Blood and Lymph Conditions

All Conditions

Heart and Blood Diseases

Rare Diseases

Myeloproliferative Disorders

Thrombocytosis

Thrombocythemia, Essential

Blood Platelet Disorders

Hematologic Diseases

Bone Marrow Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Fibrinolytic Agents

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Anagrelide

Anagrelide Retard prolonged-release formulation

Overencapsulated tablets or matched placebo, twice daily, 2-12 weeks titration to achieve stable platelet count, followed by 4 more weeks

Anagrelide retard

Overencapsulated capsule, twice daily, 2-12 weeks titration to achieve the stable platelet count, followed by 4 more weeks

Thromboreductin

Heinz Gisslinger, Prof., MD

The purpose of this study is determine whether Anagrelide Retard is non-inferior to anagrelide immediate release form in treatment of essential thrombocythemia.

Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterised by a sustained increase in platelet counts above the normal value (\> 450 x 109/L) and increased megakaryopoiesis in the bone marrow, without secondary causes of thrombocytosis.

Anagrelide hydrochloride selectively reduces platelet numbers by inhibiting megakaryocyte development and maturation in humans, without affecting other cell lineages.

Anagrelide Retard is a new, prolonged release (PR) tablet formulation of anagrelide developed by AOP Orphan Pharmaceuticals AG. The rationale for developing this new formulation is based on the assumption of having a better tolerability while maintaining an efficacy comparable to that of the immediate release formulation.

The effects of Anagrelide Retard and Thromboreductin® will be compared in terms of mean platelet count measured by a central laboratory/centralized method at 3 time points during the maintenance phase.

This is a randomised, multicentre, double-blind, active controlled study to compare the efficacy and safety of two different anagrelide formulations in patients with high-risk essential thrombocythemia (ET).

100 patients, either Anagrelide-treated or Anagrelide-naïve, with an indication to receive Thromboreductin® treatment, will be randomized into one of the two investigational medicinal product (IMP) groups (Anagrelide Retard or Thromboreductin®). Treatment allocation will be balanced within stratum (treated/naive) and age classes by central randomization. Naive patients will start with dose level 2 of the IMPs (i.e., 1 mg Thromboreductin® or 2 mg Anagrelide Retard). Anagrelide-treated patients will be switched to the dose level which is closest to the pre-study anagrelide dose at study start. Dose modifications in the titration phase will be done on a weekly basis (up to a maximum of 12 weeks) until "stable platelet counts" on two consecutive visits is achieved.

The periods of the study participation per patient are as follows:

* Screening (up to 7 days prior to randomization), ending with randomization/first IMP dose (Baseline Visit)
* Titration period (weekly visits for up to 12 weeks): to achieve "stable platelet counts" on two consecutive measurements (i.e. weekly visits)
* Maintenance period (weekly visits for 4 weeks): primary endpoint relevant period. The maintenance period for a patient starts at the visit with the second successive platelet count ≤400 G/L (or \<600 G/L, if the dose cannot be increased any more due to intolerance or because the maximal dose allowed has already been reached) if the second platelet value measured lies in the range within ± 30% of the value measured at the previous visit.
* End of study (EoS) safety follow-up visit (28 days after the last maintenance visit/EoT for early termination).

Anagrelide Retard in Essential Thrombocythemia

A Phase III Randomized, Multicenter, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Two Different Anagrelide Formulations in Patients With Essential Thrombocythemia (TEAM-ET 2.0)

AOP Orphan Pharmaceuticals AG

Infections

Symptoms and General Pathology

Wounds and Injuries

Communicable Diseases

Surgical Wound Infection

Surgical Wound

Wound Infection

Disease Attributes

Postoperative Complications

Anti-Infective Agents

Vancomycin

Anti-Bacterial Agents

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Cefuroxime

Cefuroxime axetil

Cephalosporins

Antibiotics, Antitubercular

Gentamicins

The standard prophylaxis consists of one to three intravenous doses of cefuroxime 1.5 g intravenously; or cefuroxim 3g if obesity \> 120 kg or a BMI \> 35 kg/m2; or vancomycin 1 g or clindamycin 600 mg in case of intolerance to cephalosporins

In patients alrady under current therapuetic antibiotic therapy, continuation of that therapuetic antibiotic regimen

Additional single-shot perioperative antibiotic prophylaxis with Broad-spectrum prophylaxis: vancomycin 1 g \& gentamicin 5 mg/kg.

One to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection

Standard antibiotic prophylaxis

Ilker Uçkay, Professor

Mazda Farshad, Professor

The perioperative antibiotic prophylaxis is evidence-based in orthopedic surgery. While its duration ranges from a single dose to three doses throughout the world, the choice of the prophylactic agents is undisputed. Worldwide, the surgeons use 1st or 2nd-generation cephalosporins (or vancomycin in some cases).

However, there are particular clinical situation with a high risk of antibiotic-resistant surgical site infections (SSI); independently of the duration of adminis-tered prophylaxis. These resistant SSI's occur in contaminated wounds, or during surgery under current therapeutic antibiotics, and base on "selection" by antibiotics used for therapy or for prophylaxis.

The perioperative antibiotic prophylaxis is evidence-based for the majority of orthopedic surgeries. While the debate of its duration and timing (single-dose versus triple-dose; before or after the intraoperative microbiological sampling) may continue, no clinicians doubt on the efficiency of the recommended prophylactic agents; that are mostly 1st or 2nd-generation cephalosporins, co-amoxiclav or other exceptional agents in cases of (pseudo)-allergy. However. and traditionally, up to the half of all detected pathogens of orthopedic SSI's are not covered by the prior prophylactic regimens: e.g. SSIs due to methicillin-resistant cocci or non-fermenting Gram-negative rods in orthopedic surgery.

Additionally, orthopedic surgeons operating selected patient populations (neoplasms, open fractures, postoperative wound dehiscence9, diabetic foot infections or already infected body sites) experience a high risk of prophylactic-resistant pathogens, or pathogens resistant to current therapeutic antibiotics regimens. At least 10% of all new intraoperative tissue samples, during iterative surgical debridement, yield (new) pathogens unknown to the clinicians.

This is due to selection by prophylactic or therapeutic antibiotics, which only kill the previously detected pathogens, but left over newly introduced contaminants, remnant parts of partially-diagnosed polymicrobial infections; ultimately leading to a new SSIs occurring during therapy for the first infection at the orthopedic site. This selection is unpredictable involving both Gram-positive skin pathogens as well as (multi) resistant Gram-negative rods.From a microbiological point of view, only a maximal Gram-negative coverage, alongside with a large Gram-negative coverage, would cover these selections.

The literature is in-existing how to prevent these selections. Most clinicians just continue with the standard prophylactic recommendation, or the current thera-peutic antibiotic regimen. Theoretically, clinicians cannot exclude that these selected patient populations eventually might profit from a broad-spectrum prophylaxis.

The BAPTIST trials only concern the perioperative antibiotic prophylaxis in selected situations of orthopedic surgery: tumor surgery, debridement for postoperative dehiscent wounds, debridement under antibiotics, open fractures, skin colonization with multidrug-resistant bacteria, plus, as a control; spine surgery in selected multimorbid patients. The investigators alternately randomize the standard prophylaxis (or by continuing the current antibiotic treatment) to the additional broad-spectrum single-shot of vancomycin 1g IV \& single-shot of gentamicin 5 mg/kg intravenously; before an eventual intraoperative sampling. End-of-Treatment (EOT) and/or Test-of-Cure (TOC) occur latest at the 6-week's surgical control visit. The rest of the hospital stay, treatment, the use of negative-pressure vacuum therapy, other interventions, local antibiotic therapies; therapies or procedure are at the discretion of the treating clinicians.

The investogators will randomize surgical interventions defined by the inclusion criteria in a prospective-alternating scheme (1:1) according to the scheduled position in the operating theatres. The anesthetists (or the nurses at the hospitalization units) the will administer the standard prophylaxis (or the therapeutic antibiotics) alone, or with the addition of the single-shot broad-spectrum prophylaxis regimen composed of vancomycin and gentamicin. In case of clinical suspicion of infection or massive contamination, the surgeons will perform at least three microbiological intraoperative tissue samples. Each surgery counts as an independent event. If a patient is debrided several times, he/she can have different prophylaxis regimens during each of the interventions. After the prophylactic regimen, the clinicians are free to continue with a targeted or empirical therapeutic antibiotic regimen. The antibiotic therapy per se is not an objective of this current trials.

The treatment period includes the following daily study visits:

* Visit 1 - Enrollment (Day 1)
* EOT (end of microbiological cultures) - Day 14 (+/- 3 days)
* TOC (clinical surgical control) - Day 42 (+/- 14 days)
* Follow-up (telephone) for implant-related surgery - 1 year (+/- 2 months)

At enrollment (Day 1), the investigator will prescribe the preoperative antibiotic prophylaxis based on instructions provided in the protocol according to the patient's randomization. Patients will be randomized in the ratio 1:1 into the investigational group (broad-spectrum prophylaxis) and the control group (usual prophylaxis). Each patient can be included several times with one episode for each surgical interven-tion in the operating theatre. The initial consent form is valid during 1 month and will be renewed in case of another inclusion following a delay of 1 month after the initial signature of the patient.

The microbiologists culturing the pathogens of eventual surgical site infections are blinded to the prior prophylaxis during the index surgery

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Sur-gery - the Prospective-randomized, Microbiologist-blinded, Stratified, Superiority Trials - BAPTIST Trials

The investigators might share anonomyzed key elements (data) upon scientific request to the corresponding person

Assessment of SSI at the clinical controls according to clinical criteria in the literature (pus, discharge, pain, inflammation, several deep tissue microbiological cultures

Assessments of antibiotic resistance of pathogens according to standard susceptibilty testing in the Microbiological Laboratory

Unplanned revision surgery in the operating theatre for any reasons

Asssesment in the medical files. Have therapeutic antibiotics been changed according to new intraoperative bacterial culture findings

If there is therapeutic antibiotc treatment necessary, the investigators assess the drugs, the adverse events and the global costs related to the antibiotc treatment. The costs are the global (overall) hospitalizations costs in Swiss Francs.

Assessment of all nosocomial and community-acquired infections ocrruging in the immediate postoperative period and relate them to prior perioperative antibiotic prophylaxis

Assessment of the impact of the priorantibiotic prophylaxis on the body colonization with multiresistant bacteria of concern for infection control

Balgrist University Hospital

Neoplasms

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Gastrointestinal Agents

TEMPO

Aluminum hydroxide, magnesium hydroxide, simethicone drug combination

Antioxidants

Protective Agents

Reminder letter for people at high risk of colorectal cancer.

Tempo Colo

France is one of the European countries where the incidence of colorectal cancer is the highest among cancers for both sexes. Fecal occult blood screening has been implemented since 2008. However, this screening excludes high risk people who have a 10 to 30 % risk of developing a CRC during their lifetime. Colonoscopy follow up of these persons is not organized, and it is up to the attending physician to recall the date of the surveillance colonoscopy. This results in a poor compliance with the recommendations by these people. A postal reminder of the surveillance colonoscopies sent by The French screening organizations to the patients should increase adherence to follow-up recommendations. The colorectal cancer screening organizations will collects from the hepatogastroenterologists (HGE) informations on colonoscopies of people more than 50 years old who live in the Rhone. These informations will allow to send a reminder 3 months before the date recommended by the HGE. Participation rate and timeliness will be assessed, as well as the severity of the lesions found. A medico-economic analysis will also be carried out.

A prospective interventional study to evaluate the impact of a reminder sent by the Adémas-69 organization to improve coloscopy surveillance and compliance with recommendations for high risk of colorectal cancer people.

Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy

Extending the Prerogatives of Colorectal Cancer Screening French Organizations to the Follow-up After Colonoscopy of Patients Aged 50 or More: Pilot Study in the Rhône Administrative Department

participation rate at future colonoscopy that is the number of patient that really have colonoscopy among the patients who receive a reminder letter The systematic registry of colonoscopies will permit to assess if a patient performs it.

We will assess the severity of the lesions found at colonoscopy performed at th right time : level of dysplasia ; size ; histologic characteristics ; numbers of adenoma.

French Health Insurance is the point of vue selected for the evaluation. It's a cost-utility analysis. A Markov model will be performed. The data will proceed from litterature and from data registration during the study. A complementary study will be performed specifically if needed.

For the Markov model the data needed : neoplasia, adenocarcinoma, advanced adenoma, reminders costs, treatments costs, examinations costs, organization costs.

National Cancer Institute, France

Association pour le Dépistage Organisé des Cancers dans le Rhône

Hemorrhage

This are patients who have current or previous history of rectal bleeding

This are General practitioner who are in public or private hospitals who treat patients with rectal bleeding

This study sought to find the health seeking behavior of patients with rectal bleeding as related to their risk to develop colorectal cancer and also assess the general practitioner's perceived barriers to colonoscopy for patients with bleeding per rectum.

Patients who had rectal bleeding are invited to electronic media and print media will be invited for free medical consultation. Consented patients will complete a purposely design questionnaire for the study to assess the knowledge, attitude and practice of patient with rectal bleeding as regard the possibility of occurrence of colorectal cancer.

General practitioners in three cities will be contacted to assess their screening strategy for patients with rectal bleeding

Barriers to Care in Patients With Rectal Bleeding in Nigeria

Health-seeking Behavior and Barriers to Care in Patients With Rectal Bleeding in Nigeria

To investigates patients' knowledge of the causes of rectal bleeding and their attitudes towards seeking expert opinion for possible diagnostic testing for colorectal cancer (CRC)

To seeks to examine the GPs' perceived barriers to colonoscopy for patients with bleeding per rectum

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anagrelide Retard in Essential Thrombocythemia	NCT02076815	Essential Throm...	Anagrelide reta... Thromboreductin	18 Years -	AOP Orphan Pharmaceuticals AG
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	NCT05502380	Surgical Site I... Microbial Colon... Antibiotic Resi...	Standard antibi...	18 Years -	Balgrist University Hospital
Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy	NCT03383367	Colorectal Canc...	Tempo Colo	50 Years -	Association pour le Dépistage Organisé des Cancers dans le Rhône
Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy	NCT03383367	Colorectal Canc...	Tempo Colo	50 Years -	Association pour le Dépistage Organisé des Cancers dans le Rhône
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	NCT05502380	Surgical Site I... Microbial Colon... Antibiotic Resi...	Standard antibi...	18 Years -	Balgrist University Hospital
Barriers to Care in Patients With Rectal Bleeding in Nigeria	NCT02855385	Colorectal Canc...		18 Years -	Obafemi Awolowo University Teaching Hospital
Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy	NCT03383367	Colorectal Canc...	Tempo Colo	50 Years -	Association pour le Dépistage Organisé des Cancers dans le Rhône

Spots Global Cancer Trial Database for high risk patients