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NCT ID: NCT04965220 Recruiting - Solid Tumor Clinical Trials

HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors

Start date: January 5, 2022
Phase: Phase 1
Study type: Interventional

A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors

NCT ID: NCT04965077 Recruiting - Clinical trials for Advanced or Metastatic Solid Tumor

Treatment of Advanced and Metastatic Solid Tumors With MIL97

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

This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase. The starting dose for dose escalation phase is 0.01 mg/kg Q3W, followed by 5 dose cohorts (0.03mg/kg Q3W, 0.1mg/kg Q3W, 0.2mg/kg Q3W, 0.3mg/kg Q3W and 0.45mg/kg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days. One or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.

NCT ID: NCT04965051 Recruiting - HbA1c Clinical Trials

Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM

Start date: August 2021
Phase: N/A
Study type: Interventional

In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).

NCT ID: NCT04964791 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

RMS Study of BTK Inhibitor SAR442168

Start date: August 1, 2020
Phase:
Study type: Observational

To access SAR442168 in the RMS populstion. Efficaty will be accessed by adjudicated relapse rate, disability progression, and MRI findings of disease activity.

NCT ID: NCT04964479 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus K Drug in the Treatment of First-line Non-small Cell Lung Cancer(NSCLC)

Start date: August 6, 2021
Phase: Phase 3
Study type: Interventional

A clinical study to evaluate the efficacy and safety of TQB2450 injection combined with Anlotinib Hydrochloride capsules versus K drug as a first-line treatment of advanced non-small cell lung cancer.A total of 375 subjects will be enrolled.

NCT ID: NCT04964310 Recruiting - Clinical trials for Drug-Induced Liver Injury

Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study

PAIN
Start date: August 31, 2020
Phase:
Study type: Observational

Acetaminophen (APAP) is the most commonly used NSAIDS in clinic, and it is also a common cause of drug-induced liver injury (DILI). In 2012, the proportion of DILI caused by APAP in the United States was 51%, while in Asia, it was only 7.10%. Previously, a small cohort study in the United States screened for some of the susceptibility genes for DILI due to APAP by the Genome wide association study (GWAS) method. However, the genetic susceptibility loci based on the US cohort were not applicable to the Chinese population. Therefore, we make a study design include Chinese population who ingested APAP and divided them into case group and control group according to the occurrence of DILI. We hope to be able to find the root of differences at the genetic level and explore new pathogenic mechanisms.

NCT ID: NCT04964284 Recruiting - Clinical trials for Differentiated Thyroid Cancer

Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer

Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.

NCT ID: NCT04964219 Recruiting - Clinical trials for Postoperative Analgesia

Analgesic Effects of Low-dose S-ketamine in Major Spine Fusion Surgery

Start date: February 8, 2022
Phase: Phase 4
Study type: Interventional

Despite opioid-based multimodal analgesia, moderate-to-severe pain remains a big problem in patients following multi-segment spinal fusion. As a N-methyl-D-aspartate receptor antagonist, S-ketamine has prominent analgesic effects through activating receptors both in the brain and in the spinal cord, inhibiting the excitatory postsynaptic potential, and thus blunting nociception transmission. This randomized controlled trial is designed to investigate whether perioperative S-ketamine infusion can decrease pain intensity after major spine fusion surgery.

NCT ID: NCT04964206 Recruiting - Labor Pain Clinical Trials

Neuraxial Labor Analgesia and Offspring Neurodevelopment

Start date: October 14, 2022
Phase:
Study type: Observational [Patient Registry]

How perinatal factors affect the long-term development of children has always been an issue of much concern. This study is designed to explore the potential impact of maternal neuraxial labor analgesia exposure on offspring neurodevelopment.

NCT ID: NCT04963985 Recruiting - Clinical trials for Transthyretin Amyloidosis

The Effect of Tafamidis on Transthyretin Stabilization, Safety, Tolerability and Efficacy in Transthyretin Amyloid Polyneuropathy Patients

Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

Transthyretin amyloid polyneuropathy (ATTR-PN) is a fatal illness resulting from autosomal dominantly inherited single-point mutations on the transthyretin gene. Tafamidis is a specific stabilizer of both variant and wild-type TTR. Tafamidis binds to TTR at the thyroxine binding sites and inhibits TTR tetramer dissociation, the rate limiting step in the amyloidogenic process. The result disrupts the amyloid cascade and fibril formation and interrupts disease progression. This study provides the basis for the study of the effect of tafamidis on the stability of transthyretin and its safety, tolerance and efficacy in patients with transthyretin amyloid polyneuropathy.