Good clinical practice (GCP)
The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids
... We will collect data on related Adverse Events (AEs) on the Case Report Forms (CRFs). Where these events be- come Serious Adverse Events (SAEs) they will be reported in accordance with the CTRU’s and the spon- sor’s ...
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Positive end expiratory pressure (PEEP) level to prevent expiratory flow limitation during cardiac surgery: study protocol for a randomized clinical trial (EFLcore study)
... Perioperative Clinical Outcome; FRC: Functional residual capacity; GCP: Good Clinical Practice; IBW: Ideal body weight; ICU: Intensive care unit; PAC: Pulmonary artery catheter; PEEP: ...
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A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial
... Haemorrhoidopexy; GCP: good clinical practice; GP: general practitioner; HALO: haemorrhoidal artery ligation operation; HES: hospital episode statistics; HTA: Health Technology Assessment; ...
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A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial
... Haemorrhoidopexy; GCP: good clinical practice; GP: general practitioner; HALO: haemorrhoidal artery ligation operation; HES: hospital episode statistics; HTA: Health Technology Assessment; ...
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Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial
... controlled clinical trial aims to recruit patients who have undergone abdominal surgery and experienced postoperative dysmotility to evaluate the efficacy and safety of XBP for preventing POI and accelerating ...
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Therapy of nodal Follicular Lymphoma (WHO grade 1/2) in clinical stage I/II using response adapted Involved Site Radiotherapy in combination with Obinutuzumab (Gazyvaro) GAZAI Trial (GAZyvaro and response adapted Involved site Radiotherapy): a study protocol for a single arm, non randomized, open, national, multi center phase II trial
... on Good Clinical Practice (ICH-GCP) and the ethical principles described in the ap- plicable version of the Declaration of ...and GCP regulations and the Bundesdatenschutzgesetz (BDSG) ...
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A randomised controlled trial: can acupuncture reduce drug requirement during analgosedation with propofol and alfentanil for colonoscopy? A study protocol
... governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice ...in Clinical Trials Acupuncture (STRICTA) ...
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Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial
... with Good Clinical Practice (GCP) guidelines [116], the informed consent form (ICF) will also be revised when new information becomes available that may be relevant to the participant’s con- ...
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<p>Comparative Pharmacokinetics, Bioequivalence and Safety Study of Two Recombinant Human Chorionic Gonadotropin Injections in Healthy Chinese Subjects</p>
... hormone; GCP, good clinical practice; GMR, geometric mean ratio; GMR, geo- metric mean ratio; hCG, human chorionic gonadotropin; hMG, human menopausal gonadotropin; HQC, high quality control; ...
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What Is The Economic Feasibility Of Implementing Grey Water Infrastructure At The Citywide Level?
... all clinical research trials in the Hanover medical ...all clinical trials are being done properly and within the standard operating ...all clinical trials are done within the scope of good ...
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Effectiveness of the spot on combination of moxidectin and imidacloprid (Advocate®) in the treatment of ocular thelaziosis by Thelazia callipaeda in naturally infected cats
... a Good Clinical Practice (GCP), negative controlled, blinded and randomized field study in privately owned cats living in a ...in good health conditions and with at least one live adult ...
5
Electroacupuncture for pressure ulcer: a study protocol for a randomized controlled pilot trial
... panel; GCP: Good clinical practice; ITT: Intention-to-treat; NPUAP: National pressure ulcer advisory panel; PUHTP: Proportion of ulcers healed within trial period; RCT: Randomized controlled ...
5
An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study
... Harmonisation Good Clinical Practice guidelines (ICH) (CPMP/ICH/135/95) and the regulatory requirements for participating institutions by the Spanish Clinical Research Network ...the ...
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Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols
... during clinical trials involves the detection, reporting to the appropriate body (Sponsor or regulatory authorities) within acceptable time limits depending on the seriousness of the event and the investi- gation ...
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Tranexamic acid for the prevention of postpartum bleeding in women with anaemia: study protocol for an international, randomised, double blind, placebo controlled trial
... CTU: Clinical Trials Unit; DAL: Drug Accountability Log; DMC: Data Monitoring Committee; DVT: Deep vein thrombosis; GCP: Good Clinical Practice; GMP: Good Manufacturing ...
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The Informed-Consent Policy of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Knowledge is the Best Medicine
... "Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the [r] ...
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Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial
... with good clinical practice standards will be used for data collec- tion and managed by the study coordinators and/or re- search ...sources. Clinical data will be stored in an anonymized ...
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The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial
... In the field of behaviour change, researchers are increas- ingly encouraged to report the evaluation of behaviour change interventions using established taxonomies and ontologies [33]. The outcomes included in this trial ...
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POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth
... a Clinical Trial of an Investigational Medicinal Product, no formal data monitoring committee or interim analysis are required to oversee the safety of subjects in the ...
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The FIB PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial
... different clinical contexts of bleeding as- sociate a low level of fibrinogen with increased transfusion of blood products and amount of blood loss during operation ...
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