louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04120818: Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy
Official title: Expression Profile of Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cataract
Keywords: inflammatory cytokines
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 59
Sex: ALL
Minimum age (years): 10
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: congenital cataract age from 10 months to 72 months who underwent cataract surgery or aphakic children age from 15 months to 72 months who underwent secondary IOL implantation

Brief summary: In this prospective study , a cohort of 58 eyes with congenital cataract from Wenzhou medical university was erolled.33 eyes with congenital cataract was after lensectomy and anterior vitrectomy as post-surger group, 26 eyes without cataract surgery as control group. The cytokines of MCP-1, VEGF, IL-1, IFN-γ, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15 was evaluated

Detailed description: Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E) and videos were collected to review the capsular reconstruction condition and lens implantation position.

Aqueous humor (100-200 μl) was aspirated from each patient before the surgery. The research was to evaluate the relationship between the cytokine profile in aqueous humor and the state of capsule after Lensectomy and Anterior Vitrectomy.Aqueous humor was obtained , Human Magnetic Luminex Screening Assay was used to determine the aqueous humor levels of cytokines.

Eligibility criteria: Inclusion Criteria: aphakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation

Exclusion Criteria:patients with mild cataracts do not require surgery

-

Primary outcomes:
measure: inflammatory cytokines
timeFrame: before the surgery of secondary IOL implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hosptial of Wenzhou Medical College
state: Zhejiang
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT04556318: Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)
Official title: Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with signs or symptoms of any respiratory system infection or signs or symptoms indicating SARS-CoV-2 infection or radiological findings suggesting viral lung infection

Brief summary: Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air.

In this feasibility study it is intended to find specific biomarker(s) in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).


Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
* Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
* Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR

Exclusion Criteria:

* History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
* Participation in another clinical study prior to breath analysis which could influence the result of the breath analysis

Primary outcomes:
measure: SARS-CoV-2 related volatile organic compounds (VOC)
timeFrame: 1 hour after breath gas sampling
Secondary outcomes:
measure: To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings
timeFrame: Within 3 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
city: Munich
country: Germany
facility: Technical University of Munich, Klinikum rechts der Isar
Study officials:
affiliation: Technical University of Munich, Klinikum rechts der Isar
name: Christoph Spinner, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238913: Use of Metal Stents on Benign Esophageal Lesions
Official title: Prospective Evaluation of the Clinical Utility of the Endoscopic Placement of Mental Stent for Benign Esophageal Lesions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Benign Esophageal Lesions
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a medical indication for endoscopic placement of esophageal metal stent and are referred for the porcedure as part of their standard medical care will be considered for the study.

Brief summary: The evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions.


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has medical indication to undergo endoscopic placement of esophageal metal stent
3. Subject must be able to give informed consent

Exclusion Criteria:

1. Any contraindications for endoscopic placement of esophageal metal stent
2. The subject is unable to give informed consent.

Primary outcomes:
measure: Successful stenting of Benign esophageal lesions
timeFrame: approximately 2-3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146913: AFR10 - Combination Therapy of Imatinib Mesylate (IM) + Alpha-2A Interferon for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
Official title: A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic myeloid leukaemia
resistant
refractory
Imatinib mesylate
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.


Eligibility criteria: Inclusion Criteria:

* Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM.
* Lack of major cytogenetic response after at least one year of STI 571 as single therapy.
* Male and female \* 18 years old.
* Informed consent signed up.
* Performance status grade 0 - 2 (ECOG).
* SGOT and SGPT \<3N
* Serum bilirubin \< 1.5 N
* Serum creatinine \< 1.5 N
* No HSC graft planned
* B-HCG negative for female with potential childbearing

Exclusion Criteria:

* Absence of complete hematologic response
* Extramedullar involvement
* Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week
* Depressive syndrome not controlled
* Not controlled dysthyroidy
* Auto-immune pathology not controlled
* Women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study
* Significant cardiac disease (grade 3 or more)
* Known seropositivity for HIV
* Active viral hepatitis
* Other malignant disease
* Other experimental medication

Primary outcomes:
measure: Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
Secondary outcomes:
measure: Evaluate the tolerance of a combination of STI571 and alpha-interferon
Other outcomes:
Locations:
city: Lyon
country: France
facility: Franck NICOLINI
Study officials:
affiliation: Hospices Civils de Lyon
name: Mauricette MICHALLET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05501613: Early Multimodal Neuromonitoring For Spontaneous Intracerebral Hemorrhage (ICH)
Official title: Early Multimodal Neuromonitoring Parameters as Prognostic Factors For Critically Ill Spontaneous ICH Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Critically Ill
Intracranial Pressure
Cerebral Perfusion Pressure
Prognostic
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 65
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: Critically Ill Spontaneous Intracerebral Hemorrhage Patients

Brief summary: The investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ICH) patients.

Detailed description: Retrospective observational study based on analyzing the first 48 hours of the multimodal neuromonitoring signal, from spontaneous ICH patients, whose treatment includes invasive intraparenchymal neuromonitoring, treated from January 2015 to September 2021 in a tertiary hospital.

Eligibility criteria: Inclusion Criteria:

* Spontaneous Intracerebral Hemorrhage
* ICU admission
* Need of Sedation and Ventilatory Support
* Need of Intracerebral Neuromonitoring

Exclusion Criteria:

* Etiology for Intracerebral hemorrhage such as tumor, vascular malformation, ischemic transformation.

Primary outcomes:
measure: Survival
timeFrame: 1 and 6 months
measure: Functional Outcome
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
Study officials:
References:
Clinical trial NCT03693313: The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
Official title: The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD, Autism Spectrum Disorder
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Wait List Trial
Primary purpose: TREATMENT

Brief summary: The Centers for Disease Control and Prevention estimates that 1 in 59 U.S. children have been diagnosed with an autism spectrum disorder (ASD). Peer relationships, social skills, and repetitive behaviors are a challenge for those with ASD. Exercise in the ASD population has been examined as a means to improve some of these challenges for children with ASD. This research study will try to see if a structured exercise program called CrossFit Kids can help with these challenges. This study is potentially beneficial in developing an exercise program for children with ASD that can help promote social skill development, reduce stereotypical behaviors, and provide overall health benefits.


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Autism Spectrum Disorder
* Full Scale IQ \>80 on standardized testing
* English speaking
* Parents must be able to bring children to class twice a week for 14 weeks.

Exclusion Criteria:

* Non-English speaking
* Medical condition or physical impairment precluding them from safely participating in classes (eg. spastic quadriplegic cerebral palsy, critical congenital heart disease, uncontrolled asthma, uncontrolled seizure disorder, etc.)

Primary outcomes:
measure: Improvement in social skills in children with ASD
timeFrame: 40 weeks
measure: Improvement in behavioral symptoms in children with ASD
timeFrame: 40 weeks
measure: Improvement in repetitive behaviors in children with ASD
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
Study officials:
References:
Clinical trial NCT02763813: Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome
Official title: Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.


Eligibility criteria: Inclusion Criteria:

* Sufficient teeth to allow wearing of the device
* Mild to severe OSAS
* Ability to answer the questionnaires
* No concomitant CPAP treatment
* BMI inferior to 32 kg/m2

Exclusion Criteria:

* Important dental or parodontal disease
* Central sleep apnea
* Jaw opening limitations
* Temporo-mandibular joint dysfunction
* Major gag reflex precluding the long-term use of the device
* Major or unstable cardiovascular or pulmonary disease

Primary outcomes:
measure: Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
affiliation: Hôpital FOCH 40, rue Worth 92150 Suresnes
name: Marc BLUMEN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02063113: Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
Official title: Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Myeloma in Older Patients
Keywords: Multiple myeloma,
Older patient,
Treatment,
Geriatric assessment
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 48
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.


Eligibility criteria: Inclusion Criteria:

* Patients aged 70 years and older
* Patients referred for a assessment of a newly diagnosed multiple myeloma
* Patients for who the initial therapy proposed is either melphalan-prednisone-thalidomide or melphalan-prednisone-bortezomib or included in a phase 3 trial.
* Patients who provide informed written consent

Exclusion Criteria:

* Patients who refuse the study
* Patients who won't have therapy
* Patients can't respond to geriatric assessment because of severe cognitive disorder
* Patients with a legal guardian

Primary outcomes:
measure: The occurrence of the events
timeFrame: 6 MONTHS
Secondary outcomes:
measure: Type of Vulnerability
timeFrame: 6 MONTHS
measure: Therapeutic changes
timeFrame: 6 MONTHS
measure: Toxicity during treatment
timeFrame: 6 months
measure: Progression to 1 and 2 years
timeFrame: 1 year/2year
measure: Complete response at 1 and 2 years
timeFrame: 1 year/2 years
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CHD Vendée La Roche sur Yon
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: CHD Vendée La Roche sur Yon
name: Komivi AGBETSIVI, DR
role: PRINCIPAL_INVESTIGATOR
affiliation: CH du Mans
name: VIGNARD Patricia, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Catherine Cattenoz, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Brest
name: Jean -Richard EVEILLARD, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Lille
name: François Puisieux, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Jean -Yves NIEMIER, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CGD de Marseille
name: Frédérique Retornaz, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Européen de Marseille
name: Véronique Brunel, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Laure De Decker, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05194813: Surface Treatment of the Dental Implant on the Osseointegration
Official title: The Effect of Surface Treatment of the Dental Implant on the Osseointegration in Mandibular Posterior Missing Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Surface Treatment
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental implants have become a widely accepted treatment modality for the replacement of missing single or multiple teeth in the recent years. In order to meet patients' needs for shorter treatment times and the necessity of dealing with more challenging clinical situations, implants and implant therapies have undergone continuous improvement to improve the function and longevity of the implants. Recently the constant search for improvements in modern implant have been focused on surface modifications so a new era of surface treatment have been showed up; the chemically modified hydrophilic surfaces.


Eligibility criteria: Inclusion Criteria:

* Missing mandibular posterior teeth.
* Good oral hygiene (plaque index less than 10 %)
* Good compliance to the treatment.
* Participants are free from local or systemic disease
* Willingness and ability to commit to follow-up placement.
* Adequate bone height and width to accommodate implant placement and sufficient keratinzed mucosa.
* At least 3months after tooth extraction
* Sufficient interocclusal distance

Exclusion criteria

* Presence of persistent and unresolved infection in the implant site
* Parafunctional habits.
* Heavy Smokers.
* Uncontrolled systemic disease that impedes bone healing

Primary outcomes:
measure: Change in implant stability
timeFrame: at baseline and 6 months
measure: Change in bone density
timeFrame: at baseline and 6 months
measure: Change in ridge height
timeFrame: at baseline and 6 months
measure: Biochemical assessment of bone formation
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00643019: Project Sexual Awareness for Everyone (SAFE)
Official title: Preventing Recurrent Sexually Transmitted Infections in Minority Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexually Transmitted Disease
Secondary Prevention
Behavioral Modification
Public Health
Keywords: Sexually Transmitted Infections
Secondary Prevention
Cognitive Behavioral Intervention
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2008-03-25
Enrollment: 800
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.

Detailed description: Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.

Eligibility criteria: Inclusion Criteria:

* Mexican American,
* 14 - 45 years old,
* English Speaking,
* non-viral sexually transmitted infection

Exclusion Criteria:

* Non-English speaking,
* viral sexually transmitted infection

Primary outcomes:
measure: Re-infection with a non-viral sexually transmitted infection
timeFrame: 1 year
Secondary outcomes:
measure: Changes in risky sexual behavior
timeFrame: 2 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Rochelle N Shain, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thurman AR, Holden AE, Shain RN, Perdue S, Piper JM. Preventing recurrent sexually transmitted diseases in minority adolescents: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1417-25. doi: 10.1097/AOG.0b013e318177143a.