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Hyperpolarized 13C Pyruvate as a Biomarker in Advanced Solid Tumors

Advanced Solid Tumor

This is a single center prospective imaging study investigating the utility of hyperpolarized 13C-pyruvate/metabolic MR imaging. The current protocol will serve as a companion imaging biomarker study paired with standard of care (SOC) therapeutics, as well as investigational therapies that participants may be scheduled to receive outside of this protocol.

Recruiting18 enrollment criteria

Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

Periapical Periodontitis

To evaluate the security and efficacy in the administration of encapsulated acellular system derived from Mesenchymal Stem Cells as a novel regenerative endodontic procedure which to promote the pulpar regenration.

Recruiting18 enrollment criteria

Speech Perception in Bimodal Hearing

Hearing LossSensorineural

The protocol has two aims; Aim 1 involves two experiments and Aim 2 involves three experiments. Under Aim 1, the investigator will identify that the frequency and time ranges of consonants produce consonant enhancement (i.e., "target frequency range" and "target time range", respectively), and that the frequency and time ranges of consonants cause consonant confusions (i.e., "conflicting frequency range" and "conflicting time range", respectively). Aim 2 tests the effects of the frequency and time ranges, identified through Aim 1 on consonant recognition with each of the four signal processing conditions: no signal processing (i.e., control condition), the target frequency and time ranges intensified alone, the conflicting frequency and time ranges suppressed alone, and both target range intensification and conflicting range suppression.

Recruiting8 enrollment criteria

Optimal rTMS for Cognitive Deficits and Negative Symptoms in Schizophrenia

SchizophreniaNegative Symptoms in Schizophrenia3 more

Negative symptoms and cognition decline are major challenges in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DLPFC) has been highly involved in the mechanisms of negative symptoms and cognitive symptoms of schizophrenia. However, the effect of repetitive transcranial magnetic stimulation (rTMS) over left or bilateral DLPFC has not yet been well studied. The aim of this study is to describe how the effectiveness of rTMS over different targets for cognitive deficits and negative symptoms in schizophrenia will be evaluated. The study will provide evidence to determine whether a bilateral DLPFC rTMS and is more effective than a left DLPFC rTMS alone to optimize treatment protocol in schizophrenia.

Recruiting10 enrollment criteria

Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes

Diabetes MellitusType 2

This will be a parallel, randomised, double-blind, controlled trial. Upon successful screening, subjects will be randomised to either intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks, in addition to a standardised dietary counselling for diabetes given by the hospital dietitian at baseline. The study endpoints will be evaluated after 12 weeks of starch consumption.

Recruiting19 enrollment criteria

Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer...

Cancer

The purpose of this study is to examine changes in perceived daily performance and executive functioning following chemotherapy in individuals with non-central nervous system cancers.

Recruiting9 enrollment criteria

Pembrolizumab in Combination With Plinabulin and Docetaxel For Metastatic NSCLC After ICIs (KeyPemls-004)...

Non Small Cell Lung Cancer Metastatic

A Phase 2 Study of Pembrolizumab in Combination with Plinabulin and Docetaxel in previously treated Patients with Metastatic Non-Small Cell Lung Cancer and progressive disease (PD) after immunotherapy (Anti-PD-1/PD-L1 inhibitor) alone or in combination with Platinum-doublet Chemotherapy.

Recruiting46 enrollment criteria

First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

Healthy Volunteers

This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with four sequential single ascending dose (SAD) levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581 0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0581 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.

Recruiting10 enrollment criteria

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the...

Advanced Solid Tumors

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Recruiting17 enrollment criteria

New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder

Affective Disorder

The purpose of this study is to explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.

Recruiting13 enrollment criteria
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