louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01013480: An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome
Official title: An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fragile X Syndrome
Keywords: Fragile X Syndrome
Lead sponsor: Seaside Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study 22001, "A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with FXS. This study (22002) will enter subjects who complete Study 22001 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions more closely reflective of their general medical care.


Eligibility criteria: Inclusion Criteria:

* Have completed all scheduled visits in protocol 22001 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator

Exclusion Criteria:

* Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* The occurrence or continuation of any adverse event or condition during study 22001 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension.

Primary outcomes:
measure: Irritability subscale of the Aberrant Behavior Checklist
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California-Los Angeles Neuropsychiatric Institute
state: California
city: Sacramento
country: United States
facility: M.I.N.D. Institute
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Staten Island
country: United States
facility: NYS Institute for Basic Research in Developmental Disabilities
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Neurosciences Hospital
state: North Carolina
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Kennedy Center
state: Tennessee
city: Houston
country: United States
facility: Red Oaks Psychiatry Associates, PA
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
Clinical trial NCT06697080: Umbilical Cord-derived Mesenchymal Stem Cell Exosomes on Hair Growth in Patients With Androgenetic Alopecia
Official title: A Randomized-controlled Clinical Trial to Treat Chinese Advanced AGA With Umbilical Cord-derived Mesenchymal Stem Cell Exosomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A total of 50 patients with androgenetic alopecia were selected for the study. Patients who met the inclusion/exclusion criteria were randomly assigned to groups A and B in a 1:1 ratio to receive treatment, with the enrollment date designated as Day 1. Group A visited the clinic once each in the first, second, and third months for treatment with exosomes, while Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes. At the time points of 1, 2, 3, and 6 months after the start of the treatment period, dermatoscopic examinations were conducted on patients in both groups. The differences in hair growth density, hair shaft thickness, and follicle counts within a 1 cm diameter area were compared between the two groups. Additionally, the data differences for each subject at baseline and at the end of the experiment were also assessed.


Eligibility criteria: Inclusion Criteria:Clinical diagnosis of Androgenic alopecia · AGA classification include：The No grade for male hair loss was II-V, and the Ludwig grade for female hair loss was I-III Exclusion Criteria: (1) Using medications or supplements, including finasteride, dutasteride, minoxidil or any other hormonal products, that can affect hair growth; · (2) Patients with severe diseases, immune diseases, endocrine diseases and nervous system diseases; (3) Patients with infection, allergic disease and malignant tumor

Primary outcomes:
measure: hair diameters changed over time
timeFrame: 0 days, 1 month, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Plastic and Aesthetic Surgery, Nanfang Hospital Southern 8 Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03211780: Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors
Official title: Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.

Detailed description: Use of ultrasound-based vibrometry in this setting would allow for a relatively simple study and translation of clinical practice, as the same devices are already used in this setting, and operators have familiarity with the equipment. Incorporating another additional method to generate contrast for determining malignant tissue from normal based on biomechanical properties with the same probe would have benefit as an additional diagnostic modality.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer
* Subject is able to understand the study procedures and provide informed consent.

Exclusion Criteria:

* Subject is pregnant or breast feeding.

Primary outcomes:
measure: Determining malignant esophageal tissue from normal tissue
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Matthew Urban, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01055080: Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study
Official title: Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta-cell Autoimmunity
Keywords: type 1 diabetes
beta-cell autoantibodies
cow's milk formula
bovine insulin
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Valio Ltd
name: University of Turku
name: University of Helsinki
name: University of Eastern Finland
First posted: 2010-01-25
Enrollment: 987
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

* Pre-term, maternal diabetes with insulin treatment

Primary outcomes:
measure: Beta-cell autoantibodies
timeFrame: 3,6,12,24,36,48,60,72 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Outi Vaarala, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Goffau MC, Luopajarvi K, Knip M, Ilonen J, Ruohtula T, Harkonen T, Orivuori L, Hakala S, Welling GW, Harmsen HJ, Vaarala O. Fecal microbiota composition differs between children with beta-cell autoimmunity and those without. Diabetes. 2013 Apr;62(4):1238-44. doi: 10.2337/db12-0526. Epub 2012 Dec 28.
citation: Vaarala O, Ilonen J, Ruohtula T, Pesola J, Virtanen SM, Harkonen T, Koski M, Kallioinen H, Tossavainen O, Poussa T, Jarvenpaa AL, Komulainen J, Lounamaa R, Akerblom HK, Knip M. Removal of Bovine Insulin From Cow's Milk Formula and Early Initiation of Beta-Cell Autoimmunity in the FINDIA Pilot Study. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):608-14. doi: 10.1001/archpediatrics.2011.1559.
Clinical trial NCT02798380: Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
Official title: An Open-Label Phase 2 Study to Investigate the Efficacy, Tolerability, and Safety of the HTS-519 Insert in the Treatment of Subjects With Distal Lateral Subungual Onychomycosis of the Great Toenail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: Hallux, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519 Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.

Detailed description: Open label, single-site

Eligibility criteria: Inclusion Criteria:

* Male and females 18 - 74 years of age inclusive
* Fungal toenail infection of one or both of the large (great) toenails
* The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed)
* Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit

Exclusion Criteria:

* History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition
* Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved
* Significant confounding conditions as assessed by the study doctor
* Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* No administration of systemic antifungal medications within 6 months prior to screening visit
* No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
* Tinea pedis (athlete's foot) that would require systemic treatment

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Treatment Related Adverse Events
timeFrame: Up to 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: OrthoArizona - East Valley Foot & Ankle Specialists
state: Arizona
Study officials:
affiliation: Hallux, Inc.
name: Thomas Tremblay, RN, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT04336280: Detrusor Underactivity: Presentation and Urodynamic Characteristics
Official title: The Prevalence and Clinical Presentation of Detrusor Underactivity and Its Urodynamic Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Detrusor Underactivity
Lead sponsor: Mutah University
Sponsor class: OTHER
Collaborators: name: Istishari Urology Center
First posted: 2020-04-07
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study has reviewed a retrospective chart for 334 patients underwent UDS at the Istishari Urology Center (IUC), Amman, Jordan from July 2016 to August 2019.

The study has excluded 77 records of patients in the initial stage either due to missing data (4 cases) or exclusion criteria (73 cases), the final study population was considered to be 206 patients.

Brief summary: Detrusor underactivity (DU) is a known disease of the muscles of the urinary bladder that defined as a weak contraction of the muscle resulting in a failure to achieve complete bladder emptying. Recently, DU as a cause of Lower Urinary Tract Symptoms in both men and women has been increasingly gaining attention. There is a major issue in differentiation of underactive bladder symptoms and other causes of lower urinary tract symptoms such as detrusor hyperactivity and impaired contractility (DHIC), hypersensitive bladder (HSB), detrusor overactivity (DO), bladder outlet obstruction (BOO) and Dysfunctional Voiding (DV). Urodynamics (UDS) is the standard diagnostic tool, it includes invasive recording of the pressure that is produced when the bladder muscle contracts via pressure sensors introduced in the urinary bladder through special types of urethral catheters. This study aims to determine the prevalence of DU along with its symptomatic and urodynamics (UDS) characteristics of DU in Jordanian population through a retrospective chart review.


Eligibility criteria: Inclusion Criteria:

* Patients underwent UDS from July 2016 to August 2019

Exclusion Criteria:

* Patients with neurogenic bladder (NB) due to known underlying neurological disease, history of open pelvic surgery or major abdominal surgery, or using indwelling catheters or clean intermittent catheterization (CIC).

Primary outcomes:
measure: Prevalence of detrusor underactivity in Jordan
timeFrame: 3 years
measure: Symptomatic presentation of Detrusor underactivity
timeFrame: over one month period prior to clinical evaluation during the 3 years time period
measure: Urodynamics parameters
timeFrame: Each test takes around 30-45 minutes, all urodymanics studies were performed during the study period
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Istishari Urology Center (IUC)
Study officials:
References:
Clinical trial NCT03864380: Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort
Official title: Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vascular Disorder
Sport Injury
Keywords: Retinal Vascularization
Intense effort
OCT-A
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-03-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Person running a marathon

Brief summary: The cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization.

The eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition.

The marathon is an intense and prolonged exercise (running 42.195 km) in aerobic environment. Thus the investigators propose to study the vascular parameters of the retina, before and after this physical exercise.

This will allow : 1) to collect information on the physiology of the retinal vascularization to prolonged effort, 2) to detect any retinal damage (haemorrhages, edema, occlusion ...), not known to date.

The results may highlight vascular effects related to retinal hypoxia (venous tortuosity, haemorrhage, venous occlusion, hypoxic edema). Furthermore the results may urge prevention in this sport more and more democratized.

the investigators hypothesized that prolonged physical exercice causes a change in retinal vascularization.


Eligibility criteria: Inclusion Criteria:

* Person registered at the 2019 Paris Marathon

Exclusion Criteria:

* Ophthalmological disorders making access to the fundus impossible for both eyes

Primary outcomes:
measure: Density of retinal vascular plexuses
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
affiliation: Fondation A. de Rothschild
name: Martine MAUGET FAYSSE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mauget-Faysse M, Arej N, Paternoster M, Zuber K, Derrien S, Thevenin S, Alonso AS, Salviat F, Lafolie J, Vasseur V. Retinal and choroidal blood flow variations after an endurance exercise: A real-life pilot study at the Paris Marathon. J Sci Med Sport. 2021 Nov;24(11):1100-1104. doi: 10.1016/j.jsams.2021.03.013. Epub 2021 Mar 30.
Clinical trial NCT02075580: Totally Implantable Venous Access Devices: Quality of Life and Body Image
Official title: Totally Implantable Venous Access Devices (TIVAD): Impact on Quality of Life and Body Image
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms Undergoing Chemotherapy
Keywords: cancer, quality of life, body-image, subcutaneous-implant
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
Collaborators: name: Fondazione Guido Berlucchi
First posted: 2014-03-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients modify body image and self-representation. Therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice.


Eligibility criteria: Inclusion Criteria:

* neoplastic patients
* adults
* not visible demolitive interventions
* not psychopathological diagnosis
* language understanding

Exclusion Criteria:

* not neoplastic patients
* psychopathological diagnosis
* language misunderstanding

Primary outcomes:
measure: Generic and quality of life and body image
timeFrame: 15 days
Secondary outcomes:
measure: Satisfaction with care
timeFrame: 15 days
Other outcomes:
measure: Generic and quality of life and body image
timeFrame: 15 days
measure: Generic and quality of life and body image
timeFrame: 15 days
Locations:
city: Padova
country: Italy
facility: Veneto Institute of Oncology IOV-IRCCS
Study officials:
References:
citation: Pinto E, Granziera E, Cagol M, Cappellato S, Alfieri R, Mari V, Meroni M, Zagonel V, Conte P, Pilati P, Castoro C, Cavallin F, Scarpa M. Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT). Front Psychol. 2021 Nov 12;12:703497. doi: 10.3389/fpsyg.2021.703497. eCollection 2021.
Clinical trial NCT05131880: Gait Re-education Program in Subjects With Parkinson´s Disease
Official title: Effectiveness of a Gait Re-education Program on a Sequential Square Treadmill (Tapiz Fisior) in Subjects With Parkison´s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment status.

Detailed description: All participants interested in participating in the present study will be part of the research project. Once recruited, they will be randomly assigned to two intervention groups: A and B. Group A (control group) will perform a conventional physiotherapy treatment 2/3 sessions per week of 30 minutes duration; on the other hand, group B (intervention group) will perform the treatment of group A and a therapeutic supplement of 2-3 sessions per week of about 30 minutes. During the research period, several measurements of the variables studied will be taken: one before the intervention, one immediately after the end of the intervention, and another measurement 12 weeks after the end of the intervention.

The treatment will be carried out and supervised at all times by qualified physiotherapists, who will explain to you what the treatment consists of, the days you should attend, and the schedules. No adverse effects are expected from this therapy that could pose a risk for health.

Eligibility criteria: Inclusion Criteria:

* Older than 50 years.
* Diagnosed Parkinson Disease.
* Not to be institutionalized.
* Barthel index scores of ≥ 60.
* Ability to communicate and to get up and walk at least 10 m (33 ft)

Exclusion Criteria:

* Medical criteria for contraindication of treatment.
* Severe behavioral problems that hinder participation in the training program.

Primary outcomes:
measure: Balance and Walk
timeFrame: 15 minutes
measure: Fall Risk on elderly
timeFrame: 15 minutes
measure: Fall Risk
timeFrame: 10 minutes
measure: Functionality and independence
timeFrame: 20 minutes
Secondary outcomes:
measure: General Satisfaction
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Alberto Bermejo Franco
state: Madrid
Study officials:
References: