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NCT ID: NCT06232707 Withdrawn - Multiple Myeloma Clinical Trials

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

ALUMMINATE
Start date: May 3, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT04797546 Withdrawn - Surgery Clinical Trials

Adductor Canal Block Versus Patient Controlled Analgesia, in the Surgical Stress Response for Anterior Cruciate Ligament Repair

Start date: September 2016
Phase: Phase 1
Study type: Interventional

To evaluate the surgical stress response in anterior cruciate ligament repair with an adductor canal block versus patient controlled endovenous analgesia.

NCT ID: NCT04026451 Withdrawn - Clinical trials for Mechanical Ventilation

Spectral Edge Frequency From Spectral EEG Analysis to Guide Deep Sedation in the Critical Care Setting (Pilot)

SEFICU
Start date: November 11, 2019
Phase: N/A
Study type: Interventional

Critically ill patients under mechanical ventilation (MV) have pain, anxiety, sleep deprivation and agitation. The use of analgesics and sedatives drugs (sedoanalgesia) is a common practice to produce pain relief and comfort during the VM. Despite its usefulness, it has been documented that the excessive use of sedatives is associated with an increased risk of prolonging the stay under MV and in the Intensive Care Unit (ICU). To avoid this, current evidence suggests the use of protocols guided to clinical goals, such as the sedation-agitation scale (SAS), or daily suspension of infusions to avoid excess sedation. These protocols minimize the prescription of deep sedation, which is still necessary for 20-30% of patients. Monitoring of sedation with electroencephalography in the ICU has been underutilized. In fact, only the use of indices that are generated from algorithms of the electroencephalographic signal processing has been reported. However, it has been shown that the use of these monitoring systems does not benefit the heterogeneous groups of patients in MV. Currently, the clinical monitors used to measure the effect of drugs used in a sedoanalgesia show in the screen the spectrogram of the brain electrical signal and quantify the frequency under which 95% of the electroencephalographic power is located, known as spectral edge frequency 95 (SEF95). This value in a person who is conscious is usually greater than 20 Hz, in a patient undergoing general anesthesia it is between 10 and 15 Hz. In preliminary measurements, in deeply sedated patients in the ICU, SEF95 values are under 5 Hz. This would indicate that patients in the ICU are being overdosed. It is unknown if in cases with an indication of deep sedation, the use of monitoring by spectrogram is superior to the standard management guided at clinical scales, such as SAS. Therefore, the investigators propose the following hypothesis: In patients with an appropriate indication of deep sedation (SAS 1-2), the sedoanalgesia guided by the spectral edge frequency 95 reduces the consumption of propofol compared to the deep sedoanalgesia guided by the sedation scale agitation in MV patients in the ICU maintaining a clinically adequate level of sedation.

NCT ID: NCT03704077 Withdrawn - Gastric Cancer Clinical Trials

An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Start date: October 31, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

NCT ID: NCT03196765 Withdrawn - Clinical trials for X-Linked Adrenoleukodystrophy

Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy

Start date: August 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with a long-term treatment phase.

NCT ID: NCT02947919 Withdrawn - Clinical trials for Stress, Psychological

Impact of Music in the Preoperative Stress of Children Undergoing General Surgery

Start date: July 2016
Phase: N/A
Study type: Interventional

Preoperative anxiety and stress are present in up to 60% of pediatric patients undergoing surgery, having a great physiological and emotional impact on children in both the short and long term. There are many reports on the use of music therapy in the perioperative period as a complementary technique in the preoperative stress and anxiety management. However, there are no assessments of the effect of this intervention on the physiological variables, such as salivary cortisol.

NCT ID: NCT01565070 Withdrawn - Knee Osteoarthritis Clinical Trials

Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Start date: April 2012
Phase: Phase 3
Study type: Interventional

Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.

NCT ID: NCT01282645 Withdrawn - Craniotomy Clinical Trials

Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years

Start date: July 2011
Phase: N/A
Study type: Observational

The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.

NCT ID: NCT01032512 Withdrawn - CANCER Clinical Trials

Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology

Start date: December 2009
Phase: Phase 3
Study type: Interventional

After surgical treatment, numerous trials using early postoperative enteral or parenteral nutritional support have been attempted, in order to reduce morbidity and mortality. Although it is difficult to compare among heterogeneous interventions, most of them have not been successful, a fact generally attributed to the timing of the intervention. On the other hand, nutrients that become "conditionally essential" under certain stressful circumstances, the so called nutraceuticals, have been incorporated into nutritional formulations. Both facts have prompted the idea of pre or perioperative nutrition support, using specific formulations called "immune enhancing" formulas, containing arginine, nucleotides, glutamine and omega3 fatty acids in varying concentrations. The provision of these nutraceuticals prior and early after the surgical, and particularly in oncologic surgery, theoretically permits to obtain adequate circulating and tissue concentrations for the moment when they are most needed. Exclusive postoperative provision of these substances would not be able to replenish depots and provide them for an adequate immune response and wound healing after surgery. However, regarding the preoperative approach, it is still not know which patients benefit more (less or more severely malnourished), which specific nutrient(s) are responsible for the positive effects, and the precise timing these nutrients should be provided. The present study aims to demonstrate that immune-enhancing formulas are superior to standard enteral products in reducing postoperative nutrition-related complications.

NCT ID: NCT00971503 Withdrawn - Clinical trials for Type 1 Diabetes Mellitus

Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes

Start date: February 2011
Phase: Phase 2
Study type: Interventional

Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression. Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control. The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients. This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.