louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02980783: A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
Official title: BEAM: Prospective Open Label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Treatment of Dynamic Radial Cheek Line Skin Depressions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cheek Line Depressions
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 53
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.


Eligibility criteria: Inclusion Criteria:

* Presence of dynamic radial cheek lines
* Agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study

Exclusion Criteria:

* Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study
* Undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry
* Received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study

Primary outcomes:
measure: Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
timeFrame: Baseline (Day 1) to Day 45
Secondary outcomes:
measure: Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
timeFrame: Baseline (Day 1) to Day 45
measure: Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
timeFrame: Baseline (Day 1) to Day 45
measure: Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
timeFrame: Baseline (Day 1) to Day 45
measure: Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile
timeFrame: Baseline (Day 1) to Day 45
measure: Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
timeFrame: Baseline (Day 1) to Day 45
measure: Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
timeFrame: Baseline (Day 1) to Day 45
measure: Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire
timeFrame: Day 45
Other outcomes:
Locations:
city: Lyon
country: France
facility: Laboratoire DERMSCAN
Study officials:
affiliation: Allergan
name: Graeme Kerson
role: STUDY_DIRECTOR
References:
Clinical trial NCT05002283: Accuracy of Computer Guided Free Gingival Graft
Official title: Accuracy of Computer Guided Free Gingival Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computer Guided
Free Gingival Graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A patient specific surgical guide for harvesting of free gingival graft from the palate


Eligibility criteria: Inclusion Criteria:

* patients with intraoral alveolar defect requiring soft tissue augmentation

Exclusion Criteria:

1. - patients with systemic diseases interfering with surgical interventions
2. - Poor oral hygiene

Primary outcomes:
measure: Accuracy of the guide
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Investigator
name: Mohamed Shawky, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04734483: The Effectiveness of Reconstructive Microsurgery on the Clinical and Functional State of Laryngeal Stenosis
Official title: The Effectiveness of Reconstructive Microsurgery on the Clinical and Functional State of Laryngeal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Larynx Disease
Laryngeal Stenosis
Keywords: laryngeal stenosis
laryngeal MRI
laryngeal CT
pulmonary test
laryngoscopy
Lead sponsor: Astana Medical University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, prospective, single-center
Primary purpose: TREATMENT

Brief summary: To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.

Detailed description: The study include patients with laryngeal pathology in the otorhinolaryngology clinic of the 1-city hospital at Nur-Sultan city. All patients cheek up the necessary clinical, functional, diagnostic studies and treatment measures. It is planned to examine and operate on 70 patients with laryngeal pathology.

1. To study the features of the course of stenosis of the larynx under the influence of various factors, as well as traumatic injuries.
2. To develop optimal diagnostic methods for patients with laryngeal stenosis.
3. To assess the effectiveness of endolaryngeal microsurgery in patients with laryngeal stenosis.
4. To develop recommendations for the organization of treatment for stenosis of the larynx with an increase its functional state.

Eligibility criteria: Inclusion Criteria:

* medically diagnosed with stenosis of larynx
* patients who were observed larynx by MRI and CT
* patients who need surgical treatment of stenosis of larynx

Exclusion Criteria:

* pregnancy
* patients who has positive electromyography findings of motion of laryngeal muscles
* patients who has contraindications to surgical treatment on the other diseases
* patients who has not normal results of lab. analyses

Primary outcomes:
measure: Change from baseline forced expiratory volume
timeFrame: at baseline and at 24-week postrandomization
measure: Change from baseline area between vocal cords
timeFrame: at baseline and at 24-week postrandomization
measure: Change from basiline vocal fold vibration
timeFrame: at baseline and at 24-week postrandomization
measure: Evaluate the motor system by recording action potential generated in muscle fibres like thyroarytenoid, lateral cricoarytenoid, posterior cricoarytenoid, interarytenoid, cricothyroid.
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Astana Medical University
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg Research Institute of Ear, Throat, Nose and Speech
Study officials:
affiliation: Astana Medical Academy
name: Aliya Turayeva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03785483: Implementation Intention for Physical Activity in Multiple Sclerosis
Official title: Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motivation
Mindfulness
Keywords: Physical activity
Multiple sclerosis
Motivation
Intention
Mindfulness
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: CeRSM
name: COMUE
name: Poissy-Saint Germain Hospital
name: Hôpital Raymond Poincaré
name: Paris West University Nanterre La Défense
name: Cite Sep
First posted: 2018-12-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups: motivation, mindfulness, and treatment as usual
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.


Eligibility criteria: Inclusion Criteria:

* Adult aged between 18 and 65 years
* Multiple sclerosis
* Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré
* Informed consent provided during inclusion interview

Exclusion Criteria:

* Already participating in a clinical trial
* Cognitive dysfunctions in understanding simple guidelines
* Treatment reducing fatigue since less than 3 months
* Psychiatric disorders
* Unability to exercise
* Previous cardiovascular diseases
* Regular physical activity practice

Primary outcomes:
measure: Change in physical activity
timeFrame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Secondary outcomes:
measure: Change in self-reported anxiety and depression (HADS)
timeFrame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
measure: Change in self-reported mindfulness skills (FFMQ)
timeFrame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
measure: Change in self-reported motivational regulation toward exercise (BREQ)
timeFrame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
measure: Change in self-reported beliefs toward physical activity (TPB).
timeFrame: From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond-Poincaré
city: Poissy
country: France
facility: CHU Poissy Saint germain
Study officials:
affiliation: Paris Nanterre University
name: Emilie Dematte, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00950183: Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
Official title: Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures: An Evaluation of Narcotic Consumption, Pain, Wound Healing, and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Narcotic Consumption
Pain
Wound Healing
Patient Satisfaction
Keywords: cryotherapy
postoperative pain
Iceman
primary first metatarsal osteotomy (PMO)
lateral ankle ligament reconstruction (LAR)
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: DJO Incorporated
First posted: 2009-07-31
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. This will be assessed postoperatively following the foot and ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR).


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR) surgery or primary first metatarsal osteotomy surgery
* Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and to return to the clinic for a 2 week postoperative follow- up appointment

Exclusion Criteria:

* Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome, hypersensitivity to cold
* Patients allergic to hydrocodone or oxycodone
* Patients who are unwilling to complete the patient diary and/or follow their specific cold therapy instructions

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Scores
timeFrame: postop day 1 up to postop day 14
Secondary outcomes:
measure: Narcotic Pain Medication Usage
timeFrame: postop day 1 up to postop day 14
measure: Patient Satisfaction
timeFrame: first postoperative visit (between postop day 10 and 14)
measure: Surgical Complications
timeFrame: Day of Surgery
measure: Postoperative Complications
timeFrame: postop day 1 up to postop day 14
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, PA
state: North Carolina
Study officials:
affiliation: OrthoCarolina, PA
name: Robert B Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03682783: Artificial Intelligence-assisted Glaucoma Screening (AIAGS)
Official title: The Development of Artificial Intelligence-assisted Glaucoma Screening Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma Eye
Keywords: Artificial Intelligence; Glaucoma
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both glaucoma and non-glaucoma patients who can complete fundus image test will be enrolled.

Brief summary: This study will develop an artificial intelligence (AI) program for the screening of glaucoma.

Detailed description: We have realized that the glaucomatous optic neuropathy is irreversible. But if early detection and early intervention can be performed to control the development of the disease, it can greatly reduce the blindness rate of glaucoma, improve the life quality and physiological and mental health of patients, and alleviate the social burden. Therefore, screening and early diagnosis of glaucoma is the focus of glaucoma prevention.

China has a population of 1.3 billion, which greatly increase the difficulty of disease screening. In recent years, the intersection of artificial intelligence (AI) technology and modern medicine has made efficient and rapid disease screening possible.

Eligibility criteria: Inclusion Criteria:

* able to complete fundus images

Exclusion Criteria:

* unable to complete fundus images

Primary outcomes:
measure: The specificity of the algorithm for diagnosing glaucoma
timeFrame: from January 2020 to March 2021
measure: The sensitivity of the algorithm for diagnosing glaucoma
timeFrame: from January 2020 to March 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Haiyan Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00943683: Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 256
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.


Eligibility criteria: Inclusion Criteria:

* Patient is in good, stable health
* Patient has been fed solid foods for at least 1 month
* Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
* Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

* Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks

Primary outcomes:
measure: Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment
timeFrame: During the 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.
Clinical trial NCT01409083: Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children
Official title: Evaluating the Use of Intravenous Bicarbonate as a Tool to Verify the Intravascular Position of an IV Catheter in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Verifying the Correct Position of Intravenous Catheters
Keywords: infiltration
extravasation
end-tidal carbon dioxide
sodium bicarbonate
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2011-08-03
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The increase in carbon dioxide production can be detected by measuring the exhaled carbon dioxide in the lungs.

This study is conducted to access the clinical application of measuring exhaled carbon dioxide to verify the correct position of intravenous catheters.Once the catheter is in the correct position the injected bicarbonate will be detected as a distinct elevation of exhaled carbon dioxide. A similar study was already performed in adults and was found useful. The investigators now extend the clinical application to children.

Detailed description: Extravasation is the unintentional injection or leakage of fluids into the perivascular or subcutaneous space resulting in potential tissue injury. This prospective controlled study, will assesse the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of intravenous (IV) catheters in ventilated children. Diluted sodium bicarbonate will be created using undiluted standard 8.4% (1 meq/mL) sodium bicarbonate mixed in a 1:3 ratio with sterile water to achieve a final diluted concentration of 2.1% (0.25 mEq/mL). In 20 ASA I-II mechanically ventilated children age 2-8 years, the effects of 1 ml/kg of diluted 2.1% sodium bicarbonate or 0.9% normal saline,injected in a randomized order, will be analyzed. All children will have venous blood samples taken prior to injection and 10 minutes after injection for analysis of venous blood pH and electrolytes.

Eligibility criteria: Inclusion Criteria:

* ASA I,II
* age 2-8 years

Exclusion Criteria:

* ASA III or higher

Primary outcomes:
measure: increase in exhaled carbon dioxide
timeFrame: 0.5-10.00 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT04374383: Novel Photosensitizer in The Treatment of Chronic Periodontitis
Official title: Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Periodontitis
Alveolar Bone Loss
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.

Detailed description: LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD ≥5mm in each quadrant

Exclusion Criteria:

* Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers

Primary outcomes:
measure: Release profile of the drug
timeFrame: Change from baseline to 7-days.
measure: probing pocket depths (PPD)
timeFrame: Change from baseline to 6-months.
measure: clinical attachment level (CAL)
timeFrame: Change from baseline to 6-months.
Secondary outcomes:
measure: plaque index (PI)
timeFrame: Change from baseline to 6-months.
measure: bleeding on probing (BOP)
timeFrame: Change from baseline to 6-months.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: R V Chandra
state: Telangana
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences
state: Telangana
Study officials:
References:
Clinical trial NCT01217983: Utility of Renal Biomarkers in Cirrhosis
Official title: Utility of Renal Biomarkers in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Ascitis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted for cirrhotic ascitis in the University Hospital of Geneva.

Brief summary: Evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. The investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and pre-renal causes. Finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Known or suspected cirrhosis
* Suspected ascitis
* Informed consent signed

Exclusion Criteria:

* Proven multifocal hepatocellular carcinoma
* Acute gastric hemorrhage (active or \< 2 weeks)
* Known end-stage renal disease or on dialysis before admission
* Recipients of kidney or liver transplants
* Transferred from another institution

Primary outcomes:
measure: Early detection of acute kidney injury in hospitalized cirrhotic patients with ascitis using new renal biomarkers
timeFrame: 30 days
Secondary outcomes:
measure: Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality).
timeFrame: 30 days
measure: Discrimination between different type of AKI.
timeFrame: 30 days
measure: Prediction of AKI developement using renal artery resistive indexes.
timeFrame: 30 days
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: Nephrology Division
name: Belen Ponte, Md
role: PRINCIPAL_INVESTIGATOR
References: