louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06198647: Manual Therapy for Pregnancy Related Back Pain
Official title: Effect of Tui-Na Versus Positional Release Techniques on Pregnancy Related Low Back Pain in the Third Trimester. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Low Back Pain
Keywords: manual therapy
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More than 50% of women experience pain in the lumbopelvic area during pregnancy. The prevalence of pain increases with the duration of pregnancy. Trunk muscles are needed to sustain low levels of activity for an extended duration. Preventing muscles from fatiguing is very important. Manual therapy techniques can minimize loading of the spine while improving muscular endurance and preventing fatigue. Moreover, inhibition of the trigger points of the spinal musculature is an important factor to consider.

Detailed description: Tui-Na massage and positional release therapy are both of the common manual therapies used recently for low back pain. However, no studies have compared their effects on pregnancy related low back pain in third trimester.

Eligibility criteria: Inclusion Criteria:

* low back pain
* mild to moderate disability concurring to the Oswestry Disability Index (up to 40%),
* age ranged from 20 - 40 years

Exclusion Criteria:

* Current physical therapy or medical treatment for low back pain,
* contracture or surgery affecting the lumbar spine,
* scoliosis,
* pathologies such as inflammatory diseases,
* skin diseases,
* congenital diseases,
* neurological diseases,
* dislocations, neoplasms,
* disc prolapse,
* visual or auditory problems

Primary outcomes:
measure: back pain intensity
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: The pressure pain threshold (kg/cm2)
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Benha University
state: Benah
Study officials:
affiliation: Benha University
name: Aliaa M Elabd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05500547: Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
Official title: Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carious Teeth
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to evaluate the clinical performance of new One-shade universal composite resin as posterior restoration using US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.

Detailed description: One operator will place all restorations under rubber-dam isolation. The patients will receive restorations with both materials, randomly after shade selection (The shade of single shade universal resin composite "Omnichroma" will be taken before and after placement into the cavity). During the referred period, only the two composites in study will be placed in posterior teeth in the dental office. The various materials' application procedure will be applied according to manufacturer's instructions.

Eligibility criteria: Inclusion Criteria:

* • They should have an acceptable oral hygiene level.

  * Presence of at least two occlusal carious lesions to be restored with two different types of composite.
  * The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
  * Age range between 25 and 45years.

Exclusion Criteria:

* • Severe or active periodontal or carious disease and heavy bruxism or a traumatic occlusion

  * Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
  * Alcoholic and smoker patients.
  * Patients had participated in a clinical trial within 6 months before commencement of this trial.
  * Patients unable to return for recall appointment

Primary outcomes:
measure: USPSH criteria
timeFrame: For 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Ruba Salah Anwar
Study officials:
affiliation: Minia University
name: Mona I Riad, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02887547: Biological Markers Evaluation of Accelerated Tooth Movement
Official title: Biomarkers Expression in Gingival Crevicular Fluid and Accelerated Tooth Movement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cytokine Measurements
Orthodontic Space Closure
Tooth Movement
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth movement technique, results will be assessed with biomarkers levels done using ELISA Assays

Detailed description: For this prospective study, 22 individuals were selected, with skeletal discrepancies randomly divided into two groups: 1 - accelerated tooth movement technique (ATMT) and 2 - Control.

Orthodontic records done in two times, initial and preoperative; Gingival Crevicular Fluid samples will be collected using periopapers in 7 times (1, 2, 7, 14, 28 days and after space closure- end of orthodontic treatment movement activation).

Flapless cortical perforations will be made in ATMT Group after dental extraction. Surgical protocol will be flapless to preserve periodontal health.

After extraction space closure, results will be assessed by clinical effects with biological markers levels:

CCL3/MIP-1 alpha, CCL5/RANTES, CXCL8/IL8, IL-1 alpha, IL-1 beta, IL6, TNF-alpha, TRANCE/RANK L, OCN OPG IL-10 VEGF TGF-ℬ

Those biomarkers levels will be performed using ELISA Assays. After collecting data, the results will be statistically analyzed using Shapiro-Wilk and, posteriorly, T-student or Wilcoxon.

Eligibility criteria: Inclusion Criteria:

* Adult subjects ages 18-40 years old, in good general health, with adult complete dentition, regardless of presence of third molars.
* Indication for orthognathic surgery
* Tooth extraction indication for orthodontic treatment
* Do not smoke
* Periodontal and teeth healthy
* Do not use bisphosphonates or corticosteroids

Exclusion Criteria:

* Surgically assisted rapid palatal expansion indication
* Cleft lip and palate
* Craniofacial syndrome
* Mental disorder
* Metabolic diseases

Primary outcomes:
measure: Inflammatory Cytokines ad Chemokines Detection Assay
timeFrame: 8 months
measure: Bone remodeling markers in GCF samples
timeFrame: 8 monnths
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Phd candidate
name: Liana Fattori, MS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Jose Rino Neto
role: STUDY_CHAIR
References:
Clinical trial NCT00287547: Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Official title: Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris


Eligibility criteria: Inclusion Criteria:

* Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration.
* vulgaris total body surfae area involvement of at least 10%
* Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate.

Exclusion Criteria:

* Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study.
* Functional class (V (ACR) RA or amyloidosis)
* Active vasculitis (except for subcutaneous rheumatoid nodules).
* Subjects with a history of asthma, angioedema or anaphylaxis.
* Subjects with evidence of active or latent bacterial or viral invedtions.
* Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma).
* body weight \> 100 kg (or 220 lbs.)

Primary outcomes:
measure: Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.
Secondary outcomes:
measure: Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Local Institution
state: California
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Salt LAke City
country: United States
facility: Local Institution
state: Utah
city: Burlington
country: United States
facility: Local Institution
state: Vermont
Study officials:
References:
Clinical trial NCT04223947: Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study
Official title: Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study Involving Gastroenterologists From Trainees to Experts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ENDOSCOPIC CHARACTERIZATION
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with colorectal lesions

Brief summary: Endoscopic characterization of colorectal lesions has become essential to predict histology and choose the best therapeutic strategy. We have created the CONECCT classification grouping all the endoscopic criteria already published in a single table. To validate this classification, we carried out this comparative study evaluating the endoscopic characterization performance of all recognized classifications and CONECCT in terms of inter-observer agreement and histological prediction.


Eligibility criteria: Inclusion Criteria:

* none

Exclusion Criteria:

* none

Primary outcomes:
measure: Evaluation of inter observer agreement in the use of current endoscopic classifications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: hôpital Edouard Herriot
state: Rhône Alpes
Study officials:
References:
Clinical trial NCT03689647: Using the Arms to Drive the Legs During Walking
Official title: Reducing Metabolic Cost of Walking by Exploiting Arm Swing to Drive Leg Swing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Cost of Walking With Arm Swing Assistive Device
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to understand and compare the metabolic and mechanical demands placed on the body while walking normally and walking with the use of an apparatus that drives leg swing through the use of the arms. This information will help the investigators identify how arm swing mechanics helps minimize energy demands and to use this knowledge to design walking rehabilitation interventions in the future.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy and free from neurological disease and/or body related injury
* Community-dwelling young men and women 18-36 yrs
* Use and be contacted by telephone
* Speak, read, understand, and complete a questionnaire in English
* Body mass index \< 30 kg/m2

Exclusion Criteria:

* not of the specified age range or Body Mass Index
* inadequate aerobic fitness training
* answering "no" to question #3 on Screening Form ("Is participant in good general health?")
* answering "yes" to:
* question #4 ("any difficulty with mobility?")
* question #5 ("problems with balance/dizziness?")
* question #6 ("lingering symptoms/pain from injury?")
* question #7 ("chest pain/shortness of breath?")
* question #8 ("high blood pressure/hypertension?"), or
* questions #9, 10, 11 ("first degree family history of heart attack?")
* question #12 ("smoke cigarettes?")
* question #13 ("diabetes?")
* question #14 ("high cholesterol?")
* question #15 ("Is participant pregnant?")

Primary outcomes:
measure: Metabolic Cost
timeFrame: Change from walking without assistive apparatus to walking with assistive apparatus. Measures of metabolic cost are completed within a 3-hour time window during a single laboratory visit.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Houston
name: Christopher J Arellano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vega D, Arellano CJ. Using a simple rope-pulley system that mechanically couples the arms, legs, and treadmill reduces the metabolic cost of walking. J Neuroeng Rehabil. 2021 Jun 7;18(1):96. doi: 10.1186/s12984-021-00887-3.
Clinical trial NCT01694147: EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS
Official title: Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
Keywords: relationship
endothelial injury
vascular permeability
severe sepsis related ALI/ARDS
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Septic patients receiving endotracheal mechanical ventilation for hypoxemic acute respiratory failure were eligible if the following criteria were met for no more than 48 hours before enrollment: ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FIO2) no greater than 300 mm Hg at time of enrollment, recent appearance of bilateral pulmonary infiltrates consistent with edema, and no clinical evidence of left atrial hypertension (pulmonary-capillary wedge pressure _18 mm Hg, when available).

Brief summary: To investigate the possible mechanisms of pulmonary and systemic permeability change including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome (ARDS).

Detailed description: This investigation is a prospective control study. Informed consents will be obtained from all patients or their surrogates prior to the procedure of EVLWI measurement and blood sampling for molecular measurement including cytokines.

From July 2011 to June 2014, consecutive septic patients with ARDS in intensive care units (ICUs) will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in Taiwan. EVLWI will be measured by PiCCO monitoring system. Serum cytokine such as endothelin-1, TNF-alfa, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured.

Eligibility criteria: Inclusion Criteria:

* sepsis in ICU within 48 hours,
* mechanical ventilator use,
* PaO2/FiO2 \< 300,

Exclusion Criteria:

* age younger than 20 years,
* known pregnancy,
* participation in another trial within 30 days before meeting the eligibility criteria, and
* terminal malignancy.

Primary outcomes:
measure: vascular permeability of sepsis related ALI/ARDS
timeFrame: 3 days
Secondary outcomes:
measure: relationship between endothelial injury and vascular permeability.
timeFrame: 3 days
Other outcomes:
Locations:
city: Linkou
country: Taiwan
facility: Chung Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02983747: Autologous Platelet Rich Plasma on Low Back Pain
Official title: Autologous Platelet Rich Plasma in Ultrasound Guided Intervertebral Disk Injection Therapy for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Platelet Rich Plasma
Intervertebral Disk Injection Therapy
Low Back Pain
Ultrasound Guided
Degenerative Spinal Disease
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 112
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce the pain feeling and benefit for restore of the intervertebral disk.


Eligibility criteria: Inclusion Criteria:

* Chronic low back pain more than 2months
* Visual analog scale score more than 4
* Positive X-ray, MRI or CT scan findings
* Pfirrmann grading I-III
* Well understanding and communication ability

Exclusion Criteria:

* History of allergy
* Hemorrhagic trend or use of anticoagulant therapy
* Mental diseases
* Active infection or recent infectious diseases within 3 months
* Local skin infection near the puncture location
* Severe lumbar spinal stenosis, lumbar spondylolisthesis, ossification of posterior longitudinal
* Ligament and lumbar disc herniation（more than 5mm）
* Immunologic diseases
* Tumors
* Metastatic disease
* Recent surgery less than 3 months)
* Pregnancy

Primary outcomes:
measure: Visual Analog Scale(VAS)
timeFrame: 1 year
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 1 year
measure: Functional Rating Index
timeFrame: 1 year
measure: Measuring the Quality of life using SF-36 questionnaire
timeFrame: 1 year
measure: Imaging change
timeFrame: 1 year
measure: Number of patients with side effect
timeFrame: Within 1 year after injection therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Shanghai Changzheng Hospotal
name: Xuhua Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021147: Effect of Brain Training Through Visual Mirror Feedback, Action Observation Training and Motor Imagery on Orofacial Sensorimotor Variables in Asymptomatic Subjects: A Single-blind Randomized Controlled Trial.
Official title: Effect of Brain Training Through Visual Mirror Feedback, Action Observation Training and Motor Imagery on Orofacial Sensorimotor Variables in Asymptomatic Subjects: A Single-blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise
Pain
Keywords: Motor Imagery
Action observation
Visual mirror feedback
Pain pressure thresholds
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the present study was to evaluate the effects of action observation (AO), visual mirror feedback (VMF), motor imagery (MI) combined with an orofacial exercise program in asymptomatic subjects.


Eligibility criteria: Inclusion Criteria:

1. healthy individuals with no pain
2. aged between 18 and 65 years
3. subjects with correct masticatory function and labial and lingual mobility

Exclusion Criteria:

1. individuals who presented systemic, cardiorespiratory, central nervous system or rheumatic diseases, or those who presented any musculoskeletal or craniocervical pathology
2. underage individuals
3. individuals with orofacial pain or temporomandibular disorders at the time of the study; (d) subjects' complaint of toothache or tenderness to percussion.

Primary outcomes:
measure: Pain pressure thresholds (PPTs)
timeFrame: Change from baseline and immediately post-intervention
measure: Lingual muscle endurance
timeFrame: Change from baseline and immediately post-intervention
Secondary outcomes:
measure: Maximal mouth opening (MMO)
timeFrame: Change from baseline and immediately post-intervention
measure: Lingual extensibility
timeFrame: Change from baseline and immediately post-intervention
measure: Ability to generate mental motor images
timeFrame: Change from baseline and immediately post-intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References: