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NCT ID: NCT05477524 Active, not recruiting - Lyme Disease Clinical Trials

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

VALOR
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence. Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season. Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective. If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

NCT ID: NCT05475483 Active, not recruiting - Huntington Chorea Clinical Trials

Efficacy and Safety on SOM3355 in Huntington's Disease Chorea

Start date: August 2, 2022
Phase: Phase 2
Study type: Interventional

Phase IIb, randomized, double-blind, placebo-controlled study in parallel groups assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington's Disease with choreic movements.

NCT ID: NCT05469737 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

Start date: December 14, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

NCT ID: NCT05469503 Active, not recruiting - Metabolic Syndrome Clinical Trials

Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

INSIGHT
Start date: July 15, 2022
Phase: N/A
Study type: Interventional

This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.

NCT ID: NCT05469464 Active, not recruiting - Atopic Dermatitis Clinical Trials

Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

Start date: July 11, 2022
Phase: Phase 2
Study type: Interventional

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

NCT ID: NCT05462717 Active, not recruiting - Clinical trials for Advanced Solid Tumor

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Start date: September 19, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

NCT ID: NCT05456529 Active, not recruiting - Clinical trials for Atopic Dermatitis (AD)

Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

Start date: September 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

NCT ID: NCT05453968 Active, not recruiting - Pediatric Clinical Trials

Berotralstat Treatment in Children With Hereditary Angioedema

APeX-P
Start date: October 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to < 12 years old for prophylactic treatment to prevent attacks of hereditary angioedema (HAE).

NCT ID: NCT05450692 Active, not recruiting - Clinical trials for Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

LATIFY
Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

NCT ID: NCT05448742 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Biplanar PSI Slope-reducing MOWHTO With Tibial Tuberosity Serving as Hinge Axis: Cadaveric Study

Start date: June 22, 2022
Phase: N/A
Study type: Interventional

Six cadaveric lower limbs will have PSI slope-reducing MOWHTO performed on and accuraccy of biplanar correction will be assessed.