louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03638154: Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontitis
Official title: Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Intrabony Defect
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 32
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: clinical trial was conducted to evaluate regenerative potentials of cultured gingival fibroblasts and GMSCs carried in beta tri calcium phosphate scaffold into intrabony periodontal defects in human by clinical and radiographic parameters

Detailed description: In the present study, twenty posterior two or three osseous intrabony periodontal defects were involved . They were grouped in to two groups. Group I included ten intrabony posterior defect received beta tri calcium phosphate (β TCP) bone substitute. Group II included ten posterior intrabony periodontal defect and they received a mixture of gingival fibroblast(GF) and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a resorbable collagen membrane. CBCT was used preoperatively and after 6 months for hard tissue evaluation. PDGF and BMP were measured in GCF at days 1,3,7,14.

Eligibility criteria: Inclusion Criteria:

* Presence of interproximal osseous defects estimated from radiographic evaluation (Cone Beam CT) and transgingival bone sounding ≥3mm of two or three osseous walls.

  * Probing Depth ≥5mm after initial therapy.
  * Attachment loss ≥4mm.
* full mouth plaque score and bleeding on probing score ≤ 20% after phase I therapy.

  * non vital teeth only involved.
  * no furcation involvement of the teeth presenting the intraosseous defects.
  * Thick gingival biotype more than 1 mm with enough width of attached gingiva.
* Accepts Healthy Volunteers

Exclusion Criteria:

* Patients with systemic disease or compromised immune illness using Cornell medical index
* Smoker's patients.
* Pregnant and lactating females.
* Uncooperative patients (low compliance, bad oral hygiene).
* Decision impaired individuals (prisoners, handicapped and mentally retarded patients).

Primary outcomes:
measure: bone gain in periodontal defects(by mm)
timeFrame: 6 months
Secondary outcomes:
measure: the regenerative power of the defect was evaluated by growth factor concentration in GCF.
timeFrame: day 1,3,7,14 after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University
name: Ahmed Gamal, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03890354: Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series
Official title: Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Mass
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection

Brief summary: There are a lot of surgical techniques in minimally-invasive surgery to remove gastric subepithelium tumor. Surgical approach depend on location and size of tumor. Usefully used Endostapler to cut stomach include lesion. For tumors in difficult locations some surgeons prefer laparoscopic and endoscopic cooperation or use the intragastric port technique to identify and remove the mass. But in complex procedures, gastotomy and hand sawn to identify and remove gastric subepithelium tumor is a simple technique and easy to apply. This study demonstrates the safety and effectiveness of this technique.

Detailed description: : A retrospective chart review was made of all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018. Surgical outcomes and complication of gastotomy and hand-sewn repair were analyzed.

Eligibility criteria: Inclusion Criteria:

* all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018.

Exclusion Criteria:

* conversion to open surgery

Primary outcomes:
measure: Post operative complication
timeFrame: 7 day
measure: Post operative compliction
timeFrame: 7 day
Secondary outcomes:
measure: Surgical outcome
timeFrame: 7 day
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chairat Supsamutchai
state: Bankok
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Chairat Supsamutchai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06242054: Motor Function Assessment System Based on Video Tracking and Artificial Intelligence Technique
Official title: The Development and Clinical Application of a Motor Function Assessment System Based on Video Tracking and Artificial Intelligence Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine Myelopathy
Keywords: Cervical spine myelopathy
Hand motor funciton
Video tracking technology
Artificial intelligence
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to develop a motion recognition system based on video tracking technology and combine it with artificial intelligence technology to form a motion recognition and function evaluation system in in healthy people and patients with cervical spondylotic myelopathy. The main questions it aims to answer are:

* The development of this motion recognition system,
* In the scenario of hand motor dysfunction, the key parameters of hand movement in healthy people and patients with cervical spondylotic myelopathy were evaluated, and the hand motor function model was established to achieve an objective, highly sensitive, highly specific, repeatable and easy-to-use system in clinical hand motor function evaluation.

Participants will recieved the evaluation of this system and mJOA before the surgery.

If there is a comparison group: Researchers will compare the evaluation results of healthy people to see if this system could recognized the hand motor dysfunction of patients with cervical spondylotic myelopathy.


Eligibility criteria: Inclusion Criteria:

* Study Group: 1. Patients with cervical spondylotic myelopathy diagnosed by clinical symptoms and cervical spine imaging examination (including cervical flexion and extension X-ray, cervical spine CT and cervical spine MRI).
* Control Group: 1. Healthy people without clinical and imaging manifestations of cervical spondylotic myelopathy.
* Age 18-80 years old.
* Can complete the informed consent process.

Exclusion Criteria:

* Patients with hand dysfunction caused by other reasons (such as rheumatoid arthritis, history of hand trauma, history of hand surgery, etc.).
* Patients who cannot complete the assessment process due to various reasons.

Primary outcomes:
measure: Motor Function Assessment System
timeFrame: Before the surgery
measure: mJOA
timeFrame: Before the surgery
measure: 10-Seconds Grab and Release Test
timeFrame: Before the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Feifei Zhou
state: Beijing
Study officials:
References:
Clinical trial NCT06079554: Microbiota and Metabolomics of Intestinal Type of Gastric Cancer
Official title: Microbiota and Metabolomics of Intestinal Type of Gastric Cancer in the Context of Atrophic Gastritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We underwent magnifying staining endoscopy examination in our hospital and diagnosed cases of atrophic gastritis with or without gastric cancer under endoscopy.

Brief summary: Compare with the gastric cavity without cancerous transformation in atrophic gastritis, analyze the microbiota and metabolomics changes in intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

Detailed description: This study adopts a prospective cohort study. The expected recruitment time for all participants is 6 months, and all cases are cases who would receive magnifying endoscopy examination. The extent of atrophy and the presence of early gastric cancer are determined under magnifying endoscopy. Cases are chose into the gastric cancer group and atrophic gastritis group in a 1:1 ratio. There are 16 cases of intestinal type of gastric cancer under the background of atrophic gastritis, and 16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy, totaling 32 cases. Analyze the characteristics of early gastric cancer under endoscopy, investigate the changes in microbiota and metabolomics of intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

Eligibility criteria: Inclusion Criteria:

* •Intestinal type of gastric cancer or atrophic gastritis

  * Underwent Endoscopic submucosal dissection（ESD）

Exclusion Criteria:

* • have simultaneously other cancer

  * have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases

Primary outcomes:
measure: Metabolomics results of lesions and atrophic gastritis.
timeFrame: 1year
Secondary outcomes:
measure: microbiomics of lesions and atrophic gastritis.
timeFrame: 1 year
Other outcomes:
measure: degree of gastric atrophy,
timeFrame: 1year
measure: endoscopic observation
timeFrame: 1year
Locations:
city: Chang chun
country: China
facility: the First Hospital of Jilin University
state: Ji Lin
Study officials:
References:
Clinical trial NCT03404154: Vocal in Assessment of Endometrium in Postmenopause
Official title: The Relation Between Endometrial Volume by 3D Vocal Ultrasound and Histopathology in Women With Postmenopausal Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Bleeding
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: om almasreen hospital ,Egypt
name: National Research Centre, Egypt
First posted: 2018-01-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 50
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: Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Brief summary: The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia \& carcinoma and lead to irregular bleeding

Detailed description: Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non invasive methods as Transvaginal ultrasound with 3 D application using different softwares .

One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ Computer aided Analysis ) that can measure volume especially in tissues with irregular borders And this technology is considered to be superior than the conventional 2 D ultrasound . .

Eligibility criteria: Inclusion Criteria:

-Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Exclusion Criteria:

* Women with hormone replacement therapy.
* Women showing intra-cavitary fluid collection at ultrasound examination
* Women with other gynecological lesions in the pelvis other than the uterus
* Previous diagnosis of endometrial pathology.

Primary outcomes:
measure: the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma
timeFrame: within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01784354: Acupressure for the Treatment of Raynaud's Phenomenon
Official title: Acupressure in Raynaud's Phenomenon- A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Raynaud's Phenomeon
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 23
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: The use of acupressure will be compared to targeted Raynaud's education and will evaluate the' frequency, duration and pain of Raynaud's attacks.

Detailed description: Using a Raynaud's condition score, severity of tingling, numbness and pain of attacks, the number of attacks and patient and physician visual analog scale we will assess the effect of acupressure.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Have Raynauds phenomenon, with at least 4 attacks in the last week
* on stable medications
* Willing to attend study visits

Exclusion Criteria:

* smoker
* have a history of stroke, heart attack or irregular heart rhythm
* uncontrolled blood pressure
* physical or mental illness that would interfere with participating in the study

Primary outcomes:
measure: Decrease in number of Raynaud's attacks
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT03125954: Changes in Physical Inactivity in Patients with Knee Osteoarthritis
Official title: Changes in Physical Inactivity Secondary to Exercise Therapy in Patients with Knee Osteoarthritis: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with knee osteoarthritis refered to the GLAiD program

Brief summary: This is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. The GLAiD intervention is an education and exercise based intervention aiming at decreasing pain and improving function in patients with knee osteoarthritis.

The primary outcome is change in objective recorded physical activity between baseline and follow-up.


Eligibility criteria: Inclusion Criteria:

* ≥40 years
* Diagnosed with knee OA
* Willing and able to complete study visits and procedures
* Owner of a smartphone or tablet
* Eligible for participation in the GLAID treatment
* Speaks, reads and writes Danish language

Exclusion Criteria:

* Any condition, which in the opinion of the Investigator, would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.

Primary outcomes:
measure: Objectively measured physical activity
timeFrame: 6 weeks
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score(KOOS)
timeFrame: baseline (day 1) and follow-up (after 6 weeks)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute
Study officials:
References:
citation: Bartholdy C, Skou ST, Bliddal H, Henriksen M. Changes in physical inactivity during supervised educational and exercise therapy in patients with knee osteoarthritis: A prospective cohort study. Knee. 2020 Dec;27(6):1848-1856. doi: 10.1016/j.knee.2020.09.007. Epub 2020 Nov 13.
Clinical trial NCT04267354: Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
Official title: Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facioscapulohumeral Muscular Dystrophy
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-02-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators believe that arm cycling has the potential to be effective in maintaining or improving shoulder muscle functioning. However, there is no evidence for its safety or effectiveness in the upper extremity. The aim of the study is to establish the ability of FSHD sufferers to perform arm cycling to underpin the future design of an arm exercise trial. The study hypothesis is that the limited range of shoulder movement and muscle weakness should not impact the ability of FSHD sufferers to perform arm cycling.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-60 years
2. Genetically confirmed diagnosis of FSHD
3. Willing to attend the assessment session
4. Able to understand the participant information sheet and provide written informed consent

Exclusion Criteria:

1. Aged \<18 years or \>60 years
2. Co-morbidity that would affect their ability to perform arm cycling
3. Unwilling to complete the assessments of the study
4. Unable to understand the participant information sheet and provide written informed consent.

Primary outcomes:
measure: Oxford Shoulder Score
timeFrame: At one-off study visit: Prior to completion of exercise session
Secondary outcomes:
measure: Range of movement
timeFrame: At one-off study visit: Prior to completion of exercise session
measure: Strength of muscles at shoulder and elbow joints
timeFrame: At one-off study visit: Prior to completion of exercise session
measure: Resistance of arm cycling
timeFrame: At one-off study visit: During exercise session
measure: Cadence of arm cycling
timeFrame: At one-off study visit: During exercise session
measure: Borg Rate of Perceived Exertion (RPE)
timeFrame: At one-off study visit: During exercise session
measure: Video analysis
timeFrame: At one-off study visit: During exercise session
Other outcomes:
measure: Patient suggestions
timeFrame: At one-off study visit: Immediately after completion of exercise session
measure: Patient willingness to continue
timeFrame: At one-off study visit: Immediately after completion of exercise session
Locations:
Study officials:
affiliation: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
name: Richa Kulshrestha, MBBS, MRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03826654: Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults
Official title: Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption in Healthy Adults: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: vitamin D
fortified oil
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to plain oil.

Detailed description: Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of oil every day for 2 months.

At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is the improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Eligibility criteria: Inclusion Criteria:

* 20 to 60 years
* healthy subjects
* no receiving vitamin D or omega-3 supplement in past 3 months

Exclusion Criteria:

- receiving vitamin D or omega-3 supplement during the study

Primary outcomes:
measure: 25-hydroxyvitamin D (nmol/L)
timeFrame: 8 weeks
Secondary outcomes:
measure: serum glucose (mg/dL)
timeFrame: 8 weeks
measure: serum triglyceride (mg/dL)
timeFrame: 8 weeks
measure: serum total cholesterol (mg/dL)
timeFrame: 8 weeks
measure: serum LDL
timeFrame: 8 weeks
measure: serum HDL
timeFrame: 8 weeks
measure: serum PTH (pg/mL)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Study officials:
affiliation: Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Tirang R. Neyestani, PhD
role: STUDY_CHAIR
References:
citation: Nikooyeh B, Zargaraan A, Kalayi A, Shariatzadeh N, Zahedirad M, Jamali A, Khazraie M, Hollis B, Neyestani TR. Vitamin D-fortified cooking oil is an effective way to improve vitamin D status: an institutional efficacy trial. Eur J Nutr. 2020 Sep;59(6):2547-2555. doi: 10.1007/s00394-019-02103-4. Epub 2019 Oct 12.