louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02839434: Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Blood Coagulation Tests
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-07-21
Enrollment: 105
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 treated with oral anticoagulant at curative dose

Brief summary: Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures .

Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations).

The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting time (ACT) with the aim of obtaining and maintaining an ACT \> 300-400 sec. This goal is the same whether the patient is on oral anticoagulant treatment or not, and regardless of the initial level of anticoagulation.

The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well documented, but few data have been published on the effects of heparin monitoring tests, particularly on the ACT.

The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.


Eligibility criteria: Inclusion Criteria:

* patient treated with oral anticoagulant at curative dose and requiring a requiring a venous blood sample for his management

Exclusion Criteria:

* opposition to the patient to participate to the study

Primary outcomes:
measure: Correlation between the plasmatic concentration in direct oral anticoagulants (DOAC) or International Normalized Ratio for AVK and the value of the Activated clotting time (ACT)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT06957834: Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study
Official title: Randomised Double-blinded Split-face Controlled Study to Evaluate the Effectiveness of Eflornithine Hydrochloride Cream Compared to Topical Hydroquinone 2% Cream for the Treatment of Melasma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melasma
Keywords: Melasma
Dermatology
Eflornithine
Lead sponsor: National Skin Centre
Sponsor class: NETWORK
First posted: 2025-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blinded, split-face study. Both treatments (Eflornithine hydrochloride, and Hydroquinone) will be applied simultaneously: one on the left side of the face and the other on the right side. Treatment allocation to facial sides will be randomized, and participants blinded (both treatments with similar packaging, look and consistency). Outcomes will be assessed on each side of the face by a blinded evaluator.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. The main questions it aims to answer are:

* Does Eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to Hydroquinone cream?
* What side effects might patients get while using Eflornithine hydrochloride cream?

Participants will:

* Apply both Eflornithine hydrochloride and Hydroquinone creams on separate halves of their faces every day for 3 months.
* Visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of melasma
* Fitzpatrick Type III or IV
* Able to provide informed consent

Exclusion Criteria:

* Pregnant or lactating patients
* Patients with difficulty adhering to regular topical treatments
* Patients with known contact allergies to any of the ingredients in the topical medications used in the study

Primary outcomes:
measure: Modified Melasma Area and Severity Index (mMASI)
timeFrame: At 8 weeks and 12 weeks
measure: Mexameter melanin score
timeFrame: At 8 and 12 weeks
Secondary outcomes:
measure: Mexameter erythema score
timeFrame: At 8 and 12 weeks
measure: Patient Satisfaction Score
timeFrame: At 8 and 12 weeks
measure: Physician Global Assessment
timeFrame: At 8 and 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Skin Centre
Study officials:
References:
Clinical trial NCT03830034: Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
Official title: Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 150
Sex: FEMALE
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: Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Detailed description: Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Eligibility criteria: Inclusion Criteria:

* Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound
* Hemoglobin level 8-10.5 g/dL
* Serum ferritin\<15µg/L

Exclusion Criteria:

* The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect...).
* Multiple gestations
* The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease
* Patients with known gastritis
* History of mal-absorption syndrome
* Those with known hypersensitivity to iron preparations
* Those under current iron supplementation

Primary outcomes:
measure: Hemoglobine (Hb) Rise
timeFrame: after 12 weeks of treatment.
Secondary outcomes:
measure: Hemoglobine (Hb) Rise
timeFrame: after 4,8 weeks of treatment.
measure: Adverse effects of the medication given
timeFrame: 3months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
Study officials:
affiliation: Ain Shams University
name: Ahmed Elshahawy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03657134: Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
Official title: Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Ventricular Tachycardia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 20
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: Subjects will be consented to wear the CoVa-2 monitoring system prior to (baseline), during, and after an Electrophysiology Procedure (EP). During this time, the system will measure the following parameters from subjects: heart rate (HR), Heart Rate Variability (HRV), respiration rate (RR), and Cardiac Output (CO). Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor subjects and allow them to be discharged early from the hospital. Subjects will not be measured while transferred in and out of the operating room. Approximate sample size is 20 subjects.


Eligibility criteria: Inclusion Criteria:

1. Patients with arrhythmias and other cardiac conditions that are scheduled for EP procedures.
2. Subject is over 22 years of age at the time of consenting
3. Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study

Exclusion Criteria:

1. Pregnant subjects
2. Subjects who are participating in another clinical study that may affect the results of either study
3. Subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of up to 14 hours
4. Subjects who are considered by the principle investigator to be medically unsuitable for study participation

Primary outcomes:
measure: Average Change in Heart Rate (HR)
timeFrame: Baseline, 8 Hours
measure: Average Change in Respiratory Rate (RR)
timeFrame: Baseline, 8 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lior Jankelson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06628934: Wearable Gait Sensors
Official title: Wearable Sensors for Quantitation of Impaired Gait and Balance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinocerebellar Ataxia
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Ataxia Clinics

Brief summary: This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of Spinocerebellar ataxia.

Detailed description: Study participants will complete a neurological exam with sensors (iSARA exam) and three patient-reported questionnaires (PROM-Ataxia, ABC Scale, EQ-5D-5L). Participation will take about an hour.

Eligibility criteria: Inclusion Criteria:

* Ataxia Group - Individuals who have a genetic-confirmation of SCA diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions.
* Healthy Control Group - Individuals who are able to sit or stand unassisted for 30 seconds and follow directions.

Exclusion Criteria:

* Any other neurological or musculoskeletal disorder not attributed to the SCA that could affect balance, gait or voluntary movement.

Primary outcomes:
measure: iSARA
timeFrame: 8 Years
Secondary outcomes:
measure: Patient Reported Outcome Measure of Ataxia (PROM-Ataxia)
timeFrame: 8 Years
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: 8 Years
measure: EQ-5D-5L
timeFrame: 8 Years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT06664034: Intervening on Women's Health for Rural Young Cancer Survivors
Official title: Intervening on Women's Health for Rural Young Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Fertility Issues
Contraception
Keywords: Reproductive health
Oncofertility
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: Cancer Resource Center of the Desert
name: El Centro Regional Medical Center
name: National Cancer Institute (NCI)
First posted: 2024-10-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm pilot hybrid type I trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care.


Eligibility criteria: Inclusion Criteria:

* Cancer (Stages 0-IV) diagnosis
* Primary language English or Spanish
* Receiving oncology care at rural oncology clinical participating site
* Living in Imperial County, California

Exclusion Criteria:

- Women who are pregnant at recruitment

Primary outcomes:
measure: Proportion of patient's engagement in goal-concordant reproductive health care
timeFrame: 12 weeks after oncology visit
Secondary outcomes:
Other outcomes:
Locations:
city: Brawley
country: United States
facility: San Diego State University - Imperial Valley/ School of Nursing
state: California
city: El Centro
country: United States
facility: Cancer Resource Center of the Desert
state: California
city: El Centro
country: United States
facility: El Centro Regional Medical Center
state: California
city: La Jolla
country: United States
facility: University of Califiornia San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: H. Irene Su, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03454334: Visual Performance of Four Types of Multifocal Intraocular Lenses
Official title: To Compare the Clinical Results of Different Multifocal Intraocular Lenses (IOLs) in Patients With Presbyopia or Cataracts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 141
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.


Eligibility criteria: Inclusion Criteria:

* Preoperative BCVA (distance) more impacted than 20/40
* Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision.
* By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery.
* Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities

Exclusion Criteria:

* Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism.
* Large pupil
* Corneal transplant surgery or previous glaucoma-filtering,
* A history of retinal detachments.
* Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis,
* Endothelial disease
* Iris neovascularization, and amblyopia)

Primary outcomes:
measure: Contrast sensitivity
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03906734: Mitral Valve Management During Septal Myectomy
Official title: Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Keywords: septal myectomy
hypertrophic cardiomyopathy
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2019-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

Detailed description: There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy.

Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.

Eligibility criteria: Inclusion Criteria:

* Hypertrophic obstructive cardiomyopathy
* Left ventricle outflow tract gradient \> 50 mm Hg at rest
* Systolic anterior motion mediated mitral regurgitation

Exclusion Criteria:

* Intrinsic valvular heart disease
* Coronary artery disease
* Aortic disease

Primary outcomes:
measure: Transmitral pressure gradient
timeFrame: 30-days
Secondary outcomes:
measure: Repeat bypass
timeFrame: 30 day
measure: Residual left ventricle outflow tract gradient
timeFrame: intraoperative measuerment
measure: Early mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT01618734: Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP): Efficacy and Safety.
Official title: Eltrombopag and Romiplostim Used Alternatively in Patients With Immune Thrombopenia (ITP).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenia
Thrombopoietin Receptor Agonist
Keywords: Immune Thrombocytopenia
Thrombopoietin receptor agonist
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
Collaborators: name: Paris 12 Val de Marne University
First posted: 2012-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary Immune Thrombopenia receiving romiplostim and eltrombopag alternatively.

Brief summary: TPO-r Switch is a retrospective study of the patients affected by Immune Thrombopenia (ITP) who received alternatively romiplostim and eltrombopag.

Detailed description: Thrombopoietin mimetics agents are available since 5 years in France through clinical trials first and then after their license. Two drugs are used: romiplostim and eltrombopag. These molecules have the same receptor on the megacaryocyte and induce the same stimulation of this cell leading to the differentiation and the proliferation into platelets. But romiplostim and eltrombopag have 2 different characteristics: the way of administration (oral for eltrombopag and subcutaneous for romiplostim) and the binding site to the C-MPL receptor on megacaryocyte. The aim of this study is to describe ITP patients who received these two drugs alternatively in order to know if there is a benefit for switching these molecules in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (Rodeghiero et al, 2009).
* Subject is equal to or greater than 18 years of age.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.
* Subject receiving romiplostim and eltrombopag alternatively
* Available follow-up of 2 months at least for each period

Exclusion Criteria:

- Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia

Primary outcomes:
measure: Rate of efficacy after switching from one TPO mimetics to a second one.
timeFrame: 2 months minimun
Secondary outcomes:
measure: Rate of patients with an adverse events who have a benefit after switching.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Khellaf M, Viallard JF, Hamidou M, Cheze S, Roudot-Thoraval F, Lefrere F, Fain O, Audia S, Abgrall JF, Michot JM, Dauriac C, Lefort S, Gyan E, Niault M, Durand JM, Languille L, Boutboul D, Bierling P, Michel M, Godeau B. A retrospective pilot evaluation of switching thrombopoietic receptor-agonists in immune thrombocytopenia. Haematologica. 2013 Jun;98(6):881-7. doi: 10.3324/haematol.2012.074633. Epub 2013 Feb 26.