louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06044948: Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
Official title: Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

Detailed description: Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).

Eligibility criteria: Key Inclusion Criteria:

* Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
* Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.

Key Exclusion Criteria:

* Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
* Monovision contact lens wear;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.

Primary outcomes:
measure: Distance VA With Study Lenses at Week 1
timeFrame: Week 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Eye Center
state: Florida
city: Eden Prairie
country: United States
facility: The Eye Doctors, Inc.
state: Minnesota
city: Garner
country: United States
facility: Oculus Research, Inc.
state: North Carolina
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Wyomissing
country: United States
facility: Wyomissing Optometric Center
state: Pennsylvania
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02820948: Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery
Official title: Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical-site Infection Following Elective Laparoscopic Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infection
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those patients who not (Group 2).

Incisional surgical site infection (SSI), microbiological cultures from the infected surgical wounds, postoperative pain and acute phase reactants were investigated.

Detailed description: A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing a subcutaneous sterile vitamin E acetate ointment application (Group 1) and those patients who did not receive this vitamin E ointment application (Group 2).

Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment (FilmeOft, Hulka SRL, Rovigo, Italy) was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.

Incisional SSI, microbiological cultures from the infected surgical wounds, postoperative pain was evaluated 24 hours after surgery by means of a Visual Analogic Scale (VAS), ranging from 0 mm (complete absence of pain) to 100 mm (unbearable pain) and acute phase reactants (white cell count (WBC), fibrinogen and C reactive protein) 48 hours after surgery were investigated.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of colorectal neoplasms and plans to undergo an elective laparoscopic surgery with curative aims

Exclusion Criteria:

* Open surgical approach or conversion to laparotomy
* Performance of a stoma
* Immunodepression status
* Anastomotic leak

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fundacion Jimenez Diaz
name: Damian Garcia
role: STUDY_DIRECTOR
References:
Clinical trial NCT02819648: Oral Glucocorticoids Effect on Post Endodontic Pain
Official title: The Effect of Preoperative Oral Administration of Prednisolone on Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Single Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulpitis
Keywords: symptomatic
irreversible
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this single-center randomized, double-blind, placebo-controlled clinical trial is to assess the effect of preoperative, single, oral dose of prednisolone on postoperative pain and medication intake in patients with symptomatic, irreversible pulpitis in mandibular molars.

Detailed description: Patients receive 40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); and group B (Control), where patients received two placebo tablets. All patients receive the assigned premedication 30 minutes before the administration of local anesthesia

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients, aged between 18-35 years, with mandibular molars with symptomatic irreversible pulpitis, radiographically-normal periapical area and no pain on biting or percussion.

Exclusion Criteria:

* Pregnant patients, patients with any known sensitivity or adverse reactions to any of the medications or materials used in this study, those who had used any analgesic medication during the preceding 6 hours before the treatment, those with unrestorable teeth or teeth with severe periodontal disease. Patients with active sites of pathosis in the area of injection were, also, excluded.

Primary outcomes:
measure: Degree of postoperative pain using a visual analogue scale (VAS)
timeFrame: 24 hours
Secondary outcomes:
measure: Intake of fake analgesic (sham) following endodontic treatment (Binary outcome)
timeFrame: 24 hours
measure: Intake of true analgesic following endodontic treatment (Binary outcome)
timeFrame: 24 h
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Oral & Dental Medicine
Study officials:
affiliation: Cairo Univeristy
name: Suzan Wanees, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jalalzadeh SM, Mamavi A, Shahriari S, Santos FA, Pochapski MT. Effect of pretreatment prednisolone on postendodontic pain: a double-blind parallel-randomized clinical trial. J Endod. 2010 Jun;36(6):978-81. doi: 10.1016/j.joen.2010.03.015. Epub 2010 Apr 24.
Clinical trial NCT00811148: Florida Center for Brain Tumor Research
Official title: Establishment of a UF Brain Tumor Tissue Bank: Florida Center for Brain Tumor Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumors
Keywords: Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adults scheduled to undergo brain surgery to remove tumor tissue.

Brief summary: The purpose of this research study is to collect and store brain tumor tissue samples for future research. The samples will become part of the University of Florida Brain Tumor Tissue Bank/Florida Center for Brain Tumor Research. The goal is to find improved treatments and cures for brain tumors.

Detailed description: The mission of the Florida Center for Brain Tumor Research is to discover cures for brain tumors and develop innovative brain tumor treatment modalities by providing a central repository for brain tumor biopsies and clinical information from individuals throughout the state of Florida, improving brain tumor biomedical research programs within the state of Florida, facilitating funding opportunities, fostering collaboration with brain tumor research organizations and other institutions, and fostering improved technology transfer of brain tumor research findings into clinical trials and widespread public use.

The Florida Center for Brain Tumor Research will collect and store left-over tissue that is not needed for medical care or diagnosis in a tissue bank in the Evelyn F. and William L. McKnight Brain Institute at the University of Florida. Tissue, medical information, cerebrospinal fluid, blood and answers to Quality of Life questionnaires will be stored and made available to researchers. Although developed for Florida, tumor tissue from all other states would be accepted.

Eligibility criteria: Inclusion Criteria:

* Children and adults scheduled to undergo brain surgery to remove tumor tissue.

Primary outcomes:
measure: Collect and maintain clinical data and tumor tissue removed during brain surgeries.
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Maryam Rahman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03528148: The Effects of Elliptical Cross Training Bike for Stroke Patients
Official title: China Medical University Hospital Asia University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Post stroke
Gait
Elliptical cross bike.
Postural control
Balance
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomize control trials
Primary purpose: TREATMENT

Brief summary: To investigate the effects of elliptical cross bike exercises combine conventional physical therapy on gait, postural control, balance, muscle tone, spasticity, quality of life, motor functioning, functional activity, and ADL in post stroke patients.

Detailed description: In a single-blind, randomized controlled intervention, patients were randomly assigned to an active cycling group (ACG, n=25) five times a week combine with conventional al physical therapy or a control group (CG, n=25) with conventional physical therapy 3 weeks of training in the center.

All outcome measures were administered at the beginning of the study, at the end of the 1st, 2nd, and 3rd week.

All participants will be divided two groups. One group will be experiment with conventional physical therapy as control group (CG), the other group will active cycling as active cycling group (ACG) with elliptical Cross Trainer \& Exercise Bike after conventional physical therapy.

Baseline assessment of muscle tone by Myoton-3, Modified Ashworth Scale used as a simple measure of spasticity; Barthel Index scale for performance in activities of daily living; Berg Balance Scale to measure balance; the upper and lower limb subscale of the Fugl-Meyer assessment for motor function of extremities; and BTS G-WALK was used to measure gait parameters. The data will be collect before session.

Eligibility criteria: Inclusion Criteria:

* First-ever stroke (World Health Organization ,1978).
* Joint mobility ranges of lower extremity that would not preclude pedaling(Ambrosini, Ferrante et al. 2011).
* Unilateral hemiplegia.
* Able to carry out simple instructions.
* Able to sit independent at least 20 minutes and pedal an elliptical cross bike.

Exclusion Criteria:

* Neurologic disorders with impaired functionality existing pre-stroke.
* Patients could not follow instructions.
* Cardiovascular disease or other risk factor which precluded participation in aerobic exercise.
* Peripheral neuropathy that could potentially interfere with this study.

Primary outcomes:
measure: Gait
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Chou Li-Wei, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03009448: The Experience of Older Adults Facing Depression for the First Time in Old Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MAjor Depressive Disorder
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 15
Sex: ALL
Minimum age (years): 62
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Israeli men and women after the age of retirement, 67 and 62 respectably, who are diagnosed with a major depressive episode, minor depressive episode or show depressive symptoms for the first time in their lives at old age.

Brief summary: Analysis of recent studies show that researchers find it hard to distinguish between Late Onset Depression, a first diagnosed major depressive episode which occurs at old age, and Early Onset Depression, a depressive episode at old age with a history of previous episodes. Since current data, about the phenomenology and etiology of Late Onset Depression, lake conicity it is unclear whether this phenomena should be considered as a distinct subtype of depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a stronger correlation with brain damage and environmental risk factors such as the common losses at old age and weaker correlation with family history and genetics when compared to Early Onset. Although many researchers consider brain damage to have the main contribution to the emerge of Late Onset Depression, the fact that depression has a negative effect on one's health supports the claim that it might be the result and not the rick factor. Since Late Onset Depression correlates with the common losses at old age, the investigators propose that an existential approach that deals with one's meaning, freedom, responsibly and death, might be more appropriate. Thus, the investigators ask how do older adults experience depression which they face for the first time in old age? Current study will seek to understand older adults' experience of Late Onset depression through existential paradigm by using a semi constructed interview.


Eligibility criteria: Inclusion Criteria:

1. Men aged 67 or more, women aged 62 or more
2. Diagnosis of Major Depressive Disorder, Minor Depressive Disorder or Adjustment Disorder with depressive features made after the age of 67 with men and 62 with women.
3. Basic understanding and ability to converse in Hebrew.

Exclusion Criteria:

1. History of at least one previous major depressive or minor depressive episode before the age of 62 with women or 67 with men
2. Mental Retardation or Autistic Spectrum Disorder
3. Significant cognitive impairment observed by the primary physician.
4. Schizophrenia or Schizoaffective disorder.
5. Depressive episode with psychotic features
6. Substantial suicidality

Primary outcomes:
measure: Data analysis
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hod HaSharon
country: Israel
facility: Shalvata MHC
Study officials:
References:
Clinical trial NCT01848548: Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study
Official title: Superior Laryngeal Nerve Block For Airway Anesthesia Efficacy Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Awake Endotracheal Intubation
Difficult Intubation
Airway Anesthesia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 25
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: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Scheduled Surgery Patients who require an awake intubation

Brief summary: Awake tracheal intubation is the standard management for patients as risk for airway compromise. It is also commonly done in cases where there is significant cervical spine pathology i.e. cervical myelopathy or instability. The anesthetic technique used for the awake intubation is crucial to the patient's safety. One of the most important aspects of the anesthetic technique is airway anesthesia prior to placement of an endotracheal tube. The superior laryngeal nerve is responsible for mediating the cough reflex around the vocal cords. The investigators have developed an approach to reliably block the superior laryngeal nerve by injecting local anesthetic near the nerve in a unique approach. Injecting local anesthetic into or through the thyrohyoid membrane will effectively block the superior laryngeal nerve


Eligibility criteria: Inclusion Criteria

1. Patients between the ages of 18-80 requiring an awake intubation for endotracheal intubation.
2. Ability to speak and understand English

Exclusion Criteria

1. Allergy to lidocaine
2. Emergent operative case
3. Therapeutic anticoagulation
4. Mouth opening less than 2 cm

Primary outcomes:
measure: The primary outcome measure is to assess the efficacy of blocking the superior laryngeal nerve by using cough at the vocal cords on a 4 point scale
timeFrame: Immediate Perioperative period
Secondary outcomes:
measure: Time to placement of block
timeFrame: Immediate Perioperative Period
Other outcomes:
measure: During the intubation the lowest mean arterial blood pressure (MAP)
timeFrame: Immediate Perioperative Period
measure: The lowest heart rate(HR) during intubation
timeFrame: Immediate Perioperative Period
measure: The lowest respiratory rate during the intubation
timeFrame: Immediate Perioperative Period
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04089748: Basal Tumours in Bladder Cancer, Response to chemoTherapy
Official title: Basal Tumours in Bladder Cancer, Response to chemoTherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Chemotherapy Effect
Keywords: neoadjuvant chemotherapy
cisplatine
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Institut Curie
name: APHP
First posted: 2019-09-13
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tumors from patient having muscle invasive bladder cancer

Brief summary: Determine the sensitivity/resistance to chemotherapy of the various subgroups of muscle-invasive bladder cancers, including the basal subgroup (about 25% of these tumours) according to 4 different classifications based on molecular or immunohistochemical classifiers.


Eligibility criteria: Inclusion Criteria of Patients enrolled in VESPER study:

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort and :

* having signed an informed consent form for the participation to the collection or
* dead/lost to follow-up without prior opposition expressed against research program,
* genetic analysis will only be carried out for patients who have signed the genetic consent form.

Inclusion Criteria of Patients from St Louis cohort not enrolled in VESPER study:

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort and :

* having received an informed form for the participation to the collection and not having expressed opposition against research program within 1 month or
* dead/lost to follow-up without prior opposition expressed against research program,

Exclusion Criteria:

-Patients enrolled in VESPER study:Tumors from patient having withdrawn his/her informed consent form for the participation to the collection and/or VESPER project.

OR

-Patients from St Louis not enrolled in VESPER study:Tumors from patient having expressed opposition against research program after 1 month for the participation to the collection.

Primary outcomes:
measure: Identifying molecular subgroups of bladder cancer patients within VESPER and Saint-Louis cohort, who could benefit from neoadjuvant chemotherapy, taking into account the existence of different classification systems.
timeFrame: through study completion, an average of 3 years
measure: Determining which classification(s) has(ve) the best ability to identifying subgroups of tumours sensitive or resistant to neoadjuvant chemotherapy.
timeFrame: through study completion, an average of 3 years
measure: Identifying mechanisms of resistance in basal subgroups.
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: DRCI
Study officials:
References: