오스틴제약㈜의 “멜라스민캡슐(트라넥삼산)”과 제일약품㈜의 “도란사민캡슐(트라넥삼산)”의 생물학적 동등성 평가를 위한 건강한 성인 시험대상자에서의 공개, 무작위배정, 2군, 2기, 공복, 단회, 경구투여, 교차시험

시험대상자 전원은 투여 전 최소 10시간 이상 공복을 유지한 상태에서 시험 당일 오전 8시경에 시험약 1캡슐 또는 대조약 1캡슐을 물 150 mL와 함께 경구투여 한다. 의약품은 통째로 삼켜야 하며, 삼키기 전에 약물을 씹거나 부수어서는 안 된다. 시험대상자 간 투약시간의 차이는 채혈시간을 고려하여 약 1분 이상 간격으로 한다.

On the basis of standard treatment, a combined treatment plan of TCM universal treatment and syndrome-specific treatment was given.

TCM universal treatment plan:

(Intensive treatment) Chuanzhi Tongluo Capsules (Lunan Pharmaceutical), 4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.

(Sequential treatment) Chuanzhi Tongluo Capsules (Lunan Pharmaceutical), 2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.

TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.

4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.

(Intensive treatment) Chuanzhi Tongluo Capsules

2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.

(Sequential treatment) Chuanzhi Tongluo Capsules

Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.

TCM Syndrome Differentiation Decoction

Guideline-based treatment for cerebral infarction with diabetes: aspirin (100 mg/day) + clopidogrel (75 mg/day) + atorvastatin (20 mg/day) + metformin (500 mg bid). Other antiplatelet/antidiabetic drugs may be added per clinician discretion.

Combination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). \*Doses may be adjusted per local guidelines or patient tolerance.

Standard Treatment (Guideline-Based)

Guangzhou University of Traditional Chinese Medicine

All subjects will be assigned to the XL1 Coil treatment group.

The surgeon verifies the intestinal diameter and selects the appropriate device diameter size. The device is introduced into the lumen of the intestine and advanced about 5-10cm. The surgeon uses 4-0 chromic sutures placed in the seromuscular layer to secure the XL1 Coil within the intestine. The surgeon places metal clips on proximal and distal sutures and in the mesentery adjacent to the XL1 Coil ends to mark the location for radiologic evaluation. The surgeon releases the XL1 Coil and closes the enterotomy.

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Shweta Namjoshi, MD

Matthew Lin, MD

Anisha Abreo

Joseph Forrester, MD

Clarivet Torres, MD

Meghan Fitzgerald

Mark Puder, MD

Beth Cobb

Michael Helmrath, MD

Paul Wales, MD

다운증후군 아동을 대상으로 2개월간 드럼 레슨이 자기 통제력과 타이밍 기술 향상에 미치는 영향을 연구하는 시험입니다.

Experimental group will receive the drumming lesson intervention between baseline and testing approximately 2 to 3 months later, so the effects of the intervention can be assessed in the lab measures.

Drumming lessons consisting of how to use hands to drum on djembe drum, using alternating hands to drum, drumming to a metronome and to music.

2 months of drumming lessons given by a professional drummer with extensive experience working with children with Down syndrome

Children in the Control condition will receive drumming lessons only after they have completed lab baseline and testing measures, about 2 to 3 months later.

Receiving lessons after the two lab visits should still offer any possible positive effects to participants while still allowing us to compare the Control group children's behaviors to those of the Experimental group.

Lessons after measurement

실험군은 기준선과 시험 사이에 약 2~3개월 후에 드럼 연주 레슨 개입을 받게 되므로, 실험실 측정을 통해 개입의 효과를 평가할 수 있습니다.

다운증후군 아동을 대상으로 광범위한 경험을 쌓은 전문 드러머가 제공하는 2개월간의 드럼 레슨

통제 조건에 있는 어린이는 실험실 기준선과 시험 측정을 완료한 후 약 2~3개월 후에만 드럼 레슨을 받게 됩니다.

오스틴제약㈜의 “멜라스민캡슐(트라넥삼산)”과 제일약품㈜의 “도란사민캡슐(트라넥삼산)”의 생물학적 동등성 평가를 위한 건강한 성인 시험대상자에서의 공개, 무작위배정, 2군, 2기, 공복, 단회, 경구투여, 교차시험

(집중치료) 천지동락캡슐, 표준치료(지침기반), (순차치료) 천지동락캡슐, 중의학 증후군 감별탕

단장증후군 성인 환자의 분산성 장내생성

드럼 레슨이 다운증후군 아동에게 미치는 영향