louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00366938: Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
Official title: A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, lumiracoxib, celecoxib, Cox-2
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 1464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria).
* Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion Criteria:

* Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
* Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
measure: Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
measure: Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
Secondary outcomes:
measure: Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
measure: Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
measure: Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
measure: Patient's health status using the Short Form-36 (SF-36), at week 13.
measure: Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: Novartis Pharmaceuticals Corporation
state: New Jersey
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118.
Clinical trial NCT02264938: Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation
Official title: Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation: One-year Results.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related macular degeneration (AMD) after one year of oral supplementation with AREDS-like formulation.

Detailed description: Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study, and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid \[DHA\] 540mg + eicosapentaenoic acid \[EPA\] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon 3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed in all patients, at baseline and 12 months after. Automated delineation of macular drusen was modified by the investigators when evident segmentation errors occurred.

Eligibility criteria: Inclusion Criteria:

* AREDS category 2 and 3 AMD

Exclusion Criteria:

* AREDS category 4 AMD
* other ophthalmological diseases
* currently on antioxidant supplementation

Primary outcomes:
measure: Drusen volume change
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01351038: Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma
Official title: A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: KRAS Wild Type
Resectable Type II Gastric Adenocarcinoma
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2011-05-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.


Eligibility criteria: Inclusion Criteria:

* Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
* T2-4 NX M0 disease
* ECOG performance status 0-1
* adequate hematological status
* adequate renal function
* adequate hepatic function
* adequate metabolic function

Exclusion Criteria:

* pregnant or breast feeding women
* previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
* arterial or venous thromboembolism within 6 months before enrollment
* clinically significant cardiovascular disease within 1 year before enrollment
* history of interstitial lung disease

Primary outcomes:
measure: Efficacy
measure: Safety
Secondary outcomes:
measure: Histopathological response
measure: overall survival after one year
measure: Progression free survival after one year
measure: Proportion of patients completing 3 treatment cycles
measure: Safety
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch
city: Linz
country: Austria
facility: KH Elisabethinen Linz
city: Linz
country: Austria
facility: AKh Linz
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin III
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels GmbH
city: Zams
country: Austria
facility: St. Vinzenz Krankenhaus Betriebs GmbH
Study officials:
References:
Clinical trial NCT01296438: A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1
Official title: A Randomised Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin aspart.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months.
* Body Mass Index (BMI) between 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: from 0-1 hour after trial drug administration
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: from 0-12 hours after trial drug administration
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00552838: The Impact of an Antimicrobial Utilization Program on Antimicrobial Use
Official title: The Impact of an Antimicrobial Utilization Program on Antimicrobial Use in a Large Public Hospital: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antimicrobial Prescribing Practices
Keywords: Antimicrobial prescribing
Antimicrobial utilization
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2007-11-02
Enrollment: 785
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective mechanism for improving antimicrobial use, but data on their efficacy remain limited. The researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a teaching hospital when compared to the standard of care (no AUT intervention).

Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.

Patients: Patients admitted to internal medicine ward teams who were prescribed selected antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the 10month study period.

Intervention: Eight internal medicine ward teams were randomized monthly to academic detailing by the AUT while 8 internal medicine ward teams were randomized indication-based prescription of broad spectrum antimicrobials.

Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).

Detailed description: This study was conducted when Bernard C Camins, MD (BCC), one of the investigators, was still employed at Emory University. The principal investigator is no longer at Emory University. This trial is being registered by one of the investigators, BCC, so we can submit the manuscript for publication. BCC is now at Washington University and this study was conducted while he was at Emory University.

Eligibility criteria: Inclusion Criteria:

* All patients prescribed vancomycin, piperacillin-tazobactam, or levofloxacin during the time period of the study.

Primary outcomes:
measure: Proportion of Appropriateness of Antimicrobial Prescriptions in each group.
timeFrame: 10-month period
Secondary outcomes:
measure: Clinical Cure Rate, Mortality Rate between the two groups
timeFrame: 10-month period
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Mark D King, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camins BC, King MD, Wells JB, Googe HL, Patel M, Kourbatova EV, Blumberg HM. Impact of an antimicrobial utilization program on antimicrobial use at a large teaching hospital: a randomized controlled trial. Infect Control Hosp Epidemiol. 2009 Oct;30(10):931-8. doi: 10.1086/605924.
Clinical trial NCT06630338: Use of Shear Wave Elastography for Intraoperative Brain and Glioma Stiffness Measurements
Official title: Use of Shear Wave Elastography for Intraoperative Brain and Glioma Stiffness Measurements
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioma
Recurrent Glioma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults \>= 18 years with a glioma diagnosis that will undergo brain surgery with tissue resection as standard of care.

Brief summary: This study investigates the role of intraoperative shear wave elastography ultrasound (ISWEU) in identifying healthy brain and tumor tissue stiffness differences. This data may be used to guide tumor resection in future patients.

Detailed description: PRIMARY OBJECTIVE:

I. Determine the feasibility of utilizing ISWEU measurements intraoperatively and in the human brain to measure tissue stiffness.

OUTLINE: This is an observational study.

Patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.

Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years old.
* Patients must have planned surgery for resection of a newly diagnosed or recurrent glioma.
* Patients with tumors located in the brain cortex or superficial white matter in which introduction of the ultrasound probe is straightforward and does not pose a risk for intraoperative complications.
* Patients must have a Karnofsky performance status ≥ 60%.
* Patient or legally authorized representative (LAR) willing to provide written informed consent.

Exclusion Criteria:

* Patients with deep-seated brain tumors in which introduction of the ultrasound probe poses an increased risk.
* Patients with a history of any brain infections.
* Patients with implanted devices.
* Patients with any other neurological/neurosurgical disease that could affect tissue stiffness.
* Patients with any other structural brain defect that could affect tissue stiffness.

Primary outcomes:
measure: Feasibility of utilizing Intraoperative Shear Wave Elastography Ultrasound (ISWEU) measurements intraoperatively and in the human brain to measure tissue stiffness.
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Alfredo Quinones-Hinojosa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05923138: Nutritional Approach in Adults Followed up in Spanish Hospitals for Heart Failure (BOCADOS-IC)
Official title: aBOrdaje nutriCional en ADultos Seguidos en hOspitales eSpañoles Por Insuficiencia Cardiaca (BOCADOS-IC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: HEART FAILURE
MALNUTRITION
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 264
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, open-label, prospective, multicentre clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic heart failure.

Through a simple 1:1 randomization process, patients will be assigned to the control group or the intervention group. Patients in the intervention group will undergo an individualised nutritional intervention program consisting of 3 pillars: diet optimization, specific recommendations ,and nutritional supplementation if nutritional targets are not achieved.


Eligibility criteria: Inclusion Criteria:

* Patients older than 65 years with malnutrition (MNA-SF score ≤ 11) with chronic ambulatory heart failure (HF).

Exclusion Criteria:

* Admission for heart failure (HF) in the last month,
* Chronic renal failure on dialysis.
* Patients already on nutritional treatment.
* Concomitant diseases which, apart from the HF itself, could lead to a life expectancy of less than 1 year,
* Patients included in other clinical trials.
* Patients whose clinical situation makes it impossible to perform a nutritional assessment according to the design established in the study protocol or who do not give their consent for this purpose.
* Patients who during admission undergo surgical or percutaneous treatment to correct the cause of acute HF,

Primary outcomes:
measure: COMBINED EVENT
timeFrame: 6 MONTHS
Secondary outcomes:
measure: Time to 6-month cardiovascular mortality
timeFrame: 6 MONTHS
measure: Time to all-cause admission at 6 months
timeFrame: 6 MONTHS
measure: Changes in quality of life at 3 and 6 months post-intervention
timeFrame: 6 MONTHS
measure: Changes in nutritional status at 3 and 6 months post intervention
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
Study officials:
References:
Clinical trial NCT01275638: The Effect of Moderate-Dose Steroid Therapy in Sepsis
Official title: The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Keywords: cortisol, prednisolone, adrenal insufficiency, sepsis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 55
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the new developments in sepsis treatment, mortality rate is still high. Discussions on steroid treatment in sepsis are going on. In this study, we aimed to investigate the effects of moderate dosage steroid treatment and endocrinologic changes occurring in sepsis on prognosis in patients with sepsis.

Detailed description: This prospective, randomized, single-centre, double-blind, placebo-controlled trial was conducted between April 2005 and May 2008 in the department of Medical ICU and the Department of Infectious Diseases of Erciyes University Medical School. The study was approved by our Institutional Review Board and informed consent was obtained from the patients' relatives. The study did not alter therapy, and each patient's clinical care was determined by their own physician.

Eligibility criteria: Inclusion Criteria:

* Patients over 17 years old and diagnosed with sepsis were included in the study consecutively

Exclusion Criteria:

* Already known pre-existing adrenal disease or adrenalectomy, known malignancies, tuberculosis that might have involved the adrenal gland, and administration of steroids within the 3 months before the admission. In addition, patients with burns, hemorrhagic shock or those who had suffered myocardial infarction were not included.

Primary outcomes:
measure: All-cause mortality
timeFrame: 28-day
Secondary outcomes:
measure: Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Erciyes University Medical Faculty Infectious Diseases Departmen
name: Bilgehan AYGEN, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00695708: Training-induced Cerebral Reorganization in Schizophrenia
Official title: Training-induced Cerebral Reorganization in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
neuroplasticity
sensory gating
cognitive impairment
MEG
Disorders with Psychotic Features
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2008-06-12
Enrollment: 60
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to reveal the effects of computer-aided cognitive-auditory training on cerebral reorganization in schizophrenia.

Detailed description: Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease.

In this study we compare effects of two computer-aided training programs. One focused on auditory perception and processing as a basic ability underlying higher order information processing.

The other training involves a variability of cognitive abilities.

Both trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia and disorders with psychotic features
* Intact hearing abilities

Exclusion Criteria:

* Mental retardation
* Age over 60
* Insufficient German language knowledge

Primary outcomes:
measure: Event related potential MEG, test scores in word fluency and verbal learning tasks
timeFrame: pre and post intervention
Secondary outcomes:
measure: Symptom severity, GAF score
timeFrame: pre and post intervention
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz
state: Baden Württenberg
Study officials:
affiliation: University of Konstanz, Department of Psychology
name: Brigitte Rockstroh, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Popov T, Jordanov T, Rockstroh B, Elbert T, Merzenich MM, Miller GA. Specific cognitive training normalizes auditory sensory gating in schizophrenia: a randomized trial. Biol Psychiatry. 2011 Mar 1;69(5):465-71. doi: 10.1016/j.biopsych.2010.09.028. Epub 2010 Nov 18.