louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03726996: Desipramine in Infantile Neuroaxonal Dystrophy (INAD).
Official title: Novel Off-label Use of Desipramine in Infantile Neuroaxonal Dystrophy: Targeting the Sphingolipid Metabolism Pathway to Reduce Accumulation of Ceramide.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infantile Neuroaxonal Dystrophy
Keywords: Pediatric genetic disorder
cognitive function
neuro-muscular disorder
PLA2G6
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children.

Participants will receive an initial oral dose of study drug once a day. This dose may be changed depending on response to study drug Clinically collected data will be recorded for up to 5 years. Investigators will also ask for participant permission to obtain a sample of child's skin biopsy from unused clinical sample previously collected for standard of care.

Detailed description: To be eligible participants must be able to swallow tablets The study drug is to be taken once daily Schedule of events. Day 0 - ECG and blood tests (4 ml or ¾ teaspoon) Day 3 - ECG and blood tests (4 ml or ¾ teaspoon) Day 7 - ECG and blood tests (4 ml or ¾ teaspoon) Weeks 2, 3, 4, 8 \& 12. ECG and blood tests (4 ml or ¾ teaspoon) Every 3 months for up to 5 years.

.

Eligibility criteria: Inclusion Criteria:

* 03-17years.
* Any gender
* Confirmed homozygotes or compound heterozygotes of pathogenic mutation variant(s) in PLA2G6
* Confirmed homozygotes of pathogenic mutation in PLA2G6
* Documentation of clinical presentation (signs and symptoms of neurodegenerative process) of INAD

Exclusion Criteria:

* Patient has sign and symptom suggesting an ongoing acute or chronic illness such as fever of unknown origin or infection.
* Patient has a second genetic condition
* Parents are unable or unwilling to return for continued care for up to 12 months

Primary outcomes:
measure: Change in Gross Motor Function as Measured by Gross Motor Function Measure (GMFM-66)
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Change in Motor Function as Measured by Quick Motor Function Test (QMFT)
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Change in Cognitive Function as Measured by the Vineland Adaptive Behavioral Scale
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Number of Participants With Change in Q-T Interval on ECG
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Number of Participants With Abnormal Transaminase Values
timeFrame: Baseline, 3, 6, 9, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Yong-hui Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029158: A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo
Official title: A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Scar Improvement
Keywords: Healthy volunteers
Comparison of two formulations
Improvement of scar appearance
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model


Eligibility criteria: Inclusion Criteria:

* Males and females aged 18-85 years who have given written informed consent
* Subjects with a body mass index within range 18-35 kg/m2
* Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol
* Female subjects using a highly effective method (S) of contraception

Exclusion Criteria:

* Subjects who have a history of keloid scarring, surgery within one year of the first dosing area
* Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised
* Subjects with any clinically significant medical condition or history of any condition which may impair wound healing

Primary outcomes:
measure: Global scar comparison scale
timeFrame: 12 months
Secondary outcomes:
measure: Adverse event incidence including specific assessment of local tolerability at the treated wound site
timeFrame: 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Renovo CTU
Study officials:
References:
Clinical trial NCT05810558: Impact of Glycine Therapy on Peri-implant Mucositis
Official title: Impact of Glycine-augmented Prophylaxis on Resolution of Peri-implant Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine the impact of glycine powder air-abrasive debridement (GPAD) on the microbiology of the tissues surrounding dental implants with health and inflammation (peri-implant mucositis).

Detailed description: Peri-implant mucositis, or the infection of the gingival tissues surrounding a dental implant, and peri-implantitis, or the infection of the gingival tissue surrounding a dental implant with bone loss, can lead to the failure and eventual loss of dental implants. The prevalence of peri-implant mucositis ranges from 30.7-43% and the prevalence of peri-implantitis ranges from 9.6-22% with non-smokers. Traditional treatment of this disease has been through biofilm removal using ultrasonic instrumentation. Glycine is a non-essential amino acid that possesses an anti-inflammatory, immunomodulary, and a cytoprotective effect. The goal of this investigation is to examine the impact of glycine-augmented biofilm removal on resolution of peri-implant mucositis

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Must have \>1 tooth-borne, non-splinted single dental implant
* Signs of healthy dental implants (pocket probing depth \<4mm and a lack of bleeding upon probing at peri-implant site) OR
* Signs of peri-implant mucositis (\> 4mm probing pocket depths at the dental implant site, bleeding upon probing at \>1 peri-implant site, pre-brushing plaque score of \> 1.9 (modified Plaque Index (mPI)), and radiographic evidence of bone loss less than 2mm).

Exclusion Criteria:

* Uncontrolled medical condition (i.e. Diabetes, History of smoking \<5 years)
* Pregnant or lactating females
* Untreated periodontal conditions
* Use of antibiotics in the past 3 months
* Subjects treated with medication for \>2 weeks with known effects to the oral tissues (i.e. coumadin, phenytoin, nifedipine, cyclosporine, non-steroidal anti-inflammatory drugs)
* Signs of peri-implantitis (pocket probing depth of 4-6mm with bleeding upon probing at \>1 peri-implant site AND radiographic bone loss)
* Dental implant mobility

Primary outcomes:
measure: gingival inflammation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: College of Dentistry
state: Ohio
Study officials:
affiliation: Ohio State University
name: Purnima S Kumar, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04297358: Hyperbaric Oxygen in Patients Who Had a Stroke
Official title: Hyperbaric Oxygen Treatment in Chronic Stroke a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Hyperbaric Oxygen
Keywords: Hyperbaric Oxygen
Completed Stroke
Feasibility
Prospective
Lead sponsor: Hyperbaric Center Basel
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.

Detailed description: 10 patients having suffered a stroke and having being rehabilitated will be treated with 40 consecutive Hyperbaric Oxygen Treatment (HBOT) after a minimal delay of 3 months after stroke. They will be neurologically assessed before and 3 months after HBOT. Rivermead mobility index will be also assessed.

Eligibility criteria: Inclusion Criteria:

* Patients with ischemic cortical stroke in chronic stage (≥ 3 months) with residual motor deficits confirmed by imaging with brain CT scan and/or brain MRI

Informed consent

Exclusion Criteria:

* Neurological issue:

  * inability to understand the informed consent form
  * Hemiplegia
* Hyperbaric issue:

  * Claustrophobia
  * inability to put on face mask
  * uncontrolled epilepsy
  * dementia or psychological disturbance
  * previous pneumothorax
  * pregnancy

Primary outcomes:
measure: Change in National Institutes of Health Stroke Scale (NIHSS score)
timeFrame: Change from Baseline NIHSS Score at 3 months
measure: Change in Rivermead mobility index (RMI) at 2 weeks
timeFrame: Change from Baseline RMI at 2 weeks
measure: Change in Rivermead mobility index (RMI) at 4 weeks
timeFrame: Change from Baseline RMI at 4 weeks
measure: Change in Rivermead mobility index (RMI) at 6 weeks
timeFrame: Change from Baseline RMI at 6 weeks
measure: Change in Rivermead mobility index (RMI) at 8 weeks
timeFrame: Change from Baseline RMI at 8 weeks
measure: Change in Rivermead mobility index (RMI) at 1 month
timeFrame: Change from Baseline RMI at 1 month
measure: Change in Rivermead mobility index (RMI) at 3 months
timeFrame: Change from Baseline RMI at 3 months
Secondary outcomes:
measure: Tympanic damage
timeFrame: From date of Start of HBOT until the date of End of HBOT
measure: Change in Visual Acuity
timeFrame: Change from Baseline Visual Acuity at 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Druckkammerzentrum Basel
Study officials:
affiliation: Druckkammerzentrum Basel
name: Marco Gelsomino, med pract
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426958: Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Official title: Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

Primary outcomes:
measure: Area Under Curve From 0 to tz (AUC0-tz)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
measure: Maximum Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
measure: Area Under Curve From 0 to ∞ Hours (AUC0-∞)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
Secondary outcomes:
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1200.151.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02383758: An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Official title: An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Encopresis
Autistic Disorder
Keywords: Behavioral Symptoms
Child Development Disorders, Pervasive
Bowel Incontinence
Constipation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Organization for Autism Research
First posted: 2015-03-09
Enrollment: 22
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to try to treat bowel movement (BM) accidents differently with children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC) medications to evoke predictable bowel movements. This will make it possible for investigators to use certain strategies to reward BMs in the toilet. Independence will be increased by fading out the use of medications. The investigators will also train caregivers to implement the procedures.

Detailed description: A large percentage of individuals with autism spectrum disorder (ASD) are delayed in achieving continence with bowel movements or never achieve it at all (i.e., they meet criteria for encopresis). This problem has tremendous ramifications for these individuals and their families because encopresis restricts them from integration with peers, limits access to educational opportunities, and carries significant social stigma. Previous interventions for encopresis in this population have either been unsuccessful or required implementation over very long periods.

Eligibility criteria: Inclusion Criteria:

* Age 5-21
* Confirmed diagnosis of autistic spectrum disorder using the Social Communication Questionnaire (SCQ) and the Childhood Autism Rating Scale II (CARSII)
* Clearance from gastroenterologist for use of glycerin suppository, bisacodyl suppository and senna
* Caregiver willing to give consent/assent

Exclusion Criteria:

* Age under 5 year or over 21 years
* Does not present a diagnosis of autistic spectrum disorder
* Previous intestinal surgeries or concurrent enuresis
* Caregiver unwilling to give consent/assent

Primary outcomes:
measure: Percent Continent
timeFrame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Secondary outcomes:
measure: Percent Independence
timeFrame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
measure: Mean Clinical Global Impression for Severity (CGI-S) Score
timeFrame: Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)
measure: Mean Clinical Global Impression for Improvement (CGI-I) Score
timeFrame: Post-Intervention (Week 6), Post-Intervention (Week 10)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Nathan Call, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000258: Role of Instructions in Nitrous Oxide Effects and Choice - 10
Official title: Role of Instructions in Nitrous Oxide Effects and Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
instruction
subjective effects
reinforcer
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To evaluate the role of instructions in nitrous oxide subjective effects and choice.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Choice of nitrous oxide vs placebo
timeFrame: After 30 min inhalation of each
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zacny JP, Cho AM, Toledano AY, Galinkin J, Coalson DW, Klock PA, Klafta JM, Young CJ. Effects of information on the reinforcing, subjective, and psychomotor effects of nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1997 Nov 25;48(2):85-95. doi: 10.1016/s0376-8716(97)00114-2.
Clinical trial NCT01724658: Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Official title: Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Sexual Dysfunction
Keywords: female sexual function
postmenopause
testosterone
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Additional testosterone undecanoate can improve female sexual function in postmenopausal women which one aspects of quality of life. The dose adjustment can reduce incidence of adverse effects and low cost of treatment with effective outcome.

Detailed description: Research Question:

" Does oral testosterone undecanoate improve sexual problem in postmenopausal women? " Type Research:Clinical research

Study design:

Randomized double-blinded placebo controlled trial

Eligibility criteria: Inclusion Criteria:

* postmenopausal women with age between 40-60 years
* Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5

Exclusion Criteria:

* women with previous use of hormonal replacement or anti-psychiatric drugs within 3 months
* women with history of or present premalignancies/malignancies
* women present with liver disease or abnormal liver enzyme
* women with active cardiovascular, cerebrovascular or thromboembolic disorders
* women with Present psychiatric disease
* Partner have sexual dysfunction

Primary outcomes:
measure: female sexual function index score
timeFrame: 8 weeks
Secondary outcomes:
measure: adverse effects of the drug
timeFrame: 8 week
Other outcomes:
Locations:
city: Bankok
country: Thailand
facility: King Chulalongkorn memorial hospital
Study officials:
affiliation: Menopause unit of Chulalongkorn hospital
name: Reuthairat Tungmunsakulchai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Floter A, Nathorst-Boos J, Carlstrom K, von Schoultz B. Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being. Climacteric. 2002 Dec;5(4):357-65.
citation: Tungmunsakulchai R, Chaikittisilpa S, Snabboon T, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N. Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women. BMC Womens Health. 2015 Dec 2;15:113. doi: 10.1186/s12905-015-0270-6.
Clinical trial NCT02487758: Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
Official title: Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 24
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: Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Detailed description: Thirty patients will be treated using the principles of guided bone regeneration and ridge preservation. Fifteen test patients will receive the flapless technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. The positive control group of fifteen patients will receive the flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Eligibility criteria: Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Previous head and neck radiation therapy.
7. Chemotherapy in the previous 12 months.
8. Pregnant patients.

Primary outcomes:
measure: Change in post-extraction site to 4 month change in crestal osseous width
timeFrame: 4 months
Secondary outcomes:
measure: Change in Soft tissue thickness
timeFrame: 4 months
measure: Percent osseous tissue
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
References: