*  Robert Walter Makuch, PhD | Yale School of Public Health
Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics ... Design and sample size considerations for Phase IV studies is another active research area, in which a new class of hybrid ... Selection of the treatment effect for sample size determination in a superiority clinical trial using a hybrid classical and ... Specialized Terms: Clinical studies; Methodology. Extensive Research Description. *Genetic and Brain Image Analysis of ...
  https://medicine.yale.edu/ysph/people/robert_makuch-2.profile
*  Faculty
Infant, Premature; Public Health; Smoking Cessation; Clinical Trials, Phase IV as Topic; Biostatistics ... Clinical Professor of Epidemiology. Dr. Robert Hecht is the President of Pharos Global Health Advisors. He has more than 30 ... Grau is a clinical psychologist with training in health psychology and expertise in identifying the cognitive and emotional ... Assistant Clinical Professor of Public Health. Dr. Unni Karunakara was International President of Médecins Sans Frontières / ...
  http://publichealth.yale.edu/global/people/list.aspx
*  A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome - Full Text View - ClinicalTrials.gov
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm ... MedlinePlus related topics: HIV/AIDS Drug Information available for: Atazanavir Atazanavir sulfate ... A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome. The safety and scientific validity of this study is ... A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial ...
  https://clinicaltrials.gov/show/NCT00312754?order=298
*  A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis - Full...
A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis. The ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... An Open Label, Non-comparative, Multicentre, Phase IV Study to Evaluate the Safety, Tolerability and Efficacy of Tinefcon in ... of the world's population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from ...
  https://clinicaltrials.gov/show/NCT01373567
*  Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation - Full...
Interventional (Clinical Trial) Estimated Enrollment :. 25 participants. Allocation:. Randomized. Intervention Model:. ... Genetics Home Reference related topics: Combined pituitary hormone deficiency MedlinePlus related topics: Body Weight ... Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation. The ... Study design: Placebo controlled trial in patients with central hypothyroidism following a double blind cross-over design. ...
  https://clinicaltrials.gov/ct2/show/NCT00360074?cond=%22Hypothyroidism%22&rank=14
*  PubMed, HSRProj, and ClinicalTrials.gov Search Strategies for Informing Comparative Effectiveness Research
OR clinical trial, phase iv [pt] OR clinicaltrials.gov [si] OR isrctn [si] OR randomized controlled trials as topic [mh]) OR ( ... The ClinicalTrials.gov search strategy includes Phase III or Phase IV clinical trials or observational studies with an active ... pragmatic trial[tw] OR pragmatic trials[tw] OR practical clinical trial[tw] OR. pragmatic clinical trial [pt] OR "comparative ... randomized controlled trial [pt] OR clinical trial, phase iii [pt] ...
  https://www.nlm.nih.gov/nichsr/cer/CER_search_strategies.html
*  diphtheria-tetanus-acellular pertussis-hepatitis b-inactivated: Topics by WorldWideScience.org
... vaccine were enrolled in a phase IV clinical trial; 646 10-year-olds and 645 11-year-olds completed the study, which involved a ... To date, there have been only three published HIV-1 vaccine trials in infants.We conducted a randomized phase I clinical trial ... A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian ... Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting ...
  https://worldwidescience.org/topicpages/d/diphtheria-tetanus-acellular+pertussis-hepatitis+b-inactivated.html
*  Drug Developement Process Course Announcement
... the four phases of clinical trials and clinical data management; and the regulatory review and approval process, including ... Topics include the functions and role of pharmacology, drug metabolism, pharmacokinetics, toxicology, CMC/pharmaceutical ...
  http://www.bio.net/bionet/mm/bionews/1997-September/004123.html
*  How to do Research on Therapeutic Interventions: Protocol Preparation | University of Oxford
The design and implementation of clinical trials (Phase I to Phase IV) ... Interventions course will provide students with the opportunity to learn more about and discuss the following topics:. ... clinical trial governance issues and how to address them. *Understanding and dealing with key stakeholders in clinical trial ... Understanding and addressing ethical issues in clinical trials - an introduction to Research Ethics ...
  http://www.ox.ac.uk/node/45897
*  Search of: Recruiting, Not yet recruiting, Available Studies | 'Pain Management' - List Results - ClinicalTrials.gov
Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open Liver Surgery. * ... Drug: Topic Morphine. *Drug: Placebo. Interventional. Phase 4. *Hospital General de Niños Pedro de Elizalde ... Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA. *Pectus Excavatum ... and 4 more...). 76. All. 65 Years to 90 Years (Adult, Senior). NCT03117790. DEXsleep. April 20, 2017. March 2020. March 2020. ...
  https://clinicaltrials.gov/ct2/results?recr=Open&intr=%22Pain+Management%22&show_rss=Y&sel_rss=new14
*  Improving Medication Adherence in Pediatric Inflammatory Bowel Disease - Full Text View - ClinicalTrials.gov
Inclusion for Randomization: ,90% adherence to immunomodulator and/or 5-ASA during four week run-in phase ... This randomized controlled clinical trial for nonadherence to medication randomizes participants to either the TBT or EO ... Intervention topics will differ for each condition; however, the frequency of contact is equivalent across conditions. ... protocol to improve medication adherence in children and adolescents with IBD via a randomized controlled clinical trial. ...
  https://clinicaltrials.gov/ct2/show/NCT01536509
*  About the Journal : International Clinical Psychopharmacology
... as well as those of controlled clinical trials of psychotropic drugs in Phase II and IV. Other topics covered include the ... International Clinical Psychopharmacology provides an essential link between research and clinical practice throughout ... International Clinical Psychopharmacology P.O. Box 8751 London W13 8WH UK ICP@samontgomery.co.uk ... To this end the journal publishes results of early Phase I and II studies, ...
  https://journals.lww.com/intclinpsychopharm/Pages/aboutthejournal.aspx
*  PA-10-045: Clinical Trial Planning Grants for Critical Illness and Injury in Aging (R34)
Clinical Trial Planning Grants for Critical Illness and Injury in Aging (R34) PA-10-045. NIA ... or IV clinical trial.. Topic areas for proposed clinical trials may fall under one of the categories below. Applications may ... Phase III and IV clinical trials related to critical illness and injury in aging. The planning grant mechanism is intended to ... Future Clinical Trial. *Rationale/Significance - Provide the rationale for the future clinical trial, documenting the ...
  https://grants.nih.gov/grants/guide/pa-files/PA-10-045.html
*  A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting - Full Text...
ClinicalTrials.gov Identifier: NCT00418678. Recruitment Status : Terminated (Enrollment was too slow) First Posted : January 5 ... MedlinePlus related topics: Nausea and Vomiting Drug Information available for: Nabilone U.S. FDA Resources ... A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting. The safety ... A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting. ...
  https://clinicaltrials.gov/show/NCT00418678
*  Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients - Full...
Interventional (Clinical Trial) Estimated Enrollment :. 384 participants. Allocation:. Randomized. Intervention Model:. ... MedlinePlus related topics: Hepatitis C Drug Information available for: Ribavirin Peginterferon Alfa-2a ... Open, Multicentre,Randomized Phase IV Trial to Evaluate Efficacy/Safety to Extend Treatment Duration With Peginterferon Alfa-2a ... Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients (PERICO) ...
  https://clinicaltrials.gov/ct2/show/study/NCT00526448?view=record
*  Phase 4 Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis - Full Text View -...
Interventional (Clinical Trial) Estimated Enrollment :. 110 participants. Allocation:. Randomized. Intervention Model:. ... MedlinePlus related topics: Ulcerative Colitis Drug Information available for: Ciprofloxacin Vedolizumab U.S. FDA Resources ... Phase 4 Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis (EARNEST). The safety ... ClinicalTrials.gov Identifier:. NCT02790138 History of Changes Other Study ID Numbers:. Vedolizumab-4004 U1111-1171-0918 ( ...
  https://clinicaltrials.gov/ct2/show/NCT02790138?cond=Pouchitis&cntry1=EU%3ADE&rank=1
*  DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated...
Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the ... MedlinePlus related topics: HIV/AIDS Drug Information available for: Stavudine Lamivudine Efavirenz ... DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated ... pilot trial (KalMo study). HIV Clin Trials. 2009 Nov-Dec;10(6):368-74. doi: 10.1310/hct1006-368. ...
  https://clinicaltrials.gov/show/NCT00116116?order=77
*  Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic...
Interventional (Clinical Trial) Actual Enrollment :. 60 participants. Allocation:. Randomized. Intervention Model:. Parallel ... See Studies by Topic. *See Studies on Map. *How to Search. *How to Use Search Results ... Phase Benign Prostatic Hyperplasia (BPH) Device: Greenlight XPS Laser Device: BiVAP Saline Vaporization of the prostate Phase 4 ... This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the ...
  https://clinicaltrials.gov/ct2/show/NCT01500057?recr=Open&cond=%22Prostatic+Hyperplasia%22&rank=14
*  Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients - Full Text View - ClinicalTrials.gov
Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients. ... BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm ... MedlinePlus related topics: HIV/AIDS Drug Information available for: Lamivudine Atazanavir Atazanavir sulfate ... Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084253 ...
  https://clinicaltrials.gov/show/NCT00084253
*  The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and...
Phase IV Study of General Clinical Research Center Of the Jinan Mental Hospital(TAIWAN). ... 1). Baseline Phase: Subjects diagnosed as Alzheimer's Disease and BPSD will be evaluated for entry to the trial. Subjects must ... MedlinePlus related topics: Alzheimer's Disease Dementia Drug Information available for: Galantamine Galantamine ... Participation in a clinical trial of any investigational drug within 1 month (30 days) prior to study entry. ...
  https://clinicaltrials.gov/ct2/show/NCT00626613
*  The Safety and Effectiveness of Megace in HIV-Infected Women - Full Text View - ClinicalTrials.gov
Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females. ... BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm ... MedlinePlus related topics: HIV/AIDS Drug Information available for: Megestrol acetate U.S. FDA Resources ... Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002345 ...
  https://www.clinicaltrials.gov/ct2/show/NCT00002345
*  Stereotactic Body Radiotherapy for Prostate Cancer - Full Text View - ClinicalTrials.gov
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer. ... Genetics Home Reference related topics: prostate cancer MedlinePlus related topics: Prostate Cancer ... This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data ... Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our ...
  https://clinicaltrials.gov/ct2/show/NCT01352598
*  A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects - Full Text View - ClinicalTrials.gov
This is a Phase IV, 48-week, open-label, pilot study in 30 ARV-naïve patients examining the safety, viral response, and ... Undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial ... MedlinePlus related topics: HIV/AIDS Drug Information available for: Lopinavir Etravirine U.S. FDA Resources ... A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects. ...
  https://clinicaltrials.gov/show/NCT01045369?order=173
*  A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral...
Interventional (Clinical Trial) Actual Enrollment :. 36 participants. Intervention Model:. Single Group Assignment. ... MedlinePlus related topics: HIV/AIDS Drug Information available for: Ritonavir Darunavir Rilpivirine Darunavir ethanolate ... A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral ... A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral ...
  https://clinicaltrials.gov/show/NCT01736761?order=416
*  List of vaccine topics - Wikipedia
... placebo-controlled phase 2 clinical trial". The Lancet. 381 (9871): 1037-45. doi:10.1016/S0140-6736(12)61764-4. PMID 23352749. ... Pullen, L.C. (November 7, 2011). "Epstein-Barr Virus Vaccine May Soon Enter Phase 3 Trial". Medscape Today. Retrieved April 24 ... Schleiss, M. R. (2008). "Cytomegalovirus vaccine development". Current Topics in Microbiology and Immunology. Current Topics in ... Adenovirus Vaccine Efficacy Trial Consortium (2013). "A phase 3, randomized, double-blind, placebo-controlled study of the ...
  https://en.wikipedia.org/wiki/List_of_vaccine_topics