louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01998698: Monovision vs Multifocal Lens Insertion in Cataract Patients
Official title: Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
phacoemulsification
monovision
multifocal lens
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2013-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.


Eligibility criteria: Inclusion Criteria:

* Bilateral senile cataract

Exclusion Criteria:

* Glaucoma
* Corneal pathology
* Fundus pathology
* Severe neurological/mental diseases that interfere with visual acuity
* Former intraocular operation

Primary outcomes:
measure: VF14 score
timeFrame: 6 months following operation
Secondary outcomes:
measure: Distant Visual Acuity
timeFrame: 6 months following surgery
measure: Near Vision visual acuity
timeFrame: 6 months following surgery
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Assistant Professor
name: Georgios Labiris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labiris G, Giarmoukakis A, Patsiamanidi M, Papadopoulos Z, Kozobolis VP. Mini-monovision versus multifocal intraocular lens implantation. J Cataract Refract Surg. 2015 Jan;41(1):53-7. doi: 10.1016/j.jcrs.2014.06.015. Epub 2014 Jun 21.
Clinical trial NCT00944398: Impact of Targeted Zinc Fortification Programs on Plasma Zinc Concentration
Official title: Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Zinc Deficiency
Keywords: Zinc fortification
Plasma zinc concentration
Assessment of zinc status
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Helen Keller International
name: Cheikh Anta Diop University, Senegal
name: Global Alliance for Improved Nutrition
First posted: 2009-07-23
Enrollment: 98
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of targeted zinc fortification programs.

Detailed description: The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to young children. The following specific steps will be completed:

1. Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours will be developed with assistance from experts in food technology.
2. A two-week feeding trial will be implemented to assess the change in plasma zinc concentration among young children who receive: a) the zinc-fortified cereal porridge and a liquid vitamin preparation between meals; b) a non-zinc-fortified cereal porridge and a liquid vitamin preparation between meals \[negative control group\]; or c) a non-zinc-fortified cereal porridge and a zinc-containing liquid vitamin preparation between meals \[positive control group\].

Eligibility criteria: Inclusion Criteria:

* apparently healthy

Exclusion Criteria:

* severe malnutrition
* severe anemia

Primary outcomes:
measure: Plasma zinc concentration
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Helen Keller International
Study officials:
affiliation: University of California, Davis
name: Kenneth H Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo NB, Aaron GJ, Hess SY, Dossou NI, Guiro AT, Wade S, Brown KH. Plasma zinc concentration responds to short-term zinc supplementation, but not zinc fortification, in young children in Senegal1,2. Am J Clin Nutr. 2011 Jun;93(6):1348-55. doi: 10.3945/ajcn.111.012278. Epub 2011 Apr 13.
Clinical trial NCT03502798: Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
Official title: Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dysplasia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Jacobi Medical Center
First posted: 2018-04-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine:

1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells.
2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).


Eligibility criteria: Inclusion Criteria:

* able to provide informed consent
* willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion Criteria:

* pregnant
* have a current gynecological infection or discharge
* have had any cervical surgery
* had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
* currently enrolled in any research studies involving the application of vaginal formulations
* employed or supervised by the study investigators
* have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study

Primary outcomes:
measure: Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
timeFrame: baseline
measure: Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies
timeFrame: baseline
Secondary outcomes:
measure: Identification of T-zone by Scanning a/LCI Probe
timeFrame: baseline
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: professor
name: Adam Wax, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01854398: The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Continuous positive airway pressure
diastolic function
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been reported, and improvement of diastolic function after continuous positive airway pressure (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3 months of CPAP therapy in OSA patients will significantly improve diastolic functional parameters measured by exercise stress echocardiography. Patients with severe OSA (Apnea-hypopnea index \> 30) will be included in this study, and randomized to CPAP versus sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity, 24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP therapy and parameters will be compared.


Eligibility criteria: Inclusion Criteria:

* Patietns≥20 and ≤75 years-old
* Patients who diagnosed as obstructive sleep apnea and AHI\>30 on polysomnography

Exclusion Criteria:

* Age \< 20 years-old
* Left ventricular dysfunction (LVEF\<50%) or structural heart disease on transthoracic echocardiography
* Diabetes mellitus
* Significant cardiac valvular disease (≥moderate)
* Severe hypertension (\>180/110mmHg)
* Moderate or severe kidney disease (eGFR \< 60 mL/min )
* Clinically significant liver disease
* History of coronary artery disease
* malignancy or autoimmune disease
* Acute/chronic infection status
* Pregnant status
* Patients taking anxiolytics or sedatives

Primary outcomes:
measure: The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.
timeFrame: after 3 months intervention (CPAP)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Shim CY, Kim D, Park S, Lee CJ, Cho HJ, Ha JW, Cho YJ, Hong GR. Effects of continuous positive airway pressure therapy on left ventricular diastolic function: a randomised, sham-controlled clinical trial. Eur Respir J. 2018 Jan 31;51(2):1701774. doi: 10.1183/13993003.01774-2017. Print 2018 Feb.
Clinical trial NCT04040998: Compensatory Cognitive Training For Schizophrenia
Official title: Compensatory Cognitive Training for Psychosocial Correlates and Self-stigma in Persons With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
compensatory cognitive training
generalized estimating equation
psychosocial correlates
self-stigma
Lead sponsor: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-08-01
Enrollment: 46
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effects of compensatory cognitive training plus treatment as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)
* age from 20 to 65
* attending day care center regularly for at least 3 months
* taking stable dose of medication for at least 3 months

Exclusion Criteria:

* comorbid autism spectrum disorder
* comorbid mental retardation
* lacking the reading and writing skills

Primary outcomes:
measure: Change scores of Rosenberg Self-Esteem Scale (RSES)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
measure: Change scores of General Self-Efficacy Scale (GSES)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
measure: Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
measure: Change scores of Internalized Stigma of Mental Illness (ISMIS)
timeFrame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan Psychiatric Center Ministry of Health and Welfare
Study officials:
References:
Clinical trial NCT00164398: HIP: HIV Intervention for Providers
Official title: HIP: HIV Intervention for Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose is to encourage Provider participants to evaluate high risk HIV transmission behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or unknown HIV serostatus. It is hypothesized that patients of providers participating in the HIP intervention will report higher reduction in sexual risk practices, when compared to the patients of the providers who were randomized into the control condition.


Eligibility criteria: Inclusion Criteria:

* Provider participants: (1) licensed MD, NP or PA on staff at the participating institution; (2) has a minimum panel of 5 HIV+ patients; (3) sees patients at least one-half day per week in the clinical setting; (4) is willing to participate in all intervention training sessions; and (5) is willing and able to provide full informed consent.

HIV+ patient participants:(1) report at least 1 encounter of unprotected anal or vaginal sex with known HIV- or unknown serostatus partner in the preceding six months; (2) patient's Primary Provider is enrolled as a participant in the study; (3) age 18 years or older; and (4) willing and able to provide informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative and unknown-status persons.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco - CAPS
state: California
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Dogan Eroglu, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rose CD, Courtenay-Quirk C, Knight K, Shade SB, Vittinghoff E, Gomez C, Lum PJ, Bacon O, Colfax G. HIV intervention for providers study: a randomized controlled trial of a clinician-delivered HIV risk-reduction intervention for HIV-positive people. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):572-81. doi: 10.1097/QAI.0b013e3181ee4c62.
Clinical trial NCT05912998: Comparative Study Between Autologous Adipose Tissue Graft Versus Microfracture for Treatment of Articular Cartilage Defects
Official title: Comparative Study Between Autologous Adipose Tissue Graft With Hyaline Catilage Versus Microfracture for Treatment of Articular Cartilage Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee arthroscopy using standard portals will be performed in three groups. Complete evaluation of all intra -articular structures will be performed followed by accurate localization of the cartilage defect and measurement of its dimensions. The cartilage lesion grading according to the International Cartilage Repair Society system (ICRS). The patients assigned for the first group will have Liposuction through a minor 1 cm incision on the abdomen to obtain adequate amount of emulsified adipose tissues (50 - 60 cc). Autologous adipose tissue will be mixed with autologous hyaline cartilage obtained from non-weight bearing areas of the knee in prepared mold. The graft will be mixed with fibrin glue and left to solidify a little. After obtaining the fashioned graft from the mold it will be fixed in to the defect site by fibrin glue through mini open approach and stability of the implant fitted in the site will evaluated by gentle cycling of the joint. During the graft preparation, a high tibial osteotomy will be performed. Patients assigned for the second group will have microfracture in association with open wedge high tibial osteotomy. Patients assigned for the third group will have open wedge high tibial osteotomy. Standard titanium T locked plate will be used to fix the open wedge osteotomy in the three groups.


Eligibility criteria: Inclusion Criteria:

* Age group 18 to 60 years old.
* Cartilage defect size range 2-5 cm2.
* Outer Bridge classification II \& III.
* Single full thickness symptomatic femoral condyles ulcer.
* Varus deformity of the affected knee 50 - 100.

Exclusion Criteria:

* Advanced knee osteoarthritis.
* Knee range of motion less than 1000.
* Ligamentous injury of the affected knee.
* Recent intra articular injection of any type with in last 6 months.
* Fracture around the knee.
* Inflammatory joints disorders.
* Tumors.
* Immunocompromised patients.
* Body mass index \< 35
* Valgus deformed knee any degree
* Sever varus deformed knee \< 10 0

Primary outcomes:
measure: Clinical assessment of International Knee Documentation Committee (IKDC) scores
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02893098: A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of Knee
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 232
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial


Eligibility criteria: Inclusion Criteria:

* Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain
* Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months
* Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm
* Able to walk without assistive devices
* Patients willing and able to provide signed informed consent after the nature of the study has been explained

Exclusion criteria:

* Body Mass Index (BMI) \> 32
* History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
* Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
* Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test
* Undergo Knee Replacement Surgery of the target knee

Primary outcomes:
measure: Change from baseline of Weight-bearing pain (100mm-VAS)
timeFrame: Week 14
Secondary outcomes:
measure: Change from baseline of Weight-bearing pain (100mm-VAS)
timeFrame: Weeks 3, 8, 14, and 26
measure: Change from Visit 8 of Weight-bearing pain (100mm-VAS)
timeFrame: Week 38
measure: Physical Examination : Swelling
timeFrame: Weeks 0, 3, 8, 14, 26, and 38
measure: Physical Examination : Tenderness on pressure
timeFrame: Weeks 0,3,8,14,26,and 38
measure: Physical Examination : Range of motion
timeFrame: Weeks 0, 3, 8, 14, 26, and 38
measure: Consumption of rescue medication
timeFrame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
measure: Proportion (%) of patients taking rescue medication
timeFrame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
measure: Responder Rate
timeFrame: Week 14
Other outcomes:
Locations:
city: Ansan-si
country: Korea, Republic of
facility: Huons
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01425398: A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Valvular Cardiac Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Single or multiple valve repairs or replacements without coronary artery bypass grafting
* Bentall procedure, but no other aortic procedures
* With or without accompanying MAZE procedure (surgical treatment for atrial fibrillation)

Exclusion Criteria:

* Age under 18 years old
* Urgent or emergency surgery
* Unable to provide consent
* Presently on statin therapy or exposure to statins within a month of surgery
* Chronic anti-inflammatory use, including steroids and NSAID's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period)
* Known hypersensitivity to rosuvastatin
* Active liver disease Indicated by AST/ALT higher than 3 times the upper limit of normal
* Pregnant or nursing women
* On drugs with interactions (Cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir, niacin) Severe renal impairment not on dialysis
* Creatinine clearance \< 30 ml/min/1.73 m2
* Known myopathy and inflammatory diasthesis (such as systemic lupus erythromatosus, rheumatoid arthritis, and inflammatory bowel disease)
* Human Immunodeficiency Virus

Primary outcomes:
measure: Improved Inflammatory Markers
timeFrame: Within 5 days post-op and at 3 months
Secondary outcomes:
measure: Mortality
timeFrame: Within 3 months
measure: Stroke
timeFrame: Within 3 months
measure: Myocardial Infarction
timeFrame: Within 3 months
measure: ICU length of stay
timeFrame: 3 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: RI-MUHC
name: Jacques Genest, MD
role: PRINCIPAL_INVESTIGATOR
References: