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NCT ID: NCT04559126 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

A Study of EDP-297 in Healthy Subjects

Start date: September 8, 2020
Phase: Phase 1
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

NCT ID: NCT04558918 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

APPLY-PNH
Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

This study was a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this Phase 3 study in PNH patients presenting with residual anemia despite treatment with anti-C5 antibody, was to determine whether iptacopan is efficacious and safe for the treatment of PNH through demonstration of superiority of iptacopan compared to anti-C5 antibody treatment.

NCT ID: NCT04557800 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

Start date: November 16, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), and 28-day safety study of orally administered DNL151 in healthy volunteers.

NCT ID: NCT04556682 Completed - Clinical trials for Coronary Calcification

IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions

Start date: May 1, 2021
Phase:
Study type: Observational

This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation.

NCT ID: NCT04555486 Completed - Clinical trials for Primary Hyperoxaluria Type 3

Study to Evaluate Safety, Tolerability, PK and PD of DCR-PHXC in PH Type 3 Patients

PHYOX4
Start date: September 14, 2020
Phase: Phase 1
Study type: Interventional

The DCR-PHXC-104 study is designed to assess the safety, tolerability, and pharmacological parameters of a single dose of DCR-PHXC in Primary Hyperoxaluria Type 3 (PH3). Participants should have had at least one stone event within 12 months of screening and intact renal function.

NCT ID: NCT04550195 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

Start date: September 17, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.

NCT ID: NCT04549480 Completed - Clinical trials for Healthy Participants

Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition

Start date: September 16, 2020
Phase: Phase 1
Study type: Interventional

This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. The comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100 mg x 1) as the Test treatment.

NCT ID: NCT04546425 Completed - Clinical trials for Pneumococcal Disease

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

Start date: September 9, 2020
Phase: Phase 3
Study type: Interventional

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

NCT ID: NCT04545983 Completed - Spinal Stenosis Clinical Trials

Long-term Follow-up Motion Analysis of ACD Versus ACDA

Start date: February 12, 2022
Phase: N/A
Study type: Interventional

Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. The main surgical techniques are anterior cervical discectomy with (ACDF) or without fusion (ACD), whereas both techniques result in high fusion rates. Short term outcomes of surgery show good clinical results. Long term follow-up shows a drop-in satisfaction rates, often due to the occurrence of new complaints. Pathology is often located at levels adjacent to the previously operated segment, known as adjacent segment disease (ASDis). This is thought to be the results of loss of motion at the previously operated and fused segment. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment. Objective: To investigate physiological motion of the cervical spine the investigators will analyze motion patterns at the long-term in patients who underwent surgical treatment for CDDD, either ACD or ACDA. Study design: Fundamental research. This is a prospective study that includes a cohort of patients previously operated in the setting of a randomized controlled trial. Study population: Adult patients with an indication of surgical treatment for cervical radiculopathy as a consequence of CDDD were enrolled in an RCT between 2007 and 2014 and assigned to undergo ACD or ACDA. Flexion and extension cinematographic recordings of the cervical spine were performed, with the last one at one-year follow-up. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This cohort will now be asked to participate in the long-term follow-up study assessing the motion patterns 6-13 years after ACD or ACDA surgery. Intervention: One flexion and extension cinematographic recording of the cervical spine and will be made. Main study parameters/endpoints: The sequence of segmental contributions in sagittal rotation during flexion and extension of the cervical spine will be assessed in the long-term follow-up of surgical treatment. Secondary outcomes will be to assess the amount of degeneration based on the Kellgren Score (KS) and the segmental range of motion (sROM). Long term clinical outcomes will be assessed according to VAS, NDI, SF-36 and Odom's criteria. Patients will be asked whether they have new neurological symptoms and whether they have had a re-operation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings once. The amount of radiation is a negligible risk. There will be no health benefits. There will be no follow-up.

NCT ID: NCT04545515 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes

Start date: January 11, 2021
Phase: Phase 3
Study type: Interventional

The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with F/MF genotypes.