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NCT ID: NCT04953637 Recruiting - Parkinson Disease Clinical Trials

Physiotherapy and Deep Brain Stimulation in Parkinson's Disease

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

Deep brain stimulation (DBS) is the most commonly performed surgical treatment for individuals with Parkinson's disease (PD). DBS typically works best to lessen motor symptoms such as stiffness, slowness, and tremor. Despite an overall improvement of these motor symptoms with DBS, past research failed to show an increase in community mobility and have often reported an increase in falling after surgery. The ability to move around on one's own is important for functional independence and improved quality of life. There is growing evidence supporting the positive effects of physiotherapy on individuals with PD. Gait and balance training, in particular, can improve mobility and also prevent falls. So far, no study has shown the effectiveness of rehabilitation in patients receiving DBS. The purpose of this study is to determine if DBS combined with physiotherapy is effective for improving safe independent mobility in individuals with PD, more so than with patients receiving DBS alone.

NCT ID: NCT04952480 Recruiting - Clinical trials for Small Cell Lung Cancer

Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer

DARTS
Start date: June 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects.

NCT ID: NCT04951804 Recruiting - Pancreatic Cancer Clinical Trials

EUS-CPN With and Without Bupivacaine

EUS-NB
Start date: October 7, 2021
Phase: N/A
Study type: Interventional

Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer. It is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain that may occur during and after the procedure. However, there are no data showing whether bupivacaine injection has any real influence on intra-procedural, immediate post-procedural, or long-term pain control. The injection of bupivacaine before the alcohol may have no effect, a synergistic effect, or an antagonistic effect, by diluting the alcohol, and reducing its neurolytic capacity. Inadvertent intravascular injection of bupivacaine may also cause irreversible cardiac arrhythmias and death. The investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.

NCT ID: NCT04951778 Recruiting - Clinical trials for Myelodysplastic Syndromes

Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

Start date: December 2, 2021
Phase: Phase 1
Study type: Interventional

Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 dose (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 40 participants may be enrolled in Part A of the study. The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Separate expansion cohorts for participants with R/R AML and R/R HR-MDS may enroll approximately 20 to 40 response evaluable participants per cohort. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

NCT ID: NCT04951622 Recruiting - Myasthenia Gravis Clinical Trials

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

NCT ID: NCT04950868 Recruiting - Clinical trials for Postpartum Depression

The Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression

Start date: March 18, 2022
Phase: Phase 1
Study type: Interventional

Postpartum depression is a serious disorder that affects approximately 14% of women who have recently given birth. Postpartum depression is either an episode of major depressive disorder (only low periods) or bipolar disorder (periods of lows and highs). Untreated postpartum depression can negatively affect the mother, the infant and the family. Antidepressants are the most used treatments; however, for many women these drugs are not useful, resulting in a pressing need for effective treatments for postpartum depression. Lack of sleep is common after delivery and can trigger depression in some women. Quetiapine, a drug used for bipolar disorder, major depressive disorder and occasionally sleeplessness has not been well studied in postpartum depression. This study aims to find out how mothers tolerate the drug and whether it is effective for postpartum depression. Results of this study may help investigators carry out a larger study comparing quetiapine and placebo (a sugar pill) in postpartum depression.

NCT ID: NCT04949256 Recruiting - Clinical trials for Metastatic Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)

Start date: July 28, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

NCT ID: NCT04948476 Recruiting - Acute Kidney Injury Clinical Trials

Promoting Kidney Recovery After Acute Kidney Injury Receiving Dialysis

Recover-AKI
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

The overall goal of this study is to evaluate the feasibility of conducting a randomized controlled trial comparing a standardized dialysis strategy versus usual care (dialysis prescription ordered by each patient's primary nephrologist) in patients with AKI-receiving dialysis.

NCT ID: NCT04947722 Recruiting - Osteoporosis Clinical Trials

The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

NCT ID: NCT04946812 Recruiting - Parkinson Disease Clinical Trials

Split-belt Treadmill Training to Rehabilitate Freezing of Gait and Balance in Parkinson's Disease

Start date: March 27, 2020
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) related gait and balance disorders are challenging to treat because they cannot be optimized with pharmacological intervention alone. This treatment gap is important to address because gait asymmetry and incoordination are associated with increased falls in this population, which can be functionally debilitating and lead to increased morbidity and mortality. Freezing of gait (FOG) has also been associated with reduced quality of life independent of its association with impaired mobility. Gait disorders therefore represent an unmet need in the treatment of PD. A split-belt treadmill (SB-TM) can be used to adjust the speed of each leg separately and individuals can be prompted to 'adapt' to an asymmetric gait and 're-adapt' with return to symmetrical gait in a phenomenon known as 'after-effect'.