louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00997997: Avelox in Complicated Skin and Skin Structure Infections
Official title: ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Diseases, Bacterial
Keywords: Skin Diseases, Bacterial
Product Surveillance
Postmarketing
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 6127
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being diagnosed with complicated skin and skin structure infections, mainly in hospital settings

Brief summary: This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.


Eligibility criteria: Inclusion Criteria:

* Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study.

Exclusion Criteria:

* Exclusion criteria are those specified in the local product information.

Primary outcomes:
measure: Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox
timeFrame: last documented follow-up visit, according to the respective praxis routine
Secondary outcomes:
measure: Adverse events collection
timeFrame: during entire study course, according to the respective praxis routine
measure: Overall assessment of tolerability by the physician
timeFrame: last documented follow-up visit, according to the respective praxis routine
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Bulgaria
city: Many Locations
country: Egypt
city: Many Locations
country: Germany
city: Many Locations
country: Greece
city: Many Locations
country: Indonesia
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Pakistan
city: Many Locations
country: Philippines
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Slovenia
city: Many Locations
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04184297: Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy
Official title: Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 27190
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA

Brief summary: To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk


Eligibility criteria: Inclusion Criteria:

* New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
* Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date

Exclusion Criteria:

* Less than one year of medical history information prior to the date of combined treatment initiation (index date)
* Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
* Asthma diagnosis within one year prior to the index date

Primary outcomes:
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry
timeFrame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Secondary outcomes:
measure: Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)
timeFrame: From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.
Other outcomes:
Locations:
city: Andover
country: United States
facility: HealthCore, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT06759597: The Effect of Phacoemulsification on the Macular Changes in Patients with Neovascular Age-related Macular Degeneration
Official title: Macular Changes After Phacoemulsification in Patients with Neovascular AMD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neovascular (wet) Age-Related Macular Degeneration
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: old age population had phacoemulsefcation with history of neovascular AMD

Brief summary: The macula has a very high concentration of photoreceptor cells - the cells that detect light. They send signals to the brain, which interprets them as images. The rest of the retina processes our peripheral, or side vision To explore whether cataract surgery evokes development or relapse of choroidal neovascularization (CNV) in wet age-related macular degeneration (AMD) patients followed for a 1-year postoperative period

Detailed description: Age-related macular degeneration (AMD) is a leading cause of vision loss in adults over the age of 50. AMD causes damage to a small part of the retina responsible for central vision called the macula. When damage to the macula occurs, it typically causes loss of central, detailed vision which results in difficulty with tasks such as reading, driving, threading a needle, or recognizing faces.

Phacoemulsification is a modern-day cataract surgery that employs ultrasound energy to emulsify the nucleus, vacuum to catch the nuclear material, and irrigation and aspiration for cortex and viscoelastic removal.

It is currently impossible to draw definitive conclusions whether phacoemulsification (PhE) is safe for people with age-related macular degeneration (ARMD). It is not clear if PhE causes the progression of ARMD and affects visual acuity (VA). The purpose was to analyze the possible association of PhE with ARMD progression in the early and late (up to 18 months after surgery) period.

Eligibility criteria: Inclusion Criteria:Subjects included in this study aged above 50 and presented for routine check up after undergoing phacoemulsification:

* Above 50 years old

  * not diabetic individuals
  * wet ARMD

Exclusion Criteria:

* intraoperative complications

  * Eyes with diseases predisposing them for postoperative macular edema, preexisting macular edema, and eyes that developed cystoid macular edema
  * active ocular inflammation or infection _glaucoma
  * A preoperatively worsened VA regardless phE
  * ocular trauma
  * patients with central retinal ischemia
  * previous vitrectomy
  * dry amd

Primary outcomes:
measure: To figure out the possibility of Postoperative conversion or relapse ( Dry to wet , wet to reactivated CNV)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00767897: The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients
Official title: The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Dialysis
Keywords: Dose response relationship
immunity
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: National Kidney Foundation, United States
First posted: 2008-10-07
Enrollment: 72
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Girls age 9-18 who are healthy, have chronic kidney disease stage 3 or 4, are on dialysis, or have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.

Brief summary: The proposed study is a pilot study and a first step towards developing an optimized HPV vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.


Eligibility criteria: Inclusion Criteria:

* 9-18-year-old girls who have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2).
* 9-18-year-old girls who are on dialysis.
* 9-18-year-old girls who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.
* Healthy 9-18-year-old girls

Exclusion Criteria:

* Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University/Riley Children's Hospital
state: Indiana
Study officials:
affiliation: Indiana University/Riley Children's Hospital
name: Corina Nailescu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05993897: Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling
Official title: Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes status.


Eligibility criteria: Inclusion Criteria:

1. with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or with intervention within seven days of onset).
2. Patient age 18-60 years.
3. Patients with Glomerular Filtration Rate (GFR) \>45 ml/min/1.73m2 (Cockcroft-Gault equation).
4. Patient with normal left atrium or dilated (diameter \<5 cm)

Exclusion Criteria:

1. Patients \< 18 yrs old.
2. Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
3. Patients with left atrium \> 5cm.
4. Patients with glomerular Filtration Rate (GFR) \<45 ml/min/1.73m2 (Cockcroft-Gault equation).
5. Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
6. Patient with previous ischemic stroke.

Primary outcomes:
measure: Left atrial remodeling
timeFrame: Before first administration of treatment and will be repeated 6 months after while still on treatment
measure: Changes in left atrial strain
timeFrame: Before first administration of treatment and will be repeated 6 months after while still on treatment
measure: Changes in left atrial systolic force
timeFrame: Before first administration of treatment and will be repeated 6 months after while still on treatment
Secondary outcomes:
measure: Mean percentage of time spent in atrial fibrillation
timeFrame: After the first dose of treatment till the end of the study (1 year)
measure: Mortality Rate
timeFrame: After the first dose of treatment till the end of the study (1 year)
measure: Incidence of Hospitalization due to HF
timeFrame: After the first dose of treatment till the end of the study (1 year)
measure: Number of participants with Stroke
timeFrame: After the first dose of treatment till the end of the study (1 year)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02902497: Impact of the Surgical Experience on Cochleostomy Location: A Comparative Temporal Bone Study Between Endaural and Posterior Tympanotomy Approaches for Cochlear Implantation
Official title: Impact of the Surgical Experience on Cochleostomy Location: A Comparative Temporal Bone Study Between Endaural and Posterior Tympanotomy Approaches for Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implantation
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cadaver heads

Brief summary: The goal of this study was to evaluate, in the hands of an inexperienced surgeon, the cochleostomy location of an endaural approach (MINV) compared to the conventional posterior tympanotomy (MPT) approach. Since 2010, the investigators use in the ENT department of Nice a new surgical endaural approach to perform cochlear implantation. In the hands of an inexperienced surgeon, the position of the cochleostomy has not yet been studied in detail for this technique. This is a prospective study of 24 human heads. Straight electrode arrays were implanted by an inexperienced surgeon: on one side using MPT and on the other side using MINV.


Eligibility criteria: Inclusion Criteria:

* cadaver heads
* person had provided written consent to give their entire body to science

Exclusion Criteria:

* none

Primary outcomes:
measure: position of the cochleostomy
timeFrame: at 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05130697: A Multicenter Survey Study Into Patient Experience With Mobile Apps
Official title: A Multicenter Survey Study Into Patient Experience With Mobile Apps
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Pleural Effusion
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 20
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: Participants (patients with MPE and an IPC in place) are being requested to use a pilot mobile app that is being developed to support them in their symptom management at home and to provide feedback on its usability.

Brief summary: This multicenter prospective survey study is designed to evaluate a newly developed mobile app that will support patients with malignant pleural effusion (MPE) treated with an indwelling pleural catheter (IPC). The aim is to test the mobile app with patients with MPE and get user feedback during and at the end of the study period.


Eligibility criteria: Inclusion Criteria:

* Patients with MPE and, scheduled for an indwelling pleural catheter (IPC) procedure,
* Age 18 or older

Exclusion Criteria:

* Patients without an iOS smartphone or email account
* Patients who refuse participation.

Primary outcomes:
measure: The % positive usability rating rated via an mHealth App Usability Questionnaire (MAUQ)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: University Hospitals Galway
Study officials:
References:
Clinical trial NCT01108497: Genome, Proteome and Tissue Microarray in Childhood Acute Leukemia
Official title: Genome, Proteome and Tissue Microarray in Childhood Acute Leukemia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Leukemia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 235
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children who present at Packard hospital with a new diagnosis or relapse of acute leukemia will be eligible.

Brief summary: We will study gene and protein expression in leukemia cells of children diagnosed with acute leukemia. We hope to identify genes or proteins which can help us grade leukemia at diagnosis in order to: (a) develop better means of diagnosis and (b) more accurately choose the best therapy for each patient.


Eligibility criteria: Inclusion Criteria:1. All children who present at Packard hospital with a new diagnosis or relapse of acute leukemia will be eligible. There is no bias in regards to age range, gender or ethnic background.

2. Signed informed consent

Primary outcomes:
measure: Gene Expression
timeFrame: days 0, 8, 22 or 29
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Norman James Lacayo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02201797: Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body
Official title: Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Liver Cancer
Keywords: Reproducibility of Results
Liver neoplasm
Neoplasm metastasis
Regional Perfusion
Perfusion Magnetic Resonance Imaging
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Bracco Diagnostics, Inc
First posted: 2014-07-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced) and DWI MRI can provide valuable information regarding tumor biology and response to treatment through various parameters. Validating stability of these parameters will further establish robustness and reliability of these promising biomarkers.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic liver cancer proven by pathology
* At least one liver tumor should be \> 2cm in long diameter
* Patients with viable tumor proven in the other imaging modalities

Exclusion Criteria:

* Severe claustrophobia
* Presence of MRI-incompatible metallic objects or implanted medical devices in body
* Renal failure, as determined by glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2
* Weight greater than that allowable by the MRI table
* Chemotherapy within 28 days prior to enrollment
* Prior external radiation therapy to the liver, prior transarterial chemoembolization

Primary outcomes:
measure: repeatability coefficient (RC)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyung Won Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592397: Prestudy: Lifestyle and Cardiovascular Disease
Official title: Prestudy: Lifestyle and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Mellitus
Cardiovascular Diseases
Keywords: Dietary Intervention
Nutrigenomics
Diet, Carbohydrate-Restricted
Gene Expression
Gene Expression Profiling
Oligonucleotide Array Sequence Analysis
Biological Markers
Food
Obesity
Blood
Subcutaneous Fat, Abdominal
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: FUGE Mid-Norway
First posted: 2008-01-14
Enrollment: 5
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this pilot study is to optimize conditions for a planned human intervention study focusing on how diet predispose for, and influence, lifestyle disease development and its consequence in cardiovascular disease development.

Detailed description: Common for many of the risk factors of lifestyle diseases is that they are induced by improper diet. Recent research has shown that especially total amount and composition of the macro nutrients, protein, carbohydrate and fats, is important.

A time course experiment has been performed where 5 subjects underwent a diet intervention for four weeks with a controlled, balanced macro nutrient energy content of every meal. The sampling time points were 0, 1, 2, 7, 14 and 28 days. The goals were to determine optimal length of intervention with stabilization of gene expression to occur and compare blood and subcutaneous abdominal fat tissue as source of biological material for RNA for DNA microarray analysis. Microarray analysis were performed on 3 of the 5 subjects.

Eligibility criteria: Inclusion Criteria:

* healthy males, BMI\>30

Exclusion Criteria:

* known chronic disease or in need of any medical treatment

Primary outcomes:
measure: Changes in microarray gene expression profiles in blood and subcutaneous abdominal fat tissue from healthy obese men, as a consequence of changes in dietary macro nutrient composition.
timeFrame: Four weeks
Secondary outcomes:
measure: Time to stabilization of gene expression changes due to dietary intervention.
timeFrame: 0, 1, 2, 7, 14 and 28 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
state: Mid-Norway
Study officials:
affiliation: Norwegian University of Science and Technology
name: Berit Johansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brattbakk HR, Arbo I, Aagaard S, Lindseth I, de Soysa AK, Langaas M, Kulseng B, Lindberg F, Johansen B. Balanced caloric macronutrient composition downregulates immunological gene expression in human blood cells-adipose tissue diverges. OMICS. 2013 Jan;17(1):41-52. doi: 10.1089/omi.2010.0124. Epub 2011 Jun 16.