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NCT ID: NCT04032899 Recruiting - Lactation Clinical Trials

Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis. Bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.

NCT ID: NCT04081896 Recruiting - Low Back Pain Clinical Trials

Evaluation of the Effects of a Rehabilitation Program in Individuals With Spine Pain

Start date: April 15, 2019
Phase:
Study type: Observational [Patient Registry]

SpineZone is an innovative physical therapy program with its focus on treatment of cervical, thoracic, and lumbar conditions through the use of a multi-disciplinary, technology enabled platform. Standard physical therapy modalities including psychologically informed physical therapy are employed in addition to online coaching with a fundamental tenant of core strengthening. Treatments are tracked and modified in a multi-disciplinary format taking all radiographic studies into direct consideration. The goal of this study is to utilize a registry of participants undergoing either in-clinic or online rehabilitation treatment for spine pain at the SpineZone clinical in order to understand the clinical outcomes and costs of different rehabilitation modalities in this patient population.

NCT ID: NCT04122781 Recruiting - Clinical trials for Supracondylar Humerus Fracture

Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

A novel K-wire external fixation device was developed by the investigators. The K-wires can be connected by the device. After connection, the structure of the K-wires is transformed to an external skeletal fixator. Therefore, the K-wires are stabilized and unable to migrate independently. The stability of fracture fixation is better in patient with this K-wire external fixation device. The purposes of this study are to optimize the K-wire external fixation device and test its function in real clinical practice.

NCT ID: NCT04167657 Recruiting - Clinical trials for Carcinoma, Non-Small Cell Lung

SinTilimab After Radiation (STAR Study)

STAR
Start date: April 15, 2019
Phase: Phase 2
Study type: Interventional

This is a single-arm phase II study, to investigator the efficacy and safety of sintilimab after radiation in advanced NSCLC, who had failed first line systemic therapy.

NCT ID: NCT04180930 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample

Start date: April 15, 2019
Phase:
Study type: Observational

Given the high prevalence of post-traumatic stress disorder (PTSD) in veterans and active duty military, the focus of this research study is to test the reliability of two new PTSD assessments, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) and compare the results between the two new assessments and the previous "gold standard", the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). Biomarkers believed to be related to PTSD (e.g., biofluid biomarkers, cognitive and physiological markers, and neural activity as measured by EEG) will be collected to inform targeted interventions in specific groups of patients and other large-scale biomarker discovery efforts in the field. Participants will be 950 male and female active duty military and veterans ages 18 or older who have been exposed to at least one traumatic event.

NCT ID: NCT04211025 Recruiting - Primary Care Clinical Trials

SPARK: Pilot Study

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

Research question and objectives This pilot study will help us answer the following research question: Is it feasible to conduct a large cluster randomized controlled trial (RCT) of an intervention that consists of routine screening for poverty and related social determinants and intervening in Canadian primary care clinics, and what is the sample size required? Our objectives include: 1. to collect data on the feasibility of recruiting clinics for a large cluster randomized controlled trial (RCT) 2. to collect data on the acceptability and feasibility of integrating a standardized socio-demographic data collection tool, including screening for poverty, within diverse primary care clinic workflows 3. collect data on the acceptability and feasibility of "modest" and "intensive" interventions on poverty (discussed below) 4. collect data on the recruitment rate of patients, to assist with calculating the sample size for a larger cluster RCT 5. collect data on the intervention effect size of the "modest" and "intensive" interventions on income and health outcomes to assist with calculating the sample size for a larger cluster RCT .

NCT ID: NCT04352712 Recruiting - Clinical trials for Growth Hormone Deficiency

Gene Expression in Monocytes of Growth Hormone Deficient Children

GEMGH
Start date: April 15, 2019
Phase:
Study type: Observational

The Growth hormone (GH) is mainly synthesized in the anterior portion of the pituitary gland and has an effect on different body areas. Secreted in the circulatory stream, growth hormone reaches the liver and here stimulates the secretion of somatomedin C better known as insulin-like growth factor 1 (IGF), which constitutes its main anabolic effector. Growth hormone deficiency (GHD) is characterized by a delay in the statural growth in children and is correlated with a worsening of body composition, cognitive functions, lipid metabolism, bone mineralization, cardiac performance and exercise in adults. Recombinant GH (rhGH) replacement therapy can correct these alterations and therefore improve the quality of life in treated patients, and accelerate growth in children. The optimal dosage of rhGH varies for each patient, as the response to treatment suffers from considerable inter-individual variability. To date, IGF1 is the only available biomarker whose plasma levels correlate with replacement therapy. It is important to underline how somatomedin C does not provide information about the optimal posology of rhGH for each patient in order, therefore, to predict its adverse events and efficacy. In addition, it has been shown that the effects mediated by the somatotropic hormone on some tissues are direct, therefore independent of the action of IGF1, whose plasma levels are not, in this case, predictive of therapeutic response. For this reason, it is therefore necessary to identify a more specific biomarker capable of monitoring the efficacy, individual responsiveness and any adverse events in patients receiving somatotropic hormone. The GH receptor (GHR) is expressed in several cells, including monocytes. It is therefore possible that the response of monocytes to the somatotropic hormone partially mirrors that of the chondrocyte and other cell types. Given the difficulty of obtaining osteomuscular biopsies or specific body areas in which GH mediates its biological action, the published works have identified the specific cell line in which to study the molecular effects of the hormone in monocytes, thanks to their easy accessibility and high number of GHR. In consideration of this, the investigators propose to stimulate monocytes of healthy and GHD children in vitro with rhGH and through next generation sequencing to identify the characteristic gene expression profile. The GH responsive genes identified with this study can be used for correlation studies on the response to rhGH treatment.

NCT ID: NCT04397783 Recruiting - Clinical trials for Colorectal Neoplasms

Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

LONGCROSS
Start date: April 15, 2019
Phase: N/A
Study type: Interventional

TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ". DESIGN: Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio. POPULATION: Patients undergoing colorectal cancer surgery a definitive end colostomy. OBJECTIVES: The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery. Secondary objectives are: 1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery. 2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. 4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale). DESCRIPTION OF THE INTERVENTION: An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia. DURATION OF THE STUDY: The expected duration of the study is 3 years. PATIENT FOLLOW UP TIME: The planned follow-up time is 2 years. EXPECTED RECRUITMENT TIME: 12 months.

NCT ID: NCT04610788 Recruiting - Scleroderma Clinical Trials

Cardiac Assessment by PV Loop in IPAH and Scleroderma PAH

CALIPSO
Start date: April 15, 2019
Phase:
Study type: Observational

This observational study is being done to understand why people with scleroderma can develop pulmonary arterial hypertension (high blood pressure in the lungs, abbreviated PAH) and a weak heart muscle (heart failure). The study will also help the investigators understand why people with PAH from an unknown cause (called idiopathic PAH, or IPAH) can also develop a weakened heart muscle. The response of the right side of the heart or right ventricle (RV) to standard PAH therapy in scleroderma-associated PAH and in IPAH will be assessed. Blood and tissue samples will be collected from research participants during participants' normal standard of care procedures. People with scleroderma-associated PAH or idiopathic cause (IPAH) who need a right heart catheterization may join this study.

NCT ID: NCT04921995 Recruiting - Chemotherapy Effect Clinical Trials

Immunotherapy and Chemotherapy in Unresectable Recurrent Loco-regionally Advanced Nasopharyngeal Carcinoma

RETICULA-NPC
Start date: April 15, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-center, phase II trial to evaluate the safety and efficacy of postponing or omitting re-irradiation after systemic therapy with tislelizumab and chemotherapy in patients with unresectable recurrent loco-regionally advanced nasopharyngeal carcinoma. Patients who did not respond to or progressed on another ICI are allowed to receive tislelizumab rechallenge as a subgroup.