louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01890993: Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe
Official title: Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-07-02
Enrollment: 952
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: Consecutive patients with type 2 diabetes initiated on liraglutide or a DPP-4 inhibitor and primarily managed in primary care with 12 (+/-2) months of available data will be included in this study. Only data derived from patients receiving either therapy in accordance with license indications will be included and analyzed.

Brief summary: This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.


Eligibility criteria: Inclusion Criteria:

* Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months

Exclusion Criteria:

* Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country

Primary outcomes:
measure: Change in HbA1c (glycosylated haemoglobin)
timeFrame: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
measure: Change in systolic blood pressure
timeFrame: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
Other outcomes:
Locations:
city: Paris La défense cedex
country: France
city: Mainz
country: Germany
city: Madrid
country: Spain
city: Crawley
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01682993: Corneal Cross Linking and Topography Guided Excimer Laser Treatment
Official title: Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Keratoconus
Pellucid Marginal Degeneration
Keywords: corneal cross linking
topography guided excimer laser
Keratoconus
Pellucid marginal degeneration
Post Excimer ectasia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases.

This randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Patient age 18 - 40 years
* Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia

Exclusion Criteria:

* Allergy to one of the used substances
* Tendency towards excessive scar formation
* Pregnancy
* Rheumatic diseases
* Central corneal thickness below 450 µm
* Active infection of the study eye
* Previous corneal surgery of the study eye

Primary outcomes:
measure: Safety (Pachymetry, K-readings)
timeFrame: 1 year
measure: uncorrected visual acuity (UVCA)
timeFrame: 1 year
measure: best corrected visual acuity (BCVA)
timeFrame: 1 year
Secondary outcomes:
measure: Progression of ectatic disease (by use of maximum keratometry readings = Kmax)
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT00087893: Epidemiology of Vascular Inflammation & Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Coronary Arteriosclerosis
Coronary Disease
Cerebral Arteriosclerosis
Cerebrovascular Accident
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2004-07-19
Enrollment: 931
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 1,000 men and women aged 45-84 years

Brief summary: To investigate the relationship of vascular cell phenotypes to atherosclerosis.

Detailed description: BACKGROUND:

Currently, the predominant hypothesis regarding atherosclerosis is that it is in major part driven by two independent pathways: hyperlipidemia (the "stimulation") and inflammation (the "response"). Although vascular cells mediate the influence of inflammation on atherosclerosis, very little is known about vascular cell epidemiology and the relationship of vascular cell phenotypes to atherosclerosis. The main hypothesis tested in this study is that variation in vascular cell biology is related to the population variation in atherosclerosis.

DESIGN NARRATIVE:

The cross-sectional study will be nested within a large cohort study, the Multiethnic Study of Atherosclerosis (MESA). A partial sample of 1,000 individuals who have undergone other special laboratory analyses will be identified and new measures collected as part of their upcoming site visit. A number of novel cellular phenotypes describing the innate immune response (monocyte activation, natural killer and T cell counts), the adaptive immune response (TH1 and TH2 helper cells, and memory T cells), and vessel integrity (circulating endothelial progenitor cells) will be measured in these participants. Plasma constituents will also be measured that relate to the cellular phenotypes. The overall goal is to test the hypothesis that these novel phenotypes are associated with subclinical atherosclerosis in the coronary and carotid arteries assessed by quantification of coronary calcification (CAC) and B-mode ultrasound (CIMT), in addition to the other subclinical measures available from the MESA cohort.

Eligibility criteria: No eligibility criteria

Primary outcomes:
measure: T helper bias
timeFrame: 2008
Secondary outcomes:
measure: T helper bias toward Th1 cells
timeFrame: 2008
Other outcomes:
measure: atherosclerosis
timeFrame: 2008
Locations:
Study officials:
affiliation: University of Vermont
name: Russell Tracy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01100593: Ultrasound IV Study
Official title: Optimal Catheter Length for Ultrasound-Guided Peripheral Vascular Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IV Access
Ultrasound Use
Keywords: Ultrasound
IV catheters
Extravasation
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to compare catheter length and extravasation rates for Ultrasound (US)-guided peripheral intravenous (IV) catheter insertion in a subset of emergency department patients with difficult IV access. Physicians, Emergency RNs, and Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The optimal length of catheter to use for this procedure is unknown. This study will provide data on the length of catheter required to minimize extravasation. There is no guideline on catheter length selection for US-guided peripheral vascular access. This study may decrease extravasation rates for US-guided peripheral vascular access by providing guidance on catheter length selection.

Detailed description: The purpose of this study is to compare catheter length and extravasation rates for US guided peripheral IV insertion in a subset of emergency department patients with difficult IV access. Physicians, Emergency RNs, and Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The optimal length of catheter to use for this procedure is unknown. This study will provide data on the length of catheter required to minimize extravasation. There is no guideline on catheter length selection for US-guided peripheral vascular access. This study may decrease extravasation rates for US-guided peripheral vascular access by providing guidance on catheter length selection.

The study design is a randomized non-blinded clinical trial of extravasation rates of US guided peripheral vascular access related to intravenous catheter length and venous depth in the ED. Primary endpoint is duration of usable vascular access. Secondary endpoints are catheter length, venous depth, time of procedure, successful cannulation, reasons for failure, number of skin punctures, site of cannulation, sonographic technique, type of provider obtaining access and complications.

Eligibility criteria: Inclusion Criteria:

* two failed traditional IV attempts by a nurse
* need for IV access as determined by the treating physician
* age 18 and greater

Exclusion Criteria:

* less than age 18
* subjects needing a central venous catheter
* patients unable to provide informed consent

Primary outcomes:
measure: Extravasation rates
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Paul Sierzenski, MD, RDMS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06061393: Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia
Official title: Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia (Hb<9)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anemia, Iron Deficiency
Pregnancy Anemia
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2023-09-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin \<9 gr/dl , treated with venofer and women treated with ferinject.


Eligibility criteria: Inclusion Criteria:

pregnancy\>24 weeks of gestation anemia with Hb\<8 anemia with Hb\<9 if symptomatic anemia of previous postpartum hemorrhage

Exclusion Criteria:

* Allergy to one of the study's drugs
* IV iron treatment in the last month
* chronic anemia- thalassemia, renal failure Twins pregnancy
* non iron deficiency anemia

Primary outcomes:
measure: ratio of women with Hb level >11 at delivery
timeFrame: at delivery
measure: postpartum Hb level
timeFrame: during 48 hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05358093: Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer
Official title: Retrospective Study of Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female with left breast cancer

Brief summary: Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life .

Similarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 .

Post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT .

Cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction.

Radiotherapy also have cardio toxic effect through different mechanisms


Eligibility criteria: Inclusion Criteria:

* 1. Age 18-75 years old 2. histopathology diagnosed 3. Left sided breast cancer 4. Receiving 3D hypofractionated radiotherapy 5. Patients should be non metastatic 6. performance status 0-2

Exclusion Criteria:

* • Patient \> 75 years old

  * Non histological diagnosed
  * Metastatic patient
  * Patient with cardiac or other co morbidity.
  * ECoG performance status \>2
  * pregnant or lactating patients

Primary outcomes:
measure: retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00328393: Effect of Pioglitazone on Ambulatory Blood Pressure
Official title: Effect of Pioglitazone on Ambulatory Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Diabetes Mellitus Type 2
Keywords: Hypertension
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.


Eligibility criteria: Inclusion Criteria:

* Age 45-75 years
* Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
* Casual blood pressure \> = 130/80 mmHg, \< 160/100 mmHg

Exclusion Criteria:

* Therapy with insulin
* Combination therapy of sulfonyl-urea und metformin
* Therapy with nateglinid, repaglinid or an other substance of this drug family
* Allergy against pioglitazone or other composites of the tablet
* History of heart failure (NYHA I bis IV)
* Hepatic insufficiency
* Transaminases \> 2.5-fold of the upper normal limit
* End-stage renal failure
* Syndrome of polycystic ovaries
* Absence of effective contraception in women of childbearing potential
* Pregnancy or breast-feeding

Primary outcomes:
measure: Median of systolic 24-hour ambulatory blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Median of 24-hour diastolic ambulatory blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: CRC Medical Department IV
Study officials:
affiliation: University of Erlangen-Nürnberg, Medical Department 4
name: Roland E Schmieder, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00984893: Intra-venous Zoledronic Acid Once Yearly
Official title: A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Menopausal Osteoporosis
Keywords: Osteoporosis
Bone Mineral density
fragility fractures
zoledronic acid.
Treatment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 1551
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory Female patients, at least 45 years of age, diagnosed with osteoporosis and taking either Zelodronic acid or any other oral bisphosphonates (OBP) as per the current Canadian monograph

Brief summary: The study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.


Eligibility criteria: Inclusion Criteria:

* Patient is an ambulatory female 45 years of age or older
* Postmenopausal women with diagnosis of osteoporosis
* Prescription of zoledronic acid or any OBP as per the current Canadian monograph
* Must provide informed consent

Exclusion Criteria:

* Any prior use of iv bisphosphonates within the last 2 years
* Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease)
* Metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia..
* Non-corrected hypocalcaemia at the time of zoledronic acid infusion
* Creatinine clearance \< or = 30 ml/min
* Unwillingness or inability to comply with the study requirements
* Concurrent participation in a clinical trial of an investigational drug, or within the last 30 days

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)
timeFrame: 4 years
Secondary outcomes:
measure: change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)
timeFrame: 4 years
measure: change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
timeFrame: 4 years
measure: Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
timeFrame: 4 years
measure: Risk for fractures
timeFrame: 4 years
measure: Burden of illness, health care resource utilization, and loss of productivity
timeFrame: 4 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Quebec
country: Canada
facility: Groupe de recherche en rhumatologie et maladies osseuses Inc
Study officials:
affiliation: Novartis Pharmaceuticals Canada
name: Marc Vaillancourt
role: STUDY_DIRECTOR
References:
Clinical trial NCT02230293: Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial
Official title: Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: ambulatory care,
hypertension,
health personnel,
clinical trial
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 124
Sex: ALL
Minimum age (years): 41
Maximum age (years): 67
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 multidisciplinary care improves the health condition of hypertensives.

Detailed description: A multidisciplinary approach in managing hypertensive patients has shown benefits in reducing blood pressure and risk factors for hypertension.

Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Diagnosis of hypertension

Exclusion Criteria:

* Secondary hypertension
* Hypertensive patients with congenital cardiopathy
* Surgical patients
* Proven myocardial infarction

Primary outcomes:
measure: Change from Baseline in Systolic and Diastolic Blood pressure
timeFrame: Measured at the first appointment and 1 year later
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: RS
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Silvia Goldmeier, Dr
role: STUDY_CHAIR
References: