luteal phase support (LPS) was associated with unacceptably high rates of loss in early pregnancy compared to hCG trigger, particularly in normal responder (NR) patients. During IVF and fresh embryo transfer, the luteal function is disrupted and the success of the treatment is critically dependent on exogenous luteal phase support During the last decade, two different modified LPS strategies have been proposed to overcome the mentioned luteal phase deficiency. One of these approaches has been called the "European approach" in which the endogenous steroid (progesterone and estradiol) production by the corpora lutea is boosted by exogenous LH activity, i.e., LH or hCG after GnRHa trigger. The other approach has been called the "American approach" in which luteal progesterone and estradiol are administered exogenously, thus, disregarding the function of the corpora lutea. It has been subsequently concluded that this early pregnancy loss was caused by luteal phase (LP) insufficiency, despite the use of a standard LPS package of progesterone (P) and estradiol (E2). The LP defect was primarily caused by reduced early-mid-luteal luteinizing hormone (LH) activity, resulting in a significant reduction in progesterone output by the corpora lutea (CL) as no adverse effects were seen with respect to the maturity rate of oocytes, fertilization rates, embryo quality, and reproductive outcomes during the subsequent replacement of frozen embryos derived from women who had received a GnRHa trigger . Transvaginal progesterone is commonly used for luteal phase support. Progesterone administration is initiated on the oocyte pick-up (OPU) day and continued for 12 days, until the serum beta human chorionic gonadotropin (hCG) measurement day. However, there are conflicting results regarding the dose, route of administration (oral, subcutaneous, transvaginal), duration (until the ultrasound demonstration of heartbeat in an intrauterine gestational sac, until 10 weeks of gestation, until 12 weeks of gestation), and formulations such as synthetic or micronized types of progesterone. A bolus of GnRHa, when administered 6 days after OPU in GnRH antagonist cycles, is able to induce a surge of pituitary gonadotropins (FSH and LH), eliciting an increase in steroid production (E2 and P) by the CL. The exact mechanism behind the presumed beneficial effect of LP GnRHa administration remains poorly defined. It has been hypothesized that GnRHa either supports CL function by inducing LH secretion by the pituitary gonadotrophic cells or stimulates the endometrial GnRH receptors. Tesarik postulated a direct effect of GnRHa on the embryo, as suggested by an increase in β-HCG secretion. Importantly, there are significant differences in the early-mid-LP endocrine pattern when GnRHa triggers and hCG triggers are compared, especially in terms of LH levels. From this, it could be hypothesized that the GnRHa-triggered IVF cycle could benefit more from the addition of a bolus of GnRHa to boost the circulating endogenous LH and thus, progesterone levels around the time of implantation than the hCG triggered cycle. No studies previously investigated this issue. Therefore, the aim here was to explore a possible fine-tuning of the LPS of GnRHa-triggered IVF/ICSI cycles, using the previously suggested protocol. Significantly increased implantation rates (IRs) were previously reported in oocyte recipients as well as in patients who were triggered with hCG, if they received a single mid-luteal bolus of GnRHa in addition to standard LPS . A beneficial effect of a single dose of GnRH agonist administration as a luteal phase supporting agent is yet to be determined because of the wide heterogeneity of data present in literature. Well-designed randomized clinical studies are required to clarify any effect of luteal GnRH agonist addition on pregnancy outcome measures with different doses, timing, and administration routes of GnRH agonists . Administration of 0.1 mg of the GnRH agonist triptorelin on day 3 after embryo transfer led to a significant improvement in implantation rate (12.3% vs. 7.3%) and clinical pregnancy rate (25.5% vs. 10.0%) as compared with placebo. Luteal phase support with single-dose GnRHa might be as efficient as three doses of hCG. Large prospective, randomized-controlled studies are required comparing GnRHa and hCG for luteal phase support.

NCT ID: NCT04116671 Recruiting - Stroke Clinical Trials

Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Objective: The goal of this study is to implement and test a neuro-mechanical gait assist (NMGA) device to correct walking characterized by muscle weakness, incoordination or excessive tone in Veterans with hemiparesis after stroke that adversely affects their ability to walk, exercise, perform activities of daily living, and participate fully in personal, professional and social roles. Research Plan: A prototype NMGA device will be used to develop a finite state controller (FSC) to coordinate each user's volitional effort with surface muscle stimulation and motorized knee assistance as needed. Brace mounted sensors will be used to develop a gait event detector (GED) which will serve the FSC to advance through the phases of gait or stair climbing. In addition, a rule-base intent detection algorithm will be developed using brace mounted sensors and user interface input to select among various functions including walking, stairs climbing, sit-to-stand and stand-to-sit maneuvers. The FSC controller tuning and intent algorithm development and evaluation will be on pilot subjects with difficulty walking after stroke. Outcome measures during development will provide specifications for a new prototype NMGA design which will be evaluated on pilot subjects to test the hypothesis that the NMGA improves walking speed, distance and energy consumption of walking. These baseline data and device will be used to design a follow-up clinical trial to measure orthotic impact of NMGA on mobility in activities of daily living at home and community. Methodology: After meeting inclusion criteria, pilot subjects will undergo baseline gait evaluation with EMG activities of knee flexors and extensors, ankle plantar and dorsiflexors and isokinetic knee strength and passive resistance. They will be fitted with a NMGA combining a knee-ankle-foot-orthosis with a motorized knee joint and surface neuromuscular stimulation of plantar- and dorsi- flexors, vasti and rectus femoris. Brace mounted sensor data will be used for gait event detector (GED) algorithm development and evaluation. The GED will serve the FSC to proceed through phases of gait based on supervisory rule-based user intent recognition algorithm detected by brace mounted sensors and user input interface. The FSC will coordinate feed-forward control of tuned stimulation patterns and closed-loop controlled knee power assist as needed to control foot clearance during swing and stability of the knee during stance. Based on data attained during controller development and evaluation, a new prototype NMGA will be design, constructed and evaluated on pilot subjects to test the hypothesis that a NMGA device improves safety and stability, increases walking speed and distance and minimizes user effort. Clinical Significance: The anticipated outcome is improved gait stability with improved swing knee flexion, thus, increasing the safety and preventing injurious falls of ambulatory individuals with hemiplegia due to stroke found in large and ever-increasing numbers in the aging Veteran population. Correcting gait should lead to improved quality of life and participation.

NCT ID: NCT04125329 Recruiting - Clinical trials for Diabetic Nephropathy

Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy

Start date: April 1, 2020
Phase: Early Phase 1
Study type: Interventional

This clinical trial assessed the safety of human umbilical cord mesenchymal stem cell therapy in 15 patients with diabetic nephropathy. Fifteen subjects received umbilical cord mesenchymal stem cell therapy 3 times. Approximately 1 × 106/kg of human umbilical cord mesenchymal stem cells were administered by peripheral intravenous infusion once a month .Endpoints:Primary endpoint: Safety and adverse events (safety and tolerability of umbilical cord mesenchymal stem cell therapy within 60 weeks).Secondary endpoint indicators:Efficacy measures: eGFR, urinary albumin-to-creatinine ratio, and percentage changes of 24-h urinary protein quantities from baseline to 60 weeks.

NCT ID: NCT04152967 Recruiting - Clinical trials for Congenital Heart Disease

New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of Fallot(TOF) for their significant roles in reducing pulmonary valve regurgitation and preserving right ventricle function. With a rising cases of complex CHD and patients with pulmonary valve regurgitation in TOF repair, a further demand is underway for valved conduits. Meanwhile, common biological valved conduits applied in foreign countries are not approved in China yet, with high failure and reintervention, reducing the long-term survival. Our team manufactured a novel valved conduit with 0.1mm expanded polytetrafluoroethylene and gore-tex conduit. This ePTFE valved conduit played a satisfying role in anti-regurgitation and failure rate through in vitro fluid test and animal experiments. Besides, our team manufactured templates for the conduit and also simplified the suturing process so that the repeatability of suturing valved had been risen. Until now, over 70 cases have been implanted with this ePTFE valved conduit with positive early and mid-term follow-up results. Despite the progress which have been made, there still remain some problems to solve. First, systematic prospective randomized comparative study will be performed. Second, this is just a single-center study. Third, these patients should have longer follow-up time to evaluate the ePTFE conduit long-term effect. Finally, imaging data are blank for evaluating the function of the conduit and right ventricle. In this prospective comparative research, the new designed ePTFE valved conduit and bovine jugular vein valved conduits are conducted as a randomized controlled trail. Cardiac magnetic resonance imaging is used to precisely evaluate the anti-regurgitation effect of the valved conduit and the right ventricle function. Investigators can further access the application of this newly designed ePTFE valved conduit. Investigators aim to provide a self-manufactured, low failure rate valved conduit.

NCT ID: NCT04165252 Recruiting - Preterm Birth Clinical Trials

Vaginal, Placental and Neonatal Buccal Mycobiota and Microbiome in Preterm Birth

Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

Microbiota contributes to the immunological, hormonal and metabolic homeostasis of the host. As in all natural orifices in the body, there is also a microbiota and mycobiota specific to the vagina. On the other hand, the sonographic short cervix in the second trimester of pregnancy is associated with preterm delivery, which may be an important cause of mortality and morbidity in the neonatal period. American Society of Obstetricians and Gynecologists (ACOG), British Royal Society of Obstetricians and Gynecologists (RCOG) and the American Society of Maternal Fetal Medicine (SMFM) suggest that the measurement of transvaginal sonographic cervical length at 20-24 gestational weeks for the screening of preterm birth. The aforementioned associations also recommend the use of progesterone in the treatment of women who diagnosed with short cervix by transvaginal ultrasonography due to the fact that progesterone is an effective medication in the prevention of preterm birth (Grade B). Previous vaginal microbiota studies have shown that some bacterial species such as Lactobacillus insers cause a predisposition to premature labor in women with a short cervix. However, the prominent lack in these studies is that the eukaryotic fungi in abundant vaginal flora have not been evaluated. On the other hand, it was already shown that progesterone treatment is able to prevent only 45% preterm birth in women with short cervical length. This observational prospective study thus aims to evaluate the variety of microbiota and/or mycobiota in pregnancies resulting in preterm birth and those who give birth at term. Although women with short cervical length receive progesterone regularly from the second trimester, the preterm birth may occur. In this study, the investigators also aim to evaluate the patterns of microbiota and mycobiota from vaginal swabs of women who had preterm birth with short cervical length and postpartum swabs of the placenta and fetal oral cavity.