louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04588766: Chronic Constipation With Cerebral Palsy
Official title: Evaluation of Posture, Sleep, Physical Activity and Quality of Life in Individuals With Chronic Constipation With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Constipation
Physical activity
Posture
Quality of life
Sleep
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 81
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included 81 individuals diagnosed with CP, 3-18 years of age and 2 groups with and without constipation according to Rome IV criteria.

Brief summary: This study was performed to evaluate posture, sleep, physical activity and quality of life in individuals with chronic constipation Cerebral Palsy.

Detailed description: The study included 81 individuals diagnosed with CP, 3-18 years of age and 2 groups with and without constipation according to Rome IV criteria.

General motor impairment levels with "Gross Motor Function Classification System, motor functions with "Gross Motor Function Measurement, functional independence levels Functional Independence Measurement, spasticity Modified Ashworth Scale , posture characteristics Spinal Aligment and Range of Motion Measurement, with stool characteristics Bristol Stool Form Scale the presence and severity of constipation with the Modified Constipation Assessment Scale and Constipation Severity Scale sleep quality with Pediatric Sleep Questionnaire physical activity level Physical Activity Scale and life quality was evaluated with Pediatric Quality of Life Inventory .

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in research
* Being between the ages of 2-18
* Being diagnosed with Cerebral Palsy

Exclusion Criteria:

* • Having undergone surgery involving intestinal health
* Having a chronic infectious bowel disease
* Having a congenital bowel anomaly
* Having received botox treatment in the last six months

Primary outcomes:
measure: Bristol poop scale
timeFrame: 5 minutes
Secondary outcomes:
measure: Gross motor function criterion
timeFrame: 20 minutes
measure: The Gross Motor Function Classification System
timeFrame: 2 minutes
measure: Rome IV criteria
timeFrame: 5
measure: Modified constipation assessment scale
timeFrame: 5 minutes
measure: Constipation severity scale
timeFrame: 5 minutes
measure: Six-sided pain scale-6
timeFrame: 2 minutes
measure: Beverage consumption frequency form
timeFrame: 10 minutes
measure: Sleep form in children
timeFrame: 5 minutes
measure: Physical activity scale
timeFrame: 10 minutes
measure: Spinal straightness and normal joint motion
timeFrame: 5 minutes
measure: Quality of life scale for children
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın University
Study officials:
References:
Clinical trial NCT06498466: EFFECT OF MYOFASCIAL RELEASE THERAPY IN PATIENTS WITH CERVICAL MYOFASCIAL PAIN SYNDROME
Official title: EFFECT OF MYOFASCIAL RELEASE THERAPY IN PATIENTS WITH CERVICAL MYOFASCIAL PAIN SYNDROME
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myofacial Pain Syndromes
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome.

Brief summary: Objectives: To investigate the effects of myofascial release therapy (MRT) on pain, number of trigger points (TP), pressure pain threshold (PPT), cervical range of motion (ROM), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (MPS).

In this prospective study, patients in Group I (n=30) underwent a standard physical therapy program. Patients in Group II (n=30) additionally underwent MRT 3 days a week. Before and on the 15th day after treatment, patients' pain was measured by visual analog scale (VAS), TP numbers by palpation, PPTs by pressure algometer, cervical ROM by goniometer, disability by Neck Disability Index (NDI) and quality of life by Nottingham Health Profile (NHP) was evaluated.


Eligibility criteria: Inclusion Criteria:

* volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome

Exclusion Criteria:

* presence of known infectious, inflammatory, tumoral, and advanced degenerative diseases that may cause neck pain, presence of pain reflected from internal organs, history of spine or shoulder fracture or surgery, presence of nerve root involvement findings due to cervical discopathy, having a history of neck manipulation or invasive procedures in the last 3 months.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 2 weeks
measure: Trigger Point Numbers
timeFrame: 2 weeks
measure: Pressure Pain Threshold
timeFrame: 2 weeks.
measure: Cervical Joint Range of Motion (ROM)
timeFrame: 2 weeks
measure: Neck Disability Index
timeFrame: 2 weeks
measure: Nottingham Health Profile
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
state: Çankaya
Study officials:
References:
Clinical trial NCT01918566: The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity
Official title: The Role of Endogenous GLP-1 in Regulating Glucose Stimulated Brain Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exploratory Behavior
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Our objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose with and without lactisole and exendin as well as fructose is followed by functional brain MRI, and findings are correlated with serum GLP-1 levels as an endogenous satiety signal in humans.


Eligibility criteria: Inclusion Criteria:

* right-handed healthy males, no drugs, non-smoking

Exclusion Criteria:

* drug abuse, smoker, left-handed, claustrophobia

Primary outcomes:
measure: Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task: changes in cerebral blood flow and blood hormones from baseline to treatment
timeFrame: changes from baseline to one hour after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01982266: A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip
Official title: A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Joint Disease of the Hip
Lead sponsor: Biomimedica, Inc
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 4
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: This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.


Eligibility criteria: Inclusion Criteria:

* Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement
* Skeletally mature or at least 18 years of age and has normal anatomy
* Patient signs the Informed Consent form
* Failed medical management
* There will be size limitations on patients also - available size range is 46mm-54mm.

Exclusion Criteria:

* Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components
* Previous fusion, acute femoral neck fracture and/or above knee amputation
* Revision of any previous hip procedure
* Slipped capital femoral epiphysis (SCFE)
* Rheumatoid arthritis
* AVN

Primary outcomes:
measure: Adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Arnhem
Study officials:
References:
Clinical trial NCT03981666: Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
Official title: Systematic Self-screening of Insomnia and Proposition of a Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SLEEP-4-ALL-1 is a pilot and ecological study corresponding to the developpement phase of a randomized controlled multicentric trial SLEEP-4-ALL-2. The main objective of this second study will be the validation of a stepped-care model in the treatment of persistant insomnia in cancer patients.

The primary objective of SLEEP-4-ALL-1 is to determine the acceptability of a self-screening for insomnia in cancer outpatients at Gustave Roussy.


Eligibility criteria: Inclusion Criteria:

1. Adults outpatients at Gustave Roussy,
2. with a breast, colorectal, pulmonary or urological,
3. localized or metastatic cancer,
4. during or after their treatment,
5. able to readily read and understand French,
6. able to use informatic tools confidently and with Internet access at home,
7. who have signed a written informed consent form prior to any study specific procedures,
8. affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

1. Age \> 85 years old,
2. patient receiving a cancer diagnostic during a consultation of announcement
3. with a WHO index of 3 or 4
4. severe cognitive impairements or psychiatric disorders which are incompatible with the conditions and the conduct of the study (understanding of the objectives, completion of the questionnaires)
5. simultaneous participation in another study of the same type
6. patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Primary outcomes:
measure: Acceptance rate of self-screening for insomnia
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT00985166: A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Official title: Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 801
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.


Eligibility criteria: Inclusion Criteria:

* In good health
* Received primary dose of M-M-R II at less than or equal to 12 months of age
* Received primary dose of Varivax at less than or equal to 12 months of age
* Negative history of varicella, zoster, measles, mumps, and rubella

Exclusion Criteria:

* history of receiving more than once dose of M-M-R II or Varivax
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Receipt of immune globulin, or blood product in the past 5 months

Primary outcomes:
measure: Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092.
Clinical trial NCT04761666: Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy
Official title: Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cerebral Palsy
Osteoporosis
Bone Mineral Density
Bone Remodeling Disorder
Fracture
Keywords: Cerebral Palsy
Osteoporosis
bone mineral density
bone remodelling factors
Fracture
static verticalization device
weight bearing exersices
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children whom age is between 3 and 18 years old. Children with cerebral palsy GMFCS (gross motor functionnal classification scale) IV-V.

Brief summary: Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV \& V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. The investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. The investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.


Eligibility criteria: Inclusion Criteria:

* patients with cerebral palsy GMFCS (gross motor functional classification scale) IV-V
* age of patients 3-18 years

Exclusion Criteria:

* patients with neuro muscular disease
* patient age \< 3 years old and \> 18 years old
* patient with constitutionnal bone disease
* patient with growth hormone treatment
* patient with surgery \< 6 months
* patient with fracture \<3 months
* Refusal of the legal representative

Primary outcomes:
measure: Variation of Densitometric Z score between both groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05958966: Effects of e-Cigarettes on Perceptions and Behavior - Substudy 2
Official title: Effects of e-Cigarettes on Perceptions and Behavior - Substudy 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
E-Cig Use
Cigarette Smoking
Cigarette Use, Electronic
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, adult smokers (N=200) will attend two laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation) and smoke their own cigarettes.


Eligibility criteria: Inclusion Criteria:

* Regular use of cigarettes containing nicotine.

Exclusion Criteria:

* Pregnant or planning to become pregnant.

Primary outcomes:
measure: Subjective Appeal Rating Questionnaire
timeFrame: 1 hour
measure: Sensory Attributes Rating Questionnaire
timeFrame: 1 hour
measure: Smoking Delay Task
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT04215666: Diagnostic Criteria of ARDS at High Altitudes in Western China
Official title: Diagnostic Criteria of ARDS at High Altitudes in Western China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Keywords: ARDS
Definitions
high-altitude
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Fudan University
First posted: 2020-01-02
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From 2019 to 2022, patients diagnosed with ARDS were admitted to the department of critical care medicine of qinghai university affiliated hospital, qinghai provincial people's hospital and other selected units

Brief summary: The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.

Detailed description: Will between January 2018 and December 2018 in lanzhou, and so on more than 1500 meters above sea level in qinghai region 10 intensive care patients with ARDS, respectively according to the standard in Berlin, Berlin, diagnosis of high altitude ARDS calibration standards and zhang the plateau region in western China put forward by the diagnosis of ALI/ARDS severity classification, observation group patients were ICU mortality, within 28 days, ICU mortality did not use breathing machine time, mechanical ventilation, ICU length of hospital stay, and the differences in hospitalization days.

Eligibility criteria: Inclusion Criteria:

* age ≥18
* the primary disease of ARDS caused by systemic infection, shock, severe pneumonia, aspiration and trauma
* blood gas analysis showed a progressive decline in pulmonary ventilation function
* PEEP≥5cmH2O Exclusion criteria
* Receive a large amount of hormone shock therapy in a short period of time
* Died within a short time (\< 24h) after mechanical ventilation
* Lack of data
* No chest imaging data

Primary outcomes:
measure: ICU mortality
timeFrame: up to 24 weeks
measure: 28 days mortality
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Ventilator Free time
timeFrame: up to 24 weeks
measure: Ventilator time
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Xining
country: China
facility: Affiliated hospital of qinghai university
state: Qinghai
Study officials:
affiliation: Affiliated Hospital of Qinghai University
name: Gan Guifen, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: