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NCT ID: NCT04305496 Active, not recruiting - Clinical trials for Locally Advanced (Inoperable) or Metastatic Breast Cancer

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

CAPItello-291
Start date: April 16, 2020
Phase: Phase 3
Study type: Interventional

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.

NCT ID: NCT04305418 Completed - Psychological Clinical Trials

Mindfulness- Based Intervention for Systemic Lupus Erythematosus (SLE) Patients

Start date: January 23, 2017
Phase: N/A
Study type: Interventional

Systemic lupus erythematosus (SLE) is a rheumatic autoimmune disease, involving chronic pain, fatigue, movement difficulties, and is often accompanied by tremendous psychological and psychiatric difficulties. Mindfulness-based Intervention (MBI), is a mind-body intervention, which has been documented in several studies as effective among stress- related diseases, such as crohn's disease. Nevertheless, not much is known about the efficiency of MBI among SLE patients and about the mechanisms of change through which MBI works. In the present study, the investigators are focusing on different cognitive mechanisms and their role in MBI action. The study is a randomized-controlled trial. 26 Patients diagnosed with SLE (Mean age=41.26) were randomly assigned to either a 10-weeks MBI intervention (N=15) or a waitlist-control (WL;N=11).4 central measurements points were conducted through the study, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). additionally, participant's blood test has been taken at the beginning and at the end of the intervention.

NCT ID: NCT04305054 Recruiting - Melanoma Clinical Trials

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Start date: July 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy. Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab were added in Amendment 04 on 10-May-2023, and enrollment for these arms will be initiated in July 2023.

NCT ID: NCT04305041 Active, not recruiting - Melanoma Clinical Trials

Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)

Start date: June 26, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.

NCT ID: NCT04304664 Completed - Psychological Clinical Trials

Mindfulness- Based Intervention for Fibromyalgia Patients

Start date: January 23, 2017
Phase: N/A
Study type: Interventional

Fibromyalgia is a chronic pain syndrome, often involves high levels of depression, anxiety and cognitive deficits (e.g., "Fibro Fog"). Mindfulness-based Intervention (MBI), is a mind-body intervention, which has been documented in several studies as effective among stress- related diseases, such as crohn's disease. Nevertheless, not much is known about the efficiency of MBI among fibromyalgia patients and about the mechanisms of change through which MBI works. In the present study, the investigators are focusing on different cognitive mechanisms and their role in MBI action. The study is a randomized-controlled trial. 95 Patients diagnosed with fibromyalgia (Mean age=52) were randomly assigned to either a 10-weeks MBI intervention (N=49) or a waitlist-control (WL;N=46). 4 central measurements points were conducted through the study, which included physiological and psychological variables: at the beginning of the intervention (T1), in the middle of the intervention (T2) at the end of the intervention (T3) and one 6 months follow- up measurement after the termination of the intervention (T4). additionally, participant's blood test has been taken at the beginning and at the end of the intervention.

NCT ID: NCT04303260 Recruiting - Ulcerative Colitis Clinical Trials

Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease

Start date: July 8, 2019
Phase: N/A
Study type: Interventional

The investigator is hypothesize that physical activity can have positive effects on health, general well-being , sleep quality and stress in Inflammatory Bowel Disease patients.

NCT ID: NCT04303169 Active, not recruiting - Melanoma Clinical Trials

Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)

Start date: June 26, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.

NCT ID: NCT04299035 Recruiting - Postoperative Pain Clinical Trials

ESP Block vs. Traditional Pain Management for ERAS

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

Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome. Traditional pain management in these groups of patients — such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs — may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding. We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.

NCT ID: NCT04297410 Recruiting - Prostate Cancer Clinical Trials

177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease

NALuPROST
Start date: November 20, 2019
Phase: N/A
Study type: Interventional

Despite surgical advances, up to 50% of patients with high-risk locally advanced prostate cancer will die from their disease. Drug therapy before surgery has the potential to improve treatment success by lowering tumor volume in the prostate and treating small metastases. PET PSMA is an advanced imaging technique that allows the identification of areas involved by the tumor in the prostate or in the pelvis. This technique is based on the protein PSMA (prostate-specific membrane antigen) which is located on the tumor cells. The presence of PSMA on tumor cells has been recently used for treatment purposes. A chemical element (Lutetium) that binds to PSMA and emits local radiation can destroy tumors cells. This treatment has been used in patients with advanced metastatic disease and showed promising results. The investigators hypothesized that using these particles can improve long term results in patients who undergo surgery for prostate cancer which has not extensively spread. The investigators will assess both the immediate and long-term impact of this novel treatment.

NCT ID: NCT04297189 Recruiting - Sedentary Behavior Clinical Trials

A Pilot Program Measuring Effectiveness of Health Coaching Interventions

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Women will participate in a workshop within a group and individual meetings. the workshop will include providing information regarding guidelines for healthy eating, engaging in physical activity, personal training tools to build self-efficacy and to encourage implementing a healthy life style.