louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05867628: Intensive Activities-based Locomotor Training Program in Children With Cerebral Palsy
Official title: The Impact of an Intensive Activities-based Locomotor Training Program on Activity Capacity, Performance, and Participation in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cerebral Palsy
Keywords: cerebral palsy
children
activities-based locomotor training
neuroplasticity
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The goal of the proposed work is to investigate the impact of an intensive 3-week activities-based locomotor training (AB-LT) program on activity capacity, activity performance, and participation in children with cerebral palsy (CP). Caregiver perspectives will provide a holistic assessment of the program.


Eligibility criteria: Inclusion Criteria:

* Intervention: Participants will be included if they have a diagnosis of CP and are between the ages of 2 to 12 years. They must also be enrolled in the 3-week AB-LT program at Fortis Therapy Center.

Parent Interview: Participants will be included if they are the parent or guardian (any age) of a child who participated in the 3-week AB-LT program and attended at least 3 sessions with their child.

Exclusion Criteria:

* Intervention study: Participants will be excluded if they have had surgery or botulinum toxin injections in the previous 6 months or have uncontrolled epilepsy or cardiovascular disease.

Parent Interview: Participants will be excluded if they have not attended at least 3 AB-LT sessions with their child.

Primary outcomes:
measure: Gross Motor Function Measure-66 (GMFM)
timeFrame: 6.5 months
measure: Pediatric Neuromuscular Recovery Scale (PedsNRS)
timeFrame: 6.5 months
measure: Pediatric Evaluation of Disability Inventory (PEDI-CAT)
timeFrame: 6.5 months
measure: Pediatric Quality of Life Inventory CP Module (PedsQL-CP)
timeFrame: 6.5 months
measure: Functional near-infrared spectroscopy
timeFrame: 6.5 months
measure: Electromyography
timeFrame: 6.5 months
measure: ActiGraph sensors
timeFrame: 6.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: Megan B Flores
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04277728: Hypoperfusion-hypodensity Mismatch for the Identification of Patients With Stroke Within 4.5 Hours
Official title: Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke and known time of symptom onset.

Brief summary: Intravenous thrombolysis is recommended within 4.5 hours of stroke onset. The aim of the study is to evaluate whether a hypodensity on native CT within the virtually entire area of hypoperfusion on perfusion CT, i.e. hypoperfusion-hypodensity mismatch, identifies patients within the time window of thrombolysis in a multicenter cohort. The investigators hypothesize hypoperfusion-hypodensity mismatch will identify patients ≤ 4,5 hours of symptom onset with \>70% specificity and \>85% positive predictive value.


Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke
* evidence of acute intracranial vessel occlusion (any supratentorial proximal or peripheral artery of the anterior cerebral artery, middle cerebral artery or posterior cerebral artery territory) by CT hyper dense thrombus and/or CTangiography vessel occlusion and/or by ischemic perfusion deficit
* evidence for acute ischemic perfusion deficit, i.e. acute symptoms attributable to ischemic CT perfusion lesion
* complete native CT and CTperfusion performed on admission
* sufficient CT and CTperfusion quality for judgement of acute ischemic hypodensity
* known time of symptom onset.

Exclusion Criteria:

* None

Primary outcomes:
measure: Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours
timeFrame: on admission
measure: Specificity of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours
timeFrame: on admission
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster
Study officials:
affiliation: University Hospital Muenster
name: Jens Minnerup, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sporns PB, Kemmling A, Minnerup H, Meyer L, Krogias C, Puetz V, Thierfelder K, Duering M, Kaiser D, Langner S, Massoth C, Brehm A, Rotkopf L, Kunz WG, Karch A, Fiehler J, Heindel W, Schramm P, Royl G, Wiendl H, Psychogios M, Minnerup J. CT Hypoperfusion-Hypodensity Mismatch to Identify Patients With Acute Ischemic Stroke Within 4.5 Hours of Symptom Onset. Neurology. 2021 Nov 23;97(21):e2088-e2095. doi: 10.1212/WNL.0000000000012891. Epub 2021 Oct 14.
Clinical trial NCT01101828: Self-collected Swabs for HPV Testing in 18-24 Year Old Women
Official title: Self-collected Swabs for HPV Testing in 18-24 Year Old Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillomavirus Infections
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 to 24 year old women who date online

Brief summary: The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.

Detailed description: We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.

Eligibility criteria: Inclusion Criteria:

* Have had sex with men
* Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)

Exclusion Criteria:

* Pregnant or breastfeeding

Primary outcomes:
measure: Presence of type-specific HPV DNA in self-collected vaginal swab samples
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Rachel L Winer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04884828: Asynchronies in NIV With External Gas
Official title: Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-invasive Ventilation
Keywords: Non-invasive Ventilation
trigger asynchronies
autotriggering
bench study
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 7
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: patients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell, Barcelona) who met the following criteria: over 18 years of age, hospital admission for acute chronic respiratory failure, home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Patients with underlying psychiatric disease were excluded. The study was conducted during the patient's predischarge phase (the same day or the day before)

Brief summary: NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age,
* hospital admission for acute chronic respiratory failure,
* home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night).

Exclusion Criteria:

* Patients with underlying psychiatric disease were excluded

Primary outcomes:
measure: Asynchronies ( yes or no)
timeFrame: 1 day
measure: Type of asynchronies
timeFrame: 1 day
Secondary outcomes:
measure: Type of asynchronies pre
timeFrame: 1 day
measure: Type of asynchronies post
timeFrame: 1 day
measure: Asynchronies ( yes or no) pre
timeFrame: 1 day
measure: Asynchronies ( yes or no) post
timeFrame: 1 day
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Cristina Lalmolda
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Cristina Lalmolda, RT PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946828: Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
Official title: Evaluation of the FIM - a Non Invasive Device for Temporarily and Quick Pupil Dilation (Mydriasis)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pupil Dilation
Keywords: Field Induced Mydriasis
FIM
ATI
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this clinical trial is to evaluate the FIM optimal configuration and confirm the safety and performance/efficacy of the FIM when exposed to a larger and more varied population of users.

Detailed description: 70 Eligible subjects will be enrolled to the study and examined with the FIM to determine the degree of pupil dilation/Contraction resistance.

The study will be conducted in two main stages: 1) pupil dilation measuring and 2) functional examination. The tests' sequence will be randomized, at least 30 minutes between each test.

Eligibility criteria: Inclusion Criteria:

* Healthy and not diagnosed with any chronic disease that might influence the eye and pupilary muscle.
* Age 18-45 years old.
* Willing and able to sign the informed consent, after reading the study information form

Exclusion Criteria:

* Any known or diagnosed neurological disorders.
* A known medical history of ophthalmic surgery or any other disease that might influence the iris control muscle.
* Volunteers with a narrow or closed angle of the anterior chamber
* Presence of a corneal pathology which precludes measurement of the pupil dilatation
* Using of psychiatric medications
* Pregnancy
* Recent use (last 48hr) of pupil dilator eye drops.
* The volunteer is participating in other trials using drugs or devices
* Drug or alcohol abuse

Primary outcomes:
measure: Safety
timeFrame: 4 months
measure: Functionality
timeFrame: 4 months
Secondary outcomes:
measure: Usability
timeFrame: 4 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT01276028: Acupuncture in Menopause
Official title: Acupuncture for Vasomotor Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasomotor Symptoms
Keywords: Acupuncture
Hot Flashes
Menopause
Vasomotor Symptoms
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-01-13
Enrollment: 209
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the "real world" setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.


Eligibility criteria: Inclusion Criteria:

* Women experiencing on average 4 Hot Flashes a day
* Women aged 45-60
* Peri or Post menopausal Women (No periods for at least 3 months)

Exclusion Criteria:

* Women who have initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks
* Women who have changed their dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
* Women who have initiated antidepressants in the last 3 months
* Women who have changed their dose of an antidepressant in the last 3 months
* Women who have had acupuncture in the last 4 weeks
* Women who have received acupuncture from one of the study acupuncturists in the last 6 months will be excluded from the study
* Women who describe their health as fair or poor are excluded from the study
* Women who have a diagnosis of Hemophilia
* Relatives and Co-Workers of the treating acupuncturists

Primary outcomes:
measure: Subjective Hot Flashes
timeFrame: Up to 14 months
Secondary outcomes:
measure: Objective Hot Flashes
timeFrame: 3 days
measure: Other Symptoms
timeFrame: Up to 14 months
measure: Quality of Life
timeFrame: Up to 58 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Chapel Hill Doctors
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Nancy Avis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avis NE, Coeytaux RR, Isom S, Prevette K, Morgan T. Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial. Menopause. 2016 Jun;23(6):626-37. doi: 10.1097/GME.0000000000000597.
Clinical trial NCT06401928: Electrical Brain Stimulation for Treatment of Secondary Symptoms in Multiple Sclerosis
Official title: Electrical Brain Stimulation for Improving Mental Health and Cognitive Functioning in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: The National Brain Mapping Laboratory (NBML)
Sponsor class: OTHER
Collaborators: name: Mohaghegh Ardabili University
First posted: 2024-05-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple Sclerosis (MS) is an autoimmune disease associated with physical disability, psychological impairment, and cognitive dysfunction. As a result, the disease burden is high, and treatment options are limited. In this randomized, double-blind study, the investigators planned to use repeated electrical stimulation and assess mental health-related variables (e.g., quality of life, sleep, psychological distress) and cognitive dysfunction in patients with MS.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of MS according to the diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria (Polman et al., 2011), certified by a professional neurologist
2. being 25-55 years old
3. providing written informed consent
4. If female, a negative urine pregnancy test
5. stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
6. right handed

Exclusion Criteria:

1. smoker
2. pregnancy
3. alcohol or substance dependence
4. history of seizure
5. history of other neurological disorders than MS
6. history of head injury
7. presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.

Primary outcomes:
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: up to 1 day after the intervention
measure: and Depression Anxiety Stress Scale-21 (DASS-21)
timeFrame: up to 1 day after the intervention
measure: Mini sleep questionnaire (MSQ)
timeFrame: up to 1 day after the intervention
Secondary outcomes:
measure: psychomotor speed task
timeFrame: up to 1 day after the intervention
measure: attention / vigilance task
timeFrame: up to 1 day after the intervention
Other outcomes:
Locations:
city: Rasht
country: Iran, Islamic Republic of
facility: Multiple Sclerosis Association of Guilan
state: Giulan
Study officials:
References:
Clinical trial NCT05251961: The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
Official title: The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deformity of Limb
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the value of growing rods for the correction of long bone deformities in pediatric cases attending Sohag University Hospital and follow up aiming at determining benefits and obstacles to this technique

Detailed description: * The participants will be subjected to surgical correction using growing rods as a novel technique for their long bone deformities.
* Procedure will be done under anaesethia
* Osteotomy , fracture reduction , deformity correction will be done , then introduction of the growing rod

Eligibility criteria: Inclusion Criteria:

* cases of osteogenesis imperfecta
* metabolic bone deformities
* cases of hemimelia
* traumatic bone deformities
* complex or simple deformities

Exclusion Criteria:

* adult deformities
* short bone deformities
* very narrow medulla
* osteopetrosis

Primary outcomes:
measure: The Use Of Growing Rods In Pediatric Long Bones Deformity Correction
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sarikaya I, Seker A, Erdal OA, Gunay H, Inan M, Guler B. Using a corkscrew-tipped telescopic nail in the treatment of osteogenesis imperfecta: a biomechanical study and preliminary results of 17 consecutive cases. J Pediatr Orthop B. 2019 Mar;28(2):173-178. doi: 10.1097/BPB.0000000000000537.
citation: Persiani P, Ranaldi FM, Martini L, Zambrano A, Celli M, D'Eufemia P, Villani C. Treatment of tibial deformities with the Fassier-Duval telescopic nail and minimally invasive percutaneous osteotomies in patients with osteogenesis imperfecta type III. J Pediatr Orthop B. 2019 Mar;28(2):179-185. doi: 10.1097/BPB.0000000000000536.
Clinical trial NCT04360161: Observing the Morphology of Schlemm's Canal and Crystalline Lens in Different Age
Official title: Morphology of Schlemm's Canal and Crystalline Lens in Different Age: a Swept-source Optical Coherence Tomography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schlemm's Canal Occlusion
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to quantify and observe the morphology of trabecular meshwork (TM), Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in patients with different ages using swept-source optical coherence tomography.


Eligibility criteria: Inclusion Criteria:

* healthy patients who can cooperated with the swept-source OCT measurements

Exclusion Criteria:

* history of ocular disease
* presence of central nervous system or systemic disease

Primary outcomes:
measure: area of Schlemm's canal and trabecular meshwork
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Eye Hospital of WMU
state: Zhejiang
Study officials:
affiliation: Eye Hospital of Wenzhou Medical University
name: Yune Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT03044561: Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
Official title: Effect of Sildenafil Citrate on the Outcome of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IVF Failure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF

Detailed description: sildenafil citrate may increase endometrial thickness in women with recurrent IVF failure attributed to poor endometrial development

Eligibility criteria: Inclusion Criteria:

* (1) cases of infertility, older than 20 years of age and not older than 40 years.
* (2) Body mass index (BMI):20-29.
* (3) women have experienced two or more implantation failure attributed to inadequate endometrial development.

Exclusion Criteria:

* (1) Uterine abnormalities (e.g. septate, bicornuate and fibroid uterus, Asherman Syndrome).
* (2) Any contraindication to sildenafil citrate or any of the components of its formulation including:

  * Concurrent use of organic nitrites and nitrates.
  * Severe hepatic impairment.
  * Severe renal impairment.
  * Hypotension.
  * Recent stroke or heart attack.

Primary outcomes:
measure: endometrial thickness measures
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Ain Shams University
name: ahmed khairy, professor
role: STUDY_DIRECTOR
References: