louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03235011: Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.
Official title: Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 99
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.

Brief summary: Evaluation of knowledge about contraception in sickle cell adolescents.

Detailed description: Sickle cell teenagers receive regular hospital medical care.

Adolescence is the time when the pathophysiology of the disease is re-explained and when questions around puberty (possibly delayed), sexuality and contraception are discussed.

Sickle cell disease, like any chronic disease, can have repercussion on the development and behavior of young patients.

Knowledge and understanding of young patients with sickle cell disease around these issues may be insufficient.

Eligibility criteria: Inclusion Criteria:

* Patients with sickle cell disease followed at the CHIC
* Aged 14 to 19
* Both sexes

Exclusion Criteria:

* Neurological disorders that can impede understanding of the questionnaire.
* Refusal to participate.
* Not affiliated to social security.

Primary outcomes:
measure: Score value of the questionnaire on general knowledge on contraception
timeFrame: at inclusion
Secondary outcomes:
measure: Score value of the questionnaire on specific knowledge on the transmission of the disease
timeFrame: at inclusion
measure: Score value of the questionnaire on the transmission of the disease knowledge
timeFrame: at inclusion
measure: Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty
timeFrame: at inclusion
measure: Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality
timeFrame: at inclusion
measure: age of the patient with sickle cell disease
timeFrame: at inclusion
measure: gender of the patient with sickle cell disease
timeFrame: at inclusion
measure: number of hospitalizations of the patient with sickle cell disease
timeFrame: at inclusion
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: Creteil
Study officials:
References:
Clinical trial NCT04139811: Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD
Official title: Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Keywords: Internal limiting membrane
multifocal electoretinogram (ERG)
OCT-Angiography
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.

The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.

In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.

Detailed description: interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.

Eligibility criteria: Inclusion Criteria:

* All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).

Exclusion Criteria:

* Complicated cases with advanced proliferative vitreoretinopathy (PVR).
* Patients with retinal vascular disorders and other macular disorders.
* Combined tractional and rhegmatogenous detachment.
* Previous retinal reattachment surgery or Intravitreal injections.
* Glaucomatous patients.
* Patients with corneal opacity which impairs good visualization.

Primary outcomes:
measure: anatomical outcome
timeFrame: 6 months follow up
measure: epiretinal membrane
timeFrame: 6 months follow up
Secondary outcomes:
measure: functional outcome
timeFrame: 6 months follow up
measure: superficial capillary density
timeFrame: 6 months follow up
measure: multi-focal Electroretinogram
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia UNiversity hospital
state: Minia
Study officials:
affiliation: sub-investigator
name: Mohamed F Othman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: sub-investigator
name: Ahmed Shawkat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: sub-investigator
name: khalid Murad
role: PRINCIPAL_INVESTIGATOR
affiliation: sub-investigator
name: Mohamed Abdullah
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdullah ME, Moharram HEM, Abdelhalim AS, Mourad KM, Abdelkader MF. Evaluation of primary internal limiting membrane peeling in cases with rhegmatogenous retinal detachment. Int J Retina Vitreous. 2020 May 7;6:8. doi: 10.1186/s40942-020-00213-4. eCollection 2020.
Clinical trial NCT05100511: Fundus Image-guided Focal Electroretinography, Usability Study
Official title: Fundus Image-guided Focal Electroretinography, Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Macular Edema
Macular Degeneration
Keywords: Electroretinography
ERG
Lead sponsor: Maculaser Oy
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The usability of the investigational device is examined first with 10 healthy subjects and afterwards with total of 10 patients suffering either from macular edema or macular degeneration.
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the usability of fundus image-guided focal electroretinography device with healthy subjects and with macular edema and macular degeneration patients.

Detailed description: In this study, we will study the usability of focal electroretinography device combined with slit lamp biomicroscope. The device allows simultaneous fundus imaging and focal ERG recording from the desired retinal area.

In phase I, the usability of the investigational device is tested with 10 healthy volunteers. The examinations include focal ERG and noise tests with commercial ERG electrodes. The stimulus lights are guided to the fundus using either non-contact of contact fundus lens. One electrode is selected for phase II based on signal-to-noise ration, usability, and comfort.

In phase II, fundus image-guided focal ERG recordings are conducted with total of 10 patients having either macular edema or macular degeneration. The aim of the phase II is to test whether the investigational device can be used to record focal ERG signal from the desired symptomatic retinal area.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with no signs of macular edema or macular degeneration (phase I)
* Patients with either macular edema or macular degeneration (phase II)
* Able to give informed consent

Exclusion Criteria:

* Epileptic patients
* Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.

Primary outcomes:
measure: Signal-to-noise ratio of focal electroretinography signal
timeFrame: Through study completion, an average of 1 year
measure: Focal ERG from symptomatic retinal area
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Patient comfort and usability of different ERG electrodes in focal ERG.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Retinal Outpatient Clinic
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Joni Turunen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542711: Bio-availability of a New Liquid Tumeric Extract
Official title: Liquid Tumeric Extract for Increasing Bio-availability of Curcumin in the Human Body: Pharmacokinetic Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Curcumin
Bioavilability
Healthy subjects
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract, Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the bioavailability of the liquid tumeric/curcumin extract will be better compared to the currently used curcumin powder.

Detailed description: Twelve healthy participants enrolled to the study. All volunteers will have pre study evaluation to confirm healthy state. After enrollment, each participant will be tested twice, one with the liquid tumeric/curcumin (study drug) and once with the curcumin powder (control). The days of testing will be on two days, separated by two weeks wash-out period. The participants will be assigned to randomly receive study drug or control on the 1st day, with the other regimen administered at the 2nd day. Both study drug and control will be diluted in 150ml of water. The doe of study drug will be escalated from 30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). Blood sample will be collected at 0,0.25,0.5,0.75,1,2,3,4,5,6,8h post drug. Quantization of curcumin plasma levels will be done by the high pressure liquid chormatography method. A biomarker for the potential effect of curcumin, platelet function pre and post curcumin consumption will be tested.

Eligibility criteria: Inclusion Criteria:

* Complete Healthy
* Able to attend two full days of study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shoshana Revel-Vilk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618511: Interventions to Improve HIV Antiretroviral Therapy Adherence
Official title: Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV) Infection
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Beira Operational Research Center
First posted: 2018-08-07
Enrollment: 914
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will explore whether financial incentives, reminders, information about HIV/AIDS and its treatment and anti-stigma counseling help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminders treatment group, a treatment group that receives both the financial incentive and reminder interventions. In addition, there will be an information treatment group, a stigma-relieving treatment group and a group that receives both information and stigma-relieving interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.


Eligibility criteria: Inclusion Criteria:

* Infected with HIV;
* Have not start ART, or started ART less than 90 days before;
* Have a phone number on which can discuss private health matters.

Exclusion Criteria:

* Not infected with HIV;
* On ART for more than 90 days;
* Do not have a private phone.

Primary outcomes:
measure: Medication possession ratio (MPR) at least 95%, 6 month window
timeFrame: 0-6 month interval from date of study enrollment
Secondary outcomes:
measure: Medication possession ratio (MPR) at least 95%, 3 month window
timeFrame: 0-3 month interval from date of study enrollment
measure: Medication possession ratio (MPR) at least 80%, 6 month window
timeFrame: 0-6 month interval from date of study enrollment
measure: Medication possession ratio (MPR) at least 80%, 3 month window
timeFrame: 0-3 month interval from date of study enrollment
measure: Appointment attendance rate (AAR)
timeFrame: 0-6 month interval from date of study enrollment
measure: Lost to follow-up (LTFU)
timeFrame: 0-6 month interval from date of study enrollment
measure: Test Referral, 1-month window
timeFrame: 1 month interval from date of study enrollment
Other outcomes:
Locations:
city: Beira
country: Mozambique
facility: Munhava Health Center
state: Sofala
Study officials:
affiliation: University of Michigan
name: James Riddell IV, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257411: A Method to Determine the Size of Laryngeal Mask Airway (LMA)
Official title: A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Based ProSeal LMA
Keywords: child
ear based
Proseal LMA
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 197
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I/II
* scheduled for genitourinary operation
* LMA was indicated for anesthesia

Exclusion Criteria:

* surgery lasting more than 3 h
* overweight or underweight patients
* gastroesophageal reflux
* risk of aspiration
* airway infection in the last six weeks
* decreased pulmonary or chest wall compliance.

Primary outcomes:
measure: the sizes of the PLMA determined with the ear-based formula
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Yeditepe University Hospital
state: Kozyatağı
Study officials:
References:
Clinical trial NCT00221611: Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Official title: Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Detailed description: Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Eligibility criteria: Inclusion Criteria:

* CP patients with therapy-resistent spasticity
* Patients with sufficient body weight in relation to the volume
* Oral medication has failed: insufficient effect or too many side-effects
* The patient and family understand the objectives of the treatment and accept those objectives
* Informed Consent

Exclusion Criteria:

* Contra-indications for surgery (e.g. infection)
* Hypersensitivity to oral Baclofen

Primary outcomes:
measure: Spasticity of patients after 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Dr. Uyttendale, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00250211: Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide
Official title: Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Glioma
Keywords: magnetic resonance imaging, functional
radiation therapy
temozolomide
functional imaging
concurrent chemoradiation
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2005-11-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed glioblastoma multiforme
* Ages 18-65
* Karnofsky Performance Scale (KPS) equal to or less than 70
* Minimal neurological deficit
* Eligible for concurrent temozolomide chemotherapy

Exclusion Criteria:

* Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer

Primary outcomes:
measure: determine tumor response and pattern of failure using functional MRI imaging
timeFrame: Study completion
measure: time to disease progression
timeFrame: Study completion
Secondary outcomes:
measure: distinguish residual tumor from treatment-related necrosis
timeFrame: study completion
measure: survival
measure: acute late toxicity of tomotherapy and hypofractionation
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Bassam Abdulkarim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05365711: Carriage of Beta Haemolytic Streptococci During Pregnancy
Official title: Carriage of Beta Haemolytic Streptococci During Pregnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy Related
Keywords: pregnancy
group a streptococci
group b streptococci
carriage
microbiota
Streptococcus pyogenes
Streptococcus agalactiae
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2022-05-09
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending ultrasound scan are asked to participate in the study. Partners of the pregnant women are asked to participate as well.

Brief summary: This is a prospective clinical study that aims to investigate asymptomatic carriage of beta haemolytic streptococci (especially group A streptococci, GAS and group B streptococci, GBS) during pregnancy. Association of asymptomatic carriage to possible complications of the mother or the newborn as well as the transmission between spouses will be evaluated. Maternal microbiota during labour will also be studied.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* partner of the pregnant women
* over/equal 18 years of age
* willing to participate the study

Exclusion Criteria:

* multiple pregnancy
* age \<18 years

Primary outcomes:
measure: Carriage of beta haemolytic streptococci
timeFrame: up to 30 weeks
Secondary outcomes:
measure: Pregnancy or delivery related infections/complications
timeFrame: up to12 weeks
measure: Infections/complications of newborn
timeFrame: 12 weeks after birth
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References: