louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05448794: Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder
Official title: Efficacy of Ultrasound-guided Intra-Articular Hypertonic Dextrose(Prolotherapy) and Hydrodilatation for Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To determine whether ultrasound-guided Intra-Articular Hypertonic Dextrose and hydrodilatation improves pain and function in patients with frozen shoulder(FS)

Detailed description: Setting: a medical center hospital. Participants: Subjects with primary FS with shoulder pain more than 3 months. Interventions: Participants randomly be assigned into A and B group: group A received ultrasound-guided hydrodilatation with hypertonic Dextrose with a mixture of 2mL of 50%, 1mL of 2% lidocaine, and 6ml normative saline ; group B : ultrasound-guided hydrodilatation with 9 mL of normative saline and 1 mL of 2% lidocaine.

Main Outcome Measures: The primary outcome measure was the Shoulder Pain and Disability Index score. Secondary outcomes were the VAS of shoulder pain level, muscle power and angles of shoulder passive range of motion, including flexion, abduction, extension, external rotation, and internal rotation at pretreatment and weeks 2, 4, 8, 12 and 24 of post-treatment.

Eligibility criteria: Participants diagnosed with primary FS who had experienced shoulder pain for more than 6 months and a reduction \> 30° in passive ROM of the affected shoulder in at least two directions (forward flexion, abduction, or external rotation) compared with the contralateral side were evaluated for eligibility. 23 Subjects with any degree of tear or calcified tendinitis of rotator cuff tendons, previous shoulder surgery, previous intra-articular injection for the affected shoulder within 3 months of the study; or any secondary FS caused by metabolic, rheumatic, infectious arthritis, stroke, tumor, shoulder fracture/dislocation, or acute cervical radiculopathy were excluded. 23

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Primary outcomes:
measure: the Shoulder Pain and Disability Index score
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Alberta
Study officials:
affiliation: Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan.
name: CHIH-YA CHANG, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03869294: GS Regimen as the First-line Chemotherapy in Chinese Advanced PC Patients
Official title: Gemcitabine Plus S-1 as the First-line Chemotherapy in Chinese Patients With Advanced Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Chemotherapy Effect
Chemotherapeutic Toxicity
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All advanced pancreatic cancer patients are diagnosed by histology to have pancreatic adenocarcinoma after a biopsy and received first-line GS chemotherapy at the Cancer Biotherapy Center of the First Affiliated Hospital.

Brief summary: Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line chemotherapy in Chinese patients with advanced PC, we designed this prospective study.


Eligibility criteria: Inclusion Criteria:

* 1.Histologically confirmed pancreatic adenocarcinoma 2.Locally advanced or metastatic PC 3.Chemotherapy-naïve 4.ECOG performance status of 0 or 1 5. An adequate bone marrow, liver function and kidney function

Exclusion Criteria:

* 1.Age ≥80 years 2.Brain metastasis 3.With other malignancies 4.Chronic diarrhea, cardiac disease, pregnancy or breast feeding

Primary outcomes:
measure: Progression-free survival
timeFrame: 2014-01-01 to 2017-12-31
measure: Overall survival
timeFrame: 2014-01-01 to 2017-12-31
Secondary outcomes:
measure: Objective response rate
timeFrame: 2014-01-01 to 2017-12-31
measure: adverse events
timeFrame: 2014-01-01 to 2017-12-31
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First affiliated hospital, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02918994: LearningRx Cognitive Training for TBI
Official title: LearningRx Cognitive Training for Traumatic Brain Injury (TBI): A Multiple Baseline Study Across Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury (TBI)
Lead sponsor: Gibson Institute of Cognitive Research
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with Traumatic Brain Injury (TBI).

Detailed description: Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for TBI.

Eligibility criteria: Inclusion Criteria:

* Age 18+ previously diagnosed with TBI
* Living in the greater Colorado Springs area

Exclusion Criteria:

* No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging

Primary outcomes:
measure: Evidence of overall cognitive function improvement
timeFrame: within 14 days after completing the intervention
Secondary outcomes:
measure: Evidence of change in brain activity
timeFrame: within 30 days after completing the intervention
measure: Evidence of reduction in TBI symptoms
timeFrame: within 14 days after completing the intervention
measure: Evidence of change in brain structure
timeFrame: within 30 days after completing the intervention
measure: Evidence of improvement in visual attention
timeFrame: with 14 days after completing the intervention
measure: Evidence of improvement in auditory attention
timeFrame: with 14 days after completing the intervention
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Gibson Institute of Cognitive Research
state: Colorado
Study officials:
affiliation: Gibson Institute of Cognitive Research
name: Christina Ledbetter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gibson Institute of Cognitive Research
name: Amy L Moore, PhD
role: STUDY_DIRECTOR
References:
citation: Moore AL, Carpenter DM 2nd, James RL, Miller TM, Moore JJ, Disbrow EA, Ledbetter CR. Neuroimaging and Neuropsychological Outcomes Following Clinician-Delivered Cognitive Training for Six Patients With Mild Brain Injury: A Multiple Case Study. Front Hum Neurosci. 2020 Jun 24;14:229. doi: 10.3389/fnhum.2020.00229. eCollection 2020.
Clinical trial NCT06044194: Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
Official title: Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Keywords: Mitochondrial
PBMC
L-Arg
Vit C
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: DAMOR Farmaceutici S.p.a.
First posted: 2023-09-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial
Primary purpose: TREATMENT

Brief summary: Pilot study to assess the effect of L-Arg and Vit C liposomal supplementation on mitochondrial function in patients with heart failure, through analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC).

Detailed description: Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial.

The primary objective of this study is to assess the effect of liposomal L-Arg and Vit C supplementation on mitochondrial function in patients with heart failure, by analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC). Mitochondrial respiratory function of PBMC (in extensive lymphocytes and monocytes) is readily available. These cells are involved in many inflammatory diseases, including those driven by episodes of ischemia-reperfusion, which play a key role in cardiovascular alterations. In particular, the recruitment of T cells and myocardial infiltration are well described during ischemic and non-sischemic heart failure, so the mitochondrial function of PBMC could play a significant role in this immune disorderrelated during heart failure.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosis of heart failure with preserved EF 45%.

Exclusion Criteria:

* Age \<18 years
* Left ventricular ejection fraction \<45%
* Valvular heart disease
* Previous myocardial infarction or coronary heart disease
* Hypertension
* Diabetes mellitus
* Intolerance to L-arginine and liposomal vitamin C
* Pregnancy
* Lactation.

Primary outcomes:
measure: To assess the effect of liposomal L-Arg and Vit C
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
state: Lombardia
Study officials:
References:
Clinical trial NCT02842294: Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer
Official title: Etude de Cohorte évaluant l'Impact de l'Association chimiothérapie et Bevacizumab en 1ère Ligne du Cancer Colorectal métastatique Sur la qualité de Vie Relative Des Patients. Etude COBEQOL
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Quality of Life
Keywords: bevacizumab
health related quality of life
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: metastatic colorectal cancer

Brief summary: The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.


Eligibility criteria: Inclusion Criteria:

* age\> 18years
* metastatic colorectal cancer (non resectable)
* 1st chemotherapy including bevacizuman

Exclusion Criteria:

* treatment contre-indication

Primary outcomes:
measure: time to health related quality of life score deterioration (targeted dimensions of EORTC QLQC30 : global health, fatigue, emotional functioning)
timeFrame: 1 year
Secondary outcomes:
measure: time to health related quality of life score deterioration (non targeted dimensions of EORTC QLQC30 and CR 29)
timeFrame: 1 year
measure: INT PATSAT32
timeFrame: 1 year
measure: quality-adjusted life years (QALYs) using EQ5D
timeFrame: 1 year
measure: Overall survival
timeFrame: 2 years
measure: Progression Free Survival
timeFrame: 1 year
measure: treatment preference
timeFrame: 1 year
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU Besançon
state: Franche Comté
Study officials:
affiliation: University Hospital of Besancon
name: Franck Bonnetain, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03758794: Knowledge and Attitude of Dental Interns on Child Abuse
Official title: Knowledge and Attitude of Dental Interns on Child Abuse After Implementation of Two Educational Modules: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Abuse
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1. Knowledge and attitude of dental interns of the pediatric dental department regarding child abuse recognition and reporting will be assessed 2 times before and after attending one of 2 learning modules ( interactive lecture or online module ) assessment through a questionnaire
2. assessment of the learning experience through a written questionnaire

Detailed description: 1. An introduction with the aim of the study will be given to all the interns of the pediatric dentistry department, Faculty of Dentistry, Cairo University during a regular scheduled seminar.
2. All interns willing to join the study will be asked to sign an informed consent.
3. A pre-test questionnaire on recognition and reporting of child abuse will be given to the participants
4. The participants will be randomly allocated to 2 study groups Online Group: (this group will receive the educational material through an online educational module ) Lecture Group: (this group will receive the educational material through an interactive lecture based educational module )
5. A post-test same as the pre-test will be used to assess the change in knowledge and attitude regarding child abuse recognition and reporting after the completion of the assigned educational module.
6. All participants that attended both educational modules will be asked to answer a small questionnaire about their perceptions regarding the learning experience.

Eligibility criteria: Inclusion Criteria:

* Dental Interns enrolled in the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University
* Participants of both genders
* Graduates of any dental school in Egypt

Exclusion Criteria:

* Participants who refused to sign the consent
* Participants who won't be able to have online access to the material

Primary outcomes:
measure: Questionnaire on Knowledge and Attitude of child abuse
timeFrame: 2 questionnaires each for 15 minutes before and after the learning module
Secondary outcomes:
measure: Questionnaire on Perception of the learning experience
timeFrame: A 10 minutes written questionnaire
Other outcomes:
Locations:
Study officials:
References:
citation: Walsh K, Eggins E, Hine L, Mathews B, Kenny MC, Howard S, Ayling N, Dallaston E, Pink E, Vagenas D. Child protection training for professionals to improve reporting of child abuse and neglect. Cochrane Database Syst Rev. 2022 Jul 5;7(7):CD011775. doi: 10.1002/14651858.CD011775.pub2.
Clinical trial NCT02843594: A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Iantech, Inc
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 500
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 purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.


Eligibility criteria: Inclusion Criteria:

1. Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent.
2. Subjects with a visually significant cataract scheduled to undergo cataract surgery
3. Subjects \> 18 years of age
4. BCVA at baseline not better than 20/40
5. Grade 1+ cataracts

Exclusion Criteria:

1. Subjects not able to complete the informed consent form
2. Subjects \< 18 years of age
3. Polar cataracts
4. Zonular instability

Primary outcomes:
measure: Cumulative Dispersed Phaco energy
timeFrame: Intraoperative
Secondary outcomes:
measure: Endothelial cell loss
timeFrame: 1 month
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Clinica de Ojos Panama City
Study officials:
References:
citation: Ianchulev T, Chang DF, Koo E, MacDonald S, Calvo E, Tyson FT, Vasquez A, Ahmed IIK. Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study. Br J Ophthalmol. 2019 Feb;103(2):176-180. doi: 10.1136/bjophthalmol-2017-311766. Epub 2018 Apr 18.
Clinical trial NCT04776694: Compassionate Use of Dupilumab
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-02
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide Compassionate Use of Dupilumab

Detailed description: Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03707860: Radiation Oncology Mobile Application
Official title: Radiation Oncology Mobile Application: Symptoms Reporting System and Quality Assurance Tool
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Head and Neck Cancer
Radiation Toxicity
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to our radiation oncology clinic with head and neck cancer.

Brief summary: To develop a novel a mobile phone application (available on Android and IOS) for patients receiving radiation treatment for head and neck cancer. Through this application, patients will get access to their treatment calender, through a system connected with Mosiac database, which provides a timely and precise access to their treatments schedule.

In addition, patients will be able to report their treatment related toxicity in real time fashion, these symptoms will be addressed daily instead of the weekly floor clinic checks.

Furthermore, the radiation oncologist will receive an instant notification through the application, if there is error in patient's treatment (missing field, wrong dose, etc..)


Eligibility criteria: Inclusion Criteria:

Adult patients receiving definitive or adjuvant RT to head and neck site Chemotherapy is allowed PS:0-1 Has a smart phone

Exclusion Criteria:

Poor performance early laryngeal cancer Patient with metastatic disease, or palliative intent.

Primary outcomes:
measure: Grade of symptoms improved with early intervention.
timeFrame: only during RT (7WEEKS)
Secondary outcomes:
measure: compliance on the mobile.
timeFrame: Only during RT (7WEEKS)
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
References:
Clinical trial NCT01662960: Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Official title: Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Stroke
Keywords: stroke
hemiparesis
arm movement
sensory functioning
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Detailed description: This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.

Eligibility criteria: Inclusion Criteria:

* 6 months or more post-stroke
* upper extremity Fugl-Meyer score between 10 and 50
* no longer participating in upper-extremity physical or occupational therapy
* sufficient comprehension ability to understand instructions

Exclusion Criteria:

* previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
* dementia

Primary outcomes:
measure: Upper Extremity Fugl-Meyer
timeFrame: Immediately after 1 month of treatment
measure: Action Research Arm Test
timeFrame: 1 month
measure: Rivermead Assessment of Somatosensory Performance
timeFrame: 1 month
measure: Virtual-reality Assessment of Navigation
timeFrame: 1 month
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: 1 month
measure: Wolf Motor Function Test
timeFrame: 1 months
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: Einstein Medical Center Elkins Park
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Steven Jax, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: