louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02791464: Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates
Official title: Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Meditation
TM
PTSD
Trauma
Female Prisoners
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Western Oregon University
name: Maharishi University of Management Research Institute
First posted: 2016-06-06
Enrollment: 22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The pilot study investigates the potential benefits of the Transcendental Meditation program in reducing trauma, including PTSD, in female prisoners. Subjects will be randomly assigned to either the TM program or a wait list control group for a period of four months.

Detailed description: This randomized controlled pilot study will evaluate the effects of Transcendental Meditation ® (TM) on female offenders with trauma. Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, Oregon, with at least four months left of incarceration, will be enrolled in the study. Subjects will be randomly assigned to either a TM (n=11) or a wait-list control group (n=11). Subjects will be measured at baseline and four-month posttest, using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C) Twenty of the subjects (10 in each group) will take part in their treatment assignment and complete post-testing.

Eligibility criteria: Inclusion Criteria:

* female inmates, at least 4 months left of incarceration, signed written informed consent prior to baseline testing

Exclusion Criteria:

* none

Primary outcomes:
measure: Posttraumatic Stress Checklist- Civilian Version (PCL-C) total score
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maharishi University of Management Research Institute
name: Fred Travis, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00234364: Pergolide Treatment and Valvular Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Parkinson's Disease
Pergolide
Fibrosis
Keywords: Pergolide
Ergotamine derivates
Valvular heart disease
Lead sponsor: Århus Amt
Sponsor class: OTHER_GOV
First posted: 2005-10-07
Enrollment: 155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: In a blinded echocardiographic study we investigate the frequency of valvular abnormalities in a group of Parkinson patients treated with either ergot derived dopamine agonists (pergolide and cabergoline) or non-ergot derived dopamine agonists (pramipexole and ropinirole). The ability to detect patients with valvular abnormalities by clinical approach is examined.

Detailed description: Some case reports and a single study, which included 78 Parkinson patients, has found a correlation between treatment with the ergotamine derivative dopamine agonists (pergolide) and restrictive valvular heart disease. The mechanisms are thought to be the same as with the former used anorectikum, fenfluramine and other drugs stimulating the 5HT-2B receptor.

In a blinded manner we make physiologic and echocardiographic examination on 160 Parkinson patients treated with either ergotamine or non-ergotamine derivative dopamine agonists (80 patients in each group) to see whether Parkinson patients treated with ergotamine derivatives have more heart valvular disease

Eligibility criteria: Inclusion Criteria:

* Parkinson patients who in the last year has been treated minimum 6 months with either ergotamine derivative or non-ergotamine derivative dopamine agonists (the latter included as controls)
* Informed contests

Exclusion Criteria:

* Control patients will be excluded if the have been treated with ergotamine derivates in the last 12 months or if the prior to that have had ergotamine derivates for more than 6 months
* Patients with known valvular heart disease prior to the diagnosis of Parkinson

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby Hospital
state: Aahus N
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Vibeke G Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06911164: Measurement Properties of the Turkish Version of the Low Back Pain Knowledge Questionnaire
Official title: Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Low Back Pain Knowledge Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Knowledge, Attitudes, Practice
Keywords: reliability
validity
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with low back pain

Brief summary: This study aims to assess the validity and reliability of the Turkish version of the Low Back Pain Knowledge Questionnaire (LKQ). This questionnaire is a comprehensive, disease-specific tool that evaluates knowledge about low back pain. Adapting it into Turkish will provide healthcare professionals with a valuable resource for assessing patient awareness, guiding educational programs, and improving clinical practices for low back pain management.

Detailed description: This study aims to evaluate the validity and reliability of the Turkish version of the Low Back Pain Knowledge Questionnaire (LKQ), a comprehensive tool that assesses individuals' knowledge about the characteristics, symptoms, causes, and management of low back pain. The study will follow a systematic process, including translation, cultural adaptation, and psychometric evaluation. After translating the questionnaire using the forward-backward method, a panel of experts will review it for clarity and cultural relevance. The adapted questionnaire will be tested on a diverse sample to assess internal consistency (Cronbach's alpha) and test-retest reliability. The results will provide a validated Turkish version of the LKQ, enabling healthcare professionals to assess patient knowledge, guide educational programs, and improve low back pain management and prevention strategies.

Eligibility criteria: Inclusion Criteria:

* 18 years old or over
* Turkish as their mother tongue
* Presence of back pain of any duration
* Volunteered to participate in the study

Exclusion Criteria:

* Failure to complete the questionnaire

Primary outcomes:
measure: Low Back Pain Knowledge Questionnaire (LKQ)
timeFrame: first day
measure: Back Beliefs Questionnaire
timeFrame: first day
measure: Numerical Rating Scale for Pain
timeFrame: first day
measure: Roland-Morris Disability Questionnaire
timeFrame: first day
measure: Low Back Pain Knowledge Questionnaire (LKQ)
timeFrame: 7 days after
Secondary outcomes:
Other outcomes:
Locations:
city: Altınordu
country: Turkey
facility: Ordu university
state: Ordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Elif AYGUN POLAT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06086964: Effect of Therapeutic Diet With Physiotherapy on Gross Motor and Cognition of Autistic Children
Official title: Effect of Therapeutic Diet Along With Special Physiotherapy Program on Growth Motor Development and Cognitive Function in Autism Spectrum Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Spectrum Disorder
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2023-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: : A clinical trial will be conducted to investigate the effect of free-gluten/ casein diet along with specific physiotherapy program on gross motor development and cognitive function in 3-12 years old children with ASD, And thus establish a streamlining of nutrition and physical activity for children with autism and ASD.

Detailed description: Autism is a complex neurological and developmental disability that appears within early developmental stages of life. Autism affects the normal functioning of the brain, communication development as well as social skills of the child. Autism has been regarded as a life-long condition and it cannot be cured. However, severity may decrease through special diet and physiotherapy program.

In Saudi Arabia, the prevalence revealed that confirmed cases of ASD were 42,500, and many remained undiagnosed A target group of (60) children diagnosed with autism or ASD, attending the paediatric psychiatry outpatient clinic and autism centres will be enrolled in this clinical trial study, which will be conducted in Jazan City-Saudi Arabia.

The inclusion criteria will be as follows: (1) parental consent, (2) age 3-12 years, and (3) a diagnosis of autism or ASD. Exclusion criteria were as follows: (1) autism associated with a genetic syndrome, (2) patients with comorbidities (3) known food allergy leading to avoidance of certain foods, and (4) mother or primary caretaker not available to be adherent to the prescribed diet. Three groups will be designed: (1) autistic children with regular diet and physiotherapy program. (2) Autistic children on free gluten/casein diet and (3) Autistic children on free gluten/casein diet and subjected to specific physiotherapy program. The study will be continued for 3 months.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with autism spectrum disorders.
* GMFCs 4

Exclusion Criteria:

* autistic children with any musculoskeletal deformities.
* autistic children with any bulbar affection lead to problem in swallowing.

Primary outcomes:
measure: gross motor development
timeFrame: 2 hours
measure: Cognitive function
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan University
state: Gizan
Study officials:
References:
Clinical trial NCT04645264: Effect of Catheter on Postoperative Urinary Retention
Official title: Effect of Indwelling Foley Placement, Immediate Post-Operative Straight Catheterization, or No Catheterization on Post-operative Urinary Retention After Transforaminal Lumbar Interbody Fusions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transforaminal Lumbar Interbody Fusion
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine if indwelling Foley placement at the onset of the procedure, straight catherization at the conclusion of the procedure, or no catheterization produces the lowest rates of postoperative urinary retention after transforaminal lumbar interbody fusions (TLIFs).

Detailed description: Post-operative urinary retention (POUR) is one the most common post-operative complications after elective spine surgeries. Common causes of postoperative urinary retention (POUR) include bladder stenosis, distension, trauma due to catheterizations, age, and prostate hyperplasia. The incidence of POUR increases with age, gender, types of surgery conducted, any comorbidities such as cerebral palsy or multiple sclerosis, use of drugs such as anticholinergic agents, beta blockers, or sympathomimetics, and use of IV fluids.

This condition has been associated with the development of UTIs and sepsis, increased post-operative length of stay (LOS), and 90-day readmission after surgery. In the field of spine surgery, the reported incidence of POUR is highly variable, and there is no consensus on effective methods of prevention. We set out to assess POUR from patients catheterized compared to non-catheterized following a transforaminal lumbar interbody fusion.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, spondylolysis, spondylolisthesis)
* Patients able to provide informed consent

Exclusion Criteria:

* Patients with baseline urinary dysfunction requiring manual bladder emptying via intermittent straight catheterization, suprapubic catheters, or other indwelling catheters. -Allergies or other contraindications to medicines in the post- operative urinary retention protocol
* Lack of consent

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: Date of surgery until the date of hospital discharge, up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT01798264: Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
Official title: A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-02-25
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes \>6 months
* stable diet \& exercise, metformin, TZD or met + TZD HbA1c \>6.5% \<10.0%

Exclusion Criteria:

* prior treatment with exenatide
* history of pancreatitis
* history of medullary thyroid cancer or multiple endocrine neoplasia 2

Primary outcomes:
measure: Number of Subjects With Study Drug-Related Adverse Events
timeFrame: 4 weeks
Secondary outcomes:
measure: To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
timeFrame: 4 weeks
measure: Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
timeFrame: 4 weeks
measure: Change in Weight From Baseline to 4 Weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Miami Gardens
country: United States
state: Florida
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
city: San Antonio
country: United States
facility: dGd Research
state: Texas
Study officials:
References:
citation: Henry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013 May;35(5):634-645.e1. doi: 10.1016/j.clinthera.2013.03.011. Epub 2013 Apr 8.
Clinical trial NCT05615064: Relationship Between Quality of Life, Life Satisfaction and Anxiety Levels of Wheelchair Basketball Players
Official title: Evaluation of the Relationship Between Quality of Life, Life Satisfaction and Anxiety Levels of Wheelchair Basketball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Life Satisfaction
Anxiety Levels
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: wheelchair basketball players

Brief summary: Today, there are many studies on wheelchair basketball players. However, these studies do not indicate the relationship between the quality of life, life satisfaction and anxiety levels of wheelchair basketball players, in the extent of the knowledge. As a result of this study, it is aimed to obtain information about the quality of life, life satisfaction and anxiety levels of wheelchair basketball players.

Detailed description: The study aimed to examine the relationship between the quality of life, life satisfaction and anxiety levels of wheelchair basketball players. This study was carried out with wheelchair basketball players in Istanbul between March 2022 and May 2022. Twenty-three wheelchair basketball players were included in the study. The scope of the study was explained to the wheelchair basketball players who participated in the study during the face-to-face interview, and the consent forms prepared by the researcher were distributed. The participants, who approved the consent form and agreed to participate in the study, had to fill out the sociodemographic form. The quality of life of the participants was determined by the SF-12 Quality of Life Scale; Satisfaction with life was evaluated with the Satisfaction with Life Scale, and anxiety levels were evaluated with the Beck Anxiety Scale. Statistics were performed using SPSS Version 22.0 program.

Eligibility criteria: Inclusion Criteria:

* Being between the age of 18-45
* Participating in a wheelchair basketball team regularly
* Being disabled regardless of the disability score

Exclusion Criteria:

● Being over the age of 45

Primary outcomes:
measure: Sociodemographic Features
timeFrame: 3 weeks
measure: Assesment of Quality of Life
timeFrame: 3 weeks
measure: Assessment of Life Satisfaction
timeFrame: 3 weeks
measure: Assessment of Anxiety
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
state: Turkiye
Study officials:
References:
Clinical trial NCT03975764: Fecal Microbiota in Preterm Birth
Official title: Fecal Microbiota in Preterm Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gut Microbiome
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman after vaginal delivery

Brief summary: We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor


Eligibility criteria: Inclusion Criteria:

* Woman after vaginal delivery of singleton

Exclusion Criteria:

* Fetal abnormalities
* Gestational diabetes
* Hypertensive disorder

Primary outcomes:
measure: Unique microbial fingerprint
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02215564: Bordetella Pertussis Carriage in College-aged Students
Official title: Bordetella Pertussis Carriage in College-aged Students
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carriage of Bordetella Pertussis
Keywords: Bordetella pertussis
Carriage rates in young adults
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 150
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: College-aged students/young adults

Brief summary: The objective in this observational cohort study of young adults sampled at three intervals during the academic year is to ascertain if there is carriage of B. pertussis in asymptomatic individuals. We hypothesize that in asymptomatic college students there is no carriage of B. pertussis detectable by polymerase chain reaction (PCR) assay.


Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* Not immunosuppressed
* Not HIV positive (not known to be/self-reported)
* Able to tolerate swab procedures
* Able to provide consent

Exclusion Criteria:

* No antimicrobial or immunosuppressive medications taken for chronic conditions

Primary outcomes:
measure: Number of participants with B. pertussis by PCR in nasopharyngeal sample at first timepoint
timeFrame: 30 minutes
Secondary outcomes:
measure: Number of participants with B. pertussis by PCR in nasopharyngeal sample at second timepoint
timeFrame: 30 minutes
Other outcomes:
measure: Number of participants with B. pertussis by PCR in nasopharyngeal sample at third timepoint
timeFrame: 30 minutes
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
References:
citation: Nuolivirta K, Koponen P, He Q, Halkosalo A, Korppi M, Vesikari T, Helminen M. Bordetella pertussis infection is common in nonvaccinated infants admitted for bronchiolitis. Pediatr Infect Dis J. 2010 Nov;29(11):1013-5.
citation: Zhang Q, Yin Z, Li Y, Luo H, Shao Z, Gao Y, Xu L, Kan B, Lu S, Zhang Y, Li M, Liu M, Yao P, Zhao Z, He Q. Prevalence of asymptomatic Bordetella pertussis and Bordetella parapertussis infections among school children in China as determined by pooled real-time PCR: a cross-sectional study. Scand J Infect Dis. 2014 Apr;46(4):280-7. doi: 10.3109/00365548.2013.878034. Epub 2014 Feb 13.
Clinical trial NCT04195464: Effects of Dry Needling on Muscle Function in Patients With Hip Osteoarthritis
Official title: Effects of Dry Needling on Muscle Function in Patients With Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess the effects of dry needling technique on muscle strength and muscle length in patients with hip osteoarthritis at short term.


Eligibility criteria: Inclusion Criteria:

* Diagnosed medically with a X-Ray test
* American College of Rheumatology Criteria

Exclusion Criteria:

* Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
* Vascular or neurological disease.
* Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
* Fear of needles

Primary outcomes:
measure: muscle strength
timeFrame: Baseline
measure: muscle strength
timeFrame: up to 3 weeks
measure: Physical function
timeFrame: Baseline
measure: Physical function
timeFrame: up to 3 weeks
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: up to 3 weeks
measure: Functional capacity with a validated questionnaire (WOMAC)
timeFrame: Baseline
measure: Functional capacity with a validated questionnaire (WOMAC)
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Luis Ceballos Laita
Study officials:
References:
citation: Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):959-966. doi: 10.1016/j.apmr.2021.01.077. Epub 2021 Feb 7.