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NCT ID: NCT04152863 Terminated - Clinical trials for Advanced/Metastatic Melanoma

Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

Start date: June 5, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.

NCT ID: NCT04149574 Terminated - Clinical trials for Urinary Bladder Neoplasms

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

CheckMate 7G8
Start date: January 15, 2020
Phase: Phase 3
Study type: Interventional

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

NCT ID: NCT04148911 Active, not recruiting - Clinical trials for Triple-Negative Breast Cancer

A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer

EL1SSAR
Start date: December 17, 2019
Phase: Phase 3
Study type: Interventional

Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease.

NCT ID: NCT04142723 Recruiting - Clinical trials for Hepatitis, Alcoholic

Alcoholic Hepatitis in Latin-America: A Prospective and Multicentric Study (AH-LATIN).

Start date: June 20, 2019
Phase:
Study type: Observational [Patient Registry]

The primary objective of this study is to determine the prevalence of AH in addition to its clinical characteristics and in-hospital mortality of patients that are hospitalized for AH in different hospitals across Latin American countries This study is carried out in different health centers throughout America, with all the countries belonging to the Latin American Association for the study of liver diseases (ALEH) more Canada and United States This would allow us to better understand the epidemiology of AH in our region and thus implement prevention measures with more solid data. Importantly, this would allow us to optimize therapeutic measures

NCT ID: NCT04122079 Completed - Clinical trials for Psychological Distress

Validation of the Spanish Version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile

Start date: January 9, 2019
Phase:
Study type: Observational

AIM: study the psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), an instrument that measures psychological distress, in the Chilean population. SAMPLES: two clinical samples (1. outpatients from three psychotherapeutic centers; two university clinics and a family mental health clinic and 2. self-reported clinical) and two non-clinical (1. university students; and 2. general community) samples. Students and community nonstudent participants who reported receiving psychological or psychiatric treatment (exclusion criterion) were excluded from the non-clinical sample and classified as self-reported clinical. DATA COLLECTION: In the clinical sample, data is collected at one point if the patient is undergoing treatment and at four points (at baseline (i.e. before the first session), at 2, 5 and 8-weeks) if the patient is recruited before attending the first psychotherapy session. Participants complete a paper questionnaire in the waiting room of one of the clinics. Participants from the second university outpatient clinic and a family mental health clinic complete a digital version. At baseline, participants are presented with the CORE-OM and the Outcome Questionnaire (OQ-45). At each follow-up point, they are presented with the CORE-OM plus mental health service evaluation items. In the student and community samples, data is collected at two time points (i.e. baseline and retest). At baseline, participants are presented with the CORE-OM and OQ-45. After two weeks (i.e. retest) participants are contacted via email and presented with the CORE-OM. The application modality in the non-clinical samples is mixed: students and general community participants complete paper or digital versions of the questionnaire in the classroom or community, respectively. The digital version of the questionnaire can be accessed by clicking a Uniform Resource Locator embedded in an email/message, or by scanning a Quick Response (QR) code with a smartphone. RECRUITMENT: The clinical sample is recruited at two university outpatient clinics and a family mental health clinic of Santiago, Chile which provide services to patients of low to medium income. Patients in one of the university clinics are approached in the waiting area, and those meeting inclusion criteria, and willing to participate, fill out an informed consent before responding the questionnaire. Patients from the second university clinic/family mental health clinic are referred when booking their first appointment and contacted via email by a research team member. The student sample is recruited in classrooms of Pontificia Universidad Católica. A member of the research team presents the study and invites students to participate. Students agreeing to participate fill out an informed consent form before completing paper/digital versions of the questionnaire. The general community sample is recruited using a convenience sampling method. As in other samples, participants sign an informed consent before answering the questionnaire. ANALYSES: internal consistency, test-retest stability, convergent validity and discrimination. Clinical cut-off values will be calculated by domain and sex between the clinical and non-clinical samples and sensitivity to change will be assessed using data from the subsample of outpatients who respond an online questionnaire before their first session and at one follow up point.

NCT ID: NCT04116281 Suspended - Breast Cancer Clinical Trials

Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery

Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Objectives: To evaluate the pressure pain threshold, shoulder biomechanics, cardiorespiratory function and the quality of life associated with the short and long-term physical therapy rehabilitation following breast cancer surgery. Methodology: The study presents three objectives and involves three groups of participants. Objective 1 is to develop a topographic map of pressure pain in the shoulder (using a digital pressure algometer), evaluate the biomechanics of the shoulder (using a digital inclinometer and load card), cardiorespiratory function (through frequency variability resting heart rate and distance traveled, through the six-minute walk test) and quality of life (through questionnaires of quality of life, anxiety, depression, sleep quality, upper limb functionality, fatigue and level of physical activity) between a group of women prior to the operation of breast cancer (experimental group, n = 36) and a group of asymptomatic controls for shoulder pain (control group, n = 18). Objective 2 is to evaluate the possible changes in the pain map over 24 weeks of supervised kinetic intervention (Supervised Physiotherapy experimental group, n = 18, will begin after drainage, frequency 3 times per week and duration of 60 minutes each session) compared to unsupervised kinetic intervention (Home Physiotherapy experimental group, n = 18, participants will receive an exercise booklet). Objective 3 is to evaluate the biomechanics of the shoulder, cardiorespiratory function and the quality of life with respect to the experimental group with and without kinesic supervision. To achieve objective 1, two baseline evaluations will be carried out in both experimental and control groups (considering the month prior to the surgery of the experimental group) and the average of the evaluations will be considered evaluation 1. To achieve objectives 2 and 3, evaluation 2 (after 4 weeks of intervention), 3 (after 12 weeks of intervention) and 4 (after 24 weeks of intervention) will be performed. The statistical analysis will include the examination of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and a significance level of 5% will be adopted for all comparisons. Expected results: It is expected to identify sensory, biomechanical, cardiorespiratory and quality of life alterations in the experimental group, compared to the control group. In addition, after 24 weeks of intervention, the supervised experimental group will show improvement in all the aforementioned variables with respect to the unsupervised group.

NCT ID: NCT04114565 Completed - Clinical trials for Major Depressive Disorder

Prevalence of Major Depression Among Immigrants in Santiago, Chile

STRING
Start date: July 29, 2019
Phase:
Study type: Observational

The general aim of this study is to explore the prevalence of major depressive disorder and the use of mental health services in the immigrant populations in the Metropolitan Region of Santiago, Chile. The hypotheses are: 1. A healthy immigrant effect will be observed in the studied population by which their prevalence of major depressive disorder will be lower than the prevalence in the general Chilean population. 2. A significant association will be observed between the loss of socio-economic position after migration and a greater probability of major depressive disorder. 3. A significant association will be observed between the report of victimization experience(s) in the previous year and a greater probability of major depressive disorder. 4. A significant association will be observed between financial difficulties and a greater probability of major depressive disorder. The sampling framework of the Chilean National Institute of Statistics (INE) from the 2016 Census will be used for the purpose of this research. The sampling units are as follows: 1. Primary sampling units (PSUs): conglomerates or groups of adjoining houses, organized in spatial blocks (200 households on average) 2. Secondary sampling units (SSUs): individual households within each of the conglomerates selected in the first stage 3. Final sampling units: persons meeting the study's inclusion criteria Multi-stage random probability sampling involving a 3-stage sampling design will be used - first, the sampling of the primary sampling units (PSUs); second, the sampling of households within the selected PSUs and finally, the random sampling of a household member. Participants (n=1,100) will then take part in a 45-minute interview. This interview will be a household survey using the modular version of the Composite International Diagnostic Interview (WHO-CIDI) looking at exploring a broad spectrum of factors traditionally associated with increased risk of affective disorders: 1. Sociodemographics 2. Finance 3. Variation in socioeconomic position 4. Experience of victimization 5. Discrimination 6. Experience of childhood adversity

NCT ID: NCT04109391 Completed - Breast Cancer Clinical Trials

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

Start date: August 20, 2019
Phase: Phase 3
Study type: Interventional

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.

NCT ID: NCT04109066 Completed - Breast Cancer Clinical Trials

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

CheckMate 7FL
Start date: November 20, 2019
Phase: Phase 3
Study type: Interventional

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

NCT ID: NCT04106544 Completed - Clinical trials for Sphingomyelin Lipidosis

A Prospective and Retrospective Cohort Study in Patients With Chronic Forms of Acid Sphingomyelinase Deficiency (ASMD)

Start date: September 27, 2019
Phase: N/A
Study type: Interventional

Primary Objective: - To describe the clinical features and their severity at the time of diagnosis and their evolution over time in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD - To describe Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) at enrollment and their evolution over time; disease severity at the time of diagnosis and its evolution over time Secondary Objectives: - To describe abnormal values in laboratory parameters and all values of specific clinical and imaging assessments at the time of diagnosis and their evolution over time - To study the use and applicability towards validation of a newly developed ASMD disease severity scoring system - To study the use and applicability towards validation of a newly developed ASMD PRO tool - To describe ASMD-related disease burden among patients with ASMD, caregivers, and healthcare resource utilization - To describe the association between patient demographics (eg, age, gender, race, Ashkenazi ancestry) and genotype with selected clinical features in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD