louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04078321: Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
Official title: Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Lead sponsor: Sormland County Council, Sweden
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 8
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single case studies
Primary purpose: TREATMENT

Brief summary: The main purpose with this study is to investigate the effectiveness of a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for treatment of spasticity in children with cerebral palsy.

Detailed description: The effect and use of the garment will be evaluated in single - case studies using ABAB design.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy diagnosis, with spasticity as the main symptom
* Established GMFCS, levels 1-5
* MACS level, levels 1-5
* Included in the CPUP \* national quality register
* Person should be between 4 years and up to 18 years
* Secured communication to and from person
* Neing able to convey pain or discomfort.

Exclusion Criteria:

* No treatment received within next three months before participation with botulinum toxin treatment to reduce spasticity.
* The patient may not have a shunt or other medical pump that may be affected by the electrical stimulation provided by the garment.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: four weeks
Secondary outcomes:
measure: Timed Up and Go (time)
timeFrame: four weeks
measure: Faces pain scale 0-5
timeFrame: four weeks
measure: Two questions of sleeling quality, three answer options provided
timeFrame: four weeks
measure: Adherence measured by days using the garment during the intervention
timeFrame: four weeks
measure: Level of Sitting Scale (score 1-8)
timeFrame: four weeks
measure: Box and block test (number of blocks moved in one minute)
timeFrame: four weeks
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Marina Arkkukangas
Study officials:
affiliation: Research and Development in Sörmland
name: Marina Arkkukangas, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00287521: A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: open
angle
glaucoma
ocular
hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 87
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 purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: United States Investigative Sites in Texas and Other States
state: Texas
Study officials:
References:
Clinical trial NCT02509221: Effect of Duration of Exposure of Anesthesia With Sevoflurane on Emergence Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium on Emergence
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 112
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients between 1-6 years old receiving anesthesia for non-surgical reasons

Brief summary: Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with Sevoflurane. Restless recovery from anesthesia may not only cause injury to the child or to the surgical site, but may also lead to the accidental removal of surgical dressings, IV catheters, and drains. is one of the The purpose of the study is to find whether duration of exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.


Eligibility criteria: Inclusion Criteria:

* age between 1-6 years of age
* receiving general anesthesia for non-surgical procedure

Exclusion Criteria:

* history of emergence delirium
* severe CNS disease

Primary outcomes:
measure: Incidence of emergence delirium
timeFrame: 30 mintes after anesthesia
measure: Severity of emergence delirium
timeFrame: 30 minutes after anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: University Hospital
state: New York
Study officials:
References:
Clinical trial NCT02678884: Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study
Official title: A Pilot Study of 18F-FDG PET-CT Kinetic Analysis in Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and Neck Squamous Cell Carcinoma
Radiation therapy
Head and Neck Cancers
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see how useful the information provided from Positron Emission Tomography (PET) scans can be in the actual planning and delivery of radiation treatment to patients who have head and neck cancers. Patients participating in this study, will have (in addition to their routine tests) a PET scan before and during their radiation treatment. Following the intervention, patients will be followed as per standard practice.


Eligibility criteria: Inclusion Criteria:

* Non-nasopharynx head and neck mucosal squamous cell carcinoma
* Radiologically evident gross disease
* Radiotherapy alone for curative intent
* Age equal to or more than 18 years old
* To be eligible for the second study PET-CT scan: FDG avid tumour (or minimum SUV of 2.5) on the first study PET-CT scan

Exclusion Criteria:

* Nasopharynx cancer
* H\&N SCC skin
* Distant metastases (already known or if found on baseline CT-thorax)
* Prior malignancy within the last 5 years (exclude non-H\&N SCC, BCC skin)
* Prior chemotherapy within the last 5 years or concurrent chemotherapy/EGFR inhibitors
* Prior head and neck radiotherapy
* Inability to lie supine for study duration
* Pregnancy
* Inability to provide informed consent

Primary outcomes:
measure: Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy.
timeFrame: ~ 2 years
Secondary outcomes:
measure: Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy .
timeFrame: ~ 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Center
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: John J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002384: A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Official title: Vistide (Cidofovir Intravenous) Treatment IND Protocol for Relapsing Cytomegalovirus Retinitis in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
Collaborators: name: Anderson Clinical Research
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Incomplete Closed Protocol


Eligibility criteria: Information not available

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stagg RJ, Gathe J, Lieberman RM, Nuessle SJ, Davis JL, Ruane P, Bellman PC, Horgan M, Jaffe HS. The Vistide (cidofovir injection) treatment IND for relapsing CMV retinitis (CMV-R). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:120 (abstract no 306)
Clinical trial NCT05807984: Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
Official title: A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Rectal Cancer
Recurrent
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: carbon ion therapy
Primary purpose: TREATMENT

Brief summary: Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)


Eligibility criteria: Inclusion Criteria:

* 1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
* 2) received a radical operation for their primary tumor and regional lymph nodes,
* 3) received chemo-radiation or radiation in pelvic before CIRT,
* 4) received re-irradiation by CIRT after their pelvic radiotherapy.

Exclusion Criteria:

* 1) received more than once prior radiotherapy in the same treatment field,
* 2) time to the last radiotherapy was \<1 year,
* 3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (\<5 mm).

Primary outcomes:
measure: local control
timeFrame: Local control at 3 years after CIRT
Secondary outcomes:
measure: overall survival
timeFrame: 3 years after CIRT or patient died, measured erery 3 months after CIRT
measure: progression free survival
timeFrame: 3 years after CIRT or patient died, measured erery 3 months after CIRT
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy ion center
state: Pudong
Study officials:
References:
Clinical trial NCT02561884: A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 18.5 and ≤ 30.0 kg/m2.
* No clinically significant findings in a 12-lead electrocardiogram (ECG)
* Age 18-60 years at screening

Exclusion Criteria:

* History of severe allergy or allergic reactions to the IMPs or related drugs
* History of serious clinical illness that can impact fate of drugs including major surgery

Primary outcomes:
measure: AUC
timeFrame: 0~72hr
measure: Cmax
timeFrame: 0~72hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04185584: Long-Term Safety Follow-Up Study of SCM-AGH in Subjects Who Participated and Administered SCM-AGH in to Severe Atopic Dermatitis Clinical Trials
Official title: A Long-Term Safety Follow-Up Study of SCM AGH in Subjects Who Participated in the ADT2002 Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatitis, Atopic
Keywords: SCM-AGH
Atopic Dermatitis
Stem cell therapy
Lead sponsor: SCM Lifescience Co., LTD.
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 92
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study (ClinicalTrials.gov ID: NCT04179760)

Brief summary: This is a long-term safety follow-up study of the Phase I/II multicenter study of SCM-AGH in subjects with moderate to severe atopic dermatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol ADT2002 (ClinicalTrials.gov ID: NCT04179760) will be eligible for this long-term follow-up protocol.

Detailed description: Subjects who meet all eligibility criteria for Long Term Follow Up(LTFU) study participation at the ADT2002 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.

Eligibility criteria: Inclusion Criteria:

1. Subjects who provide written informed consent
2. Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study
3. Subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site.

Exclusion Criteria:

1. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH

Primary outcomes:
measure: Long-term safety assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)
timeFrame: Up to 5 Years
measure: Long-term concomitant medication assessment of SCM-AGH in subjects with moderate to severe Atopic Dermatitis(AD)
timeFrame: Up to 5 Years
Secondary outcomes:
measure: Outcome of unresolved Adverse Events(AEs) from ADT2002 study
timeFrame: Up to 5 Years
measure: Clinically important physical examination findings
timeFrame: Up to 5 Years
measure: Number of occurrence of Abnormal, clinically significant in hematology laboratory results
timeFrame: Up to 5 Years
measure: Number of occurrence of Abnormal, clinically significant in chemistry laboratory results
timeFrame: Up to 5 Years
measure: Number of occurrence of Abnormal, clinically significant in urinalysis laboratory results
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Gwang Seong Choi, MD-Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326884: Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study
Official title: ZLP Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Iliac Aneurysm
Keywords: aortic aneurysm
iliac aneurysm
endovascular procedures
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.


Eligibility criteria: Inclusion Criteria:

* Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size
* Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

* Less than 20 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy

Primary outcomes:
measure: Composite rate of adverse clinical/device events
timeFrame: During (day 1) and after implantation through 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nara
country: Japan
facility: Nara Medical University
city: Tokyo
country: Japan
facility: Jikei University Hospital
Study officials:
affiliation: University of Pennsylvania
name: Ronald M. Fairman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01082484: Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers
Official title: Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Healthy volunteers
iontophoresis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2010-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether prostacyclin analogues' cathodal iontophoresis induce a cutaneous vasodilation in healthy volunteers's forearm, without local side effects.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* age above 18

Exclusion Criteria:

* any chronic disease
* any drug intake

Primary outcomes:
measure: Amplitude of forearm cutaneous vasodilatation assessed using laser Doppler imaging
timeFrame: 24 hours
Secondary outcomes:
measure: Local tolerance assessed clinically
timeFrame: Day 0 and after 7 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble
Study officials:
References:
citation: Blaise S, Roustit M, Hellmann M, Millet C, Cracowski JL. Cathodal iontophoresis of treprostinil induces a sustained increase in cutaneous blood flux in healthy volunteers. J Clin Pharmacol. 2013 Jan;53(1):58-66. doi: 10.1177/0091270011434352. Epub 2013 Jan 24.
Clinical trial NCT04532502: Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
Official title: Work Environment's Impact on the Sex Ratio of the Children of Resuscitation Anesthesia Assistants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Anesthetics Adverse Reaction
Keywords: Anesthesia care providers
offspring sex ratio
Inhalation induction of anesthesia
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The anesthesia department of the three French-speaking universities in Belgium wimp e-mail a questionnaire to all female assistants in anesthesia-resuscitation via a system similar to Survey Monkey. The data will be completely anonymized through those of such a system.

Reminder will be e-mailed 1 and 3 months after the questionnaire is sent out. Filling the questionnaire will be equated with consent

Brief summary: The aims of this multi center retrospective study was to determine:

* whether the sex ratio of the offspring of female assistants in anesthesia-resuscitation differs from that of the population at large
* whether the assistants' work environment at the time of their offspring's conception influences the sex of their offspring


Eligibility criteria: Inclusion Criteria:

* Female assistants in anesthesia-resuscitation in the Wallonia-Brussels Federation (Belgium) who conceived one or more children in the course of their training between 2009 and 2019 and who delivered before the end of 2019 (cut-off: midnight on 31 December 2019)

Exclusion Criteria:

* Male assistants in anesthesia-resuscitation
* Female assistants in anesthesia-resuscitation who trained before 2009 or after 2019.
* Female assistants in anesthesia-resuscitation who relied on medically assisted reproduction.

Primary outcomes:
measure: Offspring sex ratio
timeFrame: 5 years (duration of anesthesia training)
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: ULiege
Study officials:
affiliation: CHU Brugmann, Free University of Brussels, Belgium
name: Philippe J Van der Linden, MD
role: STUDY_DIRECTOR
References:
citation: Gupta D, Kaminski E, McKelvey G, Wang H. Firstborn offspring sex ratio is skewed towards female offspring in anesthesia care providers: A questionnaire-based nationwide study from United States. J Anaesthesiol Clin Pharmacol. 2013 Apr;29(2):221-7. doi: 10.4103/0970-9185.111728.
citation: Leroy C, Daelemans C, Debauche C, Van Leeuw V. Santé périnatale en Wallonie - année 2017, Centre d'Epidémiologie Périnatale 2019.