louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01753921: Evaluation of a Non-invasive Brain Compliance Measurement Device
Official title: Evaluation of a Non-invasive Brain Compliance Measurement Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetic Ketoacidosis
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Jan Medical, Inc.
First posted: 2012-12-20
Enrollment: 14
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 10-16 with DKA

Brief summary: This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.

Detailed description: At enrollment, 1 week, 1 month, 3 month, 12 month Computerized neurocognitive testing Wear NNS

MRI of the brain at 3 month and 12 months

Formal neurocognitive testing at 3 months and 12 months

Eligibility criteria: Inclusion Criteria:

To be eligible for the study, all subjects must meet the following criteria:

1. Healthy control OR
2. Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines
3. Age 10 years to less than 17 years
4. Parent/guardian understand the study protocol and agrees to comply with it.
5. Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English.

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible for the study:

1. History of head trauma with any loss of consciousness
2. History of premature birth (less than 30 weeks of gestation)
3. History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age
4. History of neurologic disease independent of diabetes (seizure disorder)

Primary outcomes:
measure: Unique signal measured in Hertz
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Tandy Aye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02918721: Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds
Official title: A Randomised, Multi-center, Subject and Evaluator-blinded Study Comparing Pain and Safety Profile Associated With Correction of Moderate to Severe Nasolabial Folds Using Restylane With and Without Addition of 0.3% Lidocaine Hydrochloride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold
Keywords: Hyaluronic Acid, Nasolabial Fold, Lidocaine
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 70
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 evaluate the pain and safety associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Men or women aged 18 years or older of Chinese origin
* Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
* Intent to undergo correction of both nasolabial folds(NLF) with a wrinkle severity in Wrinkle Severity Rating Scale(WSRS) of either 3 on both sides or 4 on both sides

Exclusion Criteria:

* Previous use of any permanent (non-biodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat below the level of the lower orbital rim
* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment
* Previous tissue revitalisation treatment with laser or light, mesotherapy radiofrequency, chemical peeling or dermabrasion in the midface within 6 months before treatment
* Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated
* Other condition preventing the subject from entering the study in the Investigator's opinion

Primary outcomes:
measure: Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS)
timeFrame: Up to 60 minutes after Injection on Day of Treatment
Secondary outcomes:
measure: Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)
timeFrame: 15, 30, 45, and 60 minutes after injection
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Q-Med AB
Study officials:
References:
Clinical trial NCT05793021: FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
Official title: FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this interventional study is to investigate the correlation between Magnetic Resonance Phenotype and levels of FKBP51s protein pre and post surgery in adult patients affected by Glioblastoma


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of Glioblastoma with surgery criteria
* Brain MRI with contrast both pre and post surgery

Exclusion Criteria:

* No availability of radiological documentation
* Glioblastoma diagnosis not confirmed by Histological examination
* Withdrawal of ICF

Primary outcomes:
measure: Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
timeFrame: 1 week
measure: Correlation between FKBP51s protein concentration in Blood Cells and Disease flow
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Study officials:
References:
Clinical trial NCT02013921: Interest of Daily Physical Activity After Cancer Treatment
Official title: Evaluation du Niveau d'activité Physique Quotidien, Chez Des Patientes Porteuses d'un Cancer du Sein en période Post thérapeutique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Tiredness
Keywords: Physical activity
Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 31
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 a breast cancer and are completing treatment

Brief summary: Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in different cancer types.

It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it to the overall calculation of physical activity in clinical practice.

To assess the AP, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry .

Subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity.

Objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive.

In this study the investigators will measure the spontaneous Daily Physical Activity by both methods andd evaluate the correclation.


Eligibility criteria: Inclusion Criteria:

* adult (age ≥ 18 years)
* Having been informed of the study orally and in writing and have not expressed opposition to his participation
* Performance status \<2
* Invasive breast adenocarcinoma, histologically documented.
* Patients with a breast cancer and are completing treatment
* Exclusion Criteria:
* Patient with metastatic cancer.
* Patient for which monitoring required by the protocol is impossible.

Primary outcomes:
measure: Daily physical activity assessment at 3 months
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Oncologie- CHU Limoges
Study officials:
References:
Clinical trial NCT04313621: Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status
Official title: Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 1218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size will be of convenience with no pre-determined cut-off for smallest or largest sample of interest, rather, the final sample of respondents will be based on however many have been designated the diagnostic codes and responds to the survey.

Brief summary: Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. Our objective with this investigation is to capture self-reported health-status for all adults having been diagnosed with lower limb apophysitis in the period of 1977 to 2020 and compared these data with normative values for the background population. We are therefore conducting a national cross-sectional study based on data from the Danish National Patient Registry. In this protocol we describe, as detailed as possible, the planned methods.


Eligibility criteria: Inclusion Criteria:

* All patients aged 18-55 having received diagnostics codes pertaining to lower limb apophysitis (Severs, Sinding-Larsen Johansson, Osgood Schlatter) in the years 1977-2020 in Denmark will be eligible to participate.

Exclusion Criteria:

* Diseased participants will be censored

Primary outcomes:
measure: Physical and mental health
timeFrame: Baseline
Secondary outcomes:
measure: Sleep: problems and duration
timeFrame: Baseline
measure: Self-reported level of satisfaction with participation in physical activity and sports
timeFrame: Baseline
measure: Knee pain
timeFrame: Baseline
measure: KOOS subscales
timeFrame: Baseline
measure: Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel
timeFrame: Baseline
measure: PAS-2
timeFrame: Baseline
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Kasper Krommes
Study officials:
References:
Clinical trial NCT04049721: Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
Official title: Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Crush Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Winthrop University Hospital
First posted: 2019-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 determine whether using hyperbaric oxygen (HBO) improves wound healing for patients who have a crush injury. The comparison of the prospective intervention group to the retrospective matched cohort aims to show that HBO can improve wound healing and decrease poor outcomes for patients with crush injuries. The information gained from this small study will serve as a basis for a follow-up prospective, randomized control trial to further delineate the role of HBO in a larger patient population.


Eligibility criteria: Inclusion Criteria:

* Presenting to NYU Winthrop Hospital with a crush injury of the extremity, including appendages, up to 14 days post injury.
* No contraindication to hyperbaric oxygen therapy.
* Able and willing to sign informed consent.

Exclusion Criteria:

* Critically-ill patient requiring intubation or pressor support.
* Crush injury isolated to the distal phalanx (Tuft fracture).
* Absolute contraindication to hyperbaric oxygen therapy (untreated pneumothorax). Relative contraindications (uncontrolled congestive heart failure, uncontrolled seizure disorder, pulmonary disease, claustrophobia) will be assessed by the treating physician.
* Unable or unwilling to sign informed consent.

Primary outcomes:
measure: healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
timeFrame: week 2
measure: healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
timeFrame: week 6
measure: healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
timeFrame: week 24
measure: healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
timeFrame: week 52
Secondary outcomes:
measure: hospital length of stay
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Patrizio Petrone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01271621: Influence of Glidescope Assisted Endotracheal Intubation on Intraocular Presure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Effect of Intubation on Intraocular Pressure
Keywords: Airtraq, Intraocular pressure
Lead sponsor: King Khaled Eye Specialist Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Tracheal intubation with traditional Macintosh laryngoscope is associated with increase in intraocular pressure along with tachycardia and hypertension. These effects are not desirable in ophthalmic patients especially in patients with glaucoma. GlideScope video laryngoscope system is a new approach for laryngoscopy and tracheal intubation. It does not require a direct line of sight to the glottis when intubating with the Glidescope and as a result intubation is much less stimulating to the patient. Therefore GlideScope video laryngoscope assisted intubation could be a preferable technique for intraocular surgery offering advantages in terms of intraocular pressure and cardiovascular stability.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1 or 2 with normal intra-ocular pressure.

Exclusion Criteria:

* history or occurrence of difficult intubation.
* presence of previous anterior segment pathology.
* previous intraocular surgery.
* patients with history of glaucoma.
* brain pathology and other neurological disorder which might affect to their intraocular pressure.

Primary outcomes:
measure: Intraocular pressure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: king Khaled Eye Specialist Hospital
Study officials:
References:
Clinical trial NCT04524221: PTG-100 for Patients With Celiac Disease
Official title: A Phase 1b Study of PTG-100 in Patients With Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Celiac Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Protagonist Therapeutics, Inc.
First posted: 2020-08-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten.

This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of celiac disease

Exclusion Criteria:

* Active GI disease or history of clinically significant diseases
* Diagnosis of Crohn's disease or ulcerative colitis.

Primary outcomes:
measure: Percentage change in villous height-to crypt ratio
timeFrame: 42 days
Secondary outcomes:
measure: Change in celiac disease antibodies
timeFrame: 42 days
measure: Changes in celiac disease antibodies
timeFrame: 42 days
measure: CD3- positive intraepithelial lymphocyte density
timeFrame: 42 days
measure: Celiac symptom index (CSI)
timeFrame: 42 days
measure: Characterization of immune modulators underlying mechanism of action in celiac disease.
timeFrame: 42 days
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Nielsen Q Fernandez-Becker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865721: Optimizing the Use of Entonox® During Screening Colonoscopy
Official title: Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Cancer Screening
Analgesia
Entonox
Colonoscopy
Keywords: Bowel cancer screening
Analgesia
Entonox
Pain
Side effects
Colonoscopy
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required.

Both these methods are used in the published studies of Entonox and in clinical practice.

Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration


Eligibility criteria: Inclusion Criteria:

* Having a bowel cancer screening programme colonoscopy

Exclusion Criteria:

* Contraindications to Entonox
* Previous bowel resections

Primary outcomes:
measure: Pain scores
timeFrame: Day 1: Prior to discharge from endoscopy department
Secondary outcomes:
measure: Pain scores
timeFrame: Day 1-4: Prior to discharge and 1-3 days later
measure: Use of analgesia and sedation
timeFrame: Day 1: During colonoscopy
measure: Patients satisfaction
timeFrame: Day 1-4: Prior to discharge and 1-3 days later
measure: Willingness to have a repeat colonoscopy
timeFrame: Day 1: Prior to discharge
measure: Side Effects
timeFrame: Day 1: During colonoscopy
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospital
name: Stuart A Riley, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ball AJ, Din S, Donnelly M, Riley SA. A randomized controlled trial comparing continuous and as-required nitrous oxide use during screening colonoscopy. Eur J Gastroenterol Hepatol. 2015 Mar;27(3):271-8. doi: 10.1097/MEG.0000000000000281.
Clinical trial NCT01331421: Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to exemestane or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: BioKinetic Clinical Applications, Inc.
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Dennis N Morrison, D.O.
role: PRINCIPAL_INVESTIGATOR
References: