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NCT ID: NCT05171855 Active, not recruiting - Clinical trials for Endocrine System Diseases

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Start date: December 16, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

NCT ID: NCT05171582 Active, not recruiting - Peri-Implantitis Clinical Trials

Peri-implantitis Surgical Regenerative Therapy Using Bovine Bone Substitute With Hyaluronic Acid

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The study aimed to assess 6- and 12-months evaluation of clinical, microbiological, and radiography outcomes after performing peri-implantitis regenerative surgical therapy with the bovine bone substitute with or without hyaluronic acid. Materials and Methods: The study could be designed as randomized control clinical trial. Patients with a minimum of one or more early, moderate and advanced stages of the peri-implant lesion will be included in the study. After meeting inclusion criteria, during a regenerative surgical procedure, after mucoperiosteal flap elevation and implant surface decontamination, all patients will be randomly divided into two groups: test group in which bovine bone substitute with hyaluronic acid (HA) (Cerabone plus, Botiss, Germany) will be applied for the filling peri-implant bone defects while in the control group peri-implant bone defects will be filled with bovine bone substitute (Cerabone, Botiss, Germany). Bone grafts will be covered in both groups with collagen dermal matrix (Mucoderm, Botiss, Germany). Clinical, radiograph and microbiological outcomes will be followed at 6 and 12 months after the surgical procedure. ISQ implant stability will be measured before, during a surgical procedure, and 7, 15, 30 days, 3, 6 and 12 months after a surgical procedure.

NCT ID: NCT05162586 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Start date: March 31, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.

NCT ID: NCT05156125 Active, not recruiting - Colitis, Ulcerative Clinical Trials

VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

NCT ID: NCT05119569 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

FENopta
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo.

NCT ID: NCT05089084 Active, not recruiting - Clinical trials for Familial Chylomicronemia

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

PALISADE
Start date: January 11, 2022
Phase: Phase 3
Study type: Interventional

The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.

NCT ID: NCT05059522 Active, not recruiting - Ovarian Cancer Clinical Trials

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Start date: September 29, 2021
Phase: Phase 3
Study type: Interventional

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

NCT ID: NCT05054140 Active, not recruiting - Multiple Sclerosis Clinical Trials

Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

CALLIPER
Start date: September 30, 2021
Phase: Phase 2
Study type: Interventional

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER

NCT ID: NCT05030428 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

VICTORION-2P
Start date: November 23, 2021
Phase: Phase 3
Study type: Interventional

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

NCT ID: NCT05027893 Active, not recruiting - Clinical trials for Postoperative Complications

Complications After Lower Third Molar Surgery

Start date: June 7, 2019
Phase: N/A
Study type: Interventional

Surgical removal of impacted mandibular wisdom teeth is a frequent intervention, usually accompanied by unpleasant sequelae (pain, swelling and trismus) in the postoperative period, sometimes even with possibly serious complications (dry socket/alveolar osteitis and postoperative infection at the surgical site - SSI). It is therefore advisable to use various medications and procedures to prevent or alleviate the occurrence of these sequelae and complications. Accordingly, there is a debate in the literature on the expedience of perioperative (prophylactic) use of antibiotics. It is interesting that numerous articles recommending perioperative (prophylactic) antibiotic use to patients undergoing the impacted mandibular third molar surgery may be found, as well as those providing arguments for the disagreement with such an approach, considering that its benefits do not outweigh the risks of adverse side effects, especially due to growing resistance of microorganisms towards antibiotics, which is a possible serious threat to global health. Concerning the perioperative (prophylactic) use of antibiotics for this indication, consensus has not yet been reached, and neither of the views has been verified by convincing scientific evidence. Having the aforementioned dilemma in mind, the main endpoint of the study was to determine the validity of perioperative (prophylactic) use of antibiotics as to alleviate customary sequelae and possible complications after surgical removal of impacted mandibular third molars and, at the same time, the effectiveness of newer antibiotics (moxifloxacin and cefixime) when used for this purpose. Moreover, microbiological investigations of susceptibility of the isolated microorganisms to antibiotics used in this research were performed, which could verify the clinically obtained results. With this in mind, two major contributions, based on scientifically verified results, could be expected from the research: (1) confirmation or refuting the validity of perioperative (prophylactic) antibiotic use to control sequelae or complications that could follow the impacted mandibular third molar surgery; and (2) confirmation of the efficacy of fluoroquinolones (moxifloxacin) and cephalosporins (cefixime) in controlling odontogenic infections.