louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04397068: Compare ELP in Patients With Elective Phaco-VTX Surgery in One Eye and a Single Lens Phaco Surgery on the Other Eye
Official title: Vergelijking Van de Postoperatieve Effectieve Lenspositie (ELP) Bij patiënten Gepland Voor Een Electieve Phacovitrectomie-ingreep (Phaco-VTX) Aan één Oog en Enkel Een Lensingreep Phaco Aan Het Andere Oog
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Pucker
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to gain more insight into the potential impact of a vitrectomy (removal of the vitreous) on postoperative effective position of the intraocular lens (IOL). Moreover, this study can provide very useful information for the optimal lens calculation in patients undergoing lens extraction with IOL implantation (whether or not combined with a vitrectomy) should undergo.

Detailed description: * Comparison ELP post phaco VTX (pucker / floaters) versus post phaco and use this information to develop a customized IOL calculation for eyes undergoing phacoVTX.
* Evidence for recording lens thickness (LT) parameter in the IOL strength calculation in KWS (in the calculation of the ELP in the light of the Olsen formula, using the C-constant) in order to be able to make an even more accurate prediction of the post-operative diopter target of the patient.

Eligibility criteria: Inclusion Criteria:

* age \> 50 yrs
* macular pucker wherefore vitrectomy is necessary

Exclusion Criteria:

* macular pathology other than macular pucker
* Corneal pathology
* Other ocular pathology that could affect the biometrics or ELP
* Previous vitrectomy in one of the eyes

Primary outcomes:
measure: Compare if ELP is different or the same at phaco or phaco-vitrectomy
timeFrame: 6 - 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Peter Stalmans
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02176668: The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects
Official title: A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 \~ 25
2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
3. negative to Helicobacter pylori in 13C urea breath test
4. Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
5. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

Exclusion Criteria:

1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
2. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
3. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
4. pregnant or lactating woman.
5. Other exclusions apply.

Primary outcomes:
measure: The Cmax of YH4808
timeFrame: Day 1(Day 35), Day 7(Day 41)
measure: The AUC0-24h of YH4808
timeFrame: Day 1(Day 35), Day 7(Day 41)
measure: The AUC0-24h of M3
timeFrame: Day 1(Day 35), Day 7(Day 41)
measure: The Cmax of M3
timeFrame: Day 1(Day 35), Day 7(Day 41)
Secondary outcomes:
measure: the arithmetic mean of 24h intragastric pH monitoring
timeFrame: Day 1(Day7)~Day2(Day8)
measure: the median of 24h intragastric pH monitoring
timeFrame: Day 1(Day7)~Day2(Day8)
measure: The Duration of stomach maintained over pH4 or 5
timeFrame: Day 1(Day7)~Day2(Day8)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Medical Center Severance Hospital Clinical Trials Center
Study officials:
affiliation: Yonsei Medical Center Severance Hospital Clinical Trials Center
name: Min soo Park, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03357068: Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans
Official title: Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans: Qualitative, Quantitative and Immunohistochemical Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Atrophy
Bone Resorption
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth design - one side of mouth is test group, other side is control group
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of citric acid demineralization in autogenous bone blocks consolidation. Half of participants will receive citric acid treatment at the bone block and recipient site. Other half will receive no demineralization treatment.

Detailed description: Autogenous bone grafts are indicated in areas where there is not enough bone height and/or width for implant installation. Treatment of bone surfaces with citric acid, promote a slight demineralization on surface that mimic natural processes of bone demineralization by osteoclasts. Thus, this treatment could accelerate the process of autogenous bone block consolidation to its recipient site.

Eligibility criteria: Inclusion Criteria:

* Presence of atrophic anterior maxilla (width 1.5 to 4 mm)
* Absence of active periodontal disease.
* Enough bone width on donor sites (oblique line or ment)

Exclusion Criteria:

* Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation
* Smokers
* Pregnant women
* Patients receiving radiotherapy or chemotherapy
* Patients using bisphosphonates

Primary outcomes:
measure: Clinical bone block consolidation
timeFrame: 5 months
measure: Computerized tomography images bone block consolidation
timeFrame: 5 months
measure: Histological bone block consolidation
timeFrame: 5 months
Secondary outcomes:
measure: Bone width
timeFrame: 5 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
References:
citation: Rezende ML, Consolaro A, Sant'Ana AC, Damante CA, Greghi SL, Passanezi E. Demineralization of the contacting surfaces in autologous onlay bone grafts improves bone formation and bone consolidation. J Periodontol. 2014 May;85(5):e121-9. doi: 10.1902/jop.2013.130298. Epub 2013 Oct 30.
Clinical trial NCT01884168: Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy
Official title: Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Tumor
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The malignant tumor patients present with malignant cavity effusion and can receive DC-CIK immunotherapy.

Brief summary: To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor presenting malignant cavity effusion after DC-CIK immunotherapy.

Detailed description: 1. The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
2. Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.
3. The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
4. The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed with malignant tumor and malignant cavity effusion.
2. An Eastern Cooperative Oncology Group（ECOG）performance status of 0-2.
3. Normal cardiac, hepatic, renal and bone marrow functions.
4. Life expectancy \>3 months.
5. Not receive other anti-tumor treatment.
6. Not receive chemotherapy in pleural and abdominal cavity.

Exclusion Criteria:

1. Previous history of other malignancies.
2. Serious or uncontrolled concurrent medical illness.

Primary outcomes:
measure: Immunotherapy response
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Cancer Center/Beijing Shijitan Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University Cancer Center /Beijing Shijitan Hospital
name: Jun Ren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05789368: Efficacy Testing of VeCollal Products
Official title: Efficacy Testing of VeCollal Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess VeCollal formula on skin condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Constant drug use
* Students who are currently taking courses taught by the principal investigator of this trial.

Primary outcomes:
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 8 weeks
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 8 weeks
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 8 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 8 weeks
Secondary outcomes:
measure: The change of skin melanin index
timeFrame: Change from Baseline skin melanin index at 8 weeks
measure: The change of skin L* value
timeFrame: Change from Baseline skin L* value at 8 weeks
measure: The change of skin erythema index
timeFrame: Change from Baseline skin erythema index at 8 weeks
measure: The change of skin moisture
timeFrame: Change from Baseline skin moisture index at 8 weeks
measure: The change of transepidermal water loss (TEWL)
timeFrame: Change from Baseline skin TEWL at 8 weeks
measure: The change of skin pores
timeFrame: Change from Baseline skin pores at 8 weeks
Other outcomes:
measure: The change of liver function biomarkers (AST, ALT) of blood
timeFrame: Change from Baseline liver function biomarkers at 8 weeks
measure: The change of renal function biomarkers (creatinine, BUN) of blood
timeFrame: Change from Baseline renal function biomarkers at 8 weeks
measure: The change of fasting blood glucose
timeFrame: Change from Baseline blood glucose at 8 weeks
measure: The change of blood lipid profiles (total cholesterol, triglyceride)
timeFrame: Change from Baseline blood lipid profiles at 8 weeks
measure: The change of self-assessment skin condition
timeFrame: Change from Baseline skin condition at 8 weeks
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05993468: A Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
Official title: A Mixed-Methods Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Post-Traumatic Stress Disorder
Keywords: mindfullness
treatment
compassion
trauma
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The inclusion criteria in each group were in accordance with the institution's clinical practice

Brief summary: This mixed-methods pilot study aim to assess the changes in symptoms of post-traumatic stress disorder (PTSD), complex post-traumatic stress disorder (CPTSD), dissociative symptoms, self-critique, and self-compassion following participation in a 16-week trauma-sensitive mindfulness and compassion (TMC) intervention. Adverse experiences of participation are also explored explicitly.

Detailed description: Seventeen clients most female with severe childhood abuse and PTSD and CPTSD participated in the TMC intervention. A mixed-methods design was used. All clients completed questionnaires before (pre) and after (post) the intervention to gain information on symptom change, self-critique, and self-compassion. Second, a qualitative interview addressing clients' experiences of participation, including an explicit focus on adverse experiences, was conducted.

Eligibility criteria: Inclusion Criteria:

* report traumatic experiences and trauma related symptoms
* be between 18 and 65 years of age
* give informed consent to participate in the study

Exclusion Criteria:

* acute suicidality
* serious psychotic symptoms
* substance abuse interfering with treatment
* crisis interfering with treatment
* violent behavior

Primary outcomes:
measure: PTSD Checklist for Diagnostic Statistical Manual (DSM) -5
timeFrame: Change from pre-treatment to immediately after the intervention
Secondary outcomes:
measure: The International Trauma Questionnaire (ITQ)
timeFrame: Change from pre-treatment to immediately after the intervention
measure: Trauma-Related Altered States of Consciousness (TRASC):
timeFrame: Change from pre-treatment to immediately after the intervention
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Change from pre-treatment to immediately after the intervention
measure: Patient Health Questionnaire-9 (PHQ 9)
timeFrame: Change from pre-treatment to immediately after the intervention
measure: Self-Compassion Scale (SCS)
timeFrame: Change from pre-treatment to immediately after the intervention
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
Study officials:
References:
Clinical trial NCT05542368: Study of Thyroid Status in Patients With IBD
Official title: Study of Thyroid State in Patients With Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Disease
Irritable Bowel Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients with IBD admitted at Assiut University Hospital, Al Rajhi Liver Hospital or attending IBD outpatient clinic.

a. Inclusion criteria: All patients with IBD Exclusion criteria: patients with

* Thyroid disease
* Acute or chronic kidney
* Acute or Chronic Liver Disease. Active Lupus -
* Malignancy
* patients taking medications that affect thyroid function as rifampin, amiodarone

Brief summary: . The aim of the present study is to study thyroid state in patients with IBD

Detailed description: All patients were subjected to history taking and physical examination with emphasis on history of autoimmune disease, extraintestinal manifestations of IBD, neck examination for goiter, symptoms and signs of thyroid dysfunction.

b) Laboratory investigations: Thyroid function test (include T3-T4- TSH)

* ESR - CRP - thyroid antibodies: (Anti TPO -Anti Thyroglobulin)

  c)-Imaging:
* Neck U/S on thyroid gland to identify patients with ultrasonographic evidence of autoimmune thyroiditis (diffuse hypoechogenicity or heterogenicity echotexture or both) and to detect thyroid nodularity.

d ) Endoscopic findings regarding diagnosis of IBD confirmed by histopathological examination

Eligibility criteria: Inclusion Criteria: All patients with IBD

-

Exclusion Criteria:

* patients with
* Thyroid disease
* Acute or chronic kidney
* Acute or Chronic Liver Disease. Active Lupus -
* Malignancy
* patients taking medications that affect thyroid function as rifampin, amiodarone .....

Primary outcomes:
measure: Percentage of thyroid disorders in patients with IBD
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Abo zaid Ali, assistant prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00186368: Microarray Analysis of Gene Expression in Prostate Tissues
Official title: Microarray Analysis of Gene Expression in Prostate Tissues (Translating Prostate Cancer Gene Expression Sub-types)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate cancer
Gene expression
tumor markers
microarray analysis
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Wisconsin, Madison
First posted: 2005-09-16
Enrollment: 867
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Per the original application in 1999: After obtaining informed consent (via the Tissue Bank consent), Protocol # 13873 (Continuing Review) PROTOCOL Print Date: September 22, 2010 PD: James Duane Brooks APPLICATION FORM Page 11 of 22 Review Type: Expedited Human Subjects Research Medical Stanford University Title: Microarray Analysis of Gene Expression in Prostatic Tissues (SQL 76528) Approval Period: 07/31/2010 - 06/30/2011 specimens will be collected from the Stanford University Department of Pathology (Tissue Bank) for patients treated at Stanford. Patients will be followed up via chart or tumor registries. Data will be used strictly for research purposes. Gene expression arrays are done in Dr. Brook's laboratory.

Brief summary: The purpose of this study is to investigate gene expression profiles and biologic features of prostate tissue and how they relate to prostate cancer development and growth.


Eligibility criteria: Inclusion Criteria:

- Patient scheduled to undergo either a biopsy or surgery for a prostate condition.

Exclusion Criteria:

- Patients without a prostate condition

Primary outcomes:
measure: Correlate genotype with pathologic phenotype and clinical outcome.
timeFrame: one time
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: James Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04352868: Customizing Myopia Control With Multifocal Toric Contact Lens
Official title: Customizing Myopia Control With Multifocal Toric Contact Lens
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Refractive Errors
Myopia
Keywords: Myopia
Multifocal contact lens
Refractive error
Myopia treatment
Myopia control
Myopia management
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.

Detailed description: The purpose of this study is to assess if a center distance toric multifocal contact lenses can slow the amount of change of myopia progression in children with myopia plus astigmatism. Multifocal contact lenses have been theorized to influence the peripheral optics of the eye such that they slow the rate of myopia progression in nearsighted children. This outcome is yet to be evaluated in children with myopia plus astigmatism.The secondary outcome is to measure the change in peripheral optics caused by the contact lens. This information is key to understanding the mechanism of multifocal contact lens optics on the eye. Ultimately this information would be used to create a software that can estimate the effect of multifocal contact lenses on the peripheral optics of the child's eye. This software can potentially be used by practitioners worldwide to better customize multifocal contact lenses to slow myopia progression.

Eligibility criteria: Inclusion Criteria:

* 8 to 12 years, inclusive, at baseline examination
* -0.50 to -6.00 D, inclusive, spherical component, cycloplegic autorefraction
* ≥0.75 DC, cycloplegic autorefraction
* 0.1 logMAR or better best-corrected visual acuity in each eye

Exclusion Criteria:

* Eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.)
* Ocular surgery, severe ocular trauma, active ocular infection or inflammation
* Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.

Primary outcomes:
measure: Refractive error progression
timeFrame: 1 years
measure: Axial length
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrew D Pucker, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: