louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01094743: Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.


Eligibility criteria: Inclusion Criteria:

1. The subject must be at least 18 years of age and no more than 39 years of age.
2. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
3. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
4. Any cylinder power must be ≤ -0.75D.
5. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
6. The subject must read and sign the Statement of Informed Consent.
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
2. Systemic disease or use of medication which might interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Pregnancy or lactation.
8. Diabetes.
9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
10. Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Primary outcomes:
measure: Visual Acuity Monocular
timeFrame: after 1 week of lens wear
measure: Visual Acuity Binocular
timeFrame: after 1 week of lens wear
measure: Subjective Assessment of Lens Comfort
timeFrame: after 1 week of lens wear
measure: Subjective Assessment of Quality of Vision
timeFrame: after 1 week of lens wear
Secondary outcomes:
measure: Limbal Redness
timeFrame: after 1 week of lens wear
measure: Bulbar Redness
timeFrame: after 1 week of lens wear
measure: Subjective Assessment of Lens Comfort
timeFrame: 10 minutes after lens insertion at time of initial lens fitting
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Salem
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT01917643: Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients
Official title: A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) and Tiotropium Bromide Among COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Exacerbation
Keywords: COPD, Comparative Effectiveness, Symbicort
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: HealthCore, Inc.
First posted: 2013-08-07
Enrollment: 2396
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: Health plan members with COPD aged 40 years or older receiving one or more prescriptions of BFC or tiotropium bromide during 3/1/2009 and 1/31/2012 who are naive to ICS/LABA and LAMA combination therapies.

Brief summary: This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.

Detailed description: Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.

Eligibility criteria: Inclusion Criteria:

* Continuous health plan enrollment for 12 months before and after index Rx
* At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
* COPD diagnosis, and aged 40 years of age at time of first prescription
* At risk population for COPD exacerbations

Exclusion Criteria:

* ICS/LABA combination or LAMA therapy during pre-index period
* Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day
* Patients diagnosed with cancer
* Patients with long-term OCS medication use during pre-index period

Primary outcomes:
measure: Time to first COPD exacerbation
timeFrame: 12 months
Secondary outcomes:
measure: COPD exacerbation rates
timeFrame: 12 months
measure: COPD respiratory medication use
timeFrame: 12 months
measure: COPD related utilization
timeFrame: 12 months
measure: All-cause utilization
timeFrame: 12 months
measure: All-cause and COPD related healthcare costs
timeFrame: 12 months
measure: Treatment patterns and adherence
timeFrame: 12 months
measure: Treatment modification
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05126043: Lipid Profile in Acute Coronary Syndrome
Official title: Triglyceride/High Density Lipoprotein-cholesterol Ratio as a Novel Marker of Atherosclerosis in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presented with acute coronary syndrome admitted to coronary care unit of Sohag University hospital according to inclusion and exclusion criteria

Brief summary: This study aims to assess the TG/Hdl-c ratio in patients with acute coronary syndrome as a novel marker of atherosclerosis.

Detailed description: Cross sectional study to:

assess triglycerides/high density lipoprotein-cholesterol ratio as a novel atherogenic marker in patients presenting with acute coronary syndrome

Eligibility criteria: Inclusion Criteria:

* all patients presented with acute coronary syndrome

Exclusion Criteria:

* patients less than 18 years
* rheumatic heart disease
* congenital heart disease

Primary outcomes:
measure: Coronary care unit admission
timeFrame: From date of randomization up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Sohag University
name: Mohamed H Ahmed, Lecturer
role: STUDY_CHAIR
References:
citation: Dzubur A, Ejubovic M, Fajkic A, Dervisevic A, Durak Nalbantic A, Avdic Agic A, Dzubur A, Mekic M. The serum triglyceride to high-density lipoprotein (HDL) ratio in patients with acute coronary syndrome with and without renal dysfunction. Med Glas (Zenica). 2019 Feb 1;16(1):28-34. doi: 10.17392/990-19.
Clinical trial NCT02823743: RECAB-ASA; Treatment of Recurrent Abortion With Aspirin
Official title: Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Habitual
Keywords: recurrent pregnancy loss, Habitual abortion
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2016-07-06
Enrollment: 400
Sex: FEMALE
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. The study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.


Eligibility criteria: Inclusion Criteria:

* recurrent abortion (≤ 3 consecutive abortions in first trimester)
* unknown etiology after work-up
* willingness to be randomized

Exclusion Criteria:

* previous participation in the study
* known cause of recurrent abortion, requiring specific management
* age ≥ 40
* BMI above 35
* IVF pregnancy if the reason for IVF was recurrent spontaneous abortion
* ongoing treatment with aspirin for other reason
* Sjoegren syndrome

Primary outcomes:
measure: Live birth
timeFrame: delivery
Secondary outcomes:
measure: Spontaneous abortion
timeFrame: up to 22 weeks
measure: Vaginal bleeding
timeFrame: up to 42 weeks
measure: Premature delivery
timeFrame: At delivery
measure: intrauterine growth retardation, measured by ultrasound as percentage deviation
timeFrame: up to 42 weeks
measure: Preeclampsia
timeFrame: up to 42 weeks
measure: Pregnancy induced hypertension
timeFrame: up to 42 weeks
measure: Placenta praevia
timeFrame: up to 42 weeks
measure: Perinatal mortality
timeFrame: Third trimester and 28 days after delivery
measure: Perinatal morbidity
timeFrame: 28 days after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Göteborg University
name: Annika Strandell, Ass.prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01431443: Consumption of Chocolate in Pregnant Women.
Official title: Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preeclampsia
Keywords: Randomized double blind trial
Cocoa flavonoids
Endothelial function
Blood pressure
Pregnant women
Preeclampsia
Uterine artery flow
Pulsatility index
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.

Detailed description: Although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. This is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia.

The primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18 and 40 years.
* Presence of uterine diastolic notches measured by uterine artery Doppler between 10 and 14 weeks.

Exclusion Criteria:

* Hypertension requiring medication.
* Currently or previously use of medications interfering with glucose or lipids metabolism.
* Use of supplements or natural health products that interfere with blood pressure.
* Consumption of 1 or more alcohol drink per day.
* Allergy or intolerance to nuts or chocolate.

Primary outcomes:
measure: Changes in endothelial function
timeFrame: within the first 12 weeks of chocolate intake
Secondary outcomes:
measure: Doppler of uterine arteries
timeFrame: within the first 12 weeks of chocolate intake
measure: Blood pressure
timeFrame: within the first 12 weeks of chocolate intake
measure: Plasma biomarker of endothelium function
timeFrame: within the first 12 weeks of chocolate intake
measure: Plasma biomarker of chocolate intake
timeFrame: within the first 12 weeks of chocolate intake
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
state: Quebec
Study officials:
affiliation: Laval University
name: Sylvie Dodin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04044443: IMPEDE and IMPEDE-FX Embolization Plug Registry
Official title: Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Vascular Embolization
Lead sponsor: Shape Memory Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult study participants considered candidates for a peripheral vascular embolization procedure

Brief summary: EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems


Eligibility criteria: Inclusion Criteria:

* Study participant is ≥18 years of age
* Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature

Exclusion Criteria:

* Study participant has an inability to provide written informed consent
* Study participant/treatment outside of the approved study device labeling, instructions for use (IFU)
* Study participant is a prisoner or member of other vulnerable population

Primary outcomes:
measure: Safety - Rate of freedom from serious adverse events
timeFrame: 30 days
measure: Efficacy - Rate of technical success (embolization of target vessel)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Efficacy - Rate of recurrence of clinical symptoms, based on original complaint
timeFrame: 90 days
measure: Efficacy - Rate of treated vessel occlusion
timeFrame: 90 days
measure: Safety - Rate of freedom from serious adverse events
timeFrame: 90 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein (Campus Kiel)
city: Leipzig
country: Germany
facility: UNIVERSITÄTSKLINIKUM LEIPZIG AöR
city: München
country: Germany
facility: Klinikum München rechts der Isar
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Stuttgart
country: Germany
facility: Klinikum StuttGart
city: Würzburg
country: Germany
facility: Uniklinikum Würzburg
city: London
country: United Kingdom
facility: St George's Hospital (St George's University Hospitals NHS Foundation Trust)
city: London
country: United Kingdom
facility: St Mary's Hospital (Imperial College Healthcare NHS Trust)
Study officials:
affiliation: St George's Hospital (St George's University Hospitals NHS Foundation Trust)
name: Robert Morgan, MBChB
role: STUDY_CHAIR
affiliation: Klinikum Stuttgart
name: Götz Richter
role: STUDY_CHAIR
References:
Clinical trial NCT03748043: the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
Official title: the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron-deficiency
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the investigators will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis

Detailed description: Iron deficiency is frequently present with chronic inflammatory disease.(1) Iron deficiency anemia results from decreased body's iron content due to blood loss, poor dietary iron intake, malabsorption, or increased iron requirement. Immune activation drives a diversion of iron to storage sites, particularly the mononuclear phagocytes system in liver and spleen leads to poor hemoglobinization and anemia. Iron deficiency and immune activation lead to disturbances of iron homeostasis.(2) this trial will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis

Eligibility criteria: Inclusion Criteria:

* children 3-17 years old with chronic tonsillitis

Exclusion Criteria:

* no other causes of Iron Deficiency Anemia

Primary outcomes:
measure: Increase in blood hemoglobin
timeFrame: 1,3 months
measure: Increase in serum ferritin
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
affiliation: South Valley University
name: shimaa Ahmed, MD
role: STUDY_CHAIR
References:
citation: Cappellini MD, Comin-Colet J, de Francisco A, Dignass A, Doehner W, Lam CS, Macdougall IC, Rogler G, Camaschella C, Kadir R, Kassebaum NJ, Spahn DR, Taher AT, Musallam KM; IRON CORE Group. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068-1078. doi: 10.1002/ajh.24820. Epub 2017 Jul 7.
citation: Nairz M, Theurl I, Wolf D, Weiss G. Iron deficiency or anemia of inflammation? : Differential diagnosis and mechanisms of anemia of inflammation. Wien Med Wochenschr. 2016 Oct;166(13-14):411-423. doi: 10.1007/s10354-016-0505-7. Epub 2016 Aug 24.
Clinical trial NCT07016243: Correlation Between Deficits in Knee ROM Recovery and Difficulty in Dorsiflexing the Tibio-tarsal Joint in Patients Undergoing Total Knee Replacement Surgery.
Official title: Correlation Between Deficits in ROM Recovery of the Knee Operated With PTG and Difficulty in Dorsiflexing the Tibio-tarsal Joint.NODORSIFLEX-IN-PTG
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Articulation Disorders
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 197
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To demonstrate in a Physical Medicine and Rehabilitation department that the deficit in dorsiflexion-tibia-talar joint range of motion can have an effect on the knee operated on with arthroplasty by limiting complete extension and, in general, the recovery of a complete range of motion.

Brief summary: To demonstrate that the deficit in dorsiflexion-tibia-talar joint range of motion can have an effect on the knee operated by arthroplasty by limiting full extension and, in general, the recovery of a full range of motion.

Detailed description: The study is of a prospective, prognostic, observational nature and involves all patients who are candidates for admission to the Rizzoli Orthopaedic Institute for primary knee replacement surgery, recruited in the Orthopaedics department and subsequently followed in the Rehabilitation Medicine department of the DRS. The recruited patients will be subjected to pre-operative measurement of the ankle ROM; if they present a limitation of the same, they will be included in the exposed group, alternatively they will be included in the non-exposed group.

Eligibility criteria: Inclusion Criteria:•

* Patients who are candidates for primary total knee replacement surgery aged 65 to 85 years;
* Patients who have provided informed consent Exclusion Criteria:•
* Patients with known neurological pathologies
* Severe joint deformations such as previous ankle surgery (arthrodesis, ankle prosthesis) congenital malformations (cavus equinus, clubfoot)
* Severe fractures that have compromised the joint
* Traumatic events affecting the lower limb that occurred less than 12 months
* Non-ambulatory patients in the preoperative period

Primary outcomes:
measure: Measurement of knee joint range of motion (ROM).
timeFrame: In our study, the joint excursion measurements of the t-t and knee will be taken by the physiotherapists involved in the study with the patient lying in a supine position on a bed, they will be taken pre-operatively (T0) i.e. before the knee arthroplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Bagheria
country: Italy
facility: Istituto Ortopedico Rizzoli Dipartimento Sicilia
state: Palermo
Study officials:
affiliation: Istituto Ortopedico Rizzoli - Dipartimento Sicilia
name: Laura Tornatore
role: PRINCIPAL_INVESTIGATOR
References: