louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01261975: Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Official title: Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Aphakia
Keywords: Ocular Surgery
Intraocular Lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.


Eligibility criteria: Inclusion Criteria:

* Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.
* Subject's ocular media must be clear except for the presence of the cataract in both eyes.

Exclusion Criteria:

* Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.

Primary outcomes:
measure: Refractive Stability
timeFrame: 12 weeks
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: Visit 1, visit 2, visit 3, visit 4
measure: Best Corrected Visual Acuity
timeFrame: visit 5, visit 6, visit 7, visit 8
measure: Uncorrected Visual Acuity
timeFrame: Visit 1, visit 2, visit 3, visit 4
measure: Uncorrected Visual Acuity
timeFrame: visit 5, visit 6, visit 7, visit 8
measure: Surgically Induced Astigmatism (SIA)
timeFrame: Visits 1-3
measure: Surgically Induced Astigmatism (SIA)
timeFrame: Visits 4-8
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Anne Williart, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06441175: Effectiveness of Cricoid Pressure During Videolaryngoscopy Versus Direct Laryngoscopy
Official title: Comparison of the Effectiveness of Cricoid Pressure on Upper Esophageal Obstruction During Videolaryngoscopy Versus Direct Laryngoscopy: a Randomized, Crossover Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cricoid Pressure
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2024-06-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy.

Detailed description: Even with appropriate cricoid pressure, the lifting force of the laryngoscope during direct laryngoscopy for tracheal intubation may counteract the cricoid pressure, making esophageal obstruction ineffective. Compared to direct laryngoscopy, videolaryngoscopy requires less lifting force, and thus, the success rate of esophageal obstruction may be higher. This study aims to compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled to have general anesthesia with tracheal intubation

Exclusion Criteria:

* Gastroesophageal reflux disease, achalasia, bowel obstruction,
* BMI \> 35 kg/m2
* Uncontrolled diabetes
* Pregnancy
* Previous esophageal, and gastric surgery
* Dental damage or anticipated difficult airways
* Who do not consent to the study

Primary outcomes:
measure: Success rate of esophageal obstruction during cricoid pressure
timeFrame: During general anesthesia induction
Secondary outcomes:
measure: Esophageal diameter
timeFrame: During cricoid pressure
measure: percentage of glottic opening score
timeFrame: During cricoid pressure
measure: Cormack-Lehane grade
timeFrame: During cricoid pressure
Other outcomes:
Locations:
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: TAE KYONG KIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04505475: Oral Surgery in Patients Taking Direct Oral Anticoagulants
Official title: Oral Surgery in Patients Taking Direct Oral Anticoagulants and Vitamin K Antagonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulants and Bleeding Disorders
Surgery
Postoperative Hemorrhage
Dentoalveolar Haemorrhage
Keywords: oral anticoagulants
dabigatran
rivaroxaban
warfarin
oral surgery
hemorrhage
Lead sponsor: University of Novi Sad
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study includes patients taking direct oral anticoagulants (DOACs) and patients taking vitamin K antagonists (VKA) who require oral surgical procedure. The groups will be matched with respect to oral surgical procedure i.e. operative trauma.

Brief summary: This study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.

Detailed description: Vitamin K antagonists (VKA) are widely used in long term prevention and treatment of thromboembolism. In the last few years direct oral anticoagulants (DOACs) are available for clinical use, mostly in prevention of stroke and systemic embolisms in patients with nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. Numerous studies confirmed that minor oral surgical procedures in patients taking VKA with therapeutic (International Normalized Ratio) INR levels can be safely performed without therapy interruption if proper local haemostatic measures are applied. Similar recommendations were given for the dental treatment of patients taking DOACs, but there is a lack of clinical studies. The aim of this study is to assess the incidence of bleeding complications after oral surgery in patients who continue their DOACs or VKA medications.

Eligibility criteria: Inclusion Criteria:

* Male and female patients over 18 years
* Patients taking regularly direct anticoagulant therapy: dabigatran, rivaroxaban or apixaban (DOACs group)
* Patients taking regularly acenocoumarol with INR 2.0-3.5 on the day of the surgery (VKA group)
* Indication for oral surgical procedure
* Signed informed consent

Exclusion Criteria:

* Liver or renal disease
* Coagulopathy
* Pregnant or breastfeeding women
* Allergy to lidocaine
* Patients who stopped taking their anticoagulant medication
* Patients taking VKA with INR \<2.0 or \>3.5 on the day of the procedure

Primary outcomes:
measure: Postoperative bleeding event
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Dental Clinic of Vojvodina
state: Vojvodina
Study officials:
affiliation: University of Novi Sad, Faculty of Medicine
name: Branislav Bajkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05334875: Repeatability of Electroretinogram and Visual Evoked Potential
Official title: Repeatability of Electroretinogram and Visual Evoked Potential in Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Disease
Visual Impairment
Vision Disorders
Keywords: Electroretinogram
Visual evoked potential
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To assess repeatability of electroretinogram and visual evoked potential in clinical practice

Detailed description: To assess repeatability of electroretinogram in evaluation of retinal function and visual evoked potential in evaluation of visual pathway in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Normal subjects visit banha university hospital seeking regular checkup and subjects asked for ERG and VEP as a pre-occupational examination.

Exclusion Criteria:

* Patients previously diagnosed with any retinal disease or visual pathway disease that may affect ERG and VEP tests.

Primary outcomes:
measure: Repeatability of ERG amplitude.
timeFrame: Changes from baseline measurements and at one week.
Secondary outcomes:
measure: Repeatability of ERG latency.
timeFrame: Changes from baseline measurements and at one week.
Other outcomes:
measure: Repeatability of VEP amplitude.
timeFrame: Changes from baseline measurements and at one week.
measure: Repeatability of VEP latency.
timeFrame: Changes from baseline measurements and at one week.
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy Tabl
state: Benha
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04185675: Comparison of Two Types of Videolaryngoscope and Direct Laryngoscope in Expected Non-difficult Airway Patients
Official title: Comparison of Two Types of Videolaryngoscope and Direct Laryngoscope in Expected Non-difficult Airway Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngoscopes
Keywords: Visual laryngoscope
Direct laryngoscope
Tracheal intubation time
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Macintosh direct laryngoscope has been mostly widely used for anesthesiologists in operation rooms or emergency situations all over the world. With rapidly development of technical devices, nowadays videolaryngoscope has become more and more popular in hospitals, for it could improve first intubation success rate and it is easier for beginners to learn. And there are many different types of videolaryngoscope for different purpose, like with or without a channel, different curvature, and so go. In this study, our aim is to study whether the videolaryngoscope which can be adjustable or not costs less intubation time and causes fewer injury in expected non-difficult airway patients by experienced anesthesiologists, compared with the classic Macintosh direct laryngoscope.


Eligibility criteria: Inclusion Criteria:

* age between18 and 65 years
* ASA(American Society of anesthesiologists) I-II
* BMI 18-30 kg/m2
* scheduled to receive elective surgery under general anesthesia with expected non-difficult airway in operation rooms.

Exclusion Criteria:

* expected difficult airway
* allergy to anesthesia induction drugs
* scheduled to receive surgeries affecting vocalisation
* with high reflux aspiration risk
* with acute and chronic cardiac or respiratory failure
* with glucocorticoids medication history
* with mental disorder or transferred to SICU(Surgical Intensive Care Unit) or ICU after surgery who can not cooperate well with others
* refused or have participated in other clinical trials that may have effects on the outcomes of this study

Primary outcomes:
measure: Tracheal intubation time
timeFrame: time from the removal of the patient's face mask for preoxygenation to confirmation of good tube position based on continuous positive end-tidal carbon dioxide reading (at least three breaths without a significant visual decrease in capnography).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Sanqing Jin, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01887275: A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
Official title: Medical Ozone Versus Conventional Interferon-α Treatment of Patients With Chronic Hepatitis B -A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B
Medical Ozone
Interferon-α
Efficacy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 439
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.

Detailed description: Total of 439 patients with chronic hepatitis B were divided according to patients' intention into two arms. 173 patients in arm I were treated with medical ozone therapy with humares which was made in Germany for at least 12 weeks.266 patients in arm II were treated with conventional interferon-α for at least 24 weeks.Patients in both groups were followed-up for 24 weeks.Virology response, biochemistry response and hepatitis B viral serological response will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks of follow-up.

Eligibility criteria: Inclusion Criteria:

* Male or female；
* HBsAg positive for over 6 months；
* ALT over 2×ULN, TBIL less than 80 µmol/L.

Exclusion Criteria:

* Patient has a history of hemorrhagic or hemolysis disease;
* Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
* Patient is co-infected with HIV or HCV;
* Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
* Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
* Pregnancy;
* Current alcohol or drug abuse;
* Difficulty to draw blood through veins;
* Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
* Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
* Patient is enrolled in any other clinical trials.

Primary outcomes:
measure: HBV DNA
timeFrame: up to 77 weeks
Secondary outcomes:
measure: HBeAg
timeFrame: up to 77 weeks
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: yabing guo, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05018975: Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection
Official title: Repurposing Tazemetostat for the Treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 Patient
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Cytokine Release Syndrome
Keywords: Systemic Cytokine Release Syndrome Due to SARS-CoV-2 Disease
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of repurposing tazemetostat for the treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 patients.

Detailed description: The investigators hypothesize that tazemetostat will mitigate the hyperinflammatory effects of COVID-19 infection, prevent respiratory deterioration, and reduce requirements of invasive ventilation. This will be conducted as a Phase II open label study. After being informed about the study and potential risks, all patients giving written informed consent will undergo randomization to receive 800 mg tazemetostat BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days, additionally the patients will be evaluated at 30 and 90 days for overall clinical status and sequelae. The study will be conducted at a single site (Loma Linda University Medical Center).

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged 18-85
* Diagnosed with q-PCR confirmed infection with SARS-Cov-2 virus and admitted to the hospital.
* Receiving non-invasive respiratory support through a nasal cannula or a face mask.
* Ability to take oral medication and be willing to adhere to the tazemetostat regimen.

Exclusion Criteria:

* Unable to take PO medication.
* Need for intubation or ECMO.
* Pregnancy or lactation
* Known allergic reactions to tazemetostat.
* Active malignancy (not in remission).
* Treatment with another investigational drug.

Primary outcomes:
measure: Length of hospital stay
timeFrame: Up to one year from date of randomization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: Ciprian P Gheorghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04387175: Intraoral Device vs Facial Mask for Class III Treatment
Official title: Comparison Between an Intraoral Device and Facial Mask for the Early Treatment of Class III Malocclusion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class III Malocclusion
Dentofacial Anomalies, Including Malocclusion
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trail is to compare the efficacy of an intraoral device (the Carriere® Motion 3D™ Class III Appliance) with the facial mask for the early treatemnt of Class III malocclusion. This is a monocentric, parallel, controlled trial with blinded examiner.


Eligibility criteria: Inclusion Criteria:

* age between 5 and 8 years
* prepubertal patients (cervical vertebral stage 1 or 2)
* Deciduous, early mixed, and intermediate mixed dentition (the lower deciduous canine should show at least 2/3 of the roots unresorbed)
* Presence of Class III skeletal imbalance (Wits appraisal equal to or smaller than
* 1 mm)

Exclusion Criteria:

* Early root resorption of the lower deciduous canines
* Periodontal disease
* Neurologic diseases
* Nickel allergy
* Patients with cleft lip and palate or craniofacial syndromes
* Patients irradiated in the head and neck area
* Patients who have undergone chemiotherapy or immunosuppresive therapy in the previous 5 years
* Patients unable to be followed for at least 1 year

Primary outcomes:
measure: Wits appraisal
timeFrame: Change in Wits appraisal evaluated on the lateral cephalograms taken at the start and at the end of active treatment (6-10 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00935675: Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinomas
Keywords: Patients with head and neck squamous cell carcinomas
head and neck squamous cell carcinomas
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 100
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: TREATMENT

Brief summary: Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score \> 11


Eligibility criteria: Inclusion Criteria:

1. Head and neck squamous cell carcinomas, stage I to IVb
2. First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy
3. HADS- T \>11
4. Aged 18 to 75 yo, written consent required
5. OMS\>2

Exclusion Criteria:

1. Palliative care
2. Previous head and neck cancer
3. Bipolar disorder or schizophrenia
4. Severe major depressive disorder (DSM-IV TR)
5. Expressed suicidal ideation
6. Severe untreated organic disorder, especially acute infectious disorder
7. ASAT/ALAT \> 3N
8. Clearance of creatinin \< 30 ml/mn
9. Hyponatremia
10. Antecedent of delirium tremens or acute alcohol withdrawal disorder
11. Antecedent of upper gastro-intestinal bleeding
12. Antecedent of toxicity or inefficacy of a previous treatment with escitalopram
13. Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline
14. Pregnancy or lactation

Primary outcomes:
measure: Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: