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NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

NCT ID: NCT04620330 Completed - Clinical trials for Non Small Cell Lung Cancer

A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer

RAMP202
Start date: December 31, 2020
Phase: Phase 2
Study type: Interventional

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

NCT ID: NCT04620239 Recruiting - Clinical trials for Transitional Cell Cancer of Renal Pelvis and Ureter

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

UCM301
Start date: March 22, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment

NCT ID: NCT04620057 Completed - Obesity, Childhood Clinical Trials

Effects of Butyrate Against Pediatric Obesity

BAPO
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Worldwide obesity is a public health concern that is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. The main drivers of obesity pathogenesis seem to be a long-term of energy discrepancy between too many calories consumed and an increase of sedentary behavior. A growing body of evidence suggests that the set of microbes that live within the digestive tract, making up the gut microbiota (GM), play a metabolic role in energy regulation and substrate metabolism. Various factors can impact GM, one of these are dietary compounds that deeply affect the growth and metabolism of gut bacteria, since fermentation of nutrients is one core function of the intestinal microbes. Among fermentation products an array of small organic metabolites are short-chain fatty acids (SCFAs) acetate, propionate and butyrate. Among SCFAs, the C-4 fatty acid butyrate, the main fuel for the colonocytes, might have a potential in alleviating obesity and related metabolic complications. Butyrate could act as a regulator of body weight: a reasonable speculation is that butyrate acts on components of the energy balance, promoting energy expenditure and/or reducing energy intake. Preclinical studies have shown that butyrate supplementation prevent high-fat diet-induced obesity and it is able to treat obesity. With the sharp increase of obesity prevalence seen in the pediatric population, novel insights are necessary to counteract this epidemic disease, the outcome of the study is to see whether oral butyrate supplementation could exert similar effect in obese children.

NCT ID: NCT04619953 Completed - Multiple Sclerosis Clinical Trials

Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

Start date: November 9, 2020
Phase: N/A
Study type: Interventional

Clinical features of Multiple Sclerosis (MS) vary widely from patient to other. About the 60% of patients with MS presents cognitive deficits associated with motor disability. The principal consequences of the motor disabilities concern difficult in gait and balance. The principal cognitive deficits concern the speed in elaborating information, the complex attention and the memory. During walking in daily life, it is often required to turn the head for looking something happening in the surrounding environment, for example when a sudden noise is heard, while crossing the street, when there's something interesting around or when is required to verbally answer to someone without stopping walking. All these examples are referred to a common daily life mechanism that has been defined as dual task (DT). Considering that the attention is a limited function, divide it in two different and simultaneous tasks (motor and cognitive), cause a cognitive-motor interference (CMI) that lead to a loss of efficacy in one or in both the tasks. The main aim of the study is to verify the impact of a brief rehabilitation training that combining motor and cognitive therapy using a dual-task paradigm, on balance and gait in MS patients, compared with the traditional therapies that provide a specific postural stability rehabilitation approach. Recruited patients will be randomized in two different groups which perform two different training. Each group perform the allocated training 3 times a week for 4 weeks. All the patients will be evaluated at the baseline (T0), at the end of the training (T1) and 60 days after the end of the training (T2).

NCT ID: NCT04619797 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

SKYSCRAPER-06
Start date: December 14, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: - Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin - Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

NCT ID: NCT04619498 Completed - Cardiac Arrest Clinical Trials

Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest

PediAppRREST
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

Pediatric cardiac arrest (PCA) has a high mortality and morbidity. Its management is complex and often deviates from guideline recommendations leading to patients' worse clinical outcomes. A new tablet app, named PediAppRREST has been developed by our research group to support the management of PCA. The aim of the study is to evaluate the impact of the PediAppRREST app on the management of a PCA simulated scenario. The investigators have planned to conduct a multicenter, simulation-based, randomized control trial assessing the number of deviations (errors and delays) from international recommendations in PCA management. The hypothesis is that teams who use the PediAppRREST app as a cognitive aid will show fewer deviations from guidelines than teams who use a static paper-based cognitive aid (American Heart Association Pediatric Advanced Life Support pocket reference card) or no cognitive aid, during the management of a simulated PCA scenario.

NCT ID: NCT04619004 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer Metastatic

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

Start date: February 2, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.

NCT ID: NCT04618874 Completed - Lung Cancer Clinical Trials

US NAB With ROSE Versus US FNAB With no ROSE

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

This is an investigator-initiated, single center, controlled, randomized clinical trial with two parallel arms in a 1:1 ratio. The objective of the study is to systematically assess the influence of rapid on-site evaluation (ROSE) on the diagnostic yield for diagnosis and molecular profiling, as well as on the safety, of pulmonologist-performed ultrasound-assisted needle aspiration biopsy (US-NAB) of superficial lesions across different metastatic sites in a series of consecutive patients with suspect locally advanced or advanced lung cancer.

NCT ID: NCT04618211 Completed - Clinical trials for Hereditary Angioedema

Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

RAPIDe-1
Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.