louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00092612: Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Coronary Disease
Keywords: Elevated Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Detailed description: The duration of treatment is 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients who have cholesterol levels within normal ranges as identified by the study

Primary outcomes:
measure: Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment
Secondary outcomes:
measure: Safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Farnier M, Volpe M, Massaad R, Davies MJ, Allen C. Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease. Int J Cardiol. 2005 Jul 10;102(2):327-32. doi: 10.1016/j.ijcard.2005.01.022.
Clinical trial NCT02838212: Adverse Drug Reactions With Fatal Outcome
Official title: Adverse Drug Reactions With Fatal Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reaction
Keywords: adverse drug reaction
hospital mortality
incidence
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 1135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All inpatients dead in the Germans Trias i Pujol University Hospital during the year 2015.

Patients with a death diagnosis in a predefined list of medical conditions, potentially caused by drugs, were the selected cases for further review.

Brief summary: The purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015

Detailed description: The investigators aimed to determine the incidence of drug-related mortality of admitted patients in a university hospital during the year 2015

Eligibility criteria: Inclusion Criteria:

* inpatients deaths and drug-related deaths.

Exclusion Criteria:

* death patients in the emergency room, patients with a death diagnosis not available, and dead patients due to other causes non-drug related.

Primary outcomes:
measure: Incidence of drug-related deaths of all hospital admissions
timeFrame: during the year 2015
Secondary outcomes:
measure: Number of drug-related deaths with the suspected drug started the previous week
timeFrame: during the year 2015
measure: Number of drug-related deaths with drug interactions between suspected drugs
timeFrame: during the year 2015
measure: Number of preventable drug-related deaths assessed by Schumock criteria
timeFrame: during the year 2015
measure: Number of drug-related deaths with polypharmacy
timeFrame: during the year 2015
measure: Number of drug-related deaths with autopsy
timeFrame: during the year 2015
measure: Number of drug-related deaths in which the suspected drug had a contributive role
timeFrame: during the year 2015
measure: Number of drug-related deaths with "certain" or "probable" categories assessed by World Health Organization (WHO) criteria and Naranjo algorithm
timeFrame: during the year 2015
measure: Number of drug-related deaths presented during hospitalization
timeFrame: during the year 2015
measure: Risk factors of drug-related deaths
timeFrame: during the year 2015
measure: Incidence of drug-related deaths of all inpatients deaths
timeFrame: during the year 2015.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Clinical Pharmacology. Hospital Universitari Germans Trias i Pujol. Badalona, Barcelona, Spain
name: Eva Montané, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00318812: Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
Official title: Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anemia
Renal Failure
Keywords: Randomized controlled trial (RCT)
Prospective Studies
ferric oxide, saccharated
Peptides
Heme
Iron
Erythropoietin,
Recombinant
Ferritin
Transferrin
Treatment Outcome
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.

Detailed description: Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects.

Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

Eligibility criteria: Inclusion Criteria:

* eGFR \&lt; 30 mL/min
* Hb 90-110 g/L
* Age \&gt; 18
* Not on renal replacement therapy
* Transferrin saturation \&lt; 20% OR Ferritin \&lt;100 mcg/L
* B12 \& folate within reference range

Exclusion Criteria:

1. Iron overload (Tsat \> 50% or ferritin \> 800 μg/L);
2. malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;
3. parenteral iron therapy, blood transfusion within the last 3 months;
4. pregnancy;
5. contraindication to any study medication and;
6. inability or refusal to give consent.

Primary outcomes:
measure: Hemoglobin Concentration at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Ferritin
timeFrame: 6 months
measure: Transferrin Saturation
timeFrame: 6 Months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Deborah Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagaraju SP, Cohn A, Akbari A, Davis JL, Zimmerman DL. Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial. BMC Nephrol. 2013 Mar 20;14:64. doi: 10.1186/1471-2369-14-64.
Clinical trial NCT01453712: Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -
Official title: Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
coronary CT angiography
radiation dose
iterative image reconstruction
detection
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.

Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.


Eligibility criteria: Inclusion Criteria:

1. patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
2. signed informed consent
3. stable sinus rhythm
4. age \> 18 years

Exclusion Criteria:

1. known allergy to contrast agents.
2. patients with known coronary artery disease
3. pregnancy
4. no stable sinus rhythm
5. coronary ct examinations not focussing on coronary arteries

Primary outcomes:
measure: Image quality
timeFrame: 1 month
Secondary outcomes:
measure: Quantitative image quality parameters
timeFrame: 1 month
measure: Prevalence of non-diagnostic examinations
timeFrame: 1 month
measure: Prevalence of coronary artery plaques
timeFrame: 1 month
measure: Prevalence of follow-up examinations
timeFrame: 1 month
measure: Radiation dose
timeFrame: 1 month
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Deutsches Herzzentrum Muenchen
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Joerg Hausleiter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deseive S, Chen MY, Korosoglou G, Leipsic J, Martuscelli E, Carrascosa P, Mirsadraee S, White C, Hadamitzky M, Martinoff S, Menges AL, Bischoff B, Massberg S, Hausleiter J. Prospective Randomized Trial on Radiation Dose Estimates of CT Angiography Applying Iterative Image Reconstruction: The PROTECTION V Study. JACC Cardiovasc Imaging. 2015 Aug;8(8):888-96. doi: 10.1016/j.jcmg.2015.02.024. Epub 2015 Jul 15.
Clinical trial NCT03494712: Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers
Official title: Safety, Tolerability and Pharmacokinetics of S 95010 After Single Escalating Intravenous Doses in Young Healthy Male Subjects. A Randomised, Doubleblind, Placebo-controlled, Monocentre, First-In-Human Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Keywords: healthy volunteer
antimiR
single ascending dose
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2018-04-11
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess, the safety and tolerability of single ascending doses of S 95010 and to assess the pharmacokinetics (PK) of S 95010.


Eligibility criteria: Inclusion Criteria:

* Young healthy male subjects aged between 18 and 45 years (both inclusive)

Exclusion Criteria:

* Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations
* Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator
* History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT \> ULN at selection
* History of renal dysfunction or GFR \< 75mL/min/1.73 m2 (MDRD equation) at selection

Primary outcomes:
measure: Safety assessed by incidence of Adverse Events
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
measure: The PK (pharmacokinetic) profile of S 95010 plasma concentration : Area under the plasma concentration-time curve (AUC)
timeFrame: During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)
measure: The PK profile of S 95010 plasma concentration : Plasma half-life
timeFrame: During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)
measure: The PK profile of S 95010 plasma concentration : Maximum plasma concentration (Cmax)
timeFrame: During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Clinical Pharmacology Unit - Stuivenberg Hospital
Study officials:
References:
Clinical trial NCT00784212: Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy
Official title: A Multicenter, Single-blind, Within-subject, Placebo-controlled Proof of Concept Study to Assess the Effect of Single Oral Doses of BGG492 on the Photoparoxysmal EEG Response in Patients With Photosensitive Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Photosensitive Epilepsy
Keywords: Photosensitive Epilepsy, photic stimulation, electroencephalogram
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout.


Eligibility criteria: Inclusion Criteria:

* diagnosis of photosensitive epilepsy

Exclusion Criteria:

- inconsistent photoparoxysmal response when stimulated by photic stimulation

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.
timeFrame: Days 1, 2 and 3
Secondary outcomes:
measure: Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy
timeFrame: From Day 1 until Day 33 after treatment start.
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Novartis Investigator Site
city: Kehl-Kork
country: Germany
facility: Novartis Investigator Site
city: Kiel
country: Germany
facility: Novartis Investigator Site
city: Radeberg
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasteleijn-Nolst Trenite D, Brandt C, Mayer T, Rosenow F, Schmidt B, Steinhoff BJ, Gardin A, Imbert G, Johns D, Sagkriotis A, Kucher K. Dose-dependent suppression of human photoparoxysmal response with the competitive AMPA/kainate receptor antagonist BGG492: Clear PK/PD relationship. Epilepsia. 2015 Jun;56(6):924-32. doi: 10.1111/epi.13008. Epub 2015 May 11.
Clinical trial NCT01998412: Iluvien Registry Safety Study
Official title: An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2013-11-28
Enrollment: 559
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies that were selected to be treated with an intravitreal implant of ILUVIEN.

Brief summary: The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.


Eligibility criteria: Inclusion Criteria:

* Any patient treated with Iluvien under this protocol will be included in the study.

Exclusion Criteria:

* Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.

Retrospective Enrollment Criteria

Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:

1. The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.
2. The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.
3. The eligible patient must be enrolled at least one year prior to the planned end of the study.

Primary outcomes:
measure: Number of participants with adverse events.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
Study officials:
References:
citation: Chakravarthy U, Taylor SR, Koch FHJ, Castro de Sousa JP, Bailey C; ILUVIEN Registry Safety Study (IRISS) Investigators Group. Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries. Br J Ophthalmol. 2019 Aug;103(8):1072-1077. doi: 10.1136/bjophthalmol-2018-312284. Epub 2018 Sep 21.
Clinical trial NCT06519812: Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi
Official title: Efficacy and Safety of Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi, A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Calculi
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety

Detailed description: This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.

Eligibility criteria: Inclusion Criteria:

* Patients are more than 18 and less than 65 years old.
* Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).

Exclusion Criteria:

* Patients with renal insufficiency (serum creatinine \> 1.6 mg/dl)
* patients with active urinary tract infection.
* Patients with congenital renal anomalies.
* Morbid obesity (BMI \> 35 kg/m2).
* Pregnancy.
* Bleeding Coagulopathy.
* Skeletal deformity

Primary outcomes:
measure: stone-free rate
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Safety of the procedure
timeFrame: intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al-Azhar University Hospital (New Damietta)
Study officials:
affiliation: assistant lecturer of urology , Al-Azhar University (Damietta)
name: Maher Abdelrehem Mohamed, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01413412: Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia
Official title: Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Postoperative Pain
Keywords: Ventral Hernia
Postoperative Pain
Ventral Hernia Pain Questionnaire
Postoperative Abdominal wall and muscle function
Biodex
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.

Detailed description: Patients with giant (\>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.

Eligibility criteria: Inclusion Criteria:

* ventral hernia \> 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.

Exclusion Criteria:

* \< 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.

Primary outcomes:
measure: Rate of complication
timeFrame: 3 month, 1 year and 3 year post-operative clinical follow-up
Secondary outcomes:
measure: Ventral Hernia Pain Questionnaire (VHPQ)
timeFrame: 1 year period of follow-up
measure: Abdominal wall function
timeFrame: 3 year period of follow up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institute CLINTEC
name: Karin Strigård, MD
role: STUDY_DIRECTOR
affiliation: Karolinska Institute CLINTEC
name: Leonard Clay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institute CLINTEC
name: Ulf Gunnarsson, MD
role: STUDY_CHAIR
References:
citation: Holmdahl V, Stark B, Clay L, Gunnarsson U, Strigard K. Long-term follow-up of full-thickness skin grafting in giant incisional hernia repair: a randomised controlled trial. Hernia. 2022 Apr;26(2):473-479. doi: 10.1007/s10029-021-02544-z. Epub 2021 Dec 14.
citation: Clay L, Stark B, Gunnarsson U, Strigard K. Full-thickness skin graft vs. synthetic mesh in the repair of giant incisional hernia: a randomized controlled multicenter study. Hernia. 2018 Apr;22(2):325-332. doi: 10.1007/s10029-017-1712-x. Epub 2017 Dec 15.