louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01300741: One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses
Official title: One Month 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 one month 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 ACUVUE ADVANCE Plus 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 NCT05931341: Pharmacokinetic Profile of Rosemary Extract Supplement
Official title: The Effects of Oral Adminstration of Softgel Capsule Including Rosemary Extract on Pharmacokinetic Profile in Healthy Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pharmacokinetics
Lead sponsor: CJ CheilJedang
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a clinical trial to observe changes in biomarkers in the blood at pre- and post-supplementation of rosemary extract in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged between 25 and 55 years
* Non-smoker
* Body Mass Index (BMI) between 20 and 30 kg/m2

Exclusion Criteria:

* Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease

Primary outcomes:
measure: Concentration in plasma
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05542134: Platelet Agregation in Patients on ECMO
Official title: Platelet Agregation in Patients on ECMO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Refractoriness
Keywords: V-A ECMO
platelet reactivity
ECMO
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 50
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: Consecutive patents treated with ECMO.

Brief summary: An observational study in which investigators will observe platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor.

Detailed description: Investigators will perform an observational study in which platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor will be observed.

Participants will be divided into three groups:

A: patients on V-A ECMO without P2Y12 inhibitors B patients on V-A ECMO with P2Y12 inhibitors with administration of P2Y12 inhibitor at the time of ECMO insertion C: patients on V-A ECMO already recieving P2Y12 inhibitors at the time of ECMO insertion.

Blood samples will be taken prior to and at 2, 4, 12, 22, 48, 72 after ECMO insertion and after removal of an ECMO. VerifyNow System will be used to measure platelet agregation (PRU test).

Eligibility criteria: Inclusion Criteria:

* all patients on VA ECMO

Exclusion Criteria:

* known P2Y12 alergy
* thrombocitopenic patents (\< 50\*109/L),
* patients treated with eptifibatide ali bivalirudin
* patients younger than 18 years
* pregnant patients

Primary outcomes:
measure: Verify now P2Y12 platelet inhibition
timeFrame: (Time Frame: Hour 2 after VA ECMO insertion)
measure: Verify now P2Y12 platelet inhibition
timeFrame: (Time Frame: Hour 4 after VA ECMO insertion)
measure: Verify now P2Y12 platelet inhibition
timeFrame: (Time Frame: Hour 12 after VA ECMO insertion)
measure: Verify now P2Y12 platelet inhibition
timeFrame: (Time Frame: Hour 22 after VA ECMO insertion)
measure: Verify now P2Y12 platelet inhibition
timeFrame: (Time Frame: Hour 48 after VA ECMO insertion)
measure: Verify now P2Y12 platelet inhibition
timeFrame: (Time Frame: Hour 72 after VA ECMO insertion)
measure: Verify now P2Y12 platelet inhibition
timeFrame: (Time Frame: Hour 24 after VA ECMO removal)
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
References:
Clinical trial NCT05640934: Melatonin for Post Operative Delirium Prevention in Elderly Patients
Official title: The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium in Old Age
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.

Detailed description: This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) I to III physical status
* Elective colorectal procedures

Exclusion Criteria:

* Allergy to the research drugs,
* Patients who have vision or hearing impairment
* History of cerebral disorders
* Uncorrected acid-base, fluid, and electrolyte abnormalities
* History of central nervous system function affecting drugs.
* Chronic sedative-hypnotic administration at least one month prior to surgery
* Alcohol abuse
* Patients with recorded preoperative nursing delirium screening score ≥ 2.

Primary outcomes:
measure: Incidence of delirium occurrence
timeFrame: Perioperative.
Secondary outcomes:
measure: Degree of Sedation
timeFrame: Perioperative.
measure: Intensity of pain
timeFrame: Perioperative
measure: Mean arterial blood pressure
timeFrame: Perioperative
measure: Heart rate
timeFrame: Perioperative
measure: Hypotension
timeFrame: Perioperative
measure: Hypoxia
timeFrame: Perioperative
measure: Blood transfusion needs
timeFrame: Perioperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
state: Shebin El-kom
Study officials:
affiliation: Menoufia University
name: Abd-Elazeem A Elbakry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University
name: Hazem E Elsersy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University
name: Islam M El-Desoky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031534: Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma
Official title: Comparative Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma : Correlation With Immunohistochemistry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Oropharynx
Keywords: F-Miso PET scan
Magnetic resonance imaging
immunohistochemistry
Head and neck cancer
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 20
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: Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.


Eligibility criteria: Inclusion Criteria:

* Patient with squamous cells carcinoma of oropharynx
* Age Superior to 10 years old
* Male or Female
* measurable target according RECIST criteria

Exclusion Criteria:

* -Other histologic cancer than squamous cells carcinoma of oropharynx
* No measurable target
* Presence of metastasis

Primary outcomes:
measure: Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia
timeFrame: 1 year
measure: Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC)
timeFrame: 1 year
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Sebastien Thureau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629134: Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lip Augmentation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 62
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: Healthy volunteers desiring lip augmentation

Brief summary: A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.


Eligibility criteria: Inclusion Criteria:

* Desire and willingness for correction of asymmetry or volume enhancement of his/her lips
* Females and males ≥ 18 years of age
* Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results

Exclusion Criteria:

* Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use
* Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Primary outcomes:
measure: Subject Rating of the Natural Look and Feel of the Lips
timeFrame: 4 weeks
measure: Injector Rating of the Natural Look and Feel of the Lips
timeFrame: 4 weeks
Secondary outcomes:
measure: Bruising of the Lips
timeFrame: 15 minutes after injection
measure: Swelling of the Lips
timeFrame: 15 minutes after injection
measure: Ease of Injection
timeFrame: 15 minutes after injection
measure: Malleability of Product
timeFrame: 15 minutes after injection
measure: Need for Massage
timeFrame: 15 minutes after injection
measure: Return to Social Engagement
timeFrame: 4 weeks
measure: Comparative Rating With Previous Treatment
timeFrame: 15 minutes after injection
measure: Rating of Injection Discomfort
timeFrame: 15 minutes after injection
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
state: North Rhine-Westphalia
Study officials:
affiliation: Allergan Medical
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014 Jun;13(2):125-34. doi: 10.1111/jocd.12085.
Clinical trial NCT04563234: Perioperative Cognitive Training in Thoracic Surgery
Official title: Perioperative Cognitive Flexibility Training for the Prevention of Persistent Pain After Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain, Postoperative
Cognitive Function Abnormal
Lung Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: More than 30% of patients undergoing thoracic surgical procedures develop persistent post-surgical pain (PPSP), which results in impaired functioning, diminished quality of life, and increased risk of chronic opioid use. The proposed project aims to determine whether a prospective, randomized, controlled study of smartphone-based perioperative cognitive flexibility training will reduce the incidence of PPSP in high-risk individuals undergoing thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 to 75 undergoing thoracic surgery
* Access to an active email account
* Score \<50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score

Exclusion Criteria:

* Unable to complete cognitive testing
* Color blindness assessed via self-report
* Participants who do not speak or read English

The inclusion criteria for the observational cohort will be the same, with the exception of Score ≥50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score.

Primary outcomes:
measure: The presence of clinically meaningful persistent post-surgical pain 3 months after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Brief Pain Inventory pain severity
timeFrame: 1 and 3 months after surgery
measure: Brief Pain Inventory pain interference
timeFrame: 1 and 3 months after surgery
measure: PROMIS Anxiety Score
timeFrame: 3 months after surgery
measure: PROMIS Depression score
timeFrame: 3 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Simon Haroutounian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
citation: Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
citation: Smith BH, Torrance N. Epidemiology of neuropathic pain and its impact on quality of life. Curr Pain Headache Rep. 2012 Jun;16(3):191-8. doi: 10.1007/s11916-012-0256-0.
Clinical trial NCT02702934: Metabolic Effects of High-amylose Wheat-based Rusks.
Official title: Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.


Eligibility criteria: Inclusion Criteria:

* Overweight/obese;
* 30-60 years.

Exclusion Criteria:

* age \<30 and \>60 years;
* fasting triglycerides ≥400 mg/dl;
* fasting cholesterol \>270 mg/dl;
* cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;
* established diabetes mellitus or any chronic disease;
* renal and liver failure (creatinine \>1.7 mg/dl and transaminases \>2 times than normal values, respectively);
* anaemia (Hb \<12 g /dl);
* any chronic disease.

Primary outcomes:
measure: Blood glucose
timeFrame: 4 hours
Secondary outcomes:
measure: Blood insulin
timeFrame: 4 hours
measure: Intestinal fermentation
timeFrame: 4 hours
measure: Blood triglycerides
timeFrame: 4 hours
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Clinical Medicine and Surgery
Study officials:
affiliation: Federico II University
name: Angela Rivellese, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02314234: Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex
Official title: Influence of Sugammadex on Facial Nerve Monitoring in Parotid Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injury to Nerve During Surgery
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patient with facial nerve monitoring undergoing parotid surgery

Brief summary: To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Detailed description: Intraoperative neuromonitoring (IONM) of facial nerve has been applied in identifying and preserving facial nerve during parotid surgery. In this setting, even a single dose of nondepolarizing muscle relaxant may lead to delayed and weakened electromyography (EMG) signal in facial nerve monitoring during parotid surgery. The aim of this study was to investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Eligibility criteria: Inclusion Criteria:

* undergoing parotid surgery

Exclusion Criteria:

* facial nerve injury, renal failure, liver cirrhosis, neuromuscular disease

Primary outcomes:
measure: evoked EMG amplitude of facial nerve
timeFrame: up to first post-op day
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: I-Cheng Lu
Study officials:
References:
Clinical trial NCT00300534: Multi-site Study of Rapid Diagnostic Syphilis Assays
Official title: Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syphilis
Keywords: Diagnosis
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2006-03-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients

Exclusion Criteria:

* Less than age 18 years

Primary outcomes:
measure: Diagnosis of Treponema pallidum infection
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Department of Health Services
state: California
city: Atlanta
country: United States
facility: Fulton County Department of Health
state: Georgia
city: Chicago
country: United States
facility: Chicago Department of Public Health
state: Illinois
city: Indianapolis
country: United States
facility: Bell Flower Clinic
state: Indiana
city: New York City
country: United States
facility: New York City Department of Health
state: New York
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Robert E. Johnson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: