Introduction to Disease Trials

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Disease Trials sentence examples within Rare Disease Trials

Rare Disease Trials

These limitations aside, the framework presented provides a proof of concept for the utility of Bayesian model-based methods for decision making in rare disease trials.

Bayesian modeling and simulation to inform rare disease drug development early decision-making: application to Duchenne muscular dystrophy

Rare Disease Trials

Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials.

Current Advances in Clinical Trials for Rare Disease Populations: Spotlight on the Patient.

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Disease Trials sentence examples within Bowel Disease Trials

Bowel Disease Trials

Our aim is to clarify the advantages and drawbacks of cluster randomized trials in order to properly interpret study results and to identify their role in upcoming inflammatory bowel disease trials.

Cluster Randomized Trials: Lessons for Inflammatory Bowel Disease Trials.

Bowel Disease Trials

BPC 157, of which the LD1 has not been achieved, has been implemented as an anti-ulcer peptide in inflammatory bowel disease trials and recently in a multiple sclerosis trial.

Stable gastric pentadecapeptide BPC 157 can improve the healing course of spinal cord injury and lead to functional recovery in rats

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Disease Trials sentence examples within Alzheimer Disease Trials

Alzheimer Disease Trials

This decision is of course their ethical privilege, and if aducanumab were effective, their collective action could revolutionize Alzheimer disease trials (8).

The Problem of Aducanumab for the Treatment of Alzheimer Disease

Alzheimer Disease Trials

Meaning Blood-based β-amyloid 42 and β-amyloid 40 ratio together with APOE genotype may be used as prescreening tests in primary care and in clinical Alzheimer disease trials to lower the costs and number of positron emission tomography scans and lumbar punctures.

Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease–Related β-Amyloid Status

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Disease Trials sentence examples within Infectiou Disease Trials

Infectiou Disease Trials

In 2018, minority subjects were generally well represented in infectious disease product approvals (23% of subjects in infectious disease trials were African American, 17% were Hispanic, and 10%were Asian) but not in oncology product approvals (4% of subjects in oncology trials were African American, 4% were Hispanic, and 15% were Asian, although several trials had less than 5% Asian subjects).

What Drug Development Sponsors, Contract Research Organizations, and Investigators Can Do to Increase Diversity in Clinical Trials

Infectiou Disease Trials

The non-inferiority trial design and recent infectious disease trials of relevance are discussed in this viewpoint.

The Overton window and a less dogmatic approach to antibiotics.

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Disease Trials sentence examples within Heart Disease Trials

Heart Disease Trials

Endpoints utilized in left heart disease trials have been applied with success to TR trials, and innovative trial designs will allow the initiation of pivotal randomized trials.

Endpoints for tricuspid regurgitation trans-catheter therapy trials.

Heart Disease Trials

We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials.

Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement: Findings From the EXTEND Study.

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Disease Trials sentence examples within Metastatic Disease Trials

Metastatic Disease Trials

CONCLUSIONS Comprehensive genomic profiling reveals GA that may be predictive of both targeted and immunotherapy benefit in patients with advanced UrthCa and that could potentially be used in future adjuvant, neoadjuvant, and metastatic disease trials.

Comprehensive genomic profiling of histologic subtypes of urethral carcinomas.

Metastatic Disease Trials

However, African American men were under enrolled in metastatic disease trials (enrollment difference –5.

Minority Recruitment Trends in Phase III Prostate Cancer Clinical Trials (2003 to 2014): Progress and Critical Areas for Improvement

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Disease Trials sentence examples within Cardiovascular Disease Trials

Cardiovascular Disease Trials

Methods: In this pooled analysis, we assessed renal outcome data from high-risk patients aged 55 years or older with a history of cardiovascular disease, 70% of whom had hypertension, randomized to The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial and to Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease trials investigating telmisartan, ramipril and their combination with a median follow-up of 56 months.

Renal outcomes and blood pressure patterns in diabetic and nondiabetic individuals at high cardiovascular risk

Cardiovascular Disease Trials

This strategy has been used successfully in cardiovascular disease trials and therefore is applicable to the current trial.

Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial

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10.1101/2021.02.05.429907

These limitations aside, the framework presented provides a proof of concept for the utility of Bayesian model-based methods for decision making in rare disease trials.

Bayesian modeling and simulation to inform rare disease drug development early decision-making: application to Duchenne muscular dystrophy

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10.1093/ecco-jcc/jjab149

Our aim is to clarify the advantages and drawbacks of cluster randomized trials in order to properly interpret study results and to identify their role in upcoming inflammatory bowel disease trials.

Cluster Randomized Trials: Lessons for Inflammatory Bowel Disease Trials.

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10.1097/HJH.0000000000002697

Methods: In this pooled analysis, we assessed renal outcome data from high-risk patients aged 55 years or older with a history of cardiovascular disease, 70% of whom had hypertension, randomized to The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial and to Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease trials investigating telmisartan, ramipril and their combination with a median follow-up of 56 months.

Renal outcomes and blood pressure patterns in diabetic and nondiabetic individuals at high cardiovascular risk

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10.3233/JPD-202184

Methods: We assessed all Parkinson’s disease trials in the WHO trials portal, from inception (1999) to September 2019.

Parkinson’s Disease Drug Development Since 1999: A Story of Repurposing and Relative Success

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10.1016/j.urolonc.2020.12.021

CONCLUSIONS Comprehensive genomic profiling reveals GA that may be predictive of both targeted and immunotherapy benefit in patients with advanced UrthCa and that could potentially be used in future adjuvant, neoadjuvant, and metastatic disease trials.

Comprehensive genomic profiling of histologic subtypes of urethral carcinomas.

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10.7326/M21-2603

This decision is of course their ethical privilege, and if aducanumab were effective, their collective action could revolutionize Alzheimer disease trials (8).

The Problem of Aducanumab for the Treatment of Alzheimer Disease

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10.1111/apt.16453

Although a small pilot, this study likely grappled with big decisions— decisions many researchers conducting coeliac disease trials must face when deciding on a study endpoint.

Editorial: testing novel interventions for coeliac disease—which outcomes matter?

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10.2174/1574884716666210316120615

Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials.

Current Advances in Clinical Trials for Rare Disease Populations: Spotlight on the Patient.

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10.1186/s13063-021-05080-4

This strategy has been used successfully in cardiovascular disease trials and therefore is applicable to the current trial.

Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial

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10.3389/fpls.2019.00924

” A large-scale low-cost phenotyping platform was developed utilizing automated unmanned vehicles and near infrared imaging cameras to assess field-based disease trials.

Identifying Verticillium dahliae Resistance in Strawberry Through Disease Screening of Multiple Populations and Image Based Phenotyping

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10.1080/14712598.2020.1702020

Whether new endpoints such as transmural and radiologic healing could become an endpoint and replace endoscopy in Crohn’s disease trials in the near future requires further investigation.

Evolving primary and secondary endpoints in randomized controlled trials leading to approval of biologics and small molecules in IBD: an historical perspective

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10.1111/hae.13717

Despite emerging novel haemostatic agents, challenges of rare disease trials are limited subjects and lack of an organized research organization with strategic resources and partnerships.

The national blueprint for future factor VIII inhibitor clinical trials: NHLBI State of the Science (SOS) Workshop on factor VIII inhibitors

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10.1186/s13018-019-1242-6

BPC 157, of which the LD1 has not been achieved, has been implemented as an anti-ulcer peptide in inflammatory bowel disease trials and recently in a multiple sclerosis trial.

Stable gastric pentadecapeptide BPC 157 can improve the healing course of spinal cord injury and lead to functional recovery in rats

More Disease Trials sentence examples
10.1016/j.jalz.2019.06.3918

There is keen interest in elucidating the biological mechanisms underlying recent failures of β‐site amyloid precursor protein–cleaving enzyme‐1 (BACE1) inhibitors in Alzheimer's disease trials.

Multiple BACE1 inhibitors abnormally increase the BACE1 protein level in neurons by prolonging its half-life

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10.1001/jamaneurol.2019.1632

Meaning Blood-based β-amyloid 42 and β-amyloid 40 ratio together with APOE genotype may be used as prescreening tests in primary care and in clinical Alzheimer disease trials to lower the costs and number of positron emission tomography scans and lumbar punctures.

Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease–Related β-Amyloid Status

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10.1002/jcph.1530

In 2018, minority subjects were generally well represented in infectious disease product approvals (23% of subjects in infectious disease trials were African American, 17% were Hispanic, and 10%were Asian) but not in oncology product approvals (4% of subjects in oncology trials were African American, 4% were Hispanic, and 15% were Asian, although several trials had less than 5% Asian subjects).

What Drug Development Sponsors, Contract Research Organizations, and Investigators Can Do to Increase Diversity in Clinical Trials

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10.1371/journal.pone.0222313

Searches of electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, PUBMED and Web of Science) identified eight eligible independent trials (seven autoimmune disease trials, one trial of healthy subjects).

The role of vitamin D in increasing circulating T regulatory cell numbers and modulating T regulatory cell phenotypes in patients with inflammatory disease or in healthy volunteers: A systematic review

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10.1371/journal.pmed.1002966

We analyzed 659 rare disease trials accounting for 70,305 enrolled patients.

Noncompletion and nonpublication of trials studying rare diseases: A cross-sectional analysis

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10.1136/jmedgenet-2019-106283

Background Classical randomisation of clinical trial patients creates a source of genetic variance that may be contributing to the high failure rate seen in neurodegenerative disease trials.

Genetic variability and potential effects on clinical trial outcomes: perspectives in Parkinson’s disease

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10.1016/j.pcad.2019.11.019

Endpoints utilized in left heart disease trials have been applied with success to TR trials, and innovative trial designs will allow the initiation of pivotal randomized trials.

Endpoints for tricuspid regurgitation trans-catheter therapy trials.

More Disease Trials sentence examples
10.1177/1740774518820814

The authors comment that these are larger than sample sizes for Alzheimer’s disease trials to date.

Editorial: We may need large trials to find treatments for neurodegenerative diseases

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10.1186/s12916-019-1427-1

For example, in asthma and psoriasis trials, 10–15% of participants had ≥ 3 conditions overall, while in osteoporosis and chronic obstructive pulmonary disease trials 40–60% of participants had ≥ 3 conditions overall.

Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis

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10.1161/CIRCINTERVENTIONS.119.008231

We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials.

Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement: Findings From the EXTEND Study.

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10.1016/J.CJCA.2019.01.010

Women enrollment varied with clinical indication, comprising 37% for non-coronary artery disease vascular trials, 30% for coronary artery disease trials, 28% for heart failure trials, and 28% for arrhythmia trials (P < 0.

Temporal Trends of Women Enrollment in Major Cardiovascular Randomized Clinical Trials.

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10.1093/JCAG/GWZ006.249

Aims: To discuss the potential of adaptive clinical trials in Crohn’s disease trials.

A250 POTENTIAL OF ADAPTIVE DESIGNS TO ADDRESS CURRENT CHALLENGES IN TRIAL EVALUATION OF TREATMENTS FOR CROHN’S DISEASE

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10.1186/s12874-019-0791-z

BackgroundMany prodromal Alzheimer’s disease trials collect two types of data: the time until clinical diagnosis of dementia and longitudinal patient information.

Using joint models to disentangle intervention effect types and baseline confounding: an application within an intervention study in prodromal Alzheimer’s disease with Fortasyn Connect

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10.1093/cid/ciz984

The non-inferiority trial design and recent infectious disease trials of relevance are discussed in this viewpoint.

The Overton window and a less dogmatic approach to antibiotics.

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10.1016/j.juro.2018.09.029

However, African American men were under enrolled in metastatic disease trials (enrollment difference –5.

Minority Recruitment Trends in Phase III Prostate Cancer Clinical Trials (2003 to 2014): Progress and Critical Areas for Improvement

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Disease Trials - These limitations aside, the framework presented provides a proof of concept for the utility of Bayesian model-based methods for decision making in rare disease trials. [1] Our aim is to clarify the advantages and drawbacks of cluster randomized trials in order to properly interpret study results and to identify their role in upcoming inflammatory bowel disease trials. [2] Methods: In this pooled analysis, we assessed renal outcome data from high-risk patients aged 55 years or older with a history of cardiovascular disease, 70% of whom had hypertension, randomized to The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial and to Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease trials investigating telmisartan, ramipril and their combination with a median follow-up of 56 months. [3] Methods: We assessed all Parkinson’s disease trials in the WHO trials portal, from inception (1999) to September 2019. [4] CONCLUSIONS Comprehensive genomic profiling reveals GA that may be predictive of both targeted and immunotherapy benefit in patients with advanced UrthCa and that could potentially be used in future adjuvant, neoadjuvant, and metastatic disease trials. [5] This decision is of course their ethical privilege, and if aducanumab were effective, their collective action could revolutionize Alzheimer disease trials (8). [6] Although a small pilot, this study likely grappled with big decisions— decisions many researchers conducting coeliac disease trials must face when deciding on a study endpoint. [7] Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. [8] This strategy has been used successfully in cardiovascular disease trials and therefore is applicable to the current trial. [9] ” A large-scale low-cost phenotyping platform was developed utilizing automated unmanned vehicles and near infrared imaging cameras to assess field-based disease trials. [10] Whether new endpoints such as transmural and radiologic healing could become an endpoint and replace endoscopy in Crohn’s disease trials in the near future requires further investigation. [11] Despite emerging novel haemostatic agents, challenges of rare disease trials are limited subjects and lack of an organized research organization with strategic resources and partnerships. [12] BPC 157, of which the LD1 has not been achieved, has been implemented as an anti-ulcer peptide in inflammatory bowel disease trials and recently in a multiple sclerosis trial. [13] There is keen interest in elucidating the biological mechanisms underlying recent failures of β‐site amyloid precursor protein–cleaving enzyme‐1 (BACE1) inhibitors in Alzheimer's disease trials. [14] Meaning Blood-based β-amyloid 42 and β-amyloid 40 ratio together with APOE genotype may be used as prescreening tests in primary care and in clinical Alzheimer disease trials to lower the costs and number of positron emission tomography scans and lumbar punctures. [15] In 2018, minority subjects were generally well represented in infectious disease product approvals (23% of subjects in infectious disease trials were African American, 17% were Hispanic, and 10%were Asian) but not in oncology product approvals (4% of subjects in oncology trials were African American, 4% were Hispanic, and 15% were Asian, although several trials had less than 5% Asian subjects). [16] Searches of electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, PUBMED and Web of Science) identified eight eligible independent trials (seven autoimmune disease trials, one trial of healthy subjects). [17] We analyzed 659 rare disease trials accounting for 70,305 enrolled patients. [18] Background Classical randomisation of clinical trial patients creates a source of genetic variance that may be contributing to the high failure rate seen in neurodegenerative disease trials. [19] Endpoints utilized in left heart disease trials have been applied with success to TR trials, and innovative trial designs will allow the initiation of pivotal randomized trials. [20] The authors comment that these are larger than sample sizes for Alzheimer’s disease trials to date. [21] For example, in asthma and psoriasis trials, 10–15% of participants had ≥ 3 conditions overall, while in osteoporosis and chronic obstructive pulmonary disease trials 40–60% of participants had ≥ 3 conditions overall. [22] We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials. [23] Women enrollment varied with clinical indication, comprising 37% for non-coronary artery disease vascular trials, 30% for coronary artery disease trials, 28% for heart failure trials, and 28% for arrhythmia trials (P < 0. [24] Aims: To discuss the potential of adaptive clinical trials in Crohn’s disease trials. [25] BackgroundMany prodromal Alzheimer’s disease trials collect two types of data: the time until clinical diagnosis of dementia and longitudinal patient information. [26] The non-inferiority trial design and recent infectious disease trials of relevance are discussed in this viewpoint. [27] However, African American men were under enrolled in metastatic disease trials (enrollment difference –5. [28]

Rare Disease Trials

These limitations aside, the framework presented provides a proof of concept for the utility of Bayesian model-based methods for decision making in rare disease trials. [1] Characterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. [2] Despite emerging novel haemostatic agents, challenges of rare disease trials are limited subjects and lack of an organized research organization with strategic resources and partnerships. [3] We analyzed 659 rare disease trials accounting for 70,305 enrolled patients. [4]

Bowel Disease Trials

Our aim is to clarify the advantages and drawbacks of cluster randomized trials in order to properly interpret study results and to identify their role in upcoming inflammatory bowel disease trials. [1] BPC 157, of which the LD1 has not been achieved, has been implemented as an anti-ulcer peptide in inflammatory bowel disease trials and recently in a multiple sclerosis trial. [2]

Alzheimer Disease Trials

This decision is of course their ethical privilege, and if aducanumab were effective, their collective action could revolutionize Alzheimer disease trials (8). [1] Meaning Blood-based β-amyloid 42 and β-amyloid 40 ratio together with APOE genotype may be used as prescreening tests in primary care and in clinical Alzheimer disease trials to lower the costs and number of positron emission tomography scans and lumbar punctures. [2]

Infectiou Disease Trials

In 2018, minority subjects were generally well represented in infectious disease product approvals (23% of subjects in infectious disease trials were African American, 17% were Hispanic, and 10%were Asian) but not in oncology product approvals (4% of subjects in oncology trials were African American, 4% were Hispanic, and 15% were Asian, although several trials had less than 5% Asian subjects). [1] The non-inferiority trial design and recent infectious disease trials of relevance are discussed in this viewpoint. [2]

Heart Disease Trials

Endpoints utilized in left heart disease trials have been applied with success to TR trials, and innovative trial designs will allow the initiation of pivotal randomized trials. [1] We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials. [2]

Metastatic Disease Trials

CONCLUSIONS Comprehensive genomic profiling reveals GA that may be predictive of both targeted and immunotherapy benefit in patients with advanced UrthCa and that could potentially be used in future adjuvant, neoadjuvant, and metastatic disease trials. [1] However, African American men were under enrolled in metastatic disease trials (enrollment difference –5. [2]

Cardiovascular Disease Trials

Methods: In this pooled analysis, we assessed renal outcome data from high-risk patients aged 55 years or older with a history of cardiovascular disease, 70% of whom had hypertension, randomized to The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial and to Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease trials investigating telmisartan, ramipril and their combination with a median follow-up of 56 months. [1] This strategy has been used successfully in cardiovascular disease trials and therefore is applicable to the current trial. [2]