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NCT ID: NCT04699474 Recruiting - Clinical trials for Spinal Cord Injuries

Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury

PROMPT-SCI
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.

NCT ID: NCT04699188 Recruiting - Lung Cancer Clinical Trials

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

KontRASt-01
Start date: February 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

NCT ID: NCT04693351 Recruiting - Clinical trials for Obsessive-Compulsive Disorder

Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

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

The study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

NCT ID: NCT04692493 Recruiting - Clinical trials for Rheumatoid Arthritis

RA-PRO PRAGMATIC TRIAL

RA-PROPR
Start date: September 22, 2021
Phase: Phase 3
Study type: Interventional

The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.

NCT ID: NCT04688398 Recruiting - Polyarthritis Clinical Trials

Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

This project proposes to conduct the first fully controlled and randomized clinical study demonstrating the impact of DPA-rich sea bass oil on the reduction of symptoms related to rheumatoid arthritis. This unique approach will allow to clinically evaluate the benefits of sea bass oil on the relief of rheumatoid arthritis-related pain in a population suffering from inflammatory arthritis.

NCT ID: NCT04688190 Recruiting - Clinical trials for Mitral Regurgitation

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

CHOICE-MI
Start date: November 1, 2020
Phase:
Study type: Observational

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

NCT ID: NCT04687735 Recruiting - Frozen Shoulder Clinical Trials

Frozen Shoulder Single Arm Prospective Study

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of combination of brachial plexus block plus physical therapy on quality of life improvement in patients with frozen shoulder condition via standard questionnaires.

NCT ID: NCT04686305 Recruiting - Clinical trials for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

DL03
Start date: March 9, 2021
Phase: Phase 1
Study type: Interventional

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

NCT ID: NCT04685577 Recruiting - Burn Degree Second Clinical Trials

Safety, Tolerability and Efficacy of Nefopam Cream in Burn Patients

Start date: July 10, 2022
Phase: Phase 2
Study type: Interventional

Burn patients very commonly develop abnormal scars after injury which can be red, raised or elevated, painful and very itchy. They can prevent normal movement of hands and other joints and lead to ugly deformities which makes physical and psychological recovery very difficult. This proposal seeks to test the usefulness of a cream called Nefopam to prevent and treat these bad scars after burns and other injury to the skin. Nefopam is a drug that has been used as a pain medicine in Europe but has been found to have anti-scarring properties in rats and pigs. It has been tested in healthy people and found to be well tolerated and safe. The study purposes to make a scratch in the hip skin in 60 adult burn patients at two burn unit sites, the University of Alberta and the University of California at Davis, Sacramento CA. Burn patients in the study will have a scratch wound in the skin of the each side of the hip, part way through the thickness of the skin which is shallow at first but gets deeper. This scratch is made with a special guide which precisely controls the length and depth of the scratch so that each scratch is the same. Part of the scratch heals without scar and the deeper part heals with a red raised scar over a small region less than 2 inches long. One side will be treated with the drug and the other with a control or placebo are in a white cream that is indistinguishable, where you cannot tell which side contains the drug. Once the wound is nearly healed, usually less than 21 days, the cream will be applied twice daily for three weeks. Measurements will be done about once per month for four months where the healing scratches will be photographed, measurements of the thickness made with ultrasound and mexameter for scar color or pigment and redness. Ultrasound is a painless probe that uses sound waves to measure scar thickness and mexameter is a painless probe on the surface of the scratch to measure color and redness. Both measurements take only minutes to complete. Patients will be asked to answer a scar assessment form about on how they feel each scratch during the treatment and the research staff will also the complete scar form as well. It is the aim of the study to find a cream the works to prevent and reduce scarring after burn injury in military or civilian patients. In the future, an useful cream for scarring in burn patients may also be helpful for other skin damage which leads to scarring.

NCT ID: NCT04684368 Recruiting - Choriocarcinoma Clinical Trials

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

Start date: July 13, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.