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NCT ID: NCT05172596 Active, not recruiting - Multiple Myeloma Clinical Trials

PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma

Start date: March 7, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed CAR-T cell therapy, manufactured with a new process. The CAR-T cell therapy will be investigated as a single agent in relapsed and refractory multiple myeloma

NCT ID: NCT05172492 Recruiting - Chronic Pain Clinical Trials

Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home

Start date: December 7, 2021
Phase: N/A
Study type: Interventional

Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life. Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women. Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis. Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected. The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.

NCT ID: NCT05172050 Completed - Clinical trials for SARS CoV 2 Infection

Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.

Start date: January 22, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of the study is to evaluate the efficacy and safety of two different doses of raloxifene orally administered compared to placebo in patients with early diagnosis of paucisymptomatic COVID-19. Primary objectives: - Evaluation of the effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 7 days of therapy - Evaluation of the effectiveness of therapy in reducing the proportion of subjects who requires supplemental oxygen therapy and/or mechanical ventilation within 14 days of starting therapy Secondary objectives: - Evaluation of the effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 14 and 28 days of therapy - Evaluation of the effectiveness of therapy in reducing the proportion of subject patients who requires supplemental oxygen therapy and/or mechanical ventilation within 7 or 28 days of starting therapy - 7, 14 and 28 days drug safety and tolerability profile - Assessment of body temperature, blood and biochemical parameters between T0 and T28

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: NCT05171452 Completed - Clinical trials for Inflammatory Bowel Diseases

Urinary PGE-MUM (PROSTAGLANDIN E-MAJOR URINARY METABOLITE) as Inflammatory Marker in Chronic Inflammatory Bowel Disease

MICIMUM
Start date: October 3, 2019
Phase:
Study type: Observational

The inflammatory bowel diseases (IBD) are lifelong, relapsing-remitting diseases. As the timing of relapse is unpredictable, and current monitoring is symptoms-based, there remains a window between the initial upregulation of the inflammatory response and the onset of clinical symptoms at which point the inflammatory episode is well established. The use of endoscopy as means of predicting relapse is not suitable for regular use. The potential role of Fecal calprotectin (FC) in IBD in predicating the risk of relapse has been well investigated with key studies. Its fecal concentration is proportional to neutrophilic influx into the intestinal tract, which is a feature of active IBD. FC correlates well with the severity of endoscopic lesions. After excretion, FC remains stable in the feces for 1 week at room temperature. However, its considerable daily variation suggests interfering factors discrete from inflammatory disease. There is increasing research into novel markers with high correlation to the presence of mucosal healing constitute a cost-effective substitute to repeated endoscopies. Recent studies have reported that the prostaglandin E-major urinary metabolite (PGE-MUM) level was significantly higher in the active phase of patients with ulcerative disease (UC) than those in the remission phase. In the active UC phase, the stimulation of inflammatory cytokines, such as tumor necrosis factor-α, leads to the upregulation of cyclooxygenase-2 (COX-2) leading to PGE2 secretion in mucosal tissue. PGE2 plays an important role in the progression of inflammation. A precise measure of serum PGE2 is difficult due to the short half-life of PGE2 in the blood. Conversely, the urinary metabolite of prostaglandin E-major (PGE-MUM, 7-hydroxy-5,11-diketotetranor-prosta-1,16-dioic acid) is stable and may reflects the histological severity of inflammation. The aim of this concept study is to evaluate the PGE-MUM concentration in urine of patients with IBD in parallel with the standard investigation of Calprotectin in stool and to assess if urinary PGE-MUM should be able to serve as a simple and robust substitutive biomarker for the non-invasive evaluation of the inflammation of the mucous membrane tissues. The measurement of PGE-MUM in urine could give patients with IBD more comfort than the measurement of calprotectin in stool.

NCT ID: NCT05171270 Recruiting - Psoriatic Arthritis Clinical Trials

AsseSSing Impact in pSoriatic Treatment

ASSIST
Start date: July 12, 2021
Phase:
Study type: Observational

Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice. This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA. This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

NCT ID: NCT05171244 Recruiting - Clinical trials for Autism Spectrum Disorder

Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)

SEVIRE
Start date: March 3, 2022
Phase: N/A
Study type: Interventional

Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with "noisy" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations. Thus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session. The investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.

NCT ID: NCT05171231 Completed - Oral Hemorrhage Clinical Trials

Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

Start date: November 3, 2021
Phase:
Study type: Observational

The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery. Patients will The data collected from the Post-Market Clinical Follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. Patients will be followed for 1 month. Adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.

NCT ID: NCT05171114 Completed - Clinical trials for Scleroderma, Systemic

Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

SCLERO-HAND
Start date: December 28, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.

NCT ID: NCT05171075 Recruiting - Pulmonary Embolism Clinical Trials

A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

MAGNOLIA
Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)