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NCT ID: NCT05243797 Recruiting - Multiple Myeloma Clinical Trials

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

MajesTEC-4
Start date: September 8, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

NCT ID: NCT05242484 Recruiting - Colitis, Ulcerative Clinical Trials

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

DUET-UC
Start date: September 19, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

NCT ID: NCT05242471 Recruiting - Crohn's Disease Clinical Trials

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

DUET-CD
Start date: July 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

NCT ID: NCT05238922 Recruiting - Solid Tumors Clinical Trials

Study of INCB123667 in Subjects With Advanced Solid Tumors

Start date: July 5, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A.

NCT ID: NCT05237999 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Effectiveness of a Blended Care Parenting Intervention for Parents With PTSD (KopOpOuders-PTSD)

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

KopOpOuders-PTSD is a new preventive blended care intervention for parents with PTSD. The purpose of this study is to evaluate its effectiveness in improving parenting and preventing child mental health problems.

NCT ID: NCT05236660 Recruiting - Diabetic Foot Ulcer Clinical Trials

Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

DIASSIST
Start date: March 2, 2022
Phase: N/A
Study type: Interventional

Preventing foot ulcers in people with diabetes can reduce costs and increase quality of life. Despite availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesise that a multimodal approach incorporating a variety of orthotic interventions that matches an individual person's need can reduce ulcer recurrence with beneficial cost-effectiveness and cost-utility.

NCT ID: NCT05235503 Recruiting - Opioid Use Clinical Trials

Influence of Δ9-tetrahydrocannabinol (THC) on Oxycodone Induced Ventilatory Depression in Healthy Volunteers

COXY
Start date: December 9, 2021
Phase: Phase 4
Study type: Interventional

Rationale: Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands. Additionally, it is well known that opioids are often used (and abused) in combination with other legal or illicit substances, for example cannabis, including medicinal (i.e. doctor prescribed) cannabis. A major opioid-induced adverse effect is respiratory depression and there are no data that show how oxycodone interacts with cannabis on the ventilatory control system. An appreciable effect is possible given the sedative effects of cannabis. Moreover, investigators previously showed that combining even a low dose of oxycodone (20 mg) with ethanol increased the likelihood of an apneic event (van der Schrier et al. Anesthesiology 2017; 102: 115-122). Because of this side effect and also due to the rising number of addicted chronic opioid users, there is an increasing imminent societal, political and medical interest in advancing research on opioids, opioid-drug interaction and alternatives for the treatment of various chronic illnesses and chronic pain. Hypothesis: The investigators hypothesize that cannabis will amplify the ventilatory depressant effect of oxycodone (primary end-point). Objective: The objective of the study is to quantify the interactive effect of Δ9-tetrahydrocannabinol (THC) and oxycodone on ventilatory control. Study design: Double blind, randomized cross-over, placebo-controlled design. Study population: Healthy human volunteers between the age of 18 and 45 years old. Intervention: Visit A: placebo capsule at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min; Visit B: oxycodone 20 mg at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min. Main study parameters/endpoints: Primary endpoint: The effect of inhaled THC on ventilation at an end-tidal PCO2 = 55 mmHg without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake. Secondary endpoints: (1) Outcome of Bowdle and Bond & Lader questionnaires; (2) Level of sedation; (3) Pain Pressure Threshold; (4) slope of the hypercapnic ventilatory response; (5) plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).

NCT ID: NCT05233397 Recruiting - Clinical trials for Recurrent Adamantinomatous Craniopharyngioma

ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Start date: December 16, 2022
Phase: Phase 2
Study type: Interventional

ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

NCT ID: NCT05232474 Recruiting - Clinical trials for Peripheral Arterial Disease

Using KomPas+ in the Treatment of Patients With Intermittent Claudication

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Intermittent claudication is the most common symptom of peripheral arterial disease (PAD). The recommended therapy is supervised exercise therapy combined with lifestyle counselling, provided by a physiotherapist. Ideally, during the treatment process patients' values and preferences are incorporated with evidence-based knowledge; shared decision making (SDM). Evidence shows the use of SDM in daily practice is scarce. Therefore, personalized outcome forecasts which provide insight into an individual's personal prognosis (called KomPas) were implemented in 2020. Now, as a next step, KomPas is further developed into a guideline-based clinical decision support system. The result is called KomPas+, a tool which integrates the person-centered approach of KomPas with the guideline recommendations for the conservative treatment of people with intermittent claudication.The primary objective of this study is to evaluate the impact of implementing KomPas+ in the physiotherapeutic treatment of patients with intermittent claudication on functional walking distance and health-related quality of life. Secondary, the level of SDM and person-centeredness of physiotherapists using KomPas or KomPas+ will be assessed. Third, the implementation process will be evaluated.

NCT ID: NCT05231785 Recruiting - Clinical trials for Early-Onset Alzheimer Disease

A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD

Start date: February 4, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for Part A: single dose. Maximum treatment duration for Part B: 12 months.