louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05604872: Association Between ORA and Residual Refractive Astigmatism After SMILE
Official title: Association Between Preoperative Ocular Residual Astigmatism(ORA) and Residual Refractive Astigmatism After SMILE Refractive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Astigmatism
Lead sponsor: Taipei Nobel Eye Clinic
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 530
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted by retrospective chart review in Taipei Nobel Eye Clinic from 2020 to 2022.

Brief summary: The aim of our study is to analysis and compare the relationship between ORA and postoperative astigmatism in low astigmatism (less than 1D) and moderate to high (1D to 3D) astigmatism patients after SMILE (Small Incision Lenticule Extraction) refractive surgery.


Eligibility criteria: Inclusion Criteria:

* Corrected distance visual acuity of both eyes reaches 0.1 logarithm of the minimum angle of resolution (logMAR)
* Stable refractive errors of myopia and astigmatism who received SMILE refractive surgery of both eyes

Exclusion Criteria:

* Cataract
* Corneal opacities or irregularities
* Dry eye (Schirmer's test I ≤ 5mm)
* Amblyopia
* Coexisting ocular pathologies
* Glaucoma
* Non-dilating pupil
* History of intraocular surgery, laser therapy, or retinopathy
* Optic nerve or macular diseases
* Estimated postoperative cornea residual stromal thickness less than 250 μm
* Pregnancy or under lactation
* Uncontrolled diabetic mellitus or systemic immune disease _Refusal or unable to maintain follow-up

Primary outcomes:
measure: Corrected distance visual acuity
timeFrame: 3 months after surgery
measure: Manifest refraction
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Nobel Eye Clinic
Study officials:
References:
citation: Gyldenkerne A, Hjortdal J, Ivarsen A. Astigmatism prediction in small-incision lenticule extraction. J Cataract Refract Surg. 2020 Apr;46(4):524-533. doi: 10.1097/j.jcrs.0000000000000083.
citation: Jun I, Kang DSY, Arba-Mosquera S, Reinstein DZ, Archer TJ, Jean SK, Kim EK, Seo KY, Lee HK, Kim TI. Comparison of clinical outcomes between vector planning and manifest refraction planning in SMILE for myopic astigmatism. J Cataract Refract Surg. 2020 Aug;46(8):1149-1158. doi: 10.1097/j.jcrs.0000000000000100.
Clinical trial NCT03377972: The Cohort Study of Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection
Official title: The Cohort Study of Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Early esophageal cancer and precancerous lesions patients undergoing endoscopic resection therapy for the first time in zhongshan hospital from September 1, 2014 to September 1,2017.
2. Early esophageal cancer and precancerous lesions patients undergoing endoscopic resection therapy for the first time in zhongshan hospital after September 1,2017.

Brief summary: Endoscopic Submucosal Dissection (ESD) is currently the main method of treatment of early esophageal cancer and precancerous lesions. Therefore, the investigators are looking forward to conduct a cohort study on early esophageal cancer patients undergoing endoscopic treatment collected from Zhongshan Hospital, Fudan University, comparing the WHO standard with Japanese standard of endoscopic therapy diagnosis. In addition，the investigators will collect patients' detailed informations and analyze the risk factors for metastasis and recurrence of early esophageal cancer.


Eligibility criteria: Inclusion Criteria:

1. Older than 15-year-old
2. Undergoing endoscopic Submucosal Dissection (ESD) in ZhongShan Hospital

Exclusion Criteria:

Preoperative patients with recurrence and Lost to follow-up of patients within 1 year

Primary outcomes:
measure: Comparison WHO diagnosis standard with JAPAN in Early Esophageal Cancer patients by accessing pathological section.
timeFrame: December 1st,2017-December 1st,2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03665272: The Evaluation of the Deepithelialized Gingival Graft Healing
Official title: Evaluation of the Effects of Different Fixation Methods on Wound Healing After Deepithelialized Gingival Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to determine for blood perfusion changes. 40 patients were devided into two groups randomly and deepithelialized gingival graft procedure was performed and healings were evaluated by laser doppler flowmetry.

Detailed description: This study evaluates the effects of different fixation methods on the early healing period of deepithelialized gingival grafts placed for non-root coverage gingival augmentation by laser Doppler flowmetry Forty patients were assigned to study groups: 1)test : tissue adhesive or 2) control group: suture. Forty patients completed the study. Blood perfusion in the recipient site was measured by laser doppler flowmetry on the day of surgery and at 3 and 7 days after surgery. Quality of life and pain at recipient sites were also investigated.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years of age
* systemically healthy
* inadequate amount or absence of keratinized gingiva on the labial side of the lower incisor region
* no restorations on the lower incisor region
* no mucogingival surgical history in the lower incisor region
* no periodontal treatment within the previous year
* no systemic antibiotics taken for 6 months before the study
* not pregnant or lactating
* no-smoking

Exclusion Criteria:

* lower 18 and upper than 65 years of age
* systemical disease
* adequate amount of keratinized gingiva on the labial side of the lower incisor region
* restorations on the lower incisor region
* mucogingival surgical history in the lower incisor region
* periodontal treatment within the previous year
* systemic antibiotics taken for ‡6months before the study
* pregnancy or lactating
* smoking history or current smokers

Primary outcomes:
measure: deepithelialized gingival graft blood perfusion change
timeFrame: measurements were performed at the day of surgery, 1, 3 and 7 days.
Secondary outcomes:
measure: Deepithelialized gingival graft recipient bed pain changes
timeFrame: measurements were performed at 1, 3 and 7 days post surgery.
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Zekeriya Taşdemir
state: Melikgazi
Study officials:
affiliation: TC Erciyes University
name: zekeriya taşdemir, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310972: Adjuvant Colon Cancer w/ ELOXatin®/5 FU Based Regimen: ACCELOX
Official title: Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Adjuvant Colon Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 6
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colon Cancer Registry

Brief summary: Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX

Detailed description: It's a study of adjuvant colon carcinoma using ELOXatin/5-FU based chemotherapeutic regimen called ACCELOX as a definitive curative therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with Adjuvant Colon Cancer

Exclusion Criteria:

* Patients with diagnosis other than Colon Cancer.

Primary outcomes:
measure: OS, PFS, DFS
timeFrame: For the duration of the experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: Al Jubran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914472: Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
Official title: A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Thrombus
Keywords: Preventing the thrombi formation
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin


Eligibility criteria: Inclusion Criteria:

1. Research that patients agreed to participate and signed the written informed consent;
2. Patients aged over 18 years, both sexes, regardless of color or social class;
3. Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system.

Exclusion Criteria:

1. Hypersensitivity to heparin sodium and / or benzyl alcohol;
2. History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
3. Severe liver disease;
4. Cancer;
5. Period of gestation;
6. Genetic abnormality of the coagulation system;
7. Multiple trauma;
8. Use of aspirin in high doses (above 200mg per day);
9. Use of glucocorticoids for at least 1 month;
10. Use of other anticoagulants;
11. Submission of a big surgery done less than 15 days;
12. History of persistent hypertension at the end of dialysis than 150/100 mmHg;
13. Indicated doses of heparin 20% above or below 150UI/kg.

Primary outcomes:
measure: Effectiveness of heparin in thrombi formation.
timeFrame: 12 consecutive sessions
Secondary outcomes:
measure: Alteration of the pharmacodynamic parameters.
timeFrame: 12 consecutive sessions.
measure: Evaluation of Anti-Xa
timeFrame: 12 consecutive sessions (4 weeks - 3times/week)
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa E Desenvolvimento Ltda
state: SP
Study officials:
References:
Clinical trial NCT04291872: Heated Glass Ionomer Cement in Primary Molars
Official title: Randomized Clinical Trial of Heated High-Viscosity Glass Ionomer Class II Restorations in Primary Molars: 12 Months Follow Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Glass-Ionomer Cement
Primary Teeth
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 88
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Control
Primary purpose: TREATMENT

Brief summary: Objective: The aim of this study was to assess the influence of heated in the clinical success of proximal high viscosity glass ionomer cement (GIC) restorations in primary molars.

Material \& Method: This randomized, split mouth, multicenter study was performed in four different centers including 88 patients aged between 5-7 years old. Selection criteria included clinically and/or radiographically detected proximal caries extending into the dentin tissue. A total of 250 primary molars were restored with a bulk fill GIC (Equia Forte, GC, Europe) and randomly allocated to one of the following groups: 1) non-heated (n = 125) and 2) heated (n = 125). LED light (GC- D-Light DUO, Tokyo Japan) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec for heat application. All restorations were clinically evaluated using modified USPHS criteria at the baseline, 6 months and 12 months. Chi-square test, Fisher's Exact Chi-square test, Continuity (Yates) correction, Fisher Freeman Halton test and Mc Nemar test were used to compare qualitative data with descriptive statistical methods (frequency). Kaplan Meier and Life Tables were used for survival analysis. P value \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

* Subject is mentally and systemically healthy
* Subject has at least two approximal carious lesions at both sides of jaws
* Subject has a normal occlusal relationship with natural dentition
* Subject has at least one adjacent tooth contact

Exclusion Criteria:

* Subject has history of bruxism,
* Subject has allergies to ingredients of glass ionomer based restorative materials.
* Cavity/Caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks,
* Subject has abrasion, erosion, abfraction,
* Subject has fistula, abscess or pathological mobility,
* Subject has pain, pulp exposure

Primary outcomes:
measure: Clinical success assessment measurement
timeFrame: 12 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02201472: Magnetic Resonance Elastography in Infants
Official title: Magnetic Resonance Elastography in Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Disease
Keywords: liver
mre
mri
neonatal
mr touch
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 2
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Magnetic resonance elastography on infants with suspected liver disease
Primary purpose: DIAGNOSTIC

Brief summary: MRI \& MRE in infants

Detailed description: The purpose of the present pilot study is to determine the feasibility of using MRI and MRE to evaluate the liver in infants with suspected liver disease.

Eligibility criteria: Inclusion Criteria:

* Infants \< 6 months of age
* Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the upper limit of normal for age)
* Parental/LAR permission obtained

Exclusion Criteria:

* Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
* Severe coagulopathy (INR \> 3 or platelets \<50,000)

Primary outcomes:
measure: Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephanie Merhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02531672: Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography
Official title: Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography: An Expanded Access Study
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Prostate Cancer
Recurrent Prostate Cancer
Keywords: 11C-choline
Positron Emission Tomography
15-117
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-08-24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to use a new imaging drug called 11C-choline that is used with a PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as bone scans, CT or MRI.


Eligibility criteria: Inclusion Criteria:

* Patient must have biopsy-proven adenocarcinoma of the prostate initially treated with curative intent (surgery and radiation therapy are most common treatments but other treatments are also eligible).
* Biochemical recurrence defined as any of the following:

  1. PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery.
  2. PSA ≥ 0.2 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
  3. PSA ≥ 0.2 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting
* Patient must have undergone standard-of-care restaging that does not clearly identify site(s) of active disease, or such prior studies must show equivocal findings for which further work-up is considered necessary to make clinical decision. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy MDP or F-18 sodium fluoride PET), FDG PET, or In-111 capromab pendetide scintigraphy no older than 3 months of consent date.
* Age ≥ 18 years.
* Patient must be able to tolerate PET/CT imaging.
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Basking Ridge (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memoral Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schӧder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03647072: PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy
Official title: Comparative Clinical and Biochemical Study Evaluating the Effect of Proton Pump I Nhibitors Versus Histamine 2 Receptor Antagonists as an Adjuvant With Chemotherapy in Patients With Non-hodgkin Lymphoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lymphoma
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 60
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: The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma.

Detailed description: The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump Inhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma to compare the difference in efficacy.

Eligibility criteria: Inclusion Criteria:

* DLBCL Lymphoma subtype --No comorbid disease

Exclusion Criteria:

* Pregnancy
* Peptic ulcer
* Severe cardiac disease
* Osteoporosis

Primary outcomes:
measure: Number of patients eith radiological and clinical improvement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Clinical pharmacy Department- Tanta University
name: Sahar K Hegazy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical pharmacy Department- Tanta University
name: Sahar M El-Haggar, prof
role: STUDY_DIRECTOR
affiliation: Clinical Oncology Department-Menoufia University
name: Suzan A Alhassanin, Ph D
role: STUDY_DIRECTOR
affiliation: Clinical pharmacy Department-Tanta University
name: Eman I A El berri, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hegazy SK, El-Haggar SM, Alhassanin SA, El-Berri EI. Comparative randomized trial evaluating the effect of proton pump inhibitor versus histamine 2 receptor antagonist as an adjuvant therapy in diffuse large B-cell lymphoma. Med Oncol. 2021 Jan 4;38(1):4. doi: 10.1007/s12032-020-01452-z.
Clinical trial NCT01979172: Comparison of Intraocular Lens Power Calculation Methods After Corneal Laser Refractive Surgery in Axial and Refractive Ammertropia
Official title: Comparison of Intraocular Lens Power Calculation Methods After Corneal Laser Refractive Surgery in Axial and Refractive Ammertropia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Refractive Errors
Keywords: LASIK
Intraocular lens
Biometry
IOL master
Lead sponsor: The National Eye Hospital, Cairo, Egypt
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient undergoing laser refractive surgery

Brief summary: The study aims at determining the best biometry calculation formula to be used in IOL calculation of cataract patients how previously underwent laser refractive correction surgery

Detailed description: Patients undergoing laser refractive surgery will will be investigated in means of Pentacam testing and IOL master biometry both preoperative and 6 weeks postoperative to determine which IOL calculation formula is the nearest and most accurate to preoperative records in different refractive sittings.

Eligibility criteria: Inclusion Criteria:

* all patient undergoing laser refractive surgery

Exclusion Criteria:

* previous ophthalmic surgery
* previous trauma
* ocular pathology other than refractive error

Primary outcomes:
measure: Best Selected IOL calculation formula
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Watany Eye Hopsital
Study officials:
affiliation: Watany Eye Hospital
name: Rami R Fikry, MD/FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Watany Eye Hospital
name: Ahmed Assaf, MD/FRCS
role: STUDY_DIRECTOR
affiliation: Watany Eye Hospital
name: Ahmed Osama, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Watany Eye Hospital
name: Moahmed O El Bahrawy, MS
role: PRINCIPAL_INVESTIGATOR
References: