louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02650050: Micropulsed Laser in Association With Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
Official title: Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Macular Edema
Mellitus Diabetes
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-01-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema.

Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are the first line treatment of macular edema.

Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective treatment with a minimum injection number and without epithelial lesions.

The main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce the number of anti-VEGF injections during the first year of treatment.

In this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.


Eligibility criteria: Inclusion Criteria:

* 18 years or more
* macular edema associated with a 1 or type 2 diabetes with a hemoglobin A1C level over 5.5% and under \<13%
* indication for a treatment with intra-vitreal injections of ranibizumab

Exclusion Criteria:

* treatment with anti-VEGF during the previous 2 months
* treatment by intra-vitreous implant of dexamethasone during the previous six months
* previous history of vitrectomy or glaucoma
* photocoagulation during the previous 3 months
* patient's opposition to participate to the study

Primary outcomes:
measure: Number of intra-vitreal anti-VEGF injections
timeFrame: One year
Secondary outcomes:
measure: Time to reduction of the macular thickness
timeFrame: One year
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
affiliation: Fondation ophtalmologique de Rothschild
name: Georges CAPUTO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02525250: Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide
Official title: Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia or Myelodysplasic Syndrome
Keywords: Acute myeloid leukemia or myelodysplasic syndrome
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy.

the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. However, it has been shown that the phenotype of NK cells and their cytotoxic functions were altered during this malignancy. In addition, in these patients, impaired NK function is associated with relapse.

lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in the production of TNF-alpha (tumor necrosis factor) by NK.

It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years and above,
* Patient with myeloid acute leukemia or with myelodysplasic syndrome, treated or should be treated with Revlimid,
* Signed consent to participate,
* Patient affiliated to a social security system or benefiting from such as a system.

Exclusion Criteria:

* Allogeneic patients beyond,
* Patient deprived of liberty or under supervision of a guardian,
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.

Primary outcomes:
measure: Evaluation of NK functions
timeFrame: Time from inclusion (Day 0) until Day 28
Secondary outcomes:
measure: cytotoxic response therapy
timeFrame: Time from inclusion until relapse or death (until 5 years)
Other outcomes:
Locations:
city: Marseille
country: France
facility: Thomas PREBET, MD
Study officials:
affiliation: Institut Paoli-Calmettes
name: Thomas PREBET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02167750: Effect of Phytochemicals on Aspects of Cognitive Performance
Official title: Effects of Phytochemicals on Aspects of Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Keywords: cognitive
phytochmicals
caffeine
cognitive performance after ingestion of test beverage
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of the research is to test the short-term effects of the consumption of beverages containing phytochemicals and caffeine on several aspects of cognitive performance.


Eligibility criteria: Inclusion Criteria:

* Subjects should be older than 17 and under 50 years of age, self report of good health

Exclusion Criteria:

* Using any prescription medication including birth control;
* Report a history of any phschiatric condition;
* Report hypersinsitivity to caffeine;
* Have visual impairment that connot be corrected with glasses or contact lenses

Primary outcomes:
measure: The primary outcome will be the changes in the ratings from computer administered tasks within the domains of mood, short-term recognition memory, and attention from pre- to post-study product consumption and between treatment conditions
timeFrame: 0-80 minutes post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Univerysity of Georgia
state: Georgia
Study officials:
References:
Clinical trial NCT05160350: Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy
Official title: Investigation of Probiotic Effect on Seizure Frequency of Adult Patients With Drug-resistant Epilepsy; A Randomized Double-blind Parallel Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Treatment
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind parallel group placebo-controlled clinical trial with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

Drug resistant epilepsy

Exclusion Criteria:

* Hypersensitivity to probiotic
* Acute pancreatitis
* Pregnancy
* Breastfeeding
* Being under treatment with corticosteroids
* Being under treatment with antibiotics during 2 months before enrollment
* Need for antibiotic therapy during the study
* Change in anti-seizure medication within the month before enrollment

Primary outcomes:
measure: Change in seizure frequency
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Bu Ali Sina Hospital
state: Mazandaran
Study officials:
References:
Clinical trial NCT03992950: Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus
Official title: Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus in Anesthetized and Paralyzed Patients During the Induction of Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy

Detailed description: The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.

Eligibility criteria: Inclusion Criteria:

* Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study

Exclusion Criteria:

* Risk of aspiration
* History of esophageal surgery
* Diseases or anatomical abnormalities of the neck, larynx, pharynx or esophagus
* Known or predicted difficult airway.

Primary outcomes:
measure: Occlusion of the esophagus
timeFrame: During 1 minute under videolaryngoscopy
Secondary outcomes:
measure: Outer diameter of the esophagus
timeFrame: During 1 minute after injection of anesthetics during induction of anesthesia
measure: Position of the oesophageal entrance relative to the glottis
timeFrame: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
measure: Position of the upper oesophagus relative to the trachea
timeFrame: During 1 minute after injection of anesthetics during induction of anesthesia and during videolaryngoscopy
measure: The best laryngeal view
timeFrame: Before and after the application of cricoid and paratracheal force during videolaryngoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
References:
citation: Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effectiveness of Cricoid and Paratracheal Pressures in Occluding the Upper Esophagus Through Induction of Anesthesia and Videolaryngoscopy: A Randomized, Crossover Study. Anesth Analg. 2022 Nov 1;135(5):1064-1072. doi: 10.1213/ANE.0000000000006154. Epub 2022 Aug 1.
Clinical trial NCT05775250: Evaluation of Two Varnishes on the Improvement of White Spot Lesions in Children
Official title: Evaluation of Giomer Varnish Versus Fluoride Varnish on The Color Improvement of White Spot Lesions in Permanent Teeth of Children: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Keywords: white spot lesion
fluoride varnish
Giomer Varnish
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized control trial evaluating the effect of the Giomer varnish versus fluoride varnish on the color improvement of the white spot lesion in permanent anterior teeth of children aged between 8-14 years by using a spectrophotometer at baseline, after 1 month, 3 months and 6 months


Eligibility criteria: Inclusion Criteria:

* • Patients with good general health.

  * Adequate oral hygiene,
  * Patients who didn't receive remineralizing agents during the last 3 months other than regular toothpaste.

Exclusion Criteria:

* Uncooperative child.
* Active carious lesion.
* Labial surface restoration.

Primary outcomes:
measure: white spot lesion color change
timeFrame: 6 months
Secondary outcomes:
measure: Patient response to the treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October University of Modern Sciences and Arts
Study officials:
affiliation: October University for Modern Sciences and arts, Cairo, Egypt
name: Naglaa I Ezzeldin, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00706550: Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects
Official title: Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: pneumococcal polysaccharide vaccine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Albert Einstein College of Medicine
name: Montefiore Medical Center
First posted: 2008-06-27
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.


Eligibility criteria: Inclusion Criteria:

* HIV infected
* CD4 count \>200
* no acute illness
* no pneumococcal vaccination within 3 years
* naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months
* willingness to start antiretroviral treatment as recommended by current guidelines

Exclusion Criteria:

* prior pneumococcal vaccination within 3 years
* prior AIDS diagnosis based on opportunistic disease
* acute illness

Primary outcomes:
measure: Immunoglobulin G (IgG) Levels
timeFrame: Baseline
measure: IgG Levels
timeFrame: One-month post-vaccine
measure: Immunoglobulin M (IgM) Levels
timeFrame: Baseline
measure: IgM Levels
timeFrame: One-month post-vaccine
measure: Opsonophagocytic Killing Activity (OPA)
timeFrame: Baseline
measure: Opsonophagocytic Killing Activity (OPA)
timeFrame: One-month post-vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Maria Rodriguez-Barradas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037050: Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
Official title: Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Gram-Positive Bacterial Infections
Bacteremia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-15
Enrollment: 739
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)


Eligibility criteria: Inclusion Criteria:

* Patients with a central indwelling catheter with signs and symptoms of infection

Exclusion Criteria:

* Patients with tunneled catheter which cannot be removed.
* Patients with evidence of endovascular infection including endocarditis.
* Patients with infection of permanent intravascular devices.
* Patients who have received more than 1 day of another antibiotic before enrollment.
* Patients with HIV and low CD4 count.

Primary outcomes:
measure: The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
measure: The empiric treatment of patients with gram-positive catheter-related bloodstream infections.
Secondary outcomes:
measure: Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02646150: Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
Official title: Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb
Ischemia
Perfusion
Keywords: Magnetic Resonance perfusion imaging
distal perfusion
Critical Limb Ischemia
endovascular revascularization
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lower extremity ischemia

Brief summary: This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging to qualitatively assess adequate distal perfusion after endovascular revascularization in Critical Limb Ischemia


Eligibility criteria: Inclusion Criteria:

* Age 20 and above
* Critical limb ischemia with ulcer
* Ankle brachial index(ABI) ≤ 0.9 or Toe brachial index (TBI) ≤ 0.5 or Transcutaneous oxygen pressure (TcPo2) ≤ 40mmHg
* ≥ 70 percentage of stenosis of infrapopliteal artery on lower extremity computed tomography angiography or lower extremity doppler
* Subject understands protocol and provides written, informed consent

Exclusion Criteria:

* Post-traumatic critical limb ischemia
* Neurogenic limb ischemia
* Life expectancy ≤ 2 years

Primary outcomes:
measure: The change of deoxyhemoglobin in MR imaging
timeFrame: 6 months
Secondary outcomes:
measure: The event rate of unplanned major and minor amputation in limb
timeFrame: 6 months
measure: The event rate of complete healing of lower extremity ulcer
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT06344650: Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.
Official title: Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acromegaly
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Campus Bio-Medico
name: Istituto Auxologico Italiano
First posted: 2024-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acromegaly patients able to sign informed consent

Brief summary: Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of acromegaly
* availability to carry out outpatient checks
* ability to provide informed consent

Exclusion Criteria:

* Pregnancy
* use of glucocorticoids (except those in use for replacement therapy)
* alcohol abuse
* exacerbation of chronic disease
* serious comorbidities (renal or hepatic failure, heart attack, stroke)
* terminally ill, prolonged immobilization (\>1 week)
* clinically evident fracture within the previous six months
* any other cause of secondary osteoporosis within the last five years
* any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.

Primary outcomes:
measure: Identify the rate of morphometric vertebral fractures in acromegalic patients
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Andrea Giustina
Study officials:
References:
Clinical trial NCT07023250: Sensorineural Hearing Loss Imprint
Official title: Sensorineural Hearing Loss Imprint on Manual Dexterity and Coordination: Pediatric and Adolescent Innovative Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sensorineural Hearing Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty-five children from both genders and their ages ranged from ten to sixteen years old were recruited from Public School for the Deaf and Hard of Hearing in Banimazar district, Minia Governorate, Egypt.

Brief summary: this study will investigate the consequences of sensorineural hearing loss on manual dexterity and coordination skills in Children.


Eligibility criteria: Inclusion Criteria:

* Both genders with a clinical diagnosis of severe to profound SNHL only. Their ages were between ten to sixteen years, able to understand simple instructions by sign language, able to use both upper and lower limbs, walk and practice daily living activities independently.

Exclusion Criteria:

* Children with cochlear implantation, any cognitive, physical, visual, or neurological conditions (other than SNHI and vestibular impairment), history of previous upper, lower limbs, trunk deformity or surgery. All of these cases were confirmed by medical records and examined by a Physical therapist, Pediatrician, and Audiologist

Primary outcomes:
measure: manual dexterity and coordination
timeFrame: it will be measured only one time in evaluation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: