louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06314776: Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy
Official title: Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Neurologic Disorder
Gait Disorders in Children
Hemiplegia
Keywords: Cerebral Palsy
Whole-Body Vibration
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution


Eligibility criteria: Inclusion Criteria:

* Diagnosis of neurological developmental disorder: Cerebral Palsy. (According to DSM-V)
* Age between 2 to 11 years.
* GMFCS I and II.
* Assessed and/or intervened in or from centers, institutions, etc. who collaborate with the University of Almería or participate in them. Specifically from the "Interactúa" Child Development and Early Care Center.
* The subject, father/mother/legal guardian of each subject, prior to inclusion in the study, must have signed the informed consent for the participation of himself or his/her child in it, leaving a record that it could be abandoned if at any time they deem it appropriate and without having to justify it.

Exclusion Criteria:

* Diagnosis of Epilepsy.
* Serious blood circulation problems.
* Recent operations.
* Prosthetics.
* Start of another type of therapy different from the current one.
* Not having indication for Physiotherapy.

Primary outcomes:
measure: Test Time Up and Go
timeFrame: One Month
measure: Timed 10-Meter Walk Test
timeFrame: One Month
measure: Gross Motor Function Measure
timeFrame: One Month
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: María del Mar Sánchez-Joya
Study officials:
References:
Clinical trial NCT06877676: Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
Official title: Pre-Approval Access US Intermediate Size Expanded Access Protocol for TAR-200 Treating Physician Use
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Non-Muscle Invasive Bladder Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2025-03-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).


Eligibility criteria: Inclusion criteria:

* Participant has exhausted all clinically appropriate alternative forms of treatment and is not eligible for, or does not have access to, a clinical trial
* Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC), carcinoma in situ (CIS) (OR Tis) with or without papillary disease (T1, high-grade Ta), within 12 months of completion of the last dose of BCG therapy, in participants who have received adequate Bacillus Calmette-Guérin (BCG)
* All visible papillary disease must be fully resected (absent) prior to initiation of treatment
* Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Exclusion criteria:

* Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
* Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
* Evidence of bladder perforation during diagnostic cystoscopy
* A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL)
* Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than HR-NMIBC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00295776: Lamictal in the Treatment of Post-Herpetic Neuralgia
Official title: Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Neuralgia, Postherpetic
Keywords: Inclusion Criteria:Minimum of 4 on the Likert Pain Scale.If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks.
Exclusion Criteria:
Currently on any antiepilepic drugs (AED), except for Gabapentin.
Currently taking opioid or unwilling to washout prior to the study,
Pregnant and lactating,
Have active severe systemic disease,
History of Stevens-Johnson syndrome or TEN,
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-02-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia.


Eligibility criteria: Inclusion Criteria:

* All patients will be over the age of 18,
* Need to have a diagnosis of Post-Herpetic Neuralgia,
* Minimum of 4 on the Likert Pain Scale,
* If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks

Exclusion Criteria:

* Currently on any antiepileptic drugs (AED), except for Gabapentin.
* Currently taking opioid or unwilling to washout prior to the study,
* Pregnant and lactating,
* Have active severe systemic disease,
* History of Stevens-Johnson syndrome or TEN,
* Clinically significant abnormal lab values,
* Known drug allergy to Lamictal,
* Patients on Fibrates (Tricor and Lopid),
* History of major psychiatric disturbance and substance abuse.
* Valproate due to increase chances of severe rash,
* Lidocaine Patch,
* Use of hormonal contraceptives (birth control pills, patch, ring, injection)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: The George Washington University Medical Faculty Associates
name: Perry K. Richardson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04297176: Economic Evaluation of Vancomycin Therapeutic Drug Monitoring Methods
Official title: Clinical and Economic Evaluation of Optimal Monitoring Parameters and Sampling Schemes for Vancomycin Therapeutic Drug Monitoring in Qatar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection, Bacterial
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Qatar University
First posted: 2020-03-05
Enrollment: 65
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: Vancomycin is a widely used antibiotic in the treatment of complicated gram positive infections. Approaches to vancomycin therapeutic drug monitioring (TDM) vary. This clinical trial aimed to compare the pharmacoeconomic outcomes between various vancomyicn TDM approaches.

Research questions: Which vancomycin therapeutic drug monitoring (TDM) approach is associated with superior economic outcomes?

-Objectives: In this proposed multicenter randomized controlled trial (RCT), we aim to compare the pharmacoeconomic outcomes of various vancomycin TDM approaches.


Eligibility criteria: Inclusion Criteria:

* adults at least 18 yrs who are hospitalized and initiated on IV vancomycin

Exclusion Criteria:

* renal instability
* immunosuppression;
* vancomycin allergy;
* history of recurrent peritonitis
* administration of \< 4 doses of vancomycin
* pregnancy;
* hemoglobin \< 8 g/dL.

Primary outcomes:
measure: therapeutic success
timeFrame: The follow up time varies according to the infection type. It ranges from 7 days to 1 month.
measure: cost-benefit
timeFrame: Ranges from 7 days to 1 month, according to the infection type and possible antibiotic changes if treatment failure occurs
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
References:
Clinical trial NCT02709876: Autologous Bone Marrow-Derived CD34+, CD133+, and CD271+ Stem Cell Transplantation for Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Retinitis Pigmentosa
Lead sponsor: Stem Cells Arabia
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm, single center trial to evaluate the safety and efficacy of autologous purified populations of bone-marrow derived stem cells in patients with Retinitis Pigmentosa (BM-SCs) through a 48 month follow up period.

Detailed description: Retinitis pigmentosa (RP) is an inherited disorder of the photoreceptor cells in the retina. Patients may lose vision since they were young or later in life. Currently, there are more than 60 genes identified as the cause of this condition, one of which, RPE65, has been studied in several gene therapy trials for Leber congenital amaurosis with promising results. Another treatment approach for RP is stem cell therapy. Studies in animal models of RP have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells. This is a single arm, single center trial to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and CD271+ stem cells through a 48 month follow-up period. The combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged retinal tissue, and the availability of clinical-grade purification system (CliniMACS) and microbeads to purify the target cell populations in clinically-approved methods.

Eligibility criteria: Inclusion Criteria:

* Retinitis pigmentosa patients diagnosed by ophthalmologists
* Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes.
* Best corrected visual acuity less than 6/120 by Snellen visual acuity chart

Exclusion Criteria:

* Other eye conditions that could mask the interpretation of the results
* Unable to return for follow up
* Underlying diseases including asthma, heart failure, myocardial infarction, liver failure, renal failure
* Pregnant and lactating women

Primary outcomes:
measure: ETDRS Visual acuity change
timeFrame: 12 months from baseline
Secondary outcomes:
measure: Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25)
timeFrame: 12 months from baseline
measure: Color Vision: Ishihara Color Test
timeFrame: 12 months from baseline
measure: Contrast sensitivity: CSV-1000E
timeFrame: 12 months from baseline
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Stem Cells Arabia
Study officials:
References:
Clinical trial NCT05234476: Behavioral Activation Plus Savoring for University Students
Official title: A Randomized Controlled Trial of Behavioral Activation Plus Savoring for University Students With Positive Valence Dysregulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood
Anhedonia
Depression
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 60
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 current investigation aims to examine whether a brief, two-session, virtual behavioral activation plus savoring intervention will increase daily positive emotion in university students.

Detailed description: Experiences of positive emotions are often unchanged following standard psychotherapy. To address this, the current investigation aims to enhance traditional brief behavioral activation with savoring, an emotion regulation strategy specifically targeting positive emotion, or affect, for university students endorsing low levels of the symptom. Individuals will be randomized to either a two-session behavioral activation plus savoring intervention or two sessions of empathic listening. Daily levels of positive emotions will be assessed throughout the study and for one week prior to and completing the intervention.

Eligibility criteria: Inclusion Criteria:

* University student
* Own a smartphone
* Positive affect score less than 32 on the Positive and Negative Affect Schedule, Short Form (PANAS-SF)

Primary outcomes:
measure: Positive Emotions: Modified Differential Emotions Scale (mDES; Fredrickson et al., 2003)
timeFrame: Change from first session to post-treatment (14 days)
Secondary outcomes:
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Change from baseline to post-treatment (21 days)
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Change from baseline to post-treatment (21 days)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
References:
Clinical trial NCT06569576: Promoting Aging in Place Through A Wellness Program
Official title: Promoting Aging in Place Through A Wellness Program: Comparing In-person and Online Delivery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Group Meetings
Telehealth
Lead sponsor: Mercy University
Sponsor class: OTHER
Collaborators: name: Yeshiva University
First posted: 2024-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing online delivery vs in-person delivery
Primary purpose: PREVENTION

Brief summary: Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults.

Detailed description: Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults. This study explores the implementation of the Healthy Aging Wellness program to support aging in place of community-dwelling older adults. It combines seated yoga exercises, mindfulness, and social activities.

Eligibility criteria: Inclusion Criteria:

* 65 years old or older
* independent in everyday life
* living at home
* Mini-Mental State Examination (MMSE) \> 26
* English speakers
* access to a device with a camera and reliable internet services if they were recruited for the tele-health group
* health status verified by primary care physician.

Exclusion Criteria:

* balance issues
* history of falls within the last 6 months
* medical conditions considered contra-indications to exercise
* cognitive impairments, which may make participation in the program unsafe.

Primary outcomes:
measure: Integrative Hope Scale (IHS)
timeFrame: up to 8 weeks
measure: Personal Wellbeing Index: 5th Edition
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Open ended interview
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Dobbs Ferry
country: United States
facility: Mercy University
state: New York
Study officials:
References:
Clinical trial NCT05474976: Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease
Official title: Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease During the Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease in Adolescents
Gluten-Free Diet in the Covid-19 Process
Keywords: Adolescence
Celiac Disease
gluten free diet
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 85
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this cross-sectional study of adolescents diagnosed with celiac disease in the 10-19 age group, registered to an association. Study sample of 85 participants who met the inclusion criteria and agreed to participate in the study.

Brief summary: Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents with celiac disease were affected differently by the restrictions during the COVID-19 pandemic. The aim of this study was to determine the compliance with a gluten-free diet during in adolescents with celiac disease during the Covid-19 pandemic and identify the associated factors.

The sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with celiac disease. Research data were collected by online questionnaires (Google Forms) between January and April 2022. Sociodemographic and disease-related data of adolescents who were compliant and those who were non-compliant with a gluten-free diet during the COVID-19 pandemic were compared.


Eligibility criteria: Inclusion Criteria:

* Being in the 10-19 age group,
* Being diagnosed with celiac disease according to the revised ESPGHAN criteria,
* Following a gluten-free diet for at least 6 months before the COVID-19 lockdown,
* Consenting to participate in the study by the adolescents and their parents.

Exclusion Criteria:

-Having any cognitive or mental disorders.

Primary outcomes:
measure: Adolescents with celiac disease adherence to their diet
timeFrame: 4 month
Secondary outcomes:
measure: The effects of the pandemic on the gluten-free diet
timeFrame: 4 month
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludağ University
Study officials:
affiliation: Uludag University
name: Ayla İrem Aydın, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02399176: Yoga in the Treatment of Osteoporosis
Official title: Yoga in the Treatment of Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis
Yoga
Lead sponsor: Manhattan Physical Medicine and Rehabilitation, LLP
Sponsor class: OTHER
Collaborators: name: New York University
First posted: 2015-03-26
Enrollment: 741
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study measures change in bone mineral density by the DEXA scan before and two or more years after beginning ten minutes of daily yoga designed to put pressure on the spine, hips and femur.

Detailed description: After collecting blood and urine samples, and pre-study DEXA scans, qualifying patients are given an entry DEXA scan and a DVD with instructions to advance from beginner versions of 12 Iyengar-style yoga poses to more advanced levels in daily practice for 2 years. fter two years or more, subsequent DEXA scans are recorded. Interested participants are also encouraged to have hip and spine X-rays, and bone quality studies on study entry and two years later. Actual subject participation, intercurrent illnesses, fractures and changes in medication are self-monitored with an on line scorecard, supplemented by emails and/or telephone calls when judged necessary by the PI. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan, changes in osteoarthritis according to the X-rays, and changes in bone quality before and two or more years after beginning the ten minutes of daily yoga. Dose-response relationships between the amount and intensity of yoga practice and bone mineral density and quality are sought. Yoga-related fractures and other adverse effects are also noted.

Eligibility criteria: Inclusion Criteria:

* Past DEXA scan and, all within 6 months of study entry, DEXA scan and normal values for: Metabolic panel, TSH, PTH, ESR (or CRP), Vitamin D 25 hydroxy, Vitamin D 1,25 dihydroxy, Urine NTX.

Exclusion Criteria:

* Known metabolic bone disease such as osteogenesis imperfecta, current treatment with steroids, chemotherapy, or currently healing fractures of lumbar spine, hips or femurs.

Primary outcomes:
measure: DEXA T-score
timeFrame: 2 years
Secondary outcomes:
measure: Change in bone quality after doing yoga for two years.
timeFrame: two years
measure: Number of fractures occurring while in study
timeFrame: two years
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Physical Medicine and Rehabilitation, LLP
state: New York
Study officials:
affiliation: Manhattan Physical Medicine and Rehabilitation, LLP
name: Loren M Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fishman, LM. "Yoga for Osteoporosis - A pilot study." Topics in Geriatric Rehabilitation Vol. 25, No. 3, 2009 pp. 244-250.