louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02872389: Power Spectral Analysis of EEG During Equi-MAC Inhalation Anesthesia
Official title: Power Spectral Analysis of the Electroencephalogram During Equi-MAC Sevoflurane vs. Desflurane Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.

Detailed description: Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there were no studies that demonstrate the difference of hypnotic potency using power spectral analysis of electroencephalographic signals (e.g., spectral edge frequency 95%, total power, % value of each bandage). The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.

Eligibility criteria: Inclusion Criteria:

* patients undergoing arthroscopic knee surgery under general anesthesia using volatile anesthetics
* patients with american society of anesthesiologist physical status I, II
* patients aged 19-65 years
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients undergoing tracheal intubation for airway management
* pregnant women

Primary outcomes:
measure: Spectral edge frequency 95% value
timeFrame: During about 30 min study period
Secondary outcomes:
measure: Bispectral index
timeFrame: During about 30 min study period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Kyoungho Ryu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01282489: Evaluation of Methods to Asses Visual Prosthesis Systems Using Sighted Volunteers and Visual Reality Simulator
Official title: Evaluation of Methods to Asses Visual Prosthesis Systems Using Sighted Volunteers and Visual Reality Simulator
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus of Study: Finding Ways to Evaluate Visual Prosthesis Systems
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Shamoon College of Engineering
First posted: 2011-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers with normal or corrected to normal sight

Brief summary: A basic requirement for every therapeutic procedure is that there be an objective and validated method to assess the benefit of the treatment for the patient. Currently, there is no acceptable procedure to quantify the benefit obtained from visual prostheses.

The goal of the proposed research is to evaluate visual tasks and tests that will be given to a very large number of volunteers with normal vision who will be using a novel virtual prosthesis simulator. This device will simulate the realistic visual information that a visual implant can provide and will be used to measure implants in current clinical trials.


Eligibility criteria: Inclusion Criteria:

Normal or corrected to normal sight (up to +/- 3.5 D) - Healthy Age 18 to 45

Exclusion Criteria:

Had any incident of dizziness from video or computer game Minors or special population

Primary outcomes:
measure: quantitative comparison with standard visual acuity test (ETDRS)
timeFrame: December 1, 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Dept Neurology, Meir Medical Center
Study officials:
References:
Clinical trial NCT01155089: Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fed conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to anastrozole or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 31 days
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clincial Applications
name: Dennis Morrison, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02854189: The Results of Oxford Unicompartmental Knee Arthroplasty in Patients With and Without Preoperative Genu Recurvatum
Official title: Department of Orthopaedics Faculty of Medicine Thammasat University Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Gonarthrosis
Genu Recurvatum
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effects of the Oxford unicompartmental knee arthroplasty on two groups of patients, namely one with genu recurvatum before the procedure and one without. Specifically, this study compare the number of occurrences of postoperative genu recurvatum and the postoperative hyperextension angles among the patients. Additionally, the knee scores, the pain scores, and the functional scores for the two groups of patients are compared.

Materials and methods: This study prospectively followed 104 patients (114 knees) who had been treated with cemented minimally invasive surgery unicompartmental knee arthroplasty and had had a minimum of 24 months of follow-up. The patients were divided into two groups: those without preoperative genu recurvatum (85 patients; 94 knees) and those with preoperative genu recurvatum (19 patients; 20 knees). The incidence of the postoperative genu recurvatum, the postoperative hyperextension angles, the knee scores, the pain scores, and the functional scores were recorded and compared between two groups..

Detailed description: The patients in both groups were applied with cemented Oxford unicompartmental knee arthroplasty with the same surgeon. The all patients were performed surgery with minimally invasive surgery technique. The gender, site, range of motion, alignment of prosthesis, operative time, blood loss, and posterior slope of tibial component also were recorded and compared between two groups. The incidence of postoperative genu recurvatum, gender, and site were computed using Fisher's exact test. The hyperextension angle, knee score, pain score, functional score,range of motion, alignment of prosthesis, posterior slope of tibial component, operative time, and blood loss were compared with student t-test.

Eligibility criteria: Inclusion Criteria:

* The medial OA knee with older than 40 years of age, ROM greater than 90°, varus deformity less than 25°, and flexion contractures less than 20°

Exclusion Criteria:

* patients who were diagnosed spontaneous osteonecrosis of knee (SPONK), patients with intraoperative ACL insufficiency, post traumatic arthritis, gouty arthritis, inflammatory joints.

Primary outcomes:
measure: hyperextension angle, the incidence of postoperative genu recurvatum
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06448689: Analytical Validation of Wrist-Based Assessment of Nocturnal Scratch in Atopic Dermatitis and Psoriasis
Official title: Prospective, Hybrid, Single-Center, Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Psoriasis
Keywords: nocturnal scratch
itch
validation
sleep impairment
pruritis
Lead sponsor: ActiGraph L.L.C
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female subjects, aged 14-70 years old, with active atopic dermatitis or psoriasis

Brief summary: Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. However, nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients' daily lives. This study deploys multiple technologies (polysomnography, video capture, wrist sensors, clinician-reported outcomes, and patient-reported outcomes) to develop and validate a wrist-based solution to quantify nocturnal scratch.


Eligibility criteria: Inclusion criteria for participants with atopic dermatitis:

* At least 14 years old
* Less than 70 years old
* Clinical diagnosis of Atopic Dermatitis
* Peak Pruritis NRS score \> 1

Inclusion criteria for participants with psoriasis:

* At least 18 years old
* Less than 70 years old
* Clinical diagnosis of plaque psoriasis
* At least a peak pruritis PNRS of 4
* Itch is caused by psoriasis, as determined by clinician

Exclusion Criteria:

* Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleep apnea, restless leg syndrome etc...)
* Movement disorder
* Flare or infection on the wrist
* Infected atopic dermatitis or psoriasis lesions
* Pregnant or lactating women
* Shift workers or participants with jetlag
* Current diagnosis of depression

Primary outcomes:
measure: Scratch Movements
timeFrame: 14 days
measure: Sleep Time
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance
Study officials:
affiliation: Université Paris Cité, VIFASOM, ERC 7330, Paris, France;b AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance, Paris, France
name: Damien Leger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867189: Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety
Official title: Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: anterior chamber flare
cataract
intraocular pressure
micro-instrument
photograph-based atlas
visual
training nurse
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Aims and objectives The purpose of this study was to develop an atlas to explore the effect of micro-instrument cleaning on the safety of cataract surgery.

Background Cataract surgery safety is affected by many factors, the most influential of which is the quality of instrument cleaning. Previous studies focused on the reaction in the eye after cataract surgery. None offered a solution for manually cleaning ophthalmic micro-instruments or response data for surgical instruments after cataract surgery.

Design The study was designed to collect quantitative data derived from postoperative ocular evaluation.

Methods We developed an atlas that details micro-instrument cleaning that could be used to train nurses to have this skill. A total of 120 cataract patients were divided evenly into experimental and control groups. In the experimental group, cataract surgery was undertaken using microsurgical instruments that were cleaned by the atlas-trained nurses. In the control group, micro-instruments were used that had been cleaned by non-atlas-trained nurses. All the patients underwent the same postoperative tests: anterior chamber cell counts and visual and intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.

Detailed description: A single surgeon conducted all of the surgery and follow-up all patients

Eligibility criteria: Inclusion Criteria:

* Cataract patients

Exclusion Criteria:

* Patients with metabolic disease, immune disease, and/or retinopathy were not included in this study.

Primary outcomes:
measure: the numbers of anterior chamber cells after cataract surgery.
timeFrame: within the 14 days after surgery
Secondary outcomes:
measure: the change of vision after cataract surgery
timeFrame: within the 14 days after surgery
Other outcomes:
measure: the change of intraocular pressure after cataract surgery
timeFrame: within the 14 days after surgery
Locations:
Study officials:
References:
Clinical trial NCT04042389: Oral Hygiene Reminders in Orthodontic Patients
Official title: Influence of WhatsApp and Electronic Mail Reminders on Oral Hygiene Compliance of Orthodontic Patients Using Planimetry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance, Treatment
Keywords: WhatsApp
Email
Oral hygiene
Compliance
Orthodontics
Planimetry
Reminders
Lead sponsor: Mahsa University
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 54
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To determine the effect of WhatsApp and Email reminders on oral hygiene compliance of orthodontic patients.

Methods: A Randomized, parallel group, double blinded study was conducted on 54 patients undergoing orthodontic treatment at MAHSA University. They were randomized to 3 groups, namely WhatsApp (W) group, Email (E) group and Control (C) group with 18 subjects in each group. Group (W) and Group (E) received oral health messages once a week through WhatsApp and E-mail reminders respectively, while Group (C) did not receive any reminders. Plaque was measured at baseline (T0), after 4 weeks (T1), and after 8 weeks (T2). For each subject, two intraoral photographs were taken after application of plaque disclosing agent; and the area covered by plaque was measured on 12, 13, 43, 22, 23 and 33 teeth by planimetry.

Detailed description: Fifty-four patients undergoing orthodontic treatment were recruited from the dental clinic of MAHSA University between Jan 2018 to April 2018. Voluntary written informed consent was obtained from all the subjects before the start of the study. They were randomly assigned into 3 groups namely WhatsApp (W) group, Email (E) group and Control (C) group with 18 subjects in each group. Oral hygiene messages through WhatsApp and Email were sent once a week for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients having fixed maxillary and mandibular orthodontic appliances with 0.022 AO conventional metal brackets,
* Aged ≥ 15 years,
* Undergone 3 months of orthodontic treatment,
* No significant medical or dental history
* Have access to cellular telephone and are online daily

Exclusion Criteria:

* Patients undergoing single arch treatment
* Missing maxillary lateral incisor, maxillary canine and mandibular canine
* Patients' orthodontic treatment duration \< 3 months and \> 4 months.

Primary outcomes:
measure: Change in plaque from baseline to 4 weeks
timeFrame: baseline (T0) to end of 4 weeks (T1)
measure: Change in plaque from baseline to 8 weeks
timeFrame: Baseline (T0) to end of 8 weeks (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Jenjarum
country: Malaysia
facility: MAHSA UNivesity
state: Selangor
Study officials:
affiliation: Mahsa University
name: Kirti Saxena, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00533689: Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Electrophysiology
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-09-21
Enrollment: 2008
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing.

This prospective, non-randomized clinical study will include patients assigned to intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as long as will be deemed necessary. Periodic electrophysiologic evaluation including Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests will be performed every 3 months.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CNV secondary to AMD
* No other ocular disease
* No history of kerato-refractive surgery
* No epilepsy
* Ability to perform electrophysiologic study

Exclusion Criteria:

* Pregnancy
* Minority
* Epilepsy
* History of kerato-refractive surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Michaella Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Anat Loewenstein, MD
role: STUDY_DIRECTOR
affiliation: Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel
name: Ido Perlman, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03326089: Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
Official title: Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: pulmonary rehabilitation
Lead sponsor: Corfu General Hospital
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an interventional double-blind randomized controlled trial, to investigate the short and long-term effects of a supervised exercise training program in patients with IPF, depending on alternate patterns of oxygen supplementation during PR.

Detailed description: The investigators hypothesize that PR service with supplemented oxygen supply regardless of hypoxemia may have significantly better short-term effects in patients with IPF. The study will take place in Corfu General Hospital, by the Departments of Pulmonary Medicine and Physiotherapy and Rehabilitation, respectively. Study participants will be divided in two equal arms 1:1 in a double-blind manner. One of the investigators blinded to their clinical data will assign each participant to PR service either i) with constant supplementary oxygen supply FiO2 50% regardless of saturation status Group A) or ii) without oxygen supply unless upon resting or exercise induced hypoxemia (saturation \<88%) (Group B).

Eligibility criteria: Inclusion Criteria:

* diagnosis of IPF based on current established criteria
* no exacerbation previous 3 months
* no participation in such program previous 3 months.
* If on treatment with pirfenidone or nintedanib, this will be recorded and patient should be on treatment for at least 3-6 months to achieve stable state.

Exclusion Criteria:

- concomitant diagnosis of congestive heart failure and lung cancer.

Primary outcomes:
measure: 6 Minute Walk Test Distance (6MWTD) (meters)
timeFrame: 2 months
measure: Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
timeFrame: 2 months
measure: Hospital Anxiety and Depression Scale (HADS) (units on scale)
timeFrame: 2 months
Secondary outcomes:
measure: 6 Minute Walk Test Distance (6MWTD) (meters)
timeFrame: 12 months
measure: Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS) (units on scale)
timeFrame: 12 months
Other outcomes:
Locations:
city: Corfu
country: Greece
facility: Corfu General Hospital
Study officials:
affiliation: Physiotherapy Director
name: Stefanos Patsiris
role: STUDY_DIRECTOR
References:
Clinical trial NCT02542189: High Sensitivity Cardiac Troponin T in Patients With Atrial Fibrillation Admitted to an Emergency Department (ED)
Official title: High Sensitivity Cardiac Troponin T in Patients With Atrial Fibrillation Admitted to an Emergency Department (ED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 3037
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of approximately 3,500 consecutive patients presenting to the emergency department of the University Clinic Heidelberg between June 2009 and March 2013.

Brief summary: The purpose of this study was to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department.


Eligibility criteria: Inclusion Criteria:

* documented atrial fibrillation in admission EKG or diagnosis of atrial fibrillation at admission.

Exclusion Criteria:

* no patients are excluded.

Primary outcomes:
measure: vascular and non-vascular death
timeFrame: up to 60 months
measure: nonfatal myocardial infarction
timeFrame: up to 60 months
measure: stroke/transitory ischemic attack (TIA)
timeFrame: up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stoyanov KM, Giannitsis E, Biener M, Mueller-Hennessen M, Arens K, Katus HA, Vafaie M. Prognostic value of elevated high-sensitivity cardiac troponin T in patients admitted to an emergency department with atrial fibrillation. Europace. 2018 Apr 1;20(4):582-588. doi: 10.1093/europace/eux063.