Gastric Cancer Stage III

Camrelizumab, 200 mg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.

Camrelizumab

Tegafur-gimeracil-oteracil potassium: 80 - 120 mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle.

Docetaxel: 40 mg/m^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle.

Docetaxel

Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University

A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR)

zhaogang

Deputy director of gastrointestinal surgery administration

RenJi Hospital

The patient will received a combination of 3 antibiotics :
Rifampicin (10mg/kg once daily)
Ethambutol (15 to 20 mg/kg once daily)
Clarithromycin (500 mg twice daily)

The patient will received a combination of 3 antibiotics :
Rifampicin (10mg/kg once daily)
Ethambutol (15 to 20 mg/kg once daily)
Azithromycin (250 mg once daily)

Lung Infection

Mycobacterium Avium Complex

The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Clarithromycin, Ethambutol and Rifampicin.

Clarithromycin 1000 MG

The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Azithromycin, Ethambutol and Rifampicin.

Azithromycin 250 mg

The patient will be received for at least 12 months, a dailty antibiotic treatment who is a combination of Azithromycin or Clarithromycin (according to the randomisation), Ethambutol and Rifampicin.

Rifampicin

Ethambutol

CHU Amiens Picardie

Saint Joseph Hospital

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

Three spontaneous sputum specimens will be obtained at baseline and 6 months. If it's not possible to obtain good quality specimens, the clinician may perform three hypertonic aerosol-induced sputum specimens on 3 consecutive days. In the absence of sputum (spontaneous or induced), bronchoscopic aspiration and two post-bronchoscopy sputum specimens will be performed.
Microscopic examination will be performed after auramine or Ziehl-Neelsen stain.
Specimens will be cultured at 37°C after decontamination on Lowenstein-Jensen solid medium and Coletsos medium. Results will be expressed quantitatively as the number of colonies per tube according to a logarithmic scale. Culture on liquid medium will also be performed.
The analysis will be based on the Mycobacteria National Reference Centre microscopy, culture and antibiotic susceptibility test results.

Several criteria will be determined at baseline and at 3 months and then compared to assess clinical improvement :
Presence or absence of cough, sputum, dyspnoea, chest pain and wheezing using a 5-point analogue scale (0=no symptom, 4=permanent symptoms) ;
WHO performance status scored from 0 to 4 ;
Global score from 0 to 24, taking into account the score of the 5 respiratory symptoms and the WHO performance status ;
Presence of blood-stained sputum (haemoptysis greater than 50 mL or requiring specialized medical intervention)
Weight in kg (patient weighed in underwear on the same scales, variations taken into account when greater than 5% of the baseline weight).

Several criteria will be determined at baseline and at 6 months and then compared to assess clinical improvement :
Presence or absence of cough, sputum, dyspnoea, chest pain and wheezing using a 5-point analogue scale (0=no symptom, 4=permanent symptoms) ;
WHO performance status scored from 0 to 4 ;
Global score from 0 to 24, taking into account the score of the 5 respiratory symptoms and the WHO performance status ;
Presence of blood-stained sputum (haemoptysis greater than 50 mL or requiring specialized medical intervention)
Weight in kg (patient weighed in underwear on the same scales, variations taken into account when greater than 5% of the baseline weight).

Several criteria will be determined at baseline and at 12 months and then compared to assess clinical improvement :
Presence or absence of cough, sputum, dyspnoea, chest pain and wheezing using a 5-point analogue scale (0=no symptom, 4=permanent symptoms) ;
WHO performance status scored from 0 to 4 ;
Global score from 0 to 24, taking into account the score of the 5 respiratory symptoms and the WHO performance status ;
Presence of blood-stained sputum (haemoptysis greater than 50 mL or requiring specialized medical intervention)
Weight in kg (patient weighed in underwear on the same scales, variations taken into account when greater than 5% of the baseline weight).

Chest x-ray will be realised at baseline and at 3 months and described according to :
type of lesion: opacity/solitary pulmonary nodule, excavated opacity/ fibrocavitary disease, interstitial syndrome (multiple nodule, dense airspace disease)
precise site (upper lobe, right middle or lower lobe, left lower or upper lobe)

Chest x-ray and chest high-resolution CT will be realised at baseline and at 6 months.
Chest x-ray will be described according to:
type of lesion: opacity/solitary pulmonary nodule, excavated opacity/ fibrocavitary disease, interstitial syndrome (multiple nodule, dense airspace disease)
precise site (upper lobe, right middle or lower lobe, left lower or upper lobe)
Chest CT will be described according to:
type of lesion: nodules, micronodules, bronchiectasis, mass, interstitial syndrome (and its type)
precise site of the segment(s) involved
number of lesions
dimensions of the various lesions (long and short axes) and volume, whenever possible.

Chest x-ray and chest high-resolution CT will be realised at baseline and at 12 months.
Chest x-ray will be described according to:
type of lesion: opacity/solitary pulmonary nodule, excavated opacity/ fibrocavitary disease, interstitial syndrome (multiple nodule, dense airspace disease)
precise site (upper lobe, right middle or lower lobe, left lower or upper lobe)
Chest CT will be described according to:
type of lesion: nodules, micronodules, bronchiectasis, mass, interstitial syndrome (and its type)
precise site of the segment(s) involved
number of lesions
dimensions of the various lesions (long and short axes) and volume, whenever possible.

Microbiological specimens, preferably 3 sputum specimens, will be obtained and processed at 3 months after treatment according to the same modalities as at baseline.

Microbiological specimens, preferably 3 sputum specimens, will be obtained and processed at 12 months after treatment according to the same modalities as at baseline.

The 12-month mortality will be determined by the survival at that date. The date of any death occurring during treatment will be recorded and the interval between the start of treatment and death will be calculated. The cause of death will be investigated and reported.

All adverse events will be notified according to the recommendations. Particular attention will be paid to gastrointestinal adverse effects (the incidence of nausea and vomiting will be recorded). These adverse events will be assessed at each visit according to the Rhodes scale.
Haematological, gastrointestinal and renal toxicities will be scored according to the WHO toxicity scale.

Centre Hospitalier Universitaire, Amiens

Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study (ETDRS) technique)

Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)

Anterior peribulbar injection of 20 mg triamcinolone

Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser

Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser

Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).

Focal Laser Photocoagulation

Posterior Peribulbar Injection of 40 mg Triamcinolone

Anterior Peribulbar Injection of 20 mg Triamcinolone

Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month

Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser

Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month

Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser

Total

Sex: Female, Male

Race/Ethnicity, Customized

Cystoid Abnormality on Ocular Coherence Tomography (OCT)

Diabetes Type

Best corrected visual acuity letter score as measured by a certified tester using an electronic early treatment diabetic retinopathy study (e-ETDRS) method and approximate Snellen equivalent. Best value on the scale is 97, worst value 0.

Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity

Received Prior Focal Photocoagulation

Received Prior Scatter (Panretinal) Photocoagulation

Ocular Coherence Tomography (OCT) images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.

Subretinal Fluid on Ocular Coherence Tomography (OCT)

Measured by Ocular Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.

Central Subfield Thickness

Duration of Diabetes

Hemoglobin A1c

Intraocular Pressure (mm Hg)

Baseline Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) Visual Acuity Letter Score: best value = 97; letter score worst value = 0

Mean visual acuity letter score

Total Retinal Volume (mm^3)

Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening.

Change in Central Subfield Thickening From Baseline Through 34 Weeks

Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment.

Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks

Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.

Change in Visual Acuity Letter Score From Baseline Through 34 Weeks

Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0

Mean Visual Acuity Letter Score at Each Follow-up Visit

Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.

Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks

Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.

Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks

4-Week Visit

8-Week Visit

17-Week Visit

34-Week Visit

Adam R. Glassman, M.S., Director

Diabetic Macular Edema

Focal laser photocoagulation (modified Early Treatment Diabetic Retinopathy Study technique)

uveitis/phosphatase

A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema

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