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NCT ID: NCT04064060 Recruiting - Beta-thalassemia Clinical Trials

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Start date: August 12, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: - Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept - Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met - The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase - Transition Phase is defined as one Enrollment visit - Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol - Follow-up Phase includes: - 42 Day Safety Follow-up Visit - During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting - Long-term Post-treatment Follow-up (LTPTFU) Phase - Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.

NCT ID: NCT04063332 Recruiting - Sepsis Clinical Trials

Functionality of Endogenous Biological Clock in Sepsis

Start date: June 3, 2019
Phase:
Study type: Observational

The aim of the current study is to demonstrate dysregulation of immune system΄s circadian rhythms as a consequence of sepsis, as well as marked malfunction of the central circadian clock in comparison with patients without sepsis , the presence of which burdens independently the final outcome and , hence, need to be addressed.

NCT ID: NCT04050306 Recruiting - Dental Caries Clinical Trials

DIMOH: New Digital Methods for Monitoring Oral Health. An in Vivo Assessment

Start date: March 27, 2019
Phase:
Study type: Observational

The objectives of this study are i) to monitor the oral health of young people over a period of one year and ii) to assess the ability of a new intraoral scanner combining fluorescence with 3D imaging to detect and monitor changes in the dental hard tissues in vivo. The working hypotheses of this study are that i) the monitoring of oral health will benefit from using a new intraoral scanner combining fluorescence with 3D imaging and ii) the new intraoral scanner combining fluorescence with 3D imaging will aid dentists to identify changes in the dental hard tissues at earlier stages than the traditional diagnostic methods (i.e. visual-tactile, radiographic methods).

NCT ID: NCT04031456 Recruiting - Clinical trials for Premature Ovarian Failure

Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

PRP
Start date: July 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

NCT ID: NCT04028193 Recruiting - Dumping Syndrome Clinical Trials

Fat Supplementation on Dumping Syndrome Associated Symptoms

Fat on DS
Start date: September 12, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is the investigation of the effect of fat supplement on gastric emptying rate and the appearance of symptoms of Dumping Syndrome in patients who have undergone gastrointestinal- duodenal surgery. Patients who have undergone bariatric surgery have been examined for the presence of the Dumping syndrome, with glucose measurements, the Sigstad's questionnaire and questionnaire of Arts. Patients diagnosed positive, reiterated the examination process in a second meeting consuming an extra fat supplement. The data obtained on the different appointments were compared between the two groups in a cross over design.

NCT ID: NCT04008030 Recruiting - Clinical trials for Metastatic Colorectal Cancer

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

CheckMate 8HW
Start date: August 5, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

NCT ID: NCT04007887 Recruiting - Clinical trials for Myocardial Infarction

Effect of an Adult EDUcation Program on CArdiovascular ouTcomEs in Post-myocardial-infarction Patients

EDUCATE
Start date: October 15, 2017
Phase: N/A
Study type: Interventional

A non-MD-led adult education program consisting in 10 one-hour sessions designed to provide information and motivation will be offered to patients who have recently been hospitalized for acute myocardial infarction (STEMI and NSTEMI), regarding the management of their treatment and strategies to aggressively optimize control of cardiovascular risk factors.. The intervention arm will be compared to a control group of patients treated with usual care.

NCT ID: NCT03993249 Recruiting - Bladder Cancer Clinical Trials

Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy

Start date: May 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic MIBC who are not candidates for radical cystectomy

NCT ID: NCT03969329 Recruiting - Clinical trials for Secondary Hyperparathyroidism

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis

NCT ID: NCT03969004 Recruiting - Clinical trials for Cutaneous Squamous Cell Carcinoma

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Start date: June 4, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: - To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT - To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT - To assess cemiplimab pharmacokinetics and immunogenicity in human serum