louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05404867: Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)
Official title: Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Functional Magnetic Resonance Imaging
Connectivity
Diffusion Tensor Imaging
Dynamometer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will try to understand the difference in brain structure between ALS patients and healthy people of similar age. ALS is a condition affecting the nervous system with disruption of the brain networks. This study aims to understand these disruptions and determine their significance in ALS.

Detailed description: Participants and healthy controls will be consented into the study. After consent, details including age, duration of disease, ALSFRS score, and grip strength will be collected. Participants will be trained to perform a grip and release task using a foam ball for 1 minute while inside an MRI scanner. Anatomical, functional and diffusion MRI sequences will be acquired during the scanning, and total scan time will be approximately 1 hour.

Eligibility criteria: Inclusion Criteria:

* Based on El Escorial Criteria we will select Probable or Definite ALS.
* Healthy controls age matched to ALS patients
* Subjects should be able to lie down in a scanner and undergo an hour-long MRI study
* Subjects should be able to understand instructions, provide consent and perform a hand task while inside the scanner

Exclusion Criteria:

* Unable to undergo MRI due to any reason
* Age \<18
* ALS patients having high aspiration risk
* Patients having cognitive limitations which prevents them from understanding the study requirements, providing consent or perform tasks inside the scanner.

Primary outcomes:
measure: fMRI
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT02054767: Anesthetic Efficacy in Irreversible Pulpitis
Official title: Anesthetic Efficacy of Articaine, Lidocaine and Mepivacaine in Patients With Irreversible Pulpitis of Mandibular Molar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: articaine
lidocaine
mepivacaine
inferior alveolar nerve block
irreversible pulpitis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and mepivacaine in patients with irreversible pulpitis of mandibular molar.

Detailed description: Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has a high failure rate and success rates are even lower when applied for the treatment of mandibular posterior teeth with irreversible pulpitis.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of irreversible pulpitis
* good health
* had at least 1 adjacent tooth plus a healthy canine

Exclusion Criteria:

* took medication could be interacting with any of the anesthetics used

Primary outcomes:
measure: pulpal anesthesia
timeFrame: Ten minutes after the inferior alveolar nerve block
Secondary outcomes:
measure: analgesia
timeFrame: the patients were instructed to report any painful sensation at three phases: 1) dentin 2) pulp chamber 3) root canal
Other outcomes:
measure: lip anesthesia
timeFrame: ten minutes after the inferior alveolar nerve block
Locations:
city: São Paulo
country: Brazil
facility: Emergency Center of the School of Dentistry at the University of São Paulo
Study officials:
affiliation: USão Paulo
name: Isabel P Tortamano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05685667: Needless Laser Injector for Antiaging Effect of Dermal Filler
Official title: Needless Laser Injector Versus Needle Injection for Antiaging Effect of Dermal Filler: A Randomized Split-face Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Problems
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.

Detailed description: A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of needless laser injector versus needle injection for anti-aging effect of dermal filler.

Eligibility criteria: Inclusion Criteria:

* patients who wanted to improve facial skin aging

Exclusion Criteria:

* a history of skin rejuvenation treatment (including filler, botulinum toxin, lasers, chemical peeling, and topical retinoid) within 6 month prior to the start of the study
* having a plan for skin rejuvenation treatment during the study
* current pregnancy or breastfeeding
* an allergy to polylactic acid (PLA) or hyaluronic acid (HA)
* uncontrolled medical diseases

Primary outcomes:
measure: Skin hydration using a Corneometer® CM 825
timeFrame: at 12 weeks after treatment
Secondary outcomes:
measure: Skin elasticity using a Cutometer® MPA 580
timeFrame: at 12 weeks after treatment
measure: Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)
timeFrame: at 12 weeks after treatment
measure: Skin aging analyzed by three-dimensional photogrammetry
timeFrame: at 12 weeks after treatment
measure: Patient's satisfaction score for antiaging effects
timeFrame: at 12 weeks after treatment
measure: Patient's pain score during treatment
timeFrame: up to 24 weeks
measure: Adverse events related to the procedure
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung Won Shin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00494767: Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs
Official title: An Exploratory Study to Evaluate Weight Loss, Body Composition Changes, Food Intake and Urine Glucose Excretion in Healthy Obese Subjects Over 8 Weeks of Dosing With GSK189075, GW869682 Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: body composition
obesity
4C model
hunger
weight loss
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology.


Eligibility criteria: Inclusion criteria:

* BMI of 30 - 40kg/m
* Females may be included if they are surgically sterile or post-menopausal

Exclusion criteria:

* Change in body weight \>4% in the last 3 months
* History of eating disorders
* had bariatric surgical intervention for obesity
* have type I or II diabetes
* Thyroid disorder not under control
* Renal or hepatobiliary disease
* Excessive alcohol consumption
* Use of drugs of abuse
* donated of blood in the last 3 months

Primary outcomes:
measure: Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies.
timeFrame: Measurements at week 8 will be compared to measurements from Day -1
Secondary outcomes:
measure: Safety (caloric losses body weight, body composition, weight and hip circumference.)
timeFrame: throughout study (Days 1-56)
measure: Leptin levels in serum
timeFrame: at several points during study
measure: Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)
timeFrame: Day 42
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01169467: Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Official title: Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endotracheal Intubation
Continuous IV Sedation
ICP Monitoring
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2010-07-26
Enrollment: 89
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 study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.

Detailed description: Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.

Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.

Eligibility criteria: Inclusion Criteria:

* Admitted to Duke University Neuro Critical Care Unit (NCCU)
* Adult (18 years of age or older)
* Expected Mechanical Ventilation for \>48 hours with sedation
* Intraventricular catheter in situ

Exclusion Criteria:

* Hypersensitivity to study drugs
* Prisoners
* Moribund state or death expected within 24 hours
* Surgery planned within 24 hours of subject enrollment
* Receiving study drug, Precedex, prior to entering study

Primary outcomes:
measure: Variability of Intracranial Pressure (ICP)
timeFrame: Baseline to 24 hours
measure: Change in Pressure Reactivity Index (PRx)
timeFrame: Baseline to 24 hours
Secondary outcomes:
measure: Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury
timeFrame: 24 hours
measure: Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury
timeFrame: Baseline to 24 hours
measure: Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury
timeFrame: Baseline to 24 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Keith Dombrowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7.
Clinical trial NCT01300767: Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses
Official title: 4 Week Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.


Eligibility criteria: Inclusion Criteria:

* Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
* Willing and able to wear spherical contact lenses within the available range of powers.
* Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Astigmatism of 1.00D or more.
* Currently wearing contact lenses in a daily disposable modality.
* Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses
* Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Comfort on Insertion
timeFrame: 4 weeks
measure: Comfort During the Day
timeFrame: 4 weeks
measure: Comfort at End of Day
timeFrame: 4 weeks
measure: Overall Comfort
timeFrame: 4 weeks
measure: Daytime Vision
timeFrame: 4 weeks
measure: Low Light Vision
timeFrame: 4 weeks
measure: Handling on Insertion
timeFrame: 4 weeks
measure: Handling at Removal
timeFrame: 4 weeks
measure: Delivers a Healthy, Natural Feeling
timeFrame: 4 weeks
measure: Lens Awareness
timeFrame: 4 weeks
measure: Overall Satisfaction
timeFrame: 4 weeks
measure: Purchase Intent
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04827667: Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer
Official title: Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 40
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: Patients with suspected or proven lung cancer, asthma or instertitial lung disease

Brief summary: The aim of this trial is to assess PD1-lymphocytes in bronchoalveolar lavage in patients with lung cancer, ILD and asthma.

Detailed description: In this trial, 20 patients with lung cancer, 10 patients with asthma and 10 patients with interstitial lung disease who have to undergo bronchocospy for medical reasons are enrolled. In each patient, bronchoalveolar lavage is performed to assess PD1-lymphocytes.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* patients with lung cancer, asthma or ILD and indication for bronchoscopy for medical reasons
* Ability to provide informed consent

Exclusion Criteria:

* acute excacerbation in patients with asthma or ILD
* endoluminal tumor growth or penumonia in patients with lung cancer

Primary outcomes:
measure: To assess and compare PD1-lmyphocytes in bronchoalveolar lavage in patients with malignant and benign lung diseases to evluate their impact in lung cancer patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT04449367: ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY
Official title: THE EFFECTIVENESS OF AN ULTRASOUND GUIDED RECTOR SPINAE BLOCK IN PATIENTS UNDERGOING THORACIC SPINE SURGERY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Analgesia
Lead sponsor: Dubai Health Authority
Sponsor class: OTHER_GOV
First posted: 2020-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underging thoracic spine sugery

Brief summary: the effectiveness of ultrasound guided erector spinae plane block in patients undergoing thoracic spine sugery

Detailed description: bilateral erector spinae plane block would be given to patients with thoracic spine sugery for postoperative analgesia \& its effectiveness would be evaluated for 2 days

Eligibility criteria: Inclusion Criteria:

* postoperative thoracic spine sugery

Exclusion Criteria:

* less then 18 years
* more than 65 years

Primary outcomes:
measure: ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Dubai Health Authority
Study officials:
References:
Clinical trial NCT03470467: Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
Official title: Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Posterior Reversible Encephalopathy Syndrome
Lead sponsor: Ictal Group
Sponsor class: OTHER
Collaborators: name: Versailles Hospital
First posted: 2018-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients requiring ICU hospitalisation

Brief summary: Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection using a standardized form : demographic data and data related to the PRES, including circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical findings, clinical and radiological features of PRES, pre-hospital and hospital care providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results of etiological investigations, cause of PRES, type and dosage of antiepileptic and antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and biological investigations. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview


Eligibility criteria: Inclusion Criteria:

* age \>= 18 years
* Posterior Reversible Encephalopathy Syndrome defined as:

  * combination of consciousness impairment, seizure activity, headaches, visual abnormalities, nausea/vomiting, and focal neurological signs AND
  * cerebral imaging abnormalities involving the white matter (brain CT scan hypodensities AND/OR Brain MRI hypoT1, hyper T2 FLAIR)
* intensive care unit admission

Exclusion Criteria:

* normal cerebral imaging

Primary outcomes:
measure: Favorable outcome
timeFrame: 1 year
Secondary outcomes:
measure: Favorable outcome
timeFrame: 3-months and 5-years, 10-years
measure: Functional impairment
timeFrame: 3-months and 1-year, 5-years, 10-years
measure: Low or moderate disability
timeFrame: 3-months and 1-year, 5-years, 10-years
measure: Recurrent PRES
timeFrame: 3-months and 1-year, 5-years, 10-years
measure: Mortality rate
timeFrame: ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Intensive Care Unit - Versailles Hospital
Study officials:
affiliation: Ictal Group
name: Stephane LEGRIEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06737367: Integrating Machine Learning for Prognostic Prediction in Stage I NSCLC by CT Images and Pathological Factors
Official title: Integrating Machine Learning for Prognostic Prediction in Stage I NSCLC: a Multicenter Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer - Non Small Cell
Keywords: NSCLC, ML, DFS
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Jinling Hospital, China

Brief summary: The investigators retrospectively collected the participants with stage I non-small cell lung cancer (NSCLC) patients resected between January 2010 to December 2020 for training and internal validation. The Clinical data, preoperative clinical information, laboratory results and CT images were collected. The investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSOcox and rsf were used to select the features. we developed a machine learning-based integrative prognostic model that utilizes radiomic and pathological variables as input using LOOCV framework. And it was further tested on the internal and external cohorts. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), IBS, DCA.


Eligibility criteria: Inclusion Criteria:

patients with stage I NSCLC (ninth AJCC edition) who underwent curative R0 resections between January 2010 and December 2020 -

Exclusion Criteria:

1. absence of enhanced CT
2. history of lung cancer or synchronous lung cancers
3. follow-up records ≤3 Months
4. carcinoma in situ (CIS) or minimally invasive NSCLC
5. death within 30 days of surgery
6. no pathological slides or reports

Primary outcomes:
measure: DFS（Disease-free survival）
timeFrame: Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: NanJing
country: China
facility: Jinling Hospital, China
Study officials:
References: