Inclusion and exclusion criteria

Protagonist Announces Plans to Initiate a Global Phase 3 Study for Rusfertide in Polycythemia Vera Following Interactions with the U.S. Food & Drug Administration and the European Medicines Agency

Retrieved on: 
Monday, March 22, 2021
Clinical research, Health sciences, Medical research, Health, Pharmaceutical industry, Medical statistics, Clinical trials, Food and Drug Administration, Inclusion and exclusion criteria, Clinical endpoint

Protagonist has also received written comments from the European Medicines Agency ("EMA") supportive of the Company's pivotal clinical development plan in PV.

Key Points: 
  • Protagonist has also received written comments from the European Medicines Agency ("EMA") supportive of the Company's pivotal clinical development plan in PV.
  • Based on the feedback from the FDA and EMA, Protagonist intends to initiate a global Phase 3 clinical trial of rusfertide in PV.
  • Frequency of phlebotomies, as well as symptom improvement as measured by MPN-TSS criteria, will be among the important secondary endpoints in the study.
  • Importantly, the Phase 3 study will have endpoints and inclusion/exclusion criteria similar to those in the ongoing Phase 2 study.

Update On IGC’s Phase 1 Clinical Trial on Alzheimer’s Patients

Retrieved on: 
Monday, February 22, 2021
Alternative medicine, FDA, Health, Clinical trials, General Health, Pharmaceutical, Health sciences, Clinical research, Medical research, Articles, Clinical trials, Inclusion and exclusion criteria, Human subject research, Informed consent, Pharmaceutical industry

Enrolling patients and commencing the trial involves obtaining Informed Consent, conducting neurological exams, and conducting initial blood tests, among others, to identify inclusion and exclusion criteria to ensure that patients meet the enrollment requirements.

Key Points: 
  • Enrolling patients and commencing the trial involves obtaining Informed Consent, conducting neurological exams, and conducting initial blood tests, among others, to identify inclusion and exclusion criteria to ensure that patients meet the enrollment requirements.
  • A Phase 1 trial is the first human trial in a multi-step process designed to obtain regulatory approval for the marketing of a new pharmaceutical drug.
  • The Phase 1 trial is conducted and managed by IGCs subsidiary, IGC Pharma LLC.
  • These forward-looking statements are based largely on IGCs expectations and are subject to several risks and uncertainties, certain of which are beyond IGCs control.

Sequana Medical Announces Positive Interim Data From North American Pivotal alfapump® Study (POSEIDON)

Retrieved on: 
Thursday, November 19, 2020
Clinical research, Pharmaceutical industry, Inclusion and exclusion criteria

Patients from the Roll-In cohort will upon implementation of the inclusion/exclusion criteria, immediately be implanted with the alfapump.

Key Points: 
  • Patients from the Roll-In cohort will upon implementation of the inclusion/exclusion criteria, immediately be implanted with the alfapump.
  • The primary safety endpoint is the rate of alfapump related re-interventions adjudicated by the Clinical Events Committee.
  • Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Sequana Medical announces positive interim data from North American pivotal alfapump® study (POSEIDON)

Retrieved on: 
Thursday, November 19, 2020
Clinical research, Pharmaceutical industry, Inclusion and exclusion criteria

Patients from the Roll-In cohort will upon implementation of the inclusion/exclusion criteria, immediately be implanted with the alfapump.

Key Points: 
  • Patients from the Roll-In cohort will upon implementation of the inclusion/exclusion criteria, immediately be implanted with the alfapump.
  • The primary safety endpoint is the rate of alfapump related re-interventions adjudicated by the Clinical Events Committee.
  • Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Onconova Therapeutics Announces that the Required Number of Survival Events Has Been Reached for the Pivotal Phase 3 INSPIRE Trial Data Analysis

Retrieved on: 
Wednesday, July 29, 2020
Health, Clinical research, Pharmaceutical industry, Medical research, RTT, Clinical trials, ClinicalTrials.gov, Myelodysplastic syndrome, Inclusion and exclusion criteria

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency.

Key Points: 
  • The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency.
  • Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).
  • Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel drugs to treat cancer, with an initial focus on myelodysplastic syndromes (MDS).
  • These statements relate to Onconova expectations regarding the INSPIRE Trial, the timing for data read outs and Onconovas other development plans.

Wider Range of Prospective Patients in the UK, Canada and the US for Continued Clinical Study

Retrieved on: 
Thursday, June 18, 2020
Health, Clinical research, Pharmaceutical industry, Medical research, Food and Drug Administration, Clinical trial, Design of experiments, Prostate cancer, Inclusion and exclusion criteria

STOCKHOLM, June 18, 2020 /PRNewswire/ -- As previously disclosed, the US authority FDA has approved SpectraCure's new and revised study protocol for the clinical study on patients with recurrent prostate cancer.

Key Points: 
  • STOCKHOLM, June 18, 2020 /PRNewswire/ -- As previously disclosed, the US authority FDA has approved SpectraCure's new and revised study protocol for the clinical study on patients with recurrent prostate cancer.
  • The new protocol expands the inclusion criteria for Gleason score, which allows a wider range of candidates to participate in the upcoming phase III study.
  • - I am very pleased that the UK and Canadian authorities have approved our new extended study protocol.
  • SpectraCure's cooperating hospitals in the US, UK and Canada are beginning to return to normal operation after the corona crisis, and there is now a relatively large number of prospective patients available for recruitment to the continued clinical study.

Wider Range of Prospective Patients in the UK, Canada and the US for Continued Clinical Study

Retrieved on: 
Thursday, June 18, 2020
Health, Clinical research, Pharmaceutical industry, Medical research, RTT, Clinical trial, Design of experiments, Inclusion and exclusion criteria, Prostate cancer

STOCKHOLM, June 18, 2020 /PRNewswire/ -- As previously disclosed, the US authority FDA has approved SpectraCure's new and revised study protocol for the clinical study on patients with recurrent prostate cancer.

Key Points: 
  • STOCKHOLM, June 18, 2020 /PRNewswire/ -- As previously disclosed, the US authority FDA has approved SpectraCure's new and revised study protocol for the clinical study on patients with recurrent prostate cancer.
  • The new protocol expands the inclusion criteria for Gleason score, which allows a wider range of candidates to participate in the upcoming phase III study.
  • SpectraCure's cooperating hospitals in the US, UK and Canada are beginning to return to normal operation after the corona crisis, and there is now a relatively large number of prospective patients available for recruitment to the continued clinical study.
  • The following files are available for download:
    Wider range of prospective patients in the UK, Canada and the US for continued clinical study

Soliton Reports Positive Pivotal Cellulite Clinical Trial Results

Retrieved on: 
Monday, June 15, 2020
Health, Clinical research, Pharmaceutical industry, Medical research, Cosmetic surgery, Cellulite, Women's health, Clinical trial, Inclusion and exclusion criteria

"We are pleased that our pivotal cellulite study demonstrated positive results and appreciate the opportunity to have our findings presented through this prestigious dermatology organization," stated Christopher Capelli, MD, founder, President and CEO of Soliton.

Key Points: 
  • "We are pleased that our pivotal cellulite study demonstrated positive results and appreciate the opportunity to have our findings presented through this prestigious dermatology organization," stated Christopher Capelli, MD, founder, President and CEO of Soliton.
  • For a more detailed overview of the results of this pivotal study, please view the brief presentation on the following website: https://secure.soliton.com/cellulite
    The pivotal cellulite clinical trial enrolled and treated 67 subjects at four clinical sites, of which 62 subjects were evaluated in the results analysis due to the exclusion of five patients for failing to meet inclusion criteria or incomplete follow-ups.
  • Eighty-five percent (85%) of subjects responded to treatment with their improvement in the Cellulite Severity Scores ranging from 6.7% to 85.7%.
  • The Soliton clinical trial protocol provided for a single 20 to 30-minute, non-invasive treatment in which the Rapid Acoustic Pulse (RAP) device was applied to the surface of the subjects' skin.

Tempus’ TIME Trial™ Program Reaches Critical Scale and Operational Milestones

Retrieved on: 
Friday, May 29, 2020
Clinical research, Health, Pharmaceutical industry, Medical research, Clinical pharmacology, Clinical trial, Design of experiments, Inclusion and exclusion criteria

Through the TIME Trial Program, Tempus is bringing the very best clinical trials to communities across the country, giving thousands of patients access to novel therapeutics.

Key Points: 
  • Through the TIME Trial Program, Tempus is bringing the very best clinical trials to communities across the country, giving thousands of patients access to novel therapeutics.
  • "We ultimately met our target goal of activating this trial in just two weeks, and hope to do the same for future patients."
  • Every week, Tempus screens thousands of new patients against the criteria of the ultra-rare trials in the TIME Trial Network.
  • Tempus screens patients from sites in the TIME Trial Network against applicable inclusion/exclusion criteria utilizing genomic sequencing data, matched with the patients clinical data.

Certified Nutraceuticals, Inc is proud to partner with Princeton Consumer Research for a Randomized, Single-Blinded, Placebo-Controlled Study

Retrieved on: 
Tuesday, May 26, 2020
Articles, Education, Health, Psychiatric diagnosis, RTT, Ageing, Clinical research, Pharmaceutical industry, Inclusion and exclusion criteria, Inclusion, Life extension, Dementia

Observations: Subjects will attend the test center at baseline (Day 1) to complete the informed consent form (ICF) and inclusion/exclusion criteria.

Key Points: 
  • Observations: Subjects will attend the test center at baseline (Day 1) to complete the informed consent form (ICF) and inclusion/exclusion criteria.
  • Subjects will complete the AD8 screening tool to identify subjects facing normal cognitive decline due to aging (Score of 0-2 inclusive).
  • KollaJell purification and extraction is Patented technology and uniquely supplies special nutrients of collagen and minerals founded only in jellyfish.
  • Mr. Alkayali was the first to introduce anti-aging supplements to the market more than a quarter of a century ago.