louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04437420: Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90
Official title: Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute T Lymphoblastic Leukemia (T-ALL)
Acute B Lymphoblastic Leukemia (B-ALL)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with acute lymphoblastic leukemia with biological samples stored at the Biology Technical Platform.

Brief summary: NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and represents hope in cancer pathologies. While it is currently being tested for solid cancers, no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of ALL (T and B-ALL).


Eligibility criteria: Inclusion Criteria:

* Patient suffering from acute lymphoblastic leukaemia whose biological samples are kept at the Biology Technical Platform.

Exclusion Criteria:

* Patient over 80 years of age

Primary outcomes:
measure: Viability on primary ALL samples
timeFrame: 2 years
Secondary outcomes:
measure: Effect on SRC phosphorylation
timeFrame: 2 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT00802620: Amniotic Membrane Associated With Conjunctival Autograft Versus Conjunctival Autograft for Recurrent Pterygia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recurrent Pterygia
Keywords: Amniotic membrane
Conjunctival autograft
Recurrent pterygia
compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.

Detailed description: Patients with recurrent pterygia without symblepharon were randomly assigned to undertake pterygium excision followed by amniotic membrane associated with a small conjunctival autograft (2x3mm) or conjunctival autograft (approximately 5x8mm) alone. The patients were examined after 1, 7, 30, 90, 180 and 360 days after the surgery. Recurrence was considered as a fibrovascular ingrowth of 1.5 mm or more beyond the limbus with conjunctival drag.

Eligibility criteria: Inclusion Criteria:

* Recurrent pterygium

Exclusion Criteria:

* Less than 15 year of age
* Symblepharon
* Glaucoma,
* Ocular Allergy
* Ocular surface disorders

Primary outcomes:
measure: Amniotic membrane treatment for recurrent pterygia
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05608720: Preparation Protocol for the First Pediatric Dental Visit
Official title: Randomized Clinical Trial to Test a Preparation Protocol for the First Pediatric Dental Visit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Child
Dentist-Patient Relations
Keywords: behavior management
first dental visit
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 48
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit

Detailed description: The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).

Eligibility criteria: Inclusion Criteria:

* child requiring a first dental visit

Exclusion Criteria:

* previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address

Primary outcomes:
measure: child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)
timeFrame: immediately after the intervention
Secondary outcomes:
measure: self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile
Study officials:
affiliation: Bologna University
name: Simone Bagattoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670420: The Application of Honey on Perineal Sutures
Official title: The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Tear
Pain
Burns
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.


Eligibility criteria: Inclusion Criteria:

* Major women
* Giving birth vaginally in the maternity of Geneva university hospital
* First and second degree perineal tears or episiotomy
* French speaking women
* The day of the delivery

Exclusion Criteria:

* Allergic to honey and bees
* Drug use
* postpartum hemorrhage

Primary outcomes:
measure: Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum
timeFrame: Day 1
measure: Saint Antoine questionnaire to measure perceived pain at day 1 post-partum
timeFrame: Day 1
measure: Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum
timeFrame: Day 4
measure: Saint Antoine questionnaire to measure perceived pain at day 4 post-partum
timeFrame: Day 4
Secondary outcomes:
measure: Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum
timeFrame: Day 1
measure: Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1
timeFrame: Day 1
measure: Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum
timeFrame: Day 4
measure: Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1
timeFrame: Day 4
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
citation: https://doi.org/10.1007/s11724-008-0083-6
Clinical trial NCT02275520: Intraosseous Access
Official title: Comparison of NIO, BIG, EZ-IO, Jamshidi and Cook Intraosseous Devices in Adult Patients Under Resuscitation by Paramedics: a Randomized Crossover Manikin Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraosseus Access
Manikin
Resuscitation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will compare the success rates and time to successful IO access during simulated adult resuscitation.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* paramedic
* more than 1 year experience in medicine

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: time to IO needle insertion
timeFrame: 1 day
Secondary outcomes:
measure: time to IO needle stabilization
timeFrame: 1 day
measure: time to intraosseuss infusion
timeFrame: 1 day
measure: Ease of use
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03584074: Clinical Trial of Pregabalin and COX2 in Spinal Stenosis
Official title: Comparative Study for Decrease of Pain Intensity and Pain Sensitivity Between Pregabalin + COX-2 Inhibitor and COX-2 Inhibitor in Patients With Lumbar Spinal Stenosis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Stenosis Lumbar
Keywords: Pregabalin
Selective COX-2 inhibitor
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this prospective, single-blind, randomized study was to compare the efficacy of the combination of celecoxib and pregabalin and celecoxib only monotherapy for treatment of chronic low-back pain.

Detailed description: The efficacy and safety of the association of celecoxib \[a selective cyclooxygenase-2 (COX-2) inhibitor\] and pregabalin (commonly used to control neuropathic pain), compared with monotherapy of each, were evaluated for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms.

We will compare the efficacy of the combination of a selective COX-2 inhibitor (celecoxib) and an antineuropathic drug, pregabalin, versus celecoxib only monotherapy, in the treatment of spinal stenosis.

Each treatment lasted 8 weeks

Primary outcome is mean pain reduction following different treatments regimes. Secondary outcomes are the changes of pain sensitivity, Oswestry disability index, adverse effects due to the treatments under study.

Eligibility criteria: Inclusion Criteria:

* Spinal stenosis

Exclusion Criteria:

* Koval grade \>=3
* Other musculoskeletal disorders which cause pain on other joint
* Bleeding risk or ulcer history
* Severe cardiovascular, pulmonary, renal, brain, liver dysfunction

Primary outcomes:
measure: Visual analog scale
timeFrame: At 8 weeks
Secondary outcomes:
measure: Pain sensitivity questionnaire (PSQ)
timeFrame: At 8 weeks
measure: Oswestry disability index (ODI)
timeFrame: At 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04075474: Preventing Early Childhood Caries With Silver Diamine Fluoride
Official title: Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dental Caries
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 730
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trial has been performed to study this topic. The aim of this randomised clinical trial is to assess whether 38% SDF is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth.

Methods/Design: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF is more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 2,100 three-year-old kindergarten children who are generally healthy and with parental consent will be recruited. This sample size is sufficient for an appropriate statistical analysis of superiority trial with power at 80%, allowing for a 15% drop-out rate. Stratified randomization will be adopted for the intervention allocation. The intervention is either 38% SDF or 5% NaF (as positive control) therapy on primary upper anterior teeth. Dental examination followed by fluoride therapy will be conducted every six months until 30 months in kindergartens by a single examiner. The examiner, children and children's parents will be blinded to the treatment allocation. Questionnaire survey will be conducted to study the children's oral health-related behaviours and their socioeconomic backgrounds.

Discussion: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, it will help change the standard of care that using 5% NaF for ECC prevention. In addition, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC.


Eligibility criteria: Inclusion Criteria:

* generally healthy, with parental consents

Exclusion Criteria:

* uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.

Primary outcomes:
measure: caries prevention
timeFrame: at 30-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Local kindergartens
Study officials:
References:
citation: Gao SS, Chen KJ, Duangthip D, Wong MCM, Lo ECM, Chu CH. Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. Trials. 2020 Feb 4;21(1):140. doi: 10.1186/s13063-020-4088-7.
Clinical trial NCT00630474: Nasal Decongestion and Obstructive Sleep Apnea
Official title: Does Nasal Decongestion Improve Obstructive Sleep Apnea ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Syndrome
Rhinitis
Keywords: sleep apnea, rhinitis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Whether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime performance.


Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea syndrome (excessive sleepiness, apnea/hypopnea index \>10/h)
* Chronic nasal congestion (complaint of impaired nasal breathing that interfered with subjective sleep quality on at least 3 nights per week during at least the last 3 months)

Exclusion Criteria:

* Nasal surgery within the last 6 months
* Current treatment with nasal decongestants or topical steroids
* Sleep disorders other than obstructive sleep apnea
* Internal medical or psychiatric disorders that interfered with sleep

Primary outcomes:
measure: sleep related breathing disturbances sleep efficiency daytime sleepiness
timeFrame: at end of one week treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Pulmonary Division, University Hospital Zurich, Switzerland
city: Zurich
country: Switzerland
facility: Pulmonary Division, University Hospital Zurich
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References:
citation: Clarenbach CF, Kohler M, Senn O, Thurnheer R, Bloch KE. Does nasal decongestion improve obstructive sleep apnea? J Sleep Res. 2008 Dec;17(4):444-9. doi: 10.1111/j.1365-2869.2008.00667.x. Epub 2008 Aug 15.
Clinical trial NCT03155074: High-Intensity Training Following Lung Transplantation
Official title: High-Intensity Training Following Lung Transplantation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant
Exercise Training
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2017-05-16
Enrollment: 54
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: The HILT study is a prospective, single-blinded, randomized controlled trial comparing a high-intensity exercise training intervention with usual care among adult lung transplant recipients. Patients randomized to the training intervention arm will undergo individually tailored high-intensity exercise training (80-95% of maximum heart rate) three hours per week for 20 weeks. Training will be conducted at local fitness centers on a one-on-one basis.


Eligibility criteria: Inclusion Criteria:

* Stable medical condition in the opinion of the enrolling investigator
* Able and willing to give informed consent

Exclusion Criteria:

* Expected survival less than 12 months
* Unable to complete a maximal exercise test on a treadmill until exhaustion
* Language barrier that interferes with data collection

Primary outcomes:
measure: Change in peak oxygen uptake
timeFrame: 0-20 weeks
Secondary outcomes:
measure: Change in total body composition (fat, muscle and bone mass)
timeFrame: 0-20 weeks
measure: Change in forced expiratory volume in one second (FEV1)
timeFrame: 0-20 weeks
measure: Change submaximal exercise capacity
timeFrame: 0-20 weeks
measure: Change in leg strength
timeFrame: 0-20 weeks
measure: Change in upper body strength
timeFrame: 0-20 weeks
measure: Change in hand strength
timeFrame: 0-20 weeks
measure: Change in health-related quality of life
timeFrame: 0-20 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Norwegian School of Sport Sciences
name: Elisabeth Edvardsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Michael T Durheim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.
Clinical trial NCT04795674: Target ADHD Executive Working Memory Study
Official title: Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: Adolescents
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess whether or not a novel executive working memory training intervention for Attention-Deficit/Hyperactivity Disorder can engage frontoparietal brain network treatment targets and behavioral performance.

Detailed description: This proposal seeks support for a 2-year milestone-driven R61 initial test of target engagement in n=62 ADHD diagnosed adolescents randomized to a 'sham training' placebo or to train 4 times each week using 4 different EWM exercises that have been combined into the format of a typical cognitive training intervention. Exercise difficulty levels in the active intervention will increase across 5 weeks to continually challenge EWM ability. EWM training will use a novel, remotely-supervised 'at home' computerized training approach. If R61 EWM training target engagement milestones are met, a 3-year R33 phase will begin. The R33 will replicate target engagement in another randomized placebo-controlled trial of n=90 new ADHD adolescents and attempt to establish a convincing link between the hypothesized targets and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in an n=40 non-ADHD control group.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD
* English speaking
* Right-handed
* \>5th grade reading level
* \>80 IQ level

Exclusion Criteria:

* Braces, metal or implant devices
* Brain abnormality, neurological disorder
* TBI or loss of consciousness\>30 minutes
* Diagnosis of Psychosis, Bipolar Disorder, ASD, PTSD, OCD, SUD, Tourette's Disorder

Primary outcomes:
measure: Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra.
timeFrame: Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training
measure: The experimental executive working memory training tasks
timeFrame: Change in scores from baseline assessment versus 5 weeks at the conclusion of training
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Institute of Living/Hartford Hospital
name: Michael C Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: