louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03212378: Safety and Efficacy of "Standardized" CHIP
Official title: Safety and Efficacy of "Standardized" Complex High-risk Interventional Procedures - a New Pathway for Protected Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 150
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: The study population consists of consecutive high-risk subjects indicated for percutaneous complex high-risk interventional procedures.

Brief summary: In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients.

The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft

Exclusion Criteria:

* Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.)
* History of recent (within 1 month) stroke or TIA
* Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors

Primary outcomes:
measure: Safety & feasibility
timeFrame: 30 days
measure: Hemodynamic Compromise (HC)
timeFrame: 30 days.
Secondary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 30 days
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
References:
Clinical trial NCT04329078: Relevance of Sensitization to Legumes in Children Allergic to Peanut
Official title: Relevance of Sensitization to Legumes in Children Allergic to Peanut
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergy;Food
Keywords: food allergy
peanut
legumes
sensitization
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children allergic to peanut with a follow-up at the Pediatric Allergy Department of the University Hospital of Nancy from january 2017 to february 2020

Brief summary: The objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut

Detailed description: Allergy to legumes is more and more frequent, especially in children allergic to peanut, with some severe reactions but little is known about cross-reactivity and clinical meanings of legumes sensitization in children allergic to peanut.

All children with a confirmed peanut allergy and followed at the University Hospital of Nancy between January 1st 2017 and February 29th 2020 will be included in order to evaluate the prevalence of sensitization and allergy to other legumes in this population.

In children allergic to peanut and to at least one other legume, we will evaluate the severity of the allergy and the sIgE profiles for peanut.

Eligibility criteria: Inclusion Criteria:

* Confirmed allergy to peanut

Exclusion Criteria:

* no available information regarding sensitization and tolerance to legumes

Primary outcomes:
measure: sensitization to legumes
timeFrame: 2017 to 2020
Secondary outcomes:
measure: allergy to legumes
timeFrame: 2017 to 2020
measure: severity of allergy to legumes
timeFrame: 2017 to 2020
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01914978: Evaluating the Effectiveness of a Handbook for Parents of Children Newly Diagnosed With Food Allergy
Official title: Living Confidently With Food Allergy: Evaluating the Effectiveness of a Handbook for the Newly Diagnosed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity, Food
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2013-08-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to evaluate the effectiveness of a handbook for parents of children newly diagnosed with food allergy. The handbook was developed to provide information and strategies to support families in effectively managing food allergies while maintaining positive quality of life. Parents of children newly diagnosed with food allergy (within the past year) will be randomized into either the treatment condition (handbook) or a control condition (management of food allergy as usual). Participants will complete study questionnaires online at three time points: baseline (this will be before receiving the handbook for the treatment group), post-intervention (2-3 weeks after baseline), and follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome measures and satisfaction with the handbook. Parents in the control group will receive the handbook following the conclusion of their participation in the study.


Eligibility criteria: Inclusion Criteria:

* Parents of children ages 0 to 18 years newly diagnosed with food allergy (within the past 12 months)
* Child's food allergy has been diagnosed by a physician
* Child has been prescribed an epinephrine auto-injector

Exclusion Criteria:

* Non-English speakers, as the handbook (study intervention) is only available in English at this time.

Primary outcomes:
measure: Change in food allergy-specific quality of life score
timeFrame: 2 week and 2-month follow-up
Secondary outcomes:
measure: Changes in food allergy knowledge score
timeFrame: 2-week and 2-month follow-up
measure: Change in confidence in allergy management skills score
timeFrame: 2-week and 2-month follow-up
measure: Change in food allergy outcome expectations score
timeFrame: 2-week and 2-month follow-up
measure: Parent satisfaction with study handbook (study intervention)
timeFrame: 2-week follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jennifer S LeBovidge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeBovidge JS, Michaud A, Deleon A, Harada L, Waserman S, Schneider L. Evaluating a handbook for parents of children with food allergy: a randomized clinical trial. Ann Allergy Asthma Immunol. 2016 Mar;116(3):230-236.e1. doi: 10.1016/j.anai.2016.01.001. Epub 2016 Feb 3.
Clinical trial NCT00245778: fMRI Study of Grasping in Autistic Patients
Official title: fMRI Study of Grasping in Autistic Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Autistic Disorder
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-10-28
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The aim of the study is to localise brain regions involved in objects recognition, in planification and adjustment of grasping, in prehension with and without eye control. The study is conducted in normal and autistic adults. We hypothesize different activations in these two populations.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of autistic disorder, right-handed, DQ\>50

Exclusion Criteria:

* epilepsia, psychotropic drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital of Tours
Study officials:
affiliation: University hospital of Tours
name: Catherine Barthelemy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05094778: A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release
Official title: A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal tunnel syndrome
carpal tunnel release
pain
nerve compression syndromes
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
Collaborators: name: Hebei Medical University Third Hospital
First posted: 2021-10-26
Enrollment: 192
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. The investigators will compared the technique with the standard dual-portal endoscopic technique.

Detailed description: Conduct a multi-center, comparison clinical trial according to clinical Trial Reporting Standards (CONSORT). Patients in the single-portal group were treated with a single-portal palm approach that passes superficially to palmar aponeurosis and cut the full transverse carpal ligament. The comparison group were treated with Chow endoscopic technique. In order to assess efficiency of single-portal palm approach, the investigators will compared the technique with the standard dual-portal endoscopic technique. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of carpal tunnel syndrome based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand
* Symptoms of carpal tunnel syndrome had lasted\>2 months or inadequate responses to the non-surgical treatments≥3 months
* moderate to severe symptoms.

Exclusion Criteria:

* mild symptoms or prior injuries to the extremity
* bilateral wrists involved, a combined nerve compression, gout, diabetes or chronic renal failure.

Primary outcomes:
measure: The sensibility of the pulps of thumb, index finger, and middle finger (mm)
timeFrame: 3 years
measure: Severity of symptoms and functional status
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen People's Hospital
name: Yongqing Zhuang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi Q, Bobos P, Lalone EA, Warren L, MacDermid JC. Comparison of the Short-Term and Long-Term Effects of Surgery and Nonsurgical Intervention in Treating Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Hand (N Y). 2020 Jan;15(1):13-22. doi: 10.1177/1558944718787892. Epub 2018 Jul 17.
Clinical trial NCT05262478: Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis
Official title: Medium-Term Radiological And Clinical Follow-Up of Alpha-D Cervical Disk Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Disc Disease
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 33
Sex: ALL
Minimum age (years): 27
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included 33 patients with cervical disc hernia and associated radiculopathy upon radiological examination, who underwent a cervical discectomy and received cervical disc protheses (CDP; arthroplasty) with a single-level anterior discectomy.

Brief summary: Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion.

In the present study, we aimed to investigate the clinical outcomes, HO incidence, and prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as developed and used by the authors to treat cervical disk diseases.


Eligibility criteria: Inclusion Criteria:

* cervical disc hernia
* underwent cervical discectomy and received cervical disc prostheses

Exclusion Criteria:

* history of cervical surgery,
* kyphotic deformity,
* rheumatological or other systemic diseases,
* severe osteophytes caused by advanced degenerative disc disease
* severe spinal stenosis

Primary outcomes:
measure: Heterotropic ossification
timeFrame: Postoperative 18-78.months
Secondary outcomes:
measure: visual analog scale
timeFrame: 4 and 12 months after surgery
measure: neck disability index
timeFrame: 4 and 12 months after surgery
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
affiliation: Mehmet Kursat Karadag
name: Mehmet K Karadag
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leven D, Meaike J, Radcliff K, Qureshi S. Cervical disc replacement surgery: indications, technique, and technical pearls. Curr Rev Musculoskelet Med. 2017 Jun;10(2):160-169. doi: 10.1007/s12178-017-9398-3.
citation: Park JH, Rhim SC, Roh SW. Mid-term follow-up of clinical and radiologic outcomes in cervical total disk replacement (Mobi-C): incidence of heterotopic ossification and risk factors. J Spinal Disord Tech. 2013 May;26(3):141-5. doi: 10.1097/BSD.0b013e31823ba071.
Clinical trial NCT04786678: Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smartphones
Official title: Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smart Phones
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep
Sleep Inertia
Stress
Keywords: Sleep
Sleep Inertia
Caffeine
Sleep Disturbance
Snooze
Alarm
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be passively monitored for 4 weeks, and all will undergo cell phone based intervention which will notify participants if they are using the cell phone past their latest bedtime for adequate sleep (e.g. if a participant habitually wakes at 8am, and are using their phone past midnight, they will receive a notification).
Primary purpose: OTHER

Brief summary: Pilot data suggests that working professionals and college students routinely use alarms and snooze. Alarm usage and snoozing is associated with several negative health biomarkers including lighter sleep, higher resting heart rate, and reduced sleep duration. It is unclear when this behavior is established, but it is likely in the teenage years when chronic sleep restriction begins to effect a large percentage of Americans. We will ask teens about psychological traits (e.g. personality) and snoozing behavior in a repeated measures design. In addition, we will implement a smartphone based intervention which notifies teens when they are awake past their minimum bedtime for adequate sleep. throughout the study, we will monitor sleep and heart-rate via wearable. From this data, we will establish the prevalence of alarm and snoozing behaviors in teens. We will determine what demographic, psychological, and behavioral traits predict snoozing, and if there are any differences in health biomarkers (e.g. sleep duration, resting heart rate)between snooze and/or alarm users. We will use data from the wearables and smartphones to generate features that can detect snoozing, and will validate them against self-report. Finally, we seek to determine if alarm and snoozing behavior can be reduced via a smartphone intervention aimed at increasing sleep duration.


Eligibility criteria: Inclusion Criteria:English as a primary language -

Exclusion Criteria:

-

Primary outcomes:
measure: Sleep Duration
timeFrame: 12 weeks, daily sleep measured passively via wearable
measure: Resting Heart Rate
timeFrame: 12 weeks, Heart rate measured every minute passively via wearable
measure: Alarm and Snooze Self Report
timeFrame: 6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
measure: Reaction Time
timeFrame: 6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00234078: Dose-response Study of OPC-12759 Ophthalmic Suspension
Official title: Dose-response Study of OPC-12759 Ophthalmic Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: OPC-12759
Dry eye syndromes
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 290
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.


Eligibility criteria: Inclusion Criteria:

1. Outpatient.
2. Subjective complaint of dry eye that has been present for minimum 20 months.
3. Primary ocular discomfort severity is moderate to severe.
4. Corneal - conjunctival damage is moderate to severe.
5. Unanesthetized Schirmer's test score of 7mm/5minutes or less.
6. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
2. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
3. Anticipated use of contact lens during the study.
4. Any history of ocular surgery within 12 months.
5. Female patients who are pregnant, possibly pregnant or breast feeding;
6. Known hypersensitivity to any component of the study drug or procedural medications.
7. Receipt of any investigational product within 4 months.

Primary outcomes:
measure: Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
timeFrame: baseline, 12 weeks
measure: Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Otsuka Pharmaceutical Co., Ltd.
Study officials:
affiliation: Dermatologicals & Ophthalmologicals Division
name: Satoshi Oshima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02557178: Home-Based Health Management of COPD Patients
Official title: Home-Based Health Management of COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Minnesota HealthSolutions
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Mayo Clinic
First posted: 2015-09-23
Enrollment: 154
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.


Eligibility criteria: Inclusion Criteria:

* diagnosis of GOLD stage II, III, or IV COPD
* current or previous smoker with at least 10 pack-years of cigarette smoking
* be hospitalized for an exacerbation of COPD

Exclusion Criteria:

* high likelihood of being lost to follow-up or contact
* inability to provide good data or follow commands
* inability to do mild exercise

Primary outcomes:
measure: Change in Number of Daily Steps Between the Intervention and Control Conditions
timeFrame: Steps measured at baseline (week 1) and week 9
measure: Change in Physical Quality of Life Between the Intervention and Control Conditions
timeFrame: Quality of Life measured at baseline (week 1) and week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Minnesota HealthSolutions
name: Sara Seifert, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benzo RP, Ridgeway J, Hoult JP, Novotny P, Thomas BE, Lam NM, V Benzo M, Kramer K, Seifert S. Feasibility of a Health Coaching and Home-Based Rehabilitation Intervention With Remote Monitoring for COPD. Respir Care. 2021 Jun;66(6):960-971. doi: 10.4187/respcare.08580. Epub 2021 Apr 27.
Clinical trial NCT01400178: Cochlear Implants in Post-lingually Children: Results After 10 Years
Official title: Cochlear Implants in Post-lingually Children: Results After 10 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Hearing Impairment
Keywords: cochlear implant
children
follow up
results
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The age at evaluation was 19,3 to 29,2 years. The age at cochlear implant surgery was 5,4 to 16,10 years. The etiology of the deafness was: meningitis (5), ototoxic (1), mumps (2) and unknown (2).

Brief summary: Objectives: To assess a group of post-lingually children after 10 years of implantation with regard to speech perception, speech intelligibility, and academic/occupational status.

Study Design: A prospective transversal study. Setting: Pediatric referral center for cochlear implantation. Patients: Ten post-lingually deafened children with Nucleus and Med-El cochlear implants.

Interventions: Speech perception and speech intelligibility tests and interview.

Main Outcome Measures: The main outcome measures were score of Hint sentences recognition (silence and noise), speech intelligibility scores(write-down intelligibility and rating scale scores) and academic/ occupational status.


Eligibility criteria: Inclusion Criteria:

* postlingually deaf
* age at cochlear implant: \< 18 years
* more than 10 years of cochlear implant use

Exclusion Criteria:

* other disabilities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Bionic Ear Center
state: SP
Study officials:
References: