Single arm pilot study

Randomized and Single-Arm Trials | Friends of Cancer Research

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Randomized and Single-Arm Trials. An arm of a clinical trial is a group of patients receiving a specific treatment (or no treatment). Trials involving several arms, or randomized trials, treat randomly-selected groups of patients with different therapies in order to compare their medical outcomes.

Randomized and Single-Arm Trials | Friends of Cancer Research

Effect of Facial Cosmetic Acupuncture on Facial Elasticity ...

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7/28/2013 · This clinical open-label, single-arm pilot study investigated the efficacy and safety of FCA on facial elasticity. FCA has been increasing in use and popularity but few introductory articles [1, 2] were available until Donoyama et al. reported in 2012 on increased water and oil content for facial skin after cosmetic acupuncture .

Effect of Facial Cosmetic Acupuncture on Facial Elasticity ...

Recommendations for Planning Pilot Studies in Clinical and ...

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Recommendations for Investigators Considering a Pilot Study. Here we provide recommendations concerning the preparatory relationship of the pilot study to one or more subsequent studies, protocol design and analysis for the pilot study, sample size considerations for the pilot and the future study, and the role of pilot studies in career development.

Recommendations for Planning Pilot Studies in Clinical and ...

Clinical trials explained - Angelman Syndrome Ireland

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Prospective single arm clinical trials:- A single arm prospective study means everyone enrolled in the clinical trial will be treated the same way. If a prospective single arm study is focusing on a drug, the data has to show some indication that there is a benefit.

Clinical trials explained - Angelman Syndrome Ireland

Preliminary results of a single-arm pilot study to assess ...

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This single-arm pilot study enrolled 47 post-menopausal women affected by vulvovaginal atrophy (VVA). The Vaginal Health Index Score (VHIS) was evaluated for all women and all completed the Female Sexual Function Index (FSFI) questionnaire at baseline (T0) and after 15 days of vaginal cream treatment with one application per day (T1).

Preliminary results of a single-arm pilot study to assess ...

A Single-Arm Pilot Study With Low-Dose Rituximab Plus ...

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5/2/2011 · A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

A Single-Arm Pilot Study With Low-Dose Rituximab Plus ...

A single-arm pilot study of guided self-help treatment ...

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4/25/2018 · Guided self-help treatments based on cognitive behavioral therapy (CBT-GSH) are regarded as a first-line effective treatment for bulimia nervosa (BN). With limited application for CBT-GSH in Japanese clinical settings, we conducted a single arm pilot study in order to confirm the acceptability and availability of CBT-GSH in Japan. 25 women with BN received 16–20 sessions of face-to-face CBT-GSH.

A single-arm pilot study of guided self-help treatment ...

(PDF) Preliminary results of a single-arm pilot study to ...

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PDF | This single-arm pilot study enrolled 47 post-menopausal women affected by vulvovaginal atrophy (VVA). The Vaginal Health Index Score (VHIS) was evaluated for all women and all completed the ...

(PDF) Preliminary results of a single-arm pilot study to ...

Single-Arm Pilot Study to Determine the Effectiveness of ...

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This was a single-arm pilot study conducted in Japan by using the shaper (SLIM-up-Pants with Style Science, Wacoal Corporation, Kyoto, Japan). The bladder neck position in a sitting posture was recorded using an open-configuration magnetic resonance system and then compared between parous women with SUI, without and with the shaper.

Single-Arm Pilot Study to Determine the Effectiveness of ...

Effect of Facial Cosmetic Acupuncture on Facial Elasticity ...

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This study was an open-label, single-arm pilot study at Kyung Hee University Hospital at Gangdong from August through September 2011. Five sessions of FCA treatment were given over three weeks. All participants received FCA twice a week for the first two weeks, then once a week for the last week, with three to four days between sessions.

Effect of Facial Cosmetic Acupuncture on Facial Elasticity ...

Open-Label,Single-Arm Pilot Study to Evaluate the ...

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1/30/2008 · Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis (PSOR-001) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Open-Label,Single-Arm Pilot Study to Evaluate the ...

Impact of Surgihoney Reactive Oxygen on surgical site ...

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A single arm pilot study of AWR patients will be carried out on patients with grade 3 and 4 (VHWG grade) ventral hernias. Patients’ pre-operative wounds will be graded according to the CDC classification scale. Post operatively the wounds will be classified according to the Wilson surgical site infection classification.

Impact of Surgihoney Reactive Oxygen on surgical site ...

Effect of administration of a probiotic preparation on gut ...

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an open-label, single-arm pilot study Ankita Singh1, Aditya N. Sarangi2,3, Amit Goel2, Rajni Srivastava1, Rajat Bhargava2, Priyanka Gaur1, Amita Aggarwal1 and Rakesh Aggarwal2,3* Abstract Background: Probiotics have been shown to be useful for the treatment of many disease conditions. These

Effect of administration of a probiotic preparation on gut ...

Effect of administration of a probiotic preparation on gut ...

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6/15/2018 · The present study had an open-label, single-arm study design, and was conducted in the Department of Gastroenterology of a tertiary-level health care institution in India. Our study adheres to CONSORT guidelines. We enrolled healthy, non-pregnant women as volunteers.

Effect of administration of a probiotic preparation on gut ...

Open-label trial - Wikipedia

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An open-label trial, or open trial, is a type of clinical trial in which both the researchers and participants know which treatment is being administered. This contrasts with single blind and double blind experimental designs, where participants are not aware of what treatment they are receiving (researchers are also unaware in a double blind trial). ...

Open-label trial - Wikipedia

Targeting Aging with Functional Food: Pasta with Opuntia ...

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6/1/2018 · The aim of this study was to analyze the antioxidant and anti-inflammatory effect of pasta with 3% of OFI cladode extracts added to show its beneficial effect in human health. We performed a single arm longitudinal intervention study in 42 healthy volunteers, administrating 500 g/week of this functional pasta for 30 days.

Targeting Aging with Functional Food: Pasta with Opuntia ...

Image-based ex-vivo drug screening for patients with ...

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Image-based ex-vivo drug screening for patients with aggressive haematological malignancies: interim results from a single-arm, open-label, pilot study. Previous Article Response comparison of multiple myeloma and monoclonal gammopathy of undetermined significance to the same anti-myeloma therapy: a retrospective cohort study.

Image-based ex-vivo drug screening for patients with ...

An open-label, single-arm pilot study in patients with ...

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Limitations: This was a small, single-arm, open-label pilot study; therefore there was neither a placebo nor a comparison group. Conclusion: Apremilast demonstrated biological activity and improved psoriasis clinical efficacy scores in patients with severe plaque-type psoriasis. The majority of …

An open-label, single-arm pilot study in patients with ...

Poster 57: Prospective, Single-Arm Pilot Study Evaluating ...

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Poster 57: Prospective, Single-Arm Pilot Study Evaluating the Safety and Efficacy of Two Hylan G-F 20 Injections in Patients With Advanced, Painful Glenohumeral Osteoarthritis With …

Poster 57: Prospective, Single-Arm Pilot Study Evaluating ...

A pilot study of durvalumab and tremelimumab and ...

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A single arm pilot study was designed to determine the overall response rate (ORR) of durvalumab and tremelimumab, and evaluate immunogenomic dynamics in metastatic endocrine receptor (ER) positive or triple negative breast cancer (TNBC).

A pilot study of durvalumab and tremelimumab and ...

single-arm study | WordReference Forums

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1/27/2010 · There was the term of "single-arm study" in an introduction of medicinal product. The context in which this term exists is; "PNH patients were also treated in a single arm 52 week study". I couldn't figure out what single arm study refers to. I googled it but nothing comes out, at least not in sense of definition. What could it be?

single-arm study | WordReference Forums

A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate ...

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A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate the Efficacy and Safety of Generic Tacrolimus (TacroBell) After Primary Renal Transplantation. Transplantation Proceedings . …

A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate ...

Prospective single-arm interventional pilot study to ...

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Molton JS, Pang Y, Wang Z, Qiu B, Wu P, Rahman-Shepherd A, Ooi WT, Paton NI. Prospective single-arm interventional pilot study to assess a smartphone-based system for measuring and supporting adherence to medication.

Prospective single-arm interventional pilot study to ...

What is the difference between Pilot Study and Pre test ...

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What is the difference between Pilot Study and Pre test? Which one should be used for sample size calculation? Is there any similarity in Pretest and Pilot Study. Sample Size.

What is the difference between Pilot Study and Pre test ...

FDA Guidance: “Design Considerations for Pivotal Clinical ...

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Considerations for Pivotal Clinical Investigations for ... feasibility/pilot studies, iterative learning and ... l A one-arm study is an observational study—not a clinical

FDA Guidance: “Design Considerations for Pivotal Clinical ...

Esmolol infusion in patients with septic shock and ...

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8/3/2018 · High adrenergic tone appears to be associated with mortality in septic shock, while adrenergic antagonism may improve survival. In preparation for a randomized trial, we conducted a prospective, single-arm pilot study of esmolol infusion for patients with septic shock and tachycardia that persists after adequate volume expansion. From April 2016 to March 2017, we enrolled patients admitted to ...

Esmolol infusion in patients with septic shock and ...

Clinical trials for medical devices: FDA and the IDE process

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Clinical trials for medical devices: FDA and the IDE process Owen Faris, Ph.D. ... study/device and the potential for the study data to ... – Feasibility data promising but single-arm . Study ...

Clinical trials for medical devices: FDA and the IDE process

What is a pilot or feasibility study? A review of current ...

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7/16/2010 · A brief definition is that a pilot study is a 'small study for helping to design a further confirmatory study'[].A very useful discussion of exactly what is a pilot study has been given by Thabane et al. [] Such kinds of study may have various purposes such as testing study procedures, validity of tools, estimation of the recruitment rate, and estimation of parameters such as the variance of ...

What is a pilot or feasibility study? A review of current ...

single-arm clinical study - definition-of.com

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single-arm clinical study - clinical study in only one arm of patients, open-label study 188 were donated in March This month, we are on track to donate 193 home recent additions webmaster page banners feed a …

single-arm clinical study - definition-of.com

Clinical Trials Study Design - Endocrine Society

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Clinical Trials Study Design . ... Study Blinding: Blinding in a study means that either subjects (single-blind) or subjects and investigators (double-blind) are not aware of the treatment into which subjects are ... In some cases, the placebo arm of the study is actually defined as a …

Clinical Trials Study Design - Endocrine Society

Blood Stasis Therapy for Traumatic Injury: A Prospective ...

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3/13/2019 · Methods: A single-center prospective pretest–post-test pilot study included 73 patients with a trauma that occurred within the past 2 weeks who were admitted into Jaseng Hospital of Korean Medicine from August 2015 through December 2015. Of the 50 patients analyzed in this study, 42 were women (mean age, 33.52).

Blood Stasis Therapy for Traumatic Injury: A Prospective ...

A pilot single arm observational study of sofosbuvir ...

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Methods. This is a pilot prospective single arm observational open‐label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6‐ to 12‐ years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half …

A pilot single arm observational study of sofosbuvir ...

Esmolol infusion in patients with septic shock and ...

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Conclusions: In a pilot, single-arm study, we report the first publi shed experience with esmololinfusionintachycardic patients with septic shock in the United States. These findings support a phase 2 trial of esmolol infusion for septic shock.

Esmolol infusion in patients with septic shock and ...

Solved: Analyzing a single arm study with repeated measure ...

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12/14/2013 · I am considering my options for analyzing a single arm multi-center study. I have a small pilot study with only one treatment group, without a control. There are two main variables of interest: 1. A "semi-continuous" one, theoretically was suppose to get discrete values between 1-10. In practice, all values apart from two are either 0,1,2. 2.

Solved: Analyzing a single arm study with repeated measure ...

Check-Cap Initiates U.S. Pilot Study of C-Scan® for ...

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4/8/2019 · The single-arm pilot study (NCT03735407) will enroll up to 45 subjects considered to be of average risk for polyps and colon cancer. The study is evaluating the safety, usability and subject ...

Check-Cap Initiates U.S. Pilot Study of C-Scan® for ...

Crossover study - Wikipedia

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In medicine, a crossover study or crossover trial is a longitudinal study in which subjects receive a sequence of different treatments (or exposures). While crossover studies can be observational studies, many important crossover studies are controlled experiments, which are discussed in this article.Crossover designs are common for experiments in many scientific disciplines, for example ...

Crossover study - Wikipedia

An Open Label Single arm Pilot Study Evaluating the ...

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Description: This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in patients with HER2 negative and BRCAmut localized breast cancer (primary tumor >1 cm). Inclusion Criteria: • Females age ≥ 18 years old • Patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation (germline or somatic)

An Open Label Single arm Pilot Study Evaluating the ...

Neoadjuvant Folfirinox And Chemoradiation Followed By ...

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Study #ALLIANCE-A021101. Neoadjuvant Folfirinox And Chemoradiation Followed By Definitive Surgery And Postoperative Gemcitabine For Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study

Neoadjuvant Folfirinox And Chemoradiation Followed By ...

An open-label single-arm pilot phase II study (PX-171-003 ...

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Notably, peripheral neuropathy and neuropathy-related AEs were generally mild and infrequent. Conclusion: This pilot study was the first phase II single-agent trial conducted with carfilzomib. Based on these findings, the study was amended to test a higher carfilzomib dose in …

An open-label single-arm pilot phase II study (PX-171-003 ...

Changing from an Single Arm Study from an Multi-Arm Study

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Single arm studies, otherwise known as longitudinal outcome studies only have one arm. There is no comparison or experiment arm. All participants have the same experience over time. Here’s how you create an outcome study on ProofPilot. if you are working in a multi-arm RCT study template, delete the control arm, by clicking the trash…

Changing from an Single Arm Study from an Multi-Arm Study

Effectiveness of a Web-Based eHealth Volume 5: 1–11 Portal ...

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Dialysis Patients: A Single-Arm Pilot Study James Kiberd1, Usman Khan2, Cynthia Stockman2, Arun Radhakrishnan3, Matthew Phillips2, Bryce A. Kiberd1,2, ... This study provided valuable information on the use of online communication portals for patients who are on either

Effectiveness of a Web-Based eHealth Volume 5: 1–11 Portal ...

An open-label single-arm pilot phase II study (PX-171-003 ...

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Conclusion: This pilot study was the first phase II single-agent trial conducted with carfilzomib. Based on these findings, the study was amended to test a higher carfilzomib dose in …

An open-label single-arm pilot phase II study (PX-171-003 ...

Palmoplantar pustulosis treated with itraconazole: a ...

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Despite the fact that this was not a placebo-controlled study, PPP is a common, chronic, relapsing, pustular the authors think that the fact that three of the eruption affecting the palms and soles. The therapy six patients reached complete response is highly for PPP is largely unsatisfactory.

Palmoplantar pustulosis treated with itraconazole: a ...

Effect of trelagliptin on vascular endothelial functions ...

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objective of the present study was to examine the effects of trelagliptin on vascular endothelial functions in patients with type 2 diabetes mellitus (DM) using flow-mediated dilatation (FMD), adiponectin, and asymmetric dimethylargi-nine (ADMA) as evaluation indicators. Methods: This study was a preliminary single-arm prospective pilot study.

Effect of trelagliptin on vascular endothelial functions ...

Effect of trelagliptin on vascular endothelial functions ...

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11/4/2016 · The objective of the present study was to examine the effects of trelagliptin on vascular endothelial functions in patients with type 2 diabetes mellitus (DM) using flow-mediated dilatation (FMD), adiponectin, and asymmetric dimethylarginine (ADMA) as evaluation indicators. This study was a preliminary single-arm prospective pilot study.

Effect of trelagliptin on vascular endothelial functions ...

A pilot safety study and single arm phase II study of ...

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Get more information about eligibility criteria and enrolling in A pilot safety study and single arm phase II study of gemcitabine and cisplatin with atezolizumab (MPDL3280A) in patients with metastatic and muscle invasive bladder cancer respectively at NYU Langone. Learn more.

A pilot safety study and single arm phase II study of ...
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