Clinical Trials Logo

Filter by:
NCT ID: NCT03791021 Completed - Clinical trials for Postpartum Depression

Early Diagnosis of PPD Through Self-portraits

ppd
Start date: January 1, 2019
Phase:
Study type: Observational

the target of the research is development of a predictive tool for early identification of women which are at higher risk for development of postpartum depression. the evaluating tools include self portraits and questionnaire during the third trimester of pregnancy. The suggested research aims to evaluate if and how it would be possible to predict the potential for postpartum mood swing disorders in pregnant women while in the third trimester. The later to prevent the mother from enduring such a detrimental experience, which influences the child development, the family as well as the mother's intimate relationship. The aim is to identify indicators to predict such potential, using questionnaires and self-portraits during pregnancy, to allow early intervention and treatment. Early diagnosis and quick treatment of pregnant women or post-partum mothers will allow them a higher level of functioning and may even prevent eventually infant neurological and developmental delays and hardships.

NCT ID: NCT03790332 Active, not recruiting - Clinical trials for Chronic Graft Versus Host Disease

Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Start date: November 19, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

NCT ID: NCT03788421 Completed - Sterility, Female Clinical Trials

Comparison Between 2 Techniques for Bilateral Salpingectomy

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

A comparison between 2 techniques for bilateral salpingectomy during cesarean section. Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.

NCT ID: NCT03787381 Completed - Clinical trials for Uterine Scar From Previous Cesarean Delivery (Diagnosis)

Uterine Niche After Cesarean Section

AMSRM
Start date: January 10, 2019
Phase: N/A
Study type: Interventional

In the past decade several articles have described a defect that can be seen on ultrasound at the site of cesarean delivery scar, known as a 'niche' .An incompletely healed scar is a long-term complication of cesarean delivery and is associated with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. This study aimes to evaluate the prevalence of niche in a large cohort study after long term follow up since operation, and characterize the risk factors for its development and for symptoms to appear.

NCT ID: NCT03786380 Terminated - Gastroparesis Clinical Trials

Diabetic Gastroparesis Study 05

Start date: December 20, 2018
Phase: Phase 3
Study type: Interventional

This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.

NCT ID: NCT03786107 Terminated - Clinical trials for Metastatic Cervical Cancer

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

Start date: March 14, 2019
Phase:
Study type: Observational

This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.

NCT ID: NCT03785925 Completed - Neoplasm Metastasis Clinical Trials

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

PIVOT-10
Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

NCT ID: NCT03785665 Completed - Colo-rectal Cancer Clinical Trials

Motility of the Check-cap's MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy

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

To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home Monitoring, Prospective Study. Up to 100 participants in various phases 2-5 capsules per person, (1 capsule at a time) The primary objective of the study is to monitor the variability of the motility of the MD1 capsules in the Gastrointestinal tract of human subjects with and without polyps in previous Colonoscopy.

NCT ID: NCT03785405 Completed - Heart Failure Clinical Trials

CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

NCT ID: NCT03781310 Recruiting - Clinical trials for Rheumatoid Arthritis

Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis

Start date: December 2018
Phase: Phase 4
Study type: Interventional

Rationale: A wide range of serum trough concentrations is observed in tocilizumab-treated rheumatoid arthritis (RA) patients, while 1 mg/L tocilizumab is sufficient to block systemic interleukin-6 receptor. A substantial proportion of patients has higher serum tocilizumab concentrations and is likely to be overexposed. We expect that patients can at least reduce the dose aiming for a concentration of 5 mg/L without reducing efficacy. Objective: To evaluate the feasibility of the study after 20 weeks of follow-up, this includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA. Study design: Double-blind randomized controlled pilot study with a follow up of 20 weeks. Study population: Consecutive RA patients that are treated with tocilizumab intravenously every four weeks for at least 24 weeks. Patients are screened for tocilizumab concentration after signing informed consent. Intervention: Patients with a concentration below 5 mg/L will continue the dose. Those patients with a tocilizumab concentration above 5 mg/L are randomly assigned (2:1) to dose reduction or to continuation of the standard care tocilizumab dose. In the intervention group, the precise dose-reduction is calculated per patient in order to achieve a tocilizumab concentration of 5 mg/L (range 4-6 mg/L). Main study parameters/endpoints: The feasibility of the study logistics is evaluated according to the dropout rate and patients opinion about the study. Second, the proportion of patients achieving the targeted tocilizumab concentration after dose reduction is evaluated. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Dose-reduction will lead to lower drug costs and possibly to reduce the risk of adverse events. Since we lower the tocilizumab concentration in a proportion of the patients, risk of a exacerbation of the disease exists. In this case, patients will receive their original dose. Previous studies showed that disease activity is controlled adequately after returning to the standard dose. However, our algorithm is designed to reach concentrations of 5 mg/L (range 4-6 mg/L) and studies showed that 1 mg/L of tocilizumab is sufficient to maintain clinical effect. The expected burden of this study is low, since study visits are planned at the time of infusion and therefore do not take extra time. The additional burden consists of an extra blood sample taken every visit and the fingerprick that is performed once.