louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05115734: Acylcarnitine Profile After Intensive Care
Official title: Acylcarnitine Profile After Intensive Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Care
Carnitine Metabolism Disturbances
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Group short stayers: Critically ill patients with ICU length of stay of 2 days: patients admitted in ICU after a scheduled cardiac surgery with sternotomy
* Group long stayers: Critically ill patients with ICU length of stay of at least 7 days, whatever the critically illness

Brief summary: The aim of the study is to compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay.

Detailed description: In a retrospective analysis focused on survivors of an ICU stay of 7 days or more, we showed that during the week following discharge, carnitine deficiency was rare, but acylcarnitine profile was altered, with an abnormal acylcarnitine/carnitine ratio in more than 25% of the population.

Carnitine has a key role in cellular energy metabolism and is a a biomarker of the mitochondria function. Moreover, mitochondrial function is proven to be severely impaired in critically ill patients and mitochondrial dysfunction has been linked to post-ICU disorders.

In this context, it is relevant to study the evolution over time of the acylcarnitine profile in ICU survivors of a prolonged ICU stay. It is also relevant to compare the same profile between survivors of a prolonged and a shorter ICU stay.

Eligibility criteria: Inclusion Criteria:

* Group short stayers: ICU length of stay of 2 days
* Group long stayers: ICU length of stay of at least 7 days

Exclusion criteria: patient refusal

Primary outcomes:
measure: Acylcarnitine profile
timeFrame: During the 5 first days following ICU discharge
measure: Acylcarnitine profile
timeFrame: 1 month following ICU discharge
measure: Acylcarnitine profile
timeFrame: 3 month following ICU discharge
measure: Acylcarnitine profile
timeFrame: 12 month following ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
References:
Clinical trial NCT02241434: Stem Cell Therapy in Duchenne Muscular Dystrophy
Official title: The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne muscular dystrophy
Autologous Bone marrow Mononuclear cell therapy
Stem Cells
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.


Eligibility criteria: Inclusion Criteria:

* age group of 3-25 years
* Duchenne muscular dystrophy diagnosed on the basis of clinical presentation

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding

Primary outcomes:
measure: Manual Muscle Testing
timeFrame: 1 year
Secondary outcomes:
measure: Brooke and Vignos Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
Clinical trial NCT05032534: Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
Official title: Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Constipation - Functional
Keywords: Transanal irrigation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Aalborg University Hospital
name: Qufora A/S
First posted: 2021-09-02
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The children will use either the old or the new cone for transanal irrigation for 6 weeks and then crossover to the contrary cone.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate if a new irrigation system for transanal irrigation (TAI) is effective and more tolerable than the currently used system at the Pediatric Ward at Aarhus University Hospital.

Detailed description: This is a randomized, controlled study.

This study will be performed at Aarhus University Hospital (Denmark) and Aalborg University Hospital (Denmark) following the same protocol.

According to the initial randomization, children will be allocated to treatment with the new system (group A) or with the currently used system (group B). After a period of 6 weeks the child will crossover to use the contrary system.

The hypothesis is that A TAI system specifically developed for children will enhance the child's toleration of irrigation due to fewer reports on pain at insertion which will lead to better compliance. This outcome will induce a comparable or better effect on their fecal incontinence and reduce the needed follow-up period due to fewer incontinence relapse.

Eligibility criteria: Inclusion Criteria:

* Fecal incontinence on neurogenic or non-neurogenic basis, where transanal irrigation is indicated.

Exclusion Criteria:

* Morbus Hirschsprungs disease.
* Anorectal malformations.
* Use of medication that are known to cause constipation (e.g. anticholinergics)

Primary outcomes:
measure: The effect on fecal incontinence episode frequency
timeFrame: 12 weeks
measure: Evaluation of discomfort and on pain assessed on a Visual Analog Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Extent of constipation
timeFrame: 12 weeks
measure: Evaluation of urinary incontinence episodes
timeFrame: 12 weeks
measure: Evaluation of compliance assessment using the different systems
timeFrame: 12 weeks
measure: Estimation in changes of the child's well-being
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: The North Denmark Region
Study officials:
References:
Clinical trial NCT04749134: MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers
Official title: MRI Development for Radiotherapy Planning and Delivery in Non-Patient Volunteers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Focus of the Study is MRI Sequence Development
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Personnel at The Christie NHS Foundation Trust

Brief summary: Non-patient volunteers will be scanned on the MR-Linac and MRSIM to facilitate the development, optimisation and validation of MRI protocols at The Christie NHS Foundation Trust.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written consent
* Volunteers must undergo and satisfy MRI safety screening
* Volunteers must be ≥ 16 years of age
* Participants must agree to registration as a non-patient in CWP (the Trust's Electronic Health Record - EHR- system) and have their MRIs read and reported for incidental findings by a clinical radiologist

Exclusion Criteria:

* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form
* Unable to tolerate MRI scan
* Known Pregnancy
* Known or suspected pathology in body region to be scanned
* Member of study team

Primary outcomes:
measure: Developed and optimised of MRI scanning sequences for use in clinical radiotherapy practice in MR guided radiotherapy
timeFrame: Through study completion - up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS FT
Study officials:
References:
Clinical trial NCT04541134: Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
Official title: A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Dysmenorrhea
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients with Primary Dysmenorrhea


Eligibility criteria: Inclusion Criteria:

* Female patients, age between 19 years to 44years
* Patients with menstrual pain over 4 out of 6 menstrual cycles before screening
* Patients with moderate or severe menstrual pain for recent 2 menstrual cycles
* Patients with regular menstrual cycles(28±7 days) for a year

Exclusion Criteria:

* Patients diagnosed or suspected of secondary dysmenorrhea
* Previous adverse reaction or known allergy to NSAIDs
* Breast feeding woman
* Patients who are not willing to use proper contraception during clinical trial period

Primary outcomes:
measure: TOTPAR-8
timeFrame: Day 1
measure: SPID-8
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06400134: Coginitve and Physical Functions in Geriatric İndividuals
Official title: Investigation of the Relationship of Cognitive Functions With Physical Performance, Grip Strength, Walking Speed, Mobility, and Frailty in Geriatric Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Change
Physical Performance
Frailty
Mobility
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 82
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Geriatric individuals

Brief summary: The aim of this study is to investigate the relationship between cognitive functions with physical performance, grip strength, walking speed, mobility, and frailty in geriatric individuals.

Decline in cognitive function and decline in physical performance are generally associated with advanced age. Cognitive dysfunction is a natural consequence of ageing and is an important factor in maintaining quality of life and independence. Investigating the relationship between cognition, physical performance, mobility, and frailty has become a challenging issue in recent years. However, there is a need to further clarify the direction of this cognitive-motor link.


Eligibility criteria: Inclusion Criteria:

* Volunteer healthy geriatric individuals aged 65 years and over
* Able to walk independently

Exclusion Criteria:

* Without neurological and rheumatological diseases,
* Without acute musculoskeletal problems in the lower extremities

Primary outcomes:
measure: Cognition function
timeFrame: 4 month
Secondary outcomes:
measure: Physical Performance
timeFrame: 4 month
measure: Grip Strength
timeFrame: 4 month
measure: Walking speed
timeFrame: 1 month
measure: Mobility
timeFrame: 4 month
measure: Frailty
timeFrame: 4 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
state: Esenboğa
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References:
Clinical trial NCT01293734: Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchial Asthma
Keywords: bronchial asthma
cold type
heat type
Asthenia type
TCM syndrome
symptoms
physical signs
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shenyang Huanggu District Central Hospital
name: Benxi City hospital of Chinese medicine
name: Anshan Central Hospital
First posted: 2011-02-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 65 years old;
* Patients with mild-to-moderate bronchial asthma on attacking stage;
* Without cardiopulmonary or other complications;
* To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;
* Informed consent form is required to be signed.

Exclusion Criteria:

* Older than 65 years or younger than 18 years old;
* Pregnant woman or suckling period woman;
* Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.
* Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;
* Irritable the physique, or allergic to the given composition of drugs in this research;
* Patients who are in the process of other clinical research.

Primary outcomes:
measure: primary Symptom
timeFrame: 30 days
measure: physical sign
timeFrame: 30 days
measure: assistant examination
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Symptom
timeFrame: 30 days
measure: physical sign
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06814834: The Efficacy of Oral Dissolution Therapy (ODT), Extracorporeal Shock Wave Lithotripsy (ESWL), and Combined ESWL and ODT as Non-Invasive Modalities for Treating Small and Medium-Sized Radiolucent Renal Stones
Official title: A Prospective Study to Compare the Efficacy of Oral Dissolution Therapy (ODT), Extracorporeal Shock Wave Lithotripsy (ESWL), and Combined ESWL and ODT as Non-Invasive Modalities for Treating Small and Medium-Sized Radiolucent Renal Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Dissolution Therapy
Extracorporeal Shock Wave Lithotripsy
Noninvasive
Small
Medium
Radiolucent Renal Stones
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 90
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: This study aimed to compare oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), and a combination of ESWL and ODT as noninvasive modalities for treating small and medium-sized renal radiolucent.

Detailed description: Various methods exist for managing small and medium-sized radiolucent renal stones. These range from observation to oral dissolution therapy (ODT), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL).

Oral dissolving therapy diminishes the recurrence rates of stones. It positively influences the medical management of stone activity following ESWL in cases with residual calculi. By integrating oral dissolution therapy with extracorporeal shock wave lithotripsy, cases may experience the advantages of both non-invasive techniques. The combination of oral dissolution therapy and ESWL is an efficient therapeutic modality for radiolucent renal stones, dramatically reducing the overall stone volume. It also reduces the frequency of necessary extracorporeal shock wave lithotripsy sessions compared to treatment with ESWL alone

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients with a single radiolucent renal stone 0.5-2 cm at largest diameter diagnosed by non-contrast MSCT of the urinary tract (CTUT) ≤ 500 HU (Hounsfield Unit) and not seen on kidney, ureter, and bladder (KUB) X-ray.

Exclusion Criteria:

* Patients with Coagulation disorders, a pacemaker, severe deformity of the skeletal system, anatomical obstruction distal to the stone, and obesity (Body Mass Index more than or equal to 35 kilograms per meter square).
* Patients with renal insufficiency (creatinine more than 1.7 mg/dl).
* Patients with active urinary tract infections.

Primary outcomes:
measure: Stone-free status
timeFrame: 3 months after the procedure
Secondary outcomes:
measure: Complication rate
timeFrame: 3 months after the procedure
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Cairo
Study officials:
References:
Clinical trial NCT04467034: Evaluation of The Stanford Tobacco Prevention Toolkit
Official title: A Randomized Controlled Trial to Evaluate The Stanford Tobacco Prevention Toolkit
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Behavior, Health
Behavior, Smoking
Keywords: children
young adults
tobacco
education
health
smoking
prevention
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2020-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. The aims of this study are to determine: (1) whether the Curriculum is effective in changing middle and high school students' resistance to using tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco products; and (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco in the short-term.


Eligibility criteria: Inclusion Criteria:

* Middle school and high school students

Exclusion Criteria:

* Non English-speakers

Primary outcomes:
measure: Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey
timeFrame: Change from baseline to follow-up at approximately 40 weeks post-baseline
Secondary outcomes:
measure: Change in skills for refusal of tobacco products scaled score as measured by investigator-originated survey
timeFrame: Change from baseline to follow-up at approximately 40 weeks post-baseline
measure: Change in knowledge of tobacco products scaled score as measured by investigator-originated survey
timeFrame: Change from baseline to follow-up at approximately 40 weeks post-baseline
measure: This survey measures use of tobacco products with questions related to the participant's ever tobacco use, past 30-day tobacco use, and past 7-day tobacco use.
timeFrame: Change from baseline to follow-up at approximately 40 weeks post-baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford School of Medicine, Department of Pediatrics
name: Bonnie L Halpern-Felsher
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford School of Medicine, Department of Epidemiology and Population Health
name: Michael Baiocchi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05243134: The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Official title: The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patellar Dislocation
Anatomic Abnormality
Trochlear Dysplasia
Femoral Anteversion
Treatment
Sport Injury
Keywords: Patellar dislocation
Anatomic deformity
trochlear dysplasia
treatment
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with patellar dislocation

Brief summary: All the data of patients with patellar dislocation will be collected to evaluate the anatomic deformities. The data includes X-ray, CT, MRI examinations, medical records, and physical examination information. Finally, we correlate the anatomic deformities with clinical efficacy. To search for the risk factors that lead to patellar dislocation and influence the therapeutic effect.


Eligibility criteria: Inclusion Criteria:

-Patients with patellar dislocation.

Exclusion Criteria:

* Patients with significant ligamentous knee injury.
* Previous fracture or surgery of the lower limb.
* Patellar dislocation caused by car accidents or other high-energy force directly on the patella.

Primary outcomes:
measure: Number of participants with redislocation of their patella after surgery as confirmed by clinical physical examination
timeFrame: Three years after surgery
measure: International Knee Documentation Committee(IKDC) score
timeFrame: Three years after surgery
measure: Magnatic Resonance Imaging evaluation
timeFrame: Three years after surgery
Secondary outcomes:
measure: Skeletal force line and various angles by X-ray evaluation
timeFrame: Preoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Lin Lin
role: STUDY_DIRECTOR
References:
citation: Xu Z, Song Y, Deng R, Ye J, Wang X, Wang H, Yu JK. CT and MRI measurements of tibial tubercle lateralization in patients with patellar dislocation were not equivalent but could be interchangeable. Knee Surg Sports Traumatol Arthrosc. 2023 Jan;31(1):349-357. doi: 10.1007/s00167-022-07119-8. Epub 2022 Sep 11.