louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02383693: Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
Official title: Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: depression
Repetitive Transcranial Magnetic Stimulation
tolerability
efficiency
TMS
refractory
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: number of center : 1

* duration of study : 24 months
* recruitement time : 23 months
* Aim :Principal

Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.

Secondary

Evaluate the impact of rTMS on cognitive functions.

Detailed description: The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (\> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).

Eligibility criteria: Inclusion Criteria:

* TRD stage I Thase-Rush
* HDRS + or = 18
* Patients age 18 to 70 years.
* Negative pregnancy test and contraception for women.
* Informed Consent

Exclusion Criteria:

* Patient was treated with mood stabilizer in the previous week
* Other disorder on axis I of the DSM IV than depressive disorder.
* Patient with an addiction problem other than tobacco and caféine
* antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker
* Previous history of head trauma the previous two years.
* intracranial hypertension.
* not affiliated to the social security Patient
* patient under constraint hospitalisation
* Under legal protection measure

Primary outcomes:
measure: 'Hamilton depression rating scale (HDRS)
timeFrame: one years
Secondary outcomes:
Other outcomes:
Locations:
city: Neuilly Sur Marne
country: France
facility: Unité de Recherche Clinique
state: Île de France
Study officials:
affiliation: E.P.S ville Evrard
name: Rene BENADHIRA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097093: Long-term Surival of GIST Patients ≥ 10 Years on Imatinib
Official title: Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: GIST
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2019-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in the 62005 trial - treated for more than 10 years with imatinib - will be enrolled in this study.

Brief summary: This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828". With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.


Eligibility criteria: Inclusion Criteria:

* Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST
* Patients who have been treated with imatinib for ten years or longer
* For the identified patients who are still alive:

  1. Able to read and answer questionnaires
  2. Able to provide written informed consent

Primary outcomes:
measure: Patient characteristics
timeFrame: At time of registration
measure: Tumour characteristics
timeFrame: At time of registration
measure: Duration of imatinib treatment
timeFrame: At time of registration
measure: Health releated quality of life
timeFrame: At time of registration
measure: Overall survival
timeFrame: At time of registration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NKI - Antoni van Leeuwenhoekziekenhuis
name: Neeltje Steeghs
role: STUDY_CHAIR
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Axel Le Cesne
role: STUDY_CHAIR
affiliation: Radboud University Medical Center Nijmegen
name: Ingrid Desar
role: STUDY_CHAIR
affiliation: Radboud University Medical Center Nijmegen
name: Olga Husson
role: STUDY_CHAIR
References:
Clinical trial NCT05538793: Deep Learning for the Discrimination Among Different Types of Keratits: a Nationwide Study
Official title: Deep Learning for the Discrimination Among Bacterial, Fungal, Viral, Amebic and Noninfectious Keratitis: a Nationwide Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratitis
Automatic Judgement
Image
Keywords: Keratitis
Slit-lamp Image
Deep Learning
Lead sponsor: Ningbo Eye Hospital
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 10369
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Child, Adult, Older Adult

Brief summary: Detecting the cause of keratitis fast is the premise of providing targeted therapy for reducing vision loss and preventing severe complications. Due to overlapping inflammatory features, even expert cornea specialists have relatively poor performance in the identification of causative pathogen of infectious keraitis. In this project, the investigators aim to develop an automated and accurate deep learning system to discriminate among bacterial, fungal, viral, amebic and noninfectious keratitis based on slit-lamp images and evaluated this system using the datasets obtained from mutiple independent clinical centers across China.


Eligibility criteria: Inclusion Criteria:

Slit-lamp images with sufficient diagnostic certainty and showing keratitis at the active phase.

Exclusion Criteria:

* Poor-quality images
* Images presenting mixed infections (i.e., cornea infected by two or more causative pathogens)

Primary outcomes:
measure: Area under the receiver operating characteristic curve of the deep learning system
timeFrame: 2020-2022
Secondary outcomes:
measure: Accuracy of the deep learning system
timeFrame: 2020-2022
measure: Sensitivity of the deep learning system
timeFrame: 2020-2022
measure: Specificity of the deep learning system
timeFrame: 2020-2022
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Eye Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical University
Study officials:
References:
Clinical trial NCT02525393: Transcranial Stimulation in Motor Stroke Rehabilitation
Official title: Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Non Invasive Brain Stimulation
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.

Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.


Eligibility criteria: Inclusion Criteria:

* ischemic or hemorrhagic stroke (\> 6 months from the accident)

Exclusion Criteria:

* general cognitive impairment (Mini Mental State Examination \< 25), severe functional disability (Barthel Index \< 45),
* psychiatric disorders,
* degenerative neurological disorders,
* epilepsy,
* severe medical conditions,
* having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil

Primary outcomes:
measure: Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
timeFrame: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months
Secondary outcomes:
measure: P300 (latency)
timeFrame: Baseline; 1 month; 6 months and 1 week; 7 months
measure: Cognition (standardized neuropsychological assessment)
timeFrame: Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
affiliation: University of Turin, Italy
name: Federico D'Agata, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05715593: The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients
Official title: The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Education, COVID-19, Quarantine, Anxiety, Pandemic
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 402
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: we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.

Detailed description: This is a randomized controlled trial conducted between February 2021 and June 2021. Patients tested positive for Covid-19 with mild to moderate forms were randomized to Education (n=267) or control (n=269). The education group received a phone health education session on day 1 (D1) following the diagnosis. The three components of the health education intervention were an explanation of the coronavirus disease, what to do in the event of complications, and the recommended preventive measures. The two groups received a telephone evaluation of their Hospital Anxiety and Depression scores on (D1) and day seven D7 following the positive diagnosis. The primary outcome was the rate of anxiety reduction in each group at D7 based on a HAD-A score ≥ 8. Secondary outcomes were the rate of anxiety reduction at D7 based on a HAD-A score ≥ 11, the percentage of people complying with isolation and the scores of adherence to preventive measures during the isolation in each group.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Covid-19 after positive PCR or positive antigen rapid test, over 18 years of age, who did not require hospitalization

Exclusion Criteria:

* Patients not reachable at the first day phone call of the diagnosis and patients unable to answer the telephone questionnaire due to their cognitive state.

Primary outcomes:
measure: The rate of anxiety reduction
timeFrame: One week (7 days) after the COVID 19 diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
Study officials:
References:
Clinical trial NCT03214393: Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy
Official title: Role of Maternal Anticardiolipin and Anti-B2 Glycoprotein I Antibodies in Correlation With Fetal Doppler in Prediction of Adverse Pregnancy Outcome in Patients With Preeclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females 32 weeks gestation or more with pre-eclampsia

Brief summary: Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.

Detailed description: Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.

Eligibility criteria: Inclusion Criteria:

* Pregnant women 32 weeks or more gestational age
* Pre-eclampsia
* Singleton pregnancy

Exclusion Criteria:

* Intrauterine fetal death
* Fetus with apparent congenital anomalies
* Pregnant females with other medical disorders
* History of essential hypertension.
* History of antepartum hemorrhage.
* History of rupture of membranes.

Primary outcomes:
measure: percentage of cases that develop severe pre-eclampsia
timeFrame: It will be calculated after 1 year from the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology
state: Greater Cairo
Study officials:
affiliation: Cairo U
name: Doaa Sh Belal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426593: Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology
Official title: Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: CHF
Heart Failure
Lead sponsor: Intersection Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the general population using various media advertising as well as through a site database. Potential subjects aged older than 30 will be recruited for a telephone interview. If they qualify based on a very brief screening interview regarding their suitability as a participant, and they are interested in participating, they will be scheduled to visit the Intersection Medical, Inc., corporate office. If they decline to participate, no further contact will be initiated.

Brief summary: This study will be conducted to collect anatomical data in an ambulatory healthy population to aid in the development of a novel non-invasive technology to assess changes in lung hydration status. It will also help in developing reference ranges of lung hydration status in healthy subjects and their associated changes with time.


Eligibility criteria: Inclusion Criteria:

* Subjects \> 30 years of age
* Subjects who are ambulatory not requiring assistance for ambulation
* Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB

Exclusion Criteria:

* Subjects with an active implantable medical device not cleared for use with the IMED-4 in the IMED- 4 Investigators Brochure.
* Subjects who are pregnant or lactating or who have been pregnant within the past three months
* Subjects who have a measured temperature of \>38° C at the time of screening
* Subjects who have tattoos and/or non-intact skin on the back in the electrode patch placement region
* Subjects who have had a past serious allergic reaction to adhesives
* Patients who decline to have their backs photographed with the IMED-4 device in position
* Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectance, etc.)

Primary outcomes:
measure: Data Collection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Intersection Medical Inc.
state: California
Study officials:
References:
Clinical trial NCT01485393: Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Official title: Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will receive both interventions in a randomized order.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.


Eligibility criteria: Inclusion Criteria:

* Primary Inclusion Criteria for "Insomniac" subjects:

Subjects will be deemed "Insomniacs" if they suffer from any of the following:

1. Subject will be required to meet the criteria for insomnia, set by the International Classification of Sleep Disorders, which requires that a patient have difficulty initiating or maintaining sleep that is not accounted for by another sleep disorder, neurologic or psychiatric disorder or substance or medication.
2. Subject will be required to not be on any current pharmacological sleep disorder treatment.
3. Between the ages of 18 and 35 years.
4. Not taking any prescription medications that alter sleep, cognitive functions, or both.

Exclusion Criteria:

Primary Exclusion Criteria for "Healthy" control subjects:

1. Abnormal sleep habits:

   * sleeping less than 5 hours each night;
   * going to sleep before 9:00 PM or after 2:00 AM on a regular basis; or
   * Waking up before 5:00 AM or after 10:00 AM on a regular basis. This will be objectively assessed by wrist actigraphy measured for a 1-week duration prior to the first study night.
2. A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.
3. A score greater than or equal to 10 on the Epworth Sleepiness Scale.
4. Takes medication that alters sleep, cognitive function, or both.
5. Has a history of a known neurological or psychiatric problem.
6. Younger than 18 or older than 35 years of age.
7. Known or suspected sleep disorder(s).

Primary outcomes:
measure: Change in Sleep Quality
timeFrame: Approximately 8 hours
Secondary outcomes:
measure: Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep
timeFrame: Approximately 30 minutes after waking up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03478293: iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
Official title: A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

Detailed description: The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open angle glaucoma (POAG)
* Subject on two ocular hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled

Primary outcomes:
measure: IOP reduction at 12 and 24 months on same number or fewer medications
timeFrame: 12 months and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Ophthalmology - UNIFESP/ Hospital São Paulo
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens, OD
role: STUDY_DIRECTOR
References: