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NCT ID: NCT04974593 Recruiting - Clinical trials for Irritable Bowel Syndrome

Predictive Value of Hydrogen/Methane Lactose Breath Testing on the Therapeutic Effect of Lactose-free Diet in Moderate to Severe ROME IV IBS.

Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fatty acids, carbon dioxide, H2 and methane (Catanzaro 2021). These compounds have an osmotic effect and can stimulate colonic contractions. These pathophysiological mechanisms encountered in patients suffering from LI generate symptoms, such as abdominal pain and cramps, flatulence, diarrhea, borborygmi among others. As dairy products are highly present in our Western diet, LI will often be considered in patients presenting with these symptoms and they will be referred for further testing. When LM is diagnosed, a lactose-free diet (LFD) will be advocated to alleviate symptoms. However, studies indicate that individuals with LM should tolerate up to 12 g of lactose when administered in a single dose (Suchy 2010). Irritable bowel syndrome (IBS) is another frequently encountered disorder. According to the Rome IV criteria, it is characterized by abdominal pain associated with a change in stool frequency or consistency, or with symptomatic improvement by defecation (Mearin 2016). Associated symptoms, such as bloating and flatulence, are frequently reported. As such, discerning between IBS and LI based on symptoms alone can be challenging. Moreover lactose is considered part of the so-called fermentable oligo-, di-, monosaccharides and polyols (FODMAPs). A low FODMAP diet has been advocated for IBS with beneficial response in at least part of the patients (Halmos 2014). Many studies investigated the role of lactose in IBS. These studies were performed in the pre-Rome IV era and before standardized interpretation rules for Hydrogen breath testing (H2BT) were published (meta-analysis by Varju 2019). This meta-analysis indicated that subjective LI was more frequently reported by IBS patients, but also objectively more prevalent in IBS patients, when assessed by any test modality. However, the role of a LFD in IBS remains uncertain. This study aims to: - Determine if the diagnosis of LM by H2BT predicts the short-term and long-term response to a LFD in moderate to severe IBS as defined by Rome IV criteria; - Determine the changes in quality of life in response to a LFD in ROME IV IBS patients.

NCT ID: NCT04974216 Recruiting - DLBCL Clinical Trials

Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older

Start date: December 20, 2021
Phase: Phase 2
Study type: Interventional

This study evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.

NCT ID: NCT04973137 Recruiting - Clinical trials for Light Chain (AL) Amyloidosis

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

AFFIRM-AL
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

NCT ID: NCT04970901 Recruiting - Clinical trials for Refractory B-Cell Non-Hodgkin Lymphoma

A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Start date: June 17, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.

NCT ID: NCT04968470 Recruiting - Complication Clinical Trials

SEBBIN Silicone Gel-filled Testicular Implants

Start date: March 16, 2021
Phase:
Study type: Observational

This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

NCT ID: NCT04965493 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

BRUIN CLL-322
Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

NCT ID: NCT04965025 Recruiting - Urethral Stricture Clinical Trials

Multi-stage Urethroplasty With Augmentation Using a Dorsal Graft Inlay Technique Comparing Graft Use in First or Second Stage

MAGIC I
Start date: November 11, 2020
Phase: N/A
Study type: Interventional

The principal aim of this pilot study is to directly compare both approaches and analyze the failure rate after one year of follow-up. These data will serve as the basis to design a larger phase II or III trial in the future with failure rate as the primary end-point. Other study objectives are thoroughly described underneath.

NCT ID: NCT04964934 Recruiting - Clinical trials for ER-Positive HER2-Negative Breast Cancer

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

SERENA-6
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

NCT ID: NCT04963036 Recruiting - Clinical trials for Maxillofacial Surgery

Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity

Start date: July 28, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.

NCT ID: NCT04961996 Recruiting - Early Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.