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NCT ID: NCT04210843 Terminated - Clinical trials for Chronic Spontaneous Urticaria

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Start date: April 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

NCT ID: NCT04210440 Completed - Hip Injuries Clinical Trials

The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression

NEC15
Start date: March 1, 2003
Phase: N/A
Study type: Interventional

This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).

NCT ID: NCT04210115 Active, not recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma (ESCC)

Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

Start date: February 28, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: - participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 - participants whose tumors express PD-L1 CPS ≥1 - all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: - EFS in participants whose tumors express PD-L1 CPS ≥10 - EFS in participants whose tumors express PD-L1 CPS ≥1 - EFS in all participants - OS in participants whose tumors express PD-L1 CPS ≥10 - OS in participants whose tumors express PD-L1 CPS ≥1 - OS in all participants

NCT ID: NCT04209855 Active, not recruiting - Clinical trials for Fallopian Tube Cancer

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

MIRASOL
Start date: December 31, 2019
Phase: Phase 3
Study type: Interventional

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

NCT ID: NCT04209764 Completed - Pain, Postoperative Clinical Trials

Prevalence of Pain in the Departments of Surgery and Oncoematology of a Children's Hospital

Start date: November 6, 2022
Phase:
Study type: Observational

Six years after, the authors will conduct the same analysis to check if there have been any improvements in the management of analgesic therapy after the measures taken according to the results of the previous study conducted in the same departments. During a single day work three committees, administering a questionnaire to patients or parents, will evaluate the adherence to international recommendations (JCI and WHO) in the management of analgesic therapy.

NCT ID: NCT04209543 Active, not recruiting - Vasomotor Symptoms Clinical Trials

Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Endometrial and General Safety Study Part)

NCT ID: NCT04209322 Completed - Clinical trials for Lumbar Disc Herniation

Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation

PRATS
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Transforaminal epidural injection of treatments, commonly steroids (TFESI), is offered to people with sciatica and might improve symptoms, reduce disability and speed up return to normal activities (NICE guidelines) Imaging-guided TFESI has traditionally been performed in the sciatica context because injection is administered directly to the nerve root, which relieves the pain markedly; however, the maintenance time is usually short. Treatment with radiofrequency for pain management is in clinical use since decades primarily with nerve lesioning (thermoablation) once the specific pain tributary nerve is identified. Pulsed radiofrequency (PRF) with neuromodulation intention (not lesioning) has been shown to be effective in reducing some types of chronic pain, both degenerative and neuropathic. Pulsed radiofrequency has been also extensively used in the context of acute and subacute sciatica due to disc herniation without sufficient level of evidence. In a prospective RCT, comparing prf directed to dorsal root ganglia and Tfesi in patients with sciatica did not allow conclusions on efficacy because of limitations of the trial. In that trial, only few participants completed the study due to violation of trial protocol translating the results as not consistent. One retrospective trial, in which the use of Prf in addition to tfesi was evaluated in patients with acute and subacute sciatica, demonstrated rapid pain relief onset and prolonged maintenance; the overall efficacy was superior to that of the single method treatment (either tfsei or prf). The investigators conducted a randomized, double-blind, controlled trial (Pulsed Radiofrequency in Addition to Tfesi for Sciatica [PRATS]) to determine if PRF in addition to TFESI leads to better outcomes in the management of patients with acute and subacute sciatica due to disc herniation, compared to TFESI alone.

NCT ID: NCT04209114 Completed - Bladder Cancer Clinical Trials

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Start date: February 5, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

NCT ID: NCT04209036 Recruiting - Uterine Fibroid Clinical Trials

Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?

Start date: November 1, 2019
Phase:
Study type: Observational

Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.

NCT ID: NCT04208854 Recruiting - Clinical trials for Locally Advanced/ Metastatic NSCLC

Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)

VINORELBINA
Start date: April 18, 2018
Phase:
Study type: Observational

Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.