louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00451763: Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia
Official title: Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retina
Telangiectasis
Keywords: Fovea centralis/pathology
Fundus oculi
Retinal neovascularization
Telangiectasis/diagnosis
Tomography, optical coherence
Vitreous Body/drug effects
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2007-03-23
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia.

In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that, unlike in age-related macular degeneration, seems to be retinal rather than choroidal in origin. Before the hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the visual acuity. Long-term visual prognosis in patients with this complication may be poor and treatment with laser photocoagulation is unproven. Although newly reported treatment, by photodynamic therapy for neovascular membrane associated with Idiopathic Macular Telangiectasia, may show vision and angiographic stability in a few cases, the improvement may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases.

The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml) in the treatment of Idiopathic Macular Telangiectasia.


Eligibility criteria: Inclusion Criteria:

* patients with idiopathic macular telangiectasia
* patient consent

Exclusion Criteria:

* heart attack or cerebrovascular attack
* previous treatment for others retinopathy
* media opacities that preclude visualization of the fundus
* inability to understands the implications of the protocol

Primary outcomes:
measure: Visual acuity
measure: Optical coherence tomography
measure: Fluorescein angiography
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: From the Retina and Vitreous Service, Department of Ophthalmology. Sao Rafael Hospital, Monte Tabor Foudation
state: Bahia
Study officials:
affiliation: University of Sao Paulo
name: Walter Y Takahashi, M.D.
role: STUDY_DIRECTOR
affiliation: Sao Rafael Hospital, Monte Tabor Foudation
name: Otacilio O Maia Jr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maia OO Jr, Bonanomi MT, Takahashi WY, Nascimento VP, Takahashi BS. Intravitreal bevacizumab for foveal detachment in idiopathic perifoveal telangiectasia. Am J Ophthalmol. 2007 Aug;144(2):296-9. doi: 10.1016/j.ajo.2007.03.059.
Clinical trial NCT01623063: Histomorphometry Analysis in Fertile and Infertile Patients
Official title: Histomorphometry Analysis in Fertile and Infertile Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: endometrium
infertility
uterus
histeroscopy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To detect similarities and differences in the endometrium of fertile and infertile patients

Detailed description: morphometric and pathologyc analysis of the endometrium in fertile and infertile patients

Eligibility criteria: Inclusion Criteria:

* 18 to 41 years old
* regular menses
* infertility over 12 months

Exclusion Criteria:

* previous uterine surgery
* use of contraceptive pills or injections less than 3 months from the inclusion in the study

Primary outcomes:
measure: glandular volume
timeFrame: 1 month
Secondary outcomes:
measure: epitelial surface
timeFrame: 1 month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas
Study officials:
affiliation: University of Sao Paulo
name: Dani Ejzenberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06153563: Evaluation of the Elasticity of the Mitral Valve
Official title: Evaluation of the Elasticity of the Mitral Valve Chordae by Uniaxial Traction in the Context of Mitral Valve Regurgitation With a Comparison of the Results: Mitral Valve Prolapse vs Restriction of Mitral Valve Movement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Disease
Keywords: Mitral valve
mitral valve chords
elasticity
Young's modulus
mitral valve histology
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 30
Sex: ALL
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: Patients programmed for mitral valve replacement who have more than 45 years old

Brief summary: There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen human tissues. The objective is to determine mechanobiological and histological characteristics of the mitral valve chords in living humans, as well as to compare differences in elasticity in different groups (Group A: patients with mitral valve prolapse versus Group B: patients with restrictive ischemic mitral valve).

Detailed description: The prospective study will be conducted on 20 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.

The harvested tissue will not be frozen and will kept in natural conditions as close as possible.

Eligibility criteria: Inclusion Criteria:

All patients programmed for mitral valve replacement who have more than 45 years old

Exclusion Criteria:

* Patients with mitral calcification
* Mitral valve rheumatic disease
* Mitral valve infections
* Redo surgery on the mitral valve

Primary outcomes:
measure: Maximum value of Young's modulus
timeFrame: Hour 1
Secondary outcomes:
measure: First histological evaluation
timeFrame: Hour 1
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Andranik PETROSYAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02947763: Single Versus Multiple Visits Endodontic Treatment
Official title: Healing Rates After Single Versus Multiple Visits Endodontic Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periapical Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year

Detailed description: Patients with necrotic teeth with apical periodontitis will be selected according to the eligibility criteria and patients are then randomized to either single visit or multiple visit using triple paste intracanal medicament. Postoperative pain will then assessed using numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing will be assessed every 3 months up to one year.

Eligibility criteria: Inclusion Criteria:

1. Adult patients; age between 16-55 years old.
2. Males or Females.
3. Maxillary or mandibular single-root tooth or a multi-rooted tooth with:

   * Non-vital response of pulp tissue.
   * Radiographic evidence of periapical lesions (minimum size 2.0 mm × 2.0 mm) related to one root in case of multi-rooted teeth.
   * Asymptomatic patients.
4. Positive patients' acceptance for participation in the study.

Exclusion Criteria:

1. Primary teeth, and permanent teeth with immature apex.
2. Teeth previously accessed or endodontically treated.
3. Patients with diabetes and immune-compromising disease.
4. Patients allergic to metronidazole, ciprofloxacin, or minocycline.
5. Vital cases or necrotic without periapical lesion.
6. Pregnant women.
7. Teeth with unfavorable conditions for rubber-dam application.
8. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.

Primary outcomes:
measure: postoperative pain
timeFrame: 24 hours
measure: postoperative pain
timeFrame: 48 hours
measure: postoperative pain
timeFrame: 72 hours
measure: postoperative pain
timeFrame: 7 days
Secondary outcomes:
measure: Radiographic healing
timeFrame: 3 months
measure: Radiographic healing
timeFrame: 6 months
measure: Radiographic healing
timeFrame: 9 months
measure: Radiographic healing
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: AbdurRahman S, Abdel Aziz SM, Gawdat SI, AbdalSamad AM. Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial. F1000Res. 2019 Jul 26;8:1203. doi: 10.12688/f1000research.19936.1. eCollection 2019.
Clinical trial NCT01673763: Post-ERCP Pancreatitis Prevention by Stent Insertion
Official title: Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Keywords: ERCP
endoscopy
pancreatitis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Northern State University, Russia
name: KU Leuven
name: Latvijas Universitates Medicinas
First posted: 2012-08-28
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
* age \> 17 years
* signed informed consent

Exclusion Criteria:

* intention to intervene main pancreatic duct
* age \< 18 years
* pregnancy
* absent of signed informed consent

Primary outcomes:
measure: Incidence of post-ERCP pancreatitis
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Deptartment of Hepatobiliary Diseases Leuven University Hospitals
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
city: Riga
country: Latvia
facility: P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas
city: Arkhangelsk
country: Russian Federation
facility: First city hospital of emergency care Northern State Medical University
Study officials:
affiliation: II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich
name: Hana Algül, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06924463: Identification of Specific Molecular Signatures in Pediatric, Adolescent, and Young Adult Rhabdomyosarcoma Through Spatial Proteome Analysis Using Mass Spectrometry
Official title: Identification de Signatures moléculaires spécifiques Dans le Rhabdomyosarcome de l'Enfant, de l'Adolescent et du Jeune Adulte, Par Analyse Spatiale du protéome Par spectrométrie de Masse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rhabdomyosarcoma
Keywords: rhabdomyosarcoma
molecular signatures
spatial proteome
targeted therapy
Lead sponsor: Lille University
Sponsor class: OTHER
Collaborators: name: Centre Oscar Lambret, Lille, France
First posted: 2025-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oscar Lambret Center (Lille, France)

Brief summary: This non-interventional study aims to develop spatial proteomics for analyzing small FFPE tumor samples in rhabdomyosarcoma. It will identify molecular signatures linked to tumor regions, subtypes, survival, and treatment resistance, using pre-existing samples and data.

Detailed description: This is a non-interventional, monocentric, retrospective cohort study aimed at developing a spatial proteomics analysis method for small tumor samples (FFPE) to precisely characterize proteins at the tissue level in rhabdomyosarcoma (RMS). Using mass spectrometry, the study will identify molecular signatures associated with different tumor regions, histological subtypes, patient survival, and treatment resistance. The goal is to identify potential protein biomarkers and therapeutic targets. Data from clinical samples will be analyzed to find biomarkers correlated with survival and resistance to treatment. No patient intervention is required, as the study uses pre-existing biological samples and clinical data.

Eligibility criteria: Inclusion Criteria:

* Age between 0 and 25 years at the time of initial diagnosis
* Diagnosis of rhabdomyosarcoma confirmed histologically
* Care at the Oscar Lambret Center between January 2005 and November 2024
* No objection to the re-use of data and biological samples collected as part of care for research activities.

Exclusion Criteria:

* Unavailability of biological sample in FFPE from biopsy and/or surgical specimen for diagnosis at Centre Oscar Lambret;
* Patient under guardianship or trusteeship.

Primary outcomes:
measure: Spatial Proteomic Profiling of Tumor Samples
timeFrame: 12 months (study duration)
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Oscar Lambret Center
state: Nord
Study officials:
References:
Clinical trial NCT02620163: Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH22162 in Subjects With Essential Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 381
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Men and women ≥ 19 years of age
* Essential hypertensive patients

  1. If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP \< 200 mmHg
  2. If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP \< 200 mmHg

Exclusion Criteria:

* Patients with known or suspected secondary hypertension
* Other exclusions applied

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
timeFrame: baseline and week 8
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2
timeFrame: baseline and week 2
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4
timeFrame: baseline and week 4
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 2
timeFrame: baseline and week 2
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 4
timeFrame: baseline and week 4
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 8
timeFrame: baseline and week 8
measure: Patients Achieving Blood Pressure Control at Week 2
timeFrame: baseline and week 2
measure: Patients Achieving Blood Pressure Control at Week 4
timeFrame: baseline and week 4
measure: Patients Achieving Blood Pressure Control at Week 8
timeFrame: baseline and week 8
measure: Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 2
timeFrame: baseline and week 2
measure: Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 4
timeFrame: baseline and week 4
measure: Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 8
timeFrame: baseline and week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yuhan
Study officials:
affiliation: Yuhan Corporation
name: Hyunhee Na, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01038063: Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period
Official title: Programmatic Implementation of ACTs in Malawi: Safety and Effectiveness of Combination Therapies With Repeated Treatments for Uncomplicated P. Falciparum Malaria Over a Three-year Period
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
name: National Malaria Control Programme, Malawi
name: Research for Equity and Community Health Trust
First posted: 2009-12-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).


Eligibility criteria: Inclusion criteria

1. Aged between 4 months and 11 months at the time of randomization
2. Bodyweight ≥ 5 kg at the time of randomization
3. Provision of informed consent by parent or guardian
4. Intention to stay in the study area for the time of the study

Exclusion criteria

1. Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products
2. Intent to reside outside of catchment area during the course of the study
3. Known hypersensitivity to the study drug randomized to
4. Known pre-existing hearing problem or neurological impairment
5. Known need at the time of randomization for concomitant prohibited medication
6. Suspected non-compliance with the follow-up schedule

Primary outcomes:
measure: Prevalence of ototoxicity at 18 months and 36 months of enrolment.
timeFrame: At 18 mo and 36 month of follow up
Secondary outcomes:
measure: Incidence of clinical malaria during 18 months and 36 months of follow-up
timeFrame: 18 and 36 months of follow up
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine
Study officials:
affiliation: Liverpool School of Tropical Medicine
name: David Lalloo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roca-Feltrer A, Lalloo DG, Phiri K, Terlouw DJ. Rolling Malaria Indicator Surveys (rMIS): a potential district-level malaria monitoring and evaluation (M&E) tool for program managers. Am J Trop Med Hyg. 2012 Jan;86(1):96-8. doi: 10.4269/ajtmh.2012.11-0397.
Clinical trial NCT04064463: Dual Reinforcement Contingency Management for Alcohol Use Disorders
Official title: Dual Reinforcement Contingency Management for Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Contingency Management
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-08-22
Enrollment: 150
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: Phosphatidylethanol (PEth) is a direct biomarker of alcohol that can detect moderate to heavy drinking with high sensitivity and specificity over 3-week periods. Reinforcing negative PEth results alongside attendance may increase the proportion of participants who respond to CM during and post treatment. In the proposed study, the investigators will collect PEth samples every 3 weeks for 12 weeks in 150 participants initiating outpatient treatment for alcohol use disorders. Using a two-group randomized design, participants will be assigned to standard care with PEth monitoring alone or with CM for attending treatment and submitting PEth negative samples. Compared to standard care and monitoring, the investigators expect that the CM intervention will result in greater attendance, more PEth negative samples, and higher proportions of self-reported non-drinking days, along with lower proportions of heavy drinking days, over the short term and the long term, measured throughout a 12-month follow-up. The investigators anticipate that the reinforcement intervention may decrease other drug use and sexual risk behaviors that spread HIV, reduce psychiatric symptoms, and improve quality of life as well.


Eligibility criteria: Inclusion Criteria:

* in intensive outpatient treatment
* DSM-5 diagnosis of an alcohol use disorder

Exclusion Criteria:

* have a condition that may hinder study participation

Primary outcomes:
measure: Group attendance
timeFrame: 12 weeks
measure: Alcohol abstinence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: The Village
state: Connecticut
Study officials:
affiliation: UConn Health
name: Sheila Alessi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: