louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05853978: The Evaluation of Balanced Salt Solution During Cataract Surgery
Official title: The Evaluation of Balanced Salt Solution During Cataract Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Fuchs Dystrophy
Cataract
Keywords: Fuchs Corneal Endothelial Dystrophy
Nuclear Sclerosis
Cataract Surgery
Paired Eye
ARF-23-001
Lead sponsor: St. Louis Eye Institute
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2023-05-11
Enrollment: 27
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to identify if the use of BSS PLUS® Sterile Intraocular Irrigating Solution as an irrigation solution leads to improved corneal outcomes vs BSS® Sterile Irrigating Solution in more compromised corneas.


Eligibility criteria: Inclusion Criteria

1. Adults, 22 years of age or older, with bilateral visually significant cataracts.
2. Subjects with Fuch's Dystrophy that present with:

   1. nonconfluent and confluent guttata; and/or
   2. CCT \> 580 microns.
3. Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension
4. Ability to comprehend and sign a statement of informed consent.
5. Ability to complete all required postoperative visits.
6. Willingness to use at least one medically acceptable form of birth control throughout the duration of study participation. (for female subjects of childbearing potential only).

Exclusion Criteria

1. Planned implantation of multifocal intraocular lenses.
2. Planned secondary procedure(s) to occur in conjunction with cataract surgery (i.e., goniotomy)
3. History of severe dry eye.
4. Retinal and retinal vascular pathologies, age-related macular degeneration
5. Uncontrolled systematic diseases, including: hypertension, diabetes, systemic cardiovascular diseases and hematological diseases.
6. Autoimmune disease such as rheumatoid arthritis.
7. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Primary outcomes:
measure: Central Corneal Thickness (CCT)
timeFrame: Postoperative: Day 1
Secondary outcomes:
measure: Intraoperative Grading of Corneal Edema
timeFrame: Day 0
measure: Number of Intraocular Irrigating Solution Drops Used
timeFrame: Day 0
Other outcomes:
measure: Corneal Surface Keratopathy and Conjunctival Staining
timeFrame: Postoperative: Day 1 and Week 1
measure: Conjunctival Injection
timeFrame: Postoperative: Day 1 and Week 1
measure: Ocular Comfort Index (OCI)
timeFrame: Postoperative: Day 1 and Week 1
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Postoperative: Month 1
measure: Endothelial Cell Density (ECD)
timeFrame: Postoperative: Month 1
Locations:
city: Town And Country
country: United States
facility: St. Louis Eye Institute
state: Missouri
Study officials:
References:
Clinical trial NCT00018278: Electrophysiologic Measures of Treatment Response in Alzheimer Disease
Official title: Verbal Memory ERPs as Indices of Treatment Response in Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the electrophysiological effects of cholinergic therapy (cholinesterase inhibitors and transdermal nicotine) in Alzheimer disease. The attempt will be to locate electrophysiological markers and predictors of cognitive and clinical treatment response.


Eligibility criteria: Patients diagnosed with mild to moderate probable Alzheimer's disease (mini-mental state exam scores between 15-27), and normal controls (age generally between 60-85). Subjects must either be planning to start daily cholinesterase therapy (e.g. Aricept, Exelon) or willing to try a transdermal nicotine patch for two 8 hour periods.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Department of Veterans Affairs
state: California
Study officials:
name: Vincente Iragui, M.D., Ph.D
name: Shuanna Morris, Ph.D.
References:
Clinical trial NCT06120478: Prediction of Risk Factors for Adverse Events After Head and Neck Vascular Recanalization Surgery Based on Machine Learning Models
Official title: The Second Affiliated Hospital of Air Force Military Medical University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Machine Learning
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing vascular recanalization surgery due to stroke

Brief summary: Prediction of risk factors for adverse events after head and neck vascular recanalization surgery based on machine learning models


Eligibility criteria: Inclusion Criteria:

* All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;
* Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;
* Patients with symptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, and with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 50% found on angiography;
* Asymptomatic head and neck artery stenosis and risk events after head and neck revascularization, with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 60% found on angiography;
* Asymptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, with a non-invasive examination of stenosis degree less than 70%, but angiography or other examinations indicate that the stenosis lesion is in an unstable state;
* Symptomatic head and neck artery stenosis and risk events after head and neck revascularization, non-invasive examination of head and neck artery stenosis and risk events after head and neck revascularization are 50% to 69%;
* Sign the project informed consent form

Exclusion Criteria:

* Patients with poor overall condition and intolerance to general anesthesia;
* Patients with mental illness or severe mental illness;
* Severe respiratory system diseases;
* Pregnant and lactating women;
* Participating in another clinical study;
* Patients with advanced tumors or those who are expected to die within one year;

Primary outcomes:
measure: death
timeFrame: one year
Secondary outcomes:
measure: Recurrence of stroke
timeFrame: one year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT02629978: Radiofrequency Ablation of Malignant Pulmonary Nodules
Official title: Efficacy and Safety of Radiofrequency Ablation of Malignant Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Carcinoma
Keywords: pulmonary
lung
cancer
carcinoma
nodule
malignant
radiofrequency ablation
RFA
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the outcomes of radiofrequency ablation in the treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable candidates for or refuse surgical resection.

Detailed description: Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique widely used to treat solid tumors. Patients with malignant pulmonary nodules will undergo a series of CT- guided percutaneous RFA procedures. During the procedures，percutaneous needles will be inserted into the target tissues under CT guidance，the needles deliver thermal energy and then destroy the tumors by causing coagulation necrosis via tissue heating. The purpose of this study is to assess the effectiveness and safety of RFA in pulmonary nodules （maximum tumor diameter ≦30 mm） was 10 mm apart from the big trachea, primary bronchi, esophagus, great vessels，heart and pleura. Preoperative and postoperative evaluations，including recent laboratory tests evaluated and imaging studies reviewed，will be performed both before and after the procedures.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed malignant pulmonary nodules.
2. Patients refuse or are not suitable for surgical resections.
3. 1-3 pulmonary nodules , with a maximum tumor diameter ≦30 mm.
4. Minimum distance of nodules are at least 10 mm apart from the surrounding tissues as big trachea, primary bronchi, esophagus, great vessels，heart and pleura.

Exclusion Criteria:

1. Patients who has uncorrectable coagulation disorders, severe heart or pulmonary failure, or uncontrolled infections.
2. With extensive extrapulmonary or intrapulmonary metastasis.
3. Have taken anticoagulant as aspirin in one week.
4. Target nodules nearby pleura or other important hilum and mediastinum structures.
5. With metal implants are adjacent to the target tissues which will be covered with ablation area.

Primary outcomes:
measure: 1- , 3- and 5-year survival rates
timeFrame: up to 5 years after the procedures
measure: complication rate
timeFrame: During the procedure or up to 5 years after the procedures
Secondary outcomes:
measure: changes of the size about the tumor on CT/MRI images
timeFrame: After the procedures up to three months
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Chinese PLA General Hospital
Study officials:
affiliation: The Chinese PLA General Hospital
name: Yueyong Xiao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04050878: Three-dimensional Assessment of Facial Alterations Induced by Dental Prostheses
Official title: Analysis of Three-dimensional Modifications Caused by Full Arch Implant Supported Dental Prosthesis With a Facial Scanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue
Keywords: Imaging, Three-Dimensional
Technology, Dental
accuracy
extra-oral scanner
Lead sponsor: Implantology Institute
Sponsor class: OTHER
Collaborators: name: Grupo de Investigação em Bioquímica e Biologia Oral
First posted: 2019-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Determine the modifications caused by the use of different implant-supported dental prostheses in the soft tissues of the face, mainly upper and lower lips, by the use of a facial scanner.
Primary purpose: DIAGNOSTIC

Brief summary: Validation of the use of a facial scanner for assessment of modifications caused by the use of dental prostheses and determination of discrepancies related to conventional measurements with digital caliper.

Detailed description: 3 dimensional evaluation of lip support by the use of full arch impplant supported rehabilitations with the use of a facial scannner. Determination of discrepacies between the obtained facial scan and conventional measurements made by a digital caliper on the face.

Eligibility criteria: Inclusion Criteria:

* Patients rehabilitated with full implant supported upper dental prostheses.

Exclusion Criteria:

* Patients without beard, facial deformities, earrings or braces.

Primary outcomes:
measure: Soft tissue changes in µm with and without implant supported dental prostheses
timeFrame: Both scanning procedures will be made in the same appointment upon 3 months use of delivery of the final implant supported full dental prostheses
Secondary outcomes:
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Instituto de Implantologia
Study officials:
affiliation: Implantology Institute
name: João Carames, DDS, Phd
role: STUDY_DIRECTOR
affiliation: Implantology Institute
name: Duarte Marques, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06542978: Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
Official title: Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Delirium
Anesthesia
Elderly
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. It is one of the most common surgical complications in the elderly, occurring in more than 75% of patients receiving mechanical ventilation in the intensive care unit(ICU).Exogenous 40 Hz stimulation can improve cognitive functioning.Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing elective gastrointestinal surgery in AICU.


Eligibility criteria: Inclusion Criteria:

* 1.Age ≥ 65 years old,gender not limited
* 2.ASA classification Ⅱ \~ Ⅳ
* 3.Elective gastrointestinal general anesthesia surgery

Exclusion Criteria:

* 1.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
* 2.Pre-operative coma, severe dementia, speech impairment or severe illness incapacitated and unable to communicate
* 3.Delirium on admission or pre-operative delirium, brain injury
* 4.Severely infected person
* 5.Severe liver dysfunction (Child-Pugh C), severe renal insufficiency (preoperative dialysis)
* 6.Severe hearing or vision impairment

Primary outcomes:
measure: The incidence of postoperative delirium
timeFrame: Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery
Secondary outcomes:
measure: Blood Markers
timeFrame: half hour, 6hours, 24hours and 48hours after transfer to aicu
measure: Sleep quality
timeFrame: 8:00 to 10:00 every morning for the first three days after surgery
measure: The incidence of pain
timeFrame: 6hours, 24hours, 48hours after surgery
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan People's Hospital
state: Henan
Study officials:
References:
Clinical trial NCT00695578: Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Official title: A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.

Detailed description: Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit.

Eligibility criteria: Inclusion Criteria:

* Subject must give written consent.
* Subjects must be \>50 years of age, male or female.
* Subjects must have had cryotherapy treatment of at least one AK's on each forearm in the Dermatology Clinic.

Exclusion Criteria:

* Subjects age \<50 years of age.
* Subjects with known allergy or sensitivity to topical Biafine or polysporin ointment.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for AK while participating in the study.
* Subjects using other topical agent's glycolic acid products, alpha-hydroxy acid products, retinoids and chemical peel agents in the treatment areas while on study.

Primary outcomes:
measure: Mean Severity Score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725478: SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease
Official title: Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Piribedil (trade name: CLARIUM)
non-ergot dopamine agonist
Morbus Parkinson
Tolerability
Efficacy
Post Marketing Surveillance
Lead sponsor: Desitin Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Morbus Parkinson who require therapy with dopamine agonists.

Brief summary: The aim of the non-interventional Post Marketing Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Tolerability and course of the disease or change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists will be documented under routine conditions. Piribedil should be prescribed according to its marketing authorisation by the responsible neurologist.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years and older.
* Indication: Morbus Parkinson.
* Treatment with piribedil for the first time.
* Monotherapy with piribedil.
* Combination therapy with L-Dopa (from the beginning or secondary) and/or in combination with other antiparkinsonian drugs.

Exclusion Criteria:

Primary outcomes:
measure: to monitor use in real practice including adverse events on piribedil
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. doi: 10.1002/mds.20750.
citation: Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. doi: 10.1002/mds.21122.
citation: Rascol O, Pathak A, Bagheri H, Montastruc JL. Dopaminagonists and fibrotic valvular heart disease: further considerations. Mov Disord. 2004 Dec;19(12):1524-5. doi: 10.1002/mds.20328. No abstract available.
Clinical trial NCT01306578: Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
Official title: Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Guillain Barre Syndrome
Keywords: Guillain Barre syndrome
IVIG
Plasma exchange
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 41
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.

Detailed description: Children with Guillain Barre syndrome (GBS) admitted to PICU at Mansoura University Children Hospital, Mansoura, Egypt with the need for mechanical ventilation were prospectively enrolled in the study.

Cases were diagnosed according to clinical criteria. The decisions to initiate, wean and terminate mechanical ventilation were made independently by the attending consultant in accordance with the unit guidelines.

Outcome variables measured were duration of mechanical ventilation, length of PICU stay and ability to walk unaided 4 weeks after PICU discharge.

Eligibility criteria: Inclusion Criteria:

* Age: children from 1 month - 18 years old
* Clinical diagnosis of Guillain Barre syndrome
* Requirement of mechanical ventilation

Exclusion Criteria:

* Need for mechanical ventilation beyond 14 days from disease onset
* Child receiving IVIG or PE prior to enrollment

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 21 days (average)
Secondary outcomes:
measure: PICU stay
timeFrame: 28 days (average)
measure: Ability to walk
timeFrame: 4 weeks from PICU discharge
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children Hospital
state: Dakahlia
Study officials:
affiliation: Head of PICU, Mansoura University Children Hospital
name: Mohammed A El-Bayoumi, MD, FRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Bayoumi MA, El-Refaey AM, Abdelkader AM, El-Assmy MM, Alwakeel AA, El-Tahan HM. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barre syndrome: a randomized study. Crit Care. 2011 Jul 11;15(4):R164. doi: 10.1186/cc10305.