louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06810752: Thyme Honey for Management of Oral Lichen Planus
Official title: Thyme Honey for Management of Oral Lichen Planus: A Non- Inferiority Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Oral Lichen Planus
Keywords: Oral Lichen Planus
Thyme Honey
triamcinolone acteonide
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study aimed to assess the effect of topical application of thyme honey in comparison to 0.1% triamcinolone acetonide oral paste on the relief of pain and clinical improvement in patients with OLP


Eligibility criteria: Inclusion Criteria:• Patients clinically and histopathologically (if required) diagnosed as suffering from OLP.

* Patients free from any visible oral lesions other than OLP.
* Patients who agreed to take supplied medications.
* Patients who agreed for the biopsy (when required).

Exclusion Criteria:• •Patients suffering from any systemic disease.

* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
* Treatment with any oral topical medications for at least four weeks prior to the study.
* Pregnant and lactating women.
* In addition, no consideration was given to patients with a history of hypersensitivity to honey.

Primary outcomes:
measure: VAS score assessement
timeFrame: 1 month
Secondary outcomes:
measure: measurement of salivary level of miRna155
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British university in Egypt
Study officials:
References:
Clinical trial NCT02848352: The Role of Expectations in Experimentally Induced Sadness
Official title: The Role of Expectations in Experimentally Induced Sadness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aimed at identifying whether different expectations have an impact on experiencing emotions in the form of sadness.


Eligibility criteria: Inclusion Criteria:

* fluent in German language

Exclusion Criteria:

* major depression
* current intake of psychotropic medication
* drug intake within the last two weeks
* alcohol consumption within the last twelve hours
* allergic to capsaicin
* allergic to sesame oil
* students in medicine, pharmacy, or psychology in their third year or older

Primary outcomes:
measure: Sadness (PANAS-X)
timeFrame: Directly after watching the film sequence, no follow-up assessments
Secondary outcomes:
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Winfried Rief, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01077752: Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia
Official title: Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Pain, postoperative
Local infiltration
Hyperalgesia, postoperative
Local anesthetic, ropivacaine, lidocaine
Colorectal laparoscopic surgery
Pain management after colorectal laparoscopic surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-03-01
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.

Detailed description: Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80
* ASA status 1 - 3
* Colorectal laparoscopic surgery with piece removal
* French speaking
* Written informed consent

Exclusion Criteria:

* laparoscopy without colorectal extraction
* chronic pain
* analgesic consumption during the 24 hours previous to the surgery
* morphine and LA intolerance
* drug addiction
* inflammatory bowel disease
* general inflammatory disease
* sepsis
* anemia \< 10 gr/dl
* liver or renal or cardiac insufficiency
* uncontrolled diabetes
* preoperative consumption of opiate/corticosteroid/beta-blockers, and anti-arrhythmic drugs, MAOIs, neuroleptics.
* preoperative consumption of NSAIDs excluding aspirin referred cardiology

Primary outcomes:
measure: Pericicatricial hyperalgesia area
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Pain intensity (rest/mobilization and long-term)
timeFrame: 72 hours, 3 months and 6 months after surgery
measure: Morphine consumption
timeFrame: During 5 days after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marc Beaussier, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576952: Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
Official title: A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Inflammation
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 268
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 ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
* If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
* Signature of the subject on the Informed Consent Form
* Willing to avoid disallowed medication for the duration of the study.
* Willing and able to follow all instructions and attend all study visits
* Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
* Additional inclusion criteria also apply

Exclusion Criteria:

* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
* Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
* Currently suffer from alcohol and/or drug abuse
* Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
* A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
* Additional exclusion criteria also apply

Primary outcomes:
measure: Ocular Inflammation
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06138652: Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial
Official title: Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Dharma Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examine whether an app- and mentor-based program reduced anxiety among individuals reporting difficulties with anxiety.

For the intervention group, this study involved completing an 8-week program focused on helping participants reach their personality goals. The program involved app-based games, journaling, and completing behavioral challenges. Participants engaged with the study app for approximately 15 minutes per day and spoke with a study mentor weekly for 1 hour. Participants were asked to complete surveys prior to and after the program. The pre-program survey lasted approximately 1 hour, and the post-program survey lasted approximately 30 minutes.

For the control group, this study involved completing surveys. Participants were asked to complete surveys 8 weeks apart. The first batch of surveys lasted approximately 1 hour, and the follow-up surveys lasted approximately 30 minutes.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe anxiety levels based on the BAI and GAD-7

Exclusion Criteria:

* We excluded participants experiencing any of the following self-reported behaviors in the past 6 months: substance abuse, self-harm, harm or destruction of another person or their property, suicidal ideations, and feeling helpless after the death of a loved one

Primary outcomes:
measure: Beck Anxiety Inventory
timeFrame: Baseline and after 8 weeks
measure: GAD-7
timeFrame: Baseline and after 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Dharma Life Sciences
state: New York
Study officials:
References:
Clinical trial NCT00456352: Duodenal Exclusion for the Treatment of T2DM
Official title: Phase IV Study of Duodenal Exclusion for the Treatment of Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of duodenal exclusion procedure for the treatment of T2DM


Eligibility criteria: Inclusion Criteria:

1. Age between 20 and 65 years
2. BMI between 23 and 34
3. Oral agents or insulin to control T2DM
4. Inadequate control of diabetes as defined as HbA1c \>/ 7.5
5. Understanding of the mechanisms of action of the treatment

Exclusion Criteria:

1. More than 10 years of T2DM diagnosis
2. More than 7 years of insulin use
3. Previous abdominal operations
4. Coagulopathy
5. Liver cirrhosis
6. Unable to comply with study requirements, follow-up schedule or give valid consent.
7. Currently pregnant.

Primary outcomes:
measure: Treatment success based on patients' glycemic control.
timeFrame: 2 weeks, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Physiologic measurements, Comorbidity improvement, Improvement in QOL.
timeFrame: 2 weeks, 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: San Paulo
country: Brazil
facility: Hospital São Camilo
Study officials:
affiliation: Medtronic - MITG
name: Noreen A Gannon
role: STUDY_DIRECTOR
affiliation: Hospital São Camilo
name: Ricardo Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06180252: PET Study of Acetylcholine Esterase Activity in Alzheimer's Disease
Official title: PET Study of Acetylcholine Esterase Activity in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Alzheimer's disease who are eligible for therapy with acetylcholine esterase inhibitors but not yet undergoing treatment.

Brief summary: The aim of this study is to understand regional variations in acetylcholine esterase activity in Alzheimer's disease. In this study the aim is to identify by PET the physiological values of the regional activity of acetylcholine esterase using the 11C PM4 tracer and to study by PET and 11C PM4 the brain activity of acetylcholine esterase in a group of patients with Alzheimer's disease, enrolled according to the inclusion and exclusion criteria. The PET data will be correlated with the clinical, neuropsychological and morphological data acquired by MRI and with the clinical-cognitive outcome.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with Alzheimer's disease;
* patients must have undergone an instrumental morphological examination to exclude other neurological pathologies.

Exclusion Criteria:

* positive history of major head trauma;
* clinically active somatic diseases.

Primary outcomes:
measure: PET with 11C MP4 as a tracer to identify acetylcholine esterase values in patients with neurodegenerative diseases.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04405752: Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study
Official title: Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Biliary Obstruction
Keywords: biliary stent
malignant biliary stenosis
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From April 2017 to April 2018, at the Paoli Calmettes Institute, 24 patients with benign or malignant biliary strictures were treated by placing a metallic biliary stent, covered or uncovered, KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).

"Control" patients, who had benefited from the placement of a biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) were searched on a database (ConsortConsore®️)extending from January 2016 to March 2018. "Cases" patients were exactly matched in a ratio 1:2 to "control" on the following criteria: age (per decade), sex, pathology responsible for biliary stenosis (i.e., benign or malignant stenosis) and type of stent (i.e., covered/uncovered). When we searched for control patients in our database, the first patient with matching criteria was included.

Brief summary: Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.


Eligibility criteria: Inclusion Criteria:

* benign and malignant biliary stricture of the lower or median portion of the main biliary duct with indication of biliary stent placement including pre-operatively drainage
* age≥ 18 years old;
* Karnofsky score ≥ 40.

Exclusion Criteria:

* hilar stenosis;
* coagulation disorder (PT \<50%, platelets \< 80,000).

Primary outcomes:
measure: Time to recurrent biliary obstruction (RBO)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhône
Study officials:
affiliation: Institut Paoli-Calmettes
name: Fabrice Caillol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04613752: Diaphragm Dysfunction in ARDS Patients With V-V ECMO
Official title: Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: ARDS
ECMO
diaphragm function
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS).

Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. The present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with VV-ECMO.

Detailed description: Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). It allows to provide a protective lung ventilation by reducing the level of airway pressures generated by the ventilator. The objective is to minimize the harmful effects of mechanical ventilation in the lungs and to provide adequate gases exchanges. This strategy requires a deep sedation to allow a perfect synchrony between the patient and the ventilator. Such a synchrony puts the respiratory muscles - in particular the diaphragm - completely at rest.

Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. Such a dysfunction has been associated with prolonged duration of mechanical ventilation and poor outcomes but its effect in patients with veno-venous extracorporeal oxygenation membrane has never been evaluated so far.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* ARDS according to the Berlin definition
* V-V ECMO
* patient or next of kin agrees to participate
* patient with health insurance

Exclusion Criteria:

* pregnancy
* Opposition to participate
* Contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"

Primary outcomes:
measure: Diaphragm function
timeFrame: until day 28
Secondary outcomes:
measure: Duration of ECMO
timeFrame: until day 60
measure: Duration of invasive mechanical ventilation
timeFrame: until day 60
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Martin Dres
role: STUDY_CHAIR
References:
Clinical trial NCT05263752: Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease
Official title: Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Diseases
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of patients over the age of 18 years who are scheduled to undergo an ERCP with Nvision VLE Imaging Low Profile System.

Brief summary: A previous study evaluating the NvisionVLE® Imaging Low Profile System revealed the system to be feasible and safe for use in bile duct. The study also revealed a potential to better define abnormalities, target sampling and therapy when utilizing the NvisionVLE® Imaging Low Profile System. This study will further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct diseases.

Detailed description: The primary objective of this retrospective and prospective study is to acquire additional data to further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct disease. The secondary objective will be to provide a tool for participating physicians to collect imaging data, clinical utility data, and other clinical data such as demographics, pathology, and treatment surveillance results for patients who have undergone an examination of the bile duct with the NvisionVLE® Imaging Low Profile System. Specific aims include completing a multi-center registry to further evaluate the safety and efficacy of the NvisionVLE® Imaging System Low Profile System and developing a tool from the NvisionVLE® Imaging Low Profile System data to better define abnormalities, target sampling and therapy in patients with bile duct disease.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019.

Exclusion Criteria:

* Below 18 years of age
* Did not undergo ERCP with NvisionVLE® Imaging Low Profile System at MDMC

Primary outcomes:
measure: Demographics- DOB
timeFrame: up to 2 years
measure: Demographics- Sex
timeFrame: up to 2 years
measure: Indication of Procedure
timeFrame: up to 2 years
measure: Previous Surgical History
timeFrame: up to 2 years
measure: Previous Imaging
timeFrame: up to 2 years
measure: Previous Procedures
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Prashant Kedia, MD
role: PRINCIPAL_INVESTIGATOR
References: