louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05053087: A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Official title: A Three-Arm, Double-Blinded, Randomized Controlled Trial Comparing the Efficacy of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Three-Arm, Double-Blinded, Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to study how well the adductor canal pain catheters works after a total knee arthroplasty or replacement of the knee joint. The catheter works by using either an intermittent bolus injection to provide a large dose of medication or continuous infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 90 years.
* Willing to participate in the study and competent to provide informed consent.
* Willing to comply with protocol procedures.
* Has an underlying diagnosis of osteoarthritis indicated for a total knee arthroplasty.

Exclusion Criteria:

* The patient must not have taken any narcotic medications (schedule II) during the 3 months leading up to the surgery.
* The patient must not be allergic or intolerant to a medication used in the multimodal pain pathway.
* Revision knee arthroplasty.
* Uncontrolled diabetes with A1C \> 8.0%.

Primary outcomes:
measure: Post-operative Pain Levels
timeFrame: 14 days post-operatively
Secondary outcomes:
measure: Amount of Medication Administered
timeFrame: 60 days, or until discontinuation of narcotic medication (whichever is later)
measure: Duration of Narcotic Used
timeFrame: 60 days, or until discontinuation of narcotic medication (whichever is later)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Benjamin Wilke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00779987: Autologous Serum Efficacy Study in Patients With Severe Dry Eye
Official title: Autologous Serum Efficacy Study in Patients With Severe Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: Dry eye
Autologous serum
Ocular Surface Disease Index
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the reduction in symptomatology of patients with severe dry eye treated with autologous serum and conventional artificial tears.

Detailed description: Severe dry eye remains an important and frequent eye disease, that reflects in a severe impairment of the patient´s life quality. Up to date there is no ideal therapy for this condition. Few studies have reported some kind of improvement in different parameters related to dry eye with the use of autologous serum, but no one has considered the patient´s symptoms with a systematic and validated evaluation method.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Severe Dry Eye, as defined by a OSDI score \> or = 40

Plus:

* Tear Break Up Time (TBUT) \< 5 seconds
* Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score.

Exclusion Criteria:

* No dry eye associated ocular disease
* Unable to comply protocol
* Severe anemia
* Previous use of autologous serum
* Concomitant use of other topical ocular drug
* Hypersensibility to any proposed interventions

Primary outcomes:
measure: To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.
timeFrame: 5 weeks
Secondary outcomes:
measure: To compare variations in objective eye measurements, such as Tear Break Up Time and corneal-conjunctival staining according to the Oxford Score, in patients treated with autologous serum and conventional artificial tears.
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: University Of Chile Clinical Hospital
state: Region Metropolitana
Study officials:
affiliation: University of Chile
name: Cristhian A Urzua, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.
Clinical trial NCT05046587: Characterization of Suicidal Depression
Official title: Characterization of Suicidal Depression Within a Large Cohort of Inpatients: a One-year Prospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Suicide
Suicidal Ideation
Suicidal Depression
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 898
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: Depressed patients with and without suicidal ideation, admitted to the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) and enrolled in one of the department's clinical studies.

Brief summary: Antidepressants are widely used to prevent suicidal risk. However, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. Indeed recent studies have shown that patients with a history of suicide attempt and/or with current suicidal ideation (SI) respond less well to antidepressant treatments. This suggests that patients with depression with SI may be different from those with depression without SI, thus requiring specific treatments for both SI reduction and depressive remission. In other words, suicidal depression may be a specific subtype of depression.

The study aims to characterize the clinical phenotype of patients with suicidal depression vs. those without suicidal depression, and to assess the occurrence of suicidal events at one year in patients with suicidal depression vs. without suicidal depression.

All data having already been collected during the particpation of patients in various clinical research studies of the department


Eligibility criteria: Inclusion criteria:

* Over 18 years old
* Hospitalization in the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) between 2012 and 2019
* Having being enrolled in one the department's clinical studies between 2012 and 2019
* Moderate to severe characterized depressive episode according to DSM-5 diagnostic criteria (severity assessed with BDI, IDSC-30 and QIDS)

Exclusion criteria:

* Protection by law (guardianship or curatorship)
* Deprivation of liberty (by judicial or administrative decision)
* Bipolar disorder

Primary outcomes:
measure: characterization of the patient clinical phenotype
timeFrame: day 1
Secondary outcomes:
measure: Suicidal events at one year
timeFrame: 1 year
measure: Hospitalization for suicidal ideation
timeFrame: 1 year
measure: Suicidal events at one year
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Bénédicte NOBILE, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06834087: Laser Treatment with Methylene Blue Vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: a Randomized Clinical Trial
Official title: Comparative Evaluation of Methylene Blue and Methylene Blue Nanoparticles Assisted Photodynamic Therapy As Adjunctive to Laser Treatment of Physiological Gingival Pigmentation: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Physiological Gingival Pigmentation
Keywords: Gingival Pigmentation, Laser Therapy, Photodynamic Therapy, Methylene Blue, Nanoparticles, Periodontology, Aesthetic Dentistry
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial aims to compare the effectiveness of methylene blue and methylene blue nanoparticles as adjuncts to photodynamic therapy in laser treatment of physiological gingival pigmentation. The study evaluates pigmentation reduction, recurrence rates, healing time, and patient satisfaction. Conducted at Kafrelsheikh University, it includes three patient groups: laser-only treatment, conventional methylene blue-assisted PDT with laser, and methylene blue nanoparticles-assisted PDT with laser. The findings will contribute to advancements in aesthetic dentistry and laser-assisted depigmentation techniques.


Eligibility criteria: Inclusion Criteria:

Patients with physiological gingival pigmentation confirmed by clinical examination.

Age range: 18-50 years.

Patients with no history of systemic diseases or conditions that could affect wound healing (e.g., diabetes, autoimmune diseases).

Patients willing to undergo laser treatment and provide informed consent.

Non-smokers or individuals who have stopped smoking for at least six months.

Exclusion Criteria:

Patients with pathological gingival pigmentation (e.g., associated with syndromes or systemic conditions).

Use of medications affecting pigmentation or healing (e.g., anticoagulants, immunosuppressants).

Pregnant or lactating women or those taking contraceptive drugs.

Individuals with known allergies to methylene blue or nanoparticles.

Primary outcomes:
measure: Reduction in Gingival Pigmentation
timeFrame: Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment
Secondary outcomes:
measure: Healing Time
timeFrame: 1 Month Post-Treatment
measure: Patient Satisfaction
timeFrame: 1 Month, 3 Months, and 6 Months Post-Treatment
measure: Recurrence of Gingival Pigmentation
timeFrame: 3 Months and 6 Months Post-Treatment
measure: Adverse Events
timeFrame: Throughout the study duration (up to 6 Months Post-Treatment)
Other outcomes:
Locations:
city: Kafr ash Shaykh
country: Egypt
facility: Kafrelsheikh University, Faculty of Oral and Dental Medicine
state: kafr ash Shaikh/ elhamrawy
Study officials:
References:
Clinical trial NCT01058187: Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids
Official title: Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Levels of Fatty Acids in the Blood Cells of Infants
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: University of Alberta
First posted: 2010-01-28
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants 12-25 days of age

Brief summary: To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids


Eligibility criteria: Inclusion Criteria:

* Singleton birth
* 12-25 days of age
* Gestational age of 37-42 weeks
* Solely formula fed for at least 24 hours prior to randomization
* Birth weight 2500 g - 4000 g

Exclusion Criteria:

* Serious concurrent illness or congenital malformation
* Systemic or congenital infection
* Immunocompromised
* History of intolerance or allergy to cow milk
* Maternal autoimmune disorder
* Participation in another clinical study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Institute for Human Nutrition, University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Tom Clandinin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miklavcic JJ, Larsen BM, Mazurak VC, Scalabrin DM, MacDonald IM, Shoemaker GK, Casey L, Van Aerde JE, Clandinin MT. Reduction of Arachidonate Is Associated With Increase in B-Cell Activation Marker in Infants: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):446-453. doi: 10.1097/MPG.0000000000001283.
Clinical trial NCT05900687: Developing and Testing Mobile Health Question Prompt List in Gastroesophageal Reflux Disease
Official title: Developing, Refining, and Testing a Mobile Health Question Prompt List in Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux
Patient Activation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-06-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of GERD
* GerdQ score of \>=8
* documented PPI use for GERD
* internet access at home or computer/mobile device
* ability to provide written or e-consent.

Exclusion Criteria:

* Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)
* non-English speaking patients

Primary outcomes:
measure: Patient Activation Measure Scale Score
timeFrame: month 3
measure: Patient Activation Measure Scale Score
timeFrame: month 6
Secondary outcomes:
measure: Pill Count
timeFrame: months 3 and 6
measure: 12-item Short Form Survey
timeFrame: months 3 and 6
measure: Gerd-Q
timeFrame: months 3 and 6
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Afrin N Kamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03811587: Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
Official title: Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diet
Fasting
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
name: Health Holland
name: IFOM ETS - The AIRC Institute of Molecular Oncology
name: L-Nutra
First posted: 2019-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised to the intervention or control group.
Primary purpose: TREATMENT

Brief summary: In this randomized, controlled, assessor blinded and prospective intervention study the investigators will evaluate the clinical feasibility and effectiveness of intermittent use of a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.

Detailed description: 100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a BMI≥ 27, who are treated with diet only and have a HbA1c \> 48, or who are treated with diet and a dose of metformin can participate in the study. Participants will use a fasting-mimicking diet for 5 consecutive days per month. For the other days, there are no regulations. During follow-up of one year, several study parameters will be measured including HbA1c and antidiabetic medication dosage.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Age \> 17 years and \<75 years
* Treatment with diet only and have a HbA1c \> 48, or treatment with diet and metformin
* BMI ≥ 27

Exclusion Criteria:

* Recent myocardial infarction (\< 6 months)
* Creatinine clearance \< 30 ml/min/1,73m2 (MDRD)
* Pregnancy
* Contraindications for MRI
* Allergy for nuts, sesame, soya or another ingredient of the diet
* History of syncope with calorie restriction in the past
* Any significant other disease (at the discretion of the investigator)

Primary outcomes:
measure: Concentration of HbA1c
timeFrame: 12 months
measure: Dosage of antidiabetic medication used
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: Zuid-Holland
Study officials:
affiliation: Leiden Univerity Medical Centre
name: Hanno Pijl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle ME, Willems van Dijk K, Longo VD, Lamb HJ, Numans ME, Pijl H. Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes. BMC Endocr Disord. 2020 Jun 24;20(1):94. doi: 10.1186/s12902-020-00576-7.
Clinical trial NCT05474287: SJOV vs. HFNO for Hypoxia During Procedural Sedation at High Altitudes
Official title: Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
High Altitude
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Tibet Autonomous Region People's Hospital
First posted: 2022-07-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.

Detailed description: The participants will be randomly allocated to either SJOV or HFNO in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the HFNO group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older;
2. underwent routine gastrointestinal endoscopy under procedural sedation;
3. consented to participate in this trial.

Exclusion Criteria:

1. infection of the upper airway;
2. anatomical abnormalities of the face, nose, and upper airway;
3. coagulopathies;
4. anticipated or known difficult airway;
5. known allergy against propofol, soybeans, and egg;
6. absence from the high-altitude environment during the past 3 months.

Primary outcomes:
measure: Hypoxia during sedation
timeFrame: During sedation procedure
Secondary outcomes:
measure: respiratory-related complications
timeFrame: During sedation procedure
measure: cardiovascular-related complications
timeFrame: During sedation procedure
measure: fatal complications
timeFrame: from sedation initiation to 20 min after patients are awake
Other outcomes:
Locations:
city: Lhasa
country: China
facility: Tibet autonomous region people's hospital
state: Tibet
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06285487: Depression in Youth Onset Type 2 Diabetes
Official title: Depression in Youth Onset Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Depression
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes diagnosis ≥ 3 months
* Age 12-17yr
* Elevated depression symptoms
* HbA1c ≥7.0%

Exclusion Criteria:

* Currently receiving psychotherapy from a licensed counselor
* Psychotropic meds \<8 weeks

Primary outcomes:
measure: Acceptability of IPT-T2D
timeFrame: 3 Months
measure: Depression Changes
timeFrame: 3 Months
measure: Changes in Glycemic Control
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: