linjc16/ctgov huggingface dataset:
Efficacy of a Fibrin Sealant in Burn Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.

Detailed Description
-----------------
Burn patients require extensive split-thickness skin grafting operations. These operations necessitate excision of burn wounds and the procurement of autografts. Both of these result in bleeding open wounds. Fibrin sealants may be of benefit in three aspects of burn surgery: as a hemostatic agent on excised burns, as a hemostatic agent on donor sites, and as a method of fixation of skin grafts to wounds. Skin grafts are routinely secured with surgical staples. Patients with large burns will commonly have hundreds, even thousands of staples used during the course of their care. Problems associated with the use of surgical staples include: discomfort upon removal and staples become deeply embedded in the tissue. If effective in securing skin grafts, fibrin glue would directly benefit burn patients by decreasing the number of staples required, and thereby decreasing the number of retained staples. Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process. Subjects will serve as their own control. They will have an area of their wound treated with the fibrin sealant and another area treated with the standard of care. Both areas will be compared for hemostasis, skin graft fixation, wound healing, and cosmetic outcome.

Official Title
-----------------
Efficacy of a Fibrin Sealant in Burn Surgery

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Tisseel Fibrin Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requires skin grafting of an acute or reconstructive burn wound. Exclusion Criteria: Active disseminated intravascular coagulation (DIC) or known hypersensitivity to bovine protein.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tisseel Fibrin Sealant|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial wound hemostasis |  |  | 
| initial donor site hemostasis |  |  | 
| initial graft fixation |  |  | 
| percent graft take at 1 week |  |  | 
| outcome and cosmetic appearance at routine intervals up to 24 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burns, hemostasis, skin graft, Surgical Hemostasis, Grafting, Skin
Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism

Study Overview
=================
Brief Summary
-----------------
Aims of this study are to observe the correlation between ABCB1、VDR、TBX21、NR3C1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. Investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. The patients are divided into glucocorticoid sensitive (GS) group and glucocorticoid resistance (GR) group according to the change of central vision after treatment. Patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (SNP) typing test. Through statistical analysis, the data differences between GS group and GR group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.

Official Title
-----------------
Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study

Conditions
-----------------
Glucocorticoid Resistance, Gene, Neuromyelitis Optica

Intervention / Treatment
-----------------
* Drug: Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of neuromyelitis optica Chinese Han nationality, gender is unlimited; Must be able to accept methylprednisolone pulse therapy Exclusion Criteria: Other optic nerve diseases, such as ischemic, compressive, invasive, traumatic, toxic and nutritional metabolic, hereditary optic neuropathy; Visual path and central lesion on optic chiasma; Other eye diseases, such as anterior segment lesions, retinopathy, macular lesions, ametropia, glaucoma, etc; Non-organic visual impairment; Treated with glucocorticoid in two weeks.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| glucocorticoid sensitive (GS) group<br> | Drug: Methylprednisolone<br>* methylprednisolone pulse therapy: 500-1000mg/d，３-５ｄ<br>|
| glucocorticoid resistance (GR) group<br> | Drug: Methylprednisolone<br>* methylprednisolone pulse therapy: 500-1000mg/d，３-５ｄ<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of best corrected visual acuity (BCVA) | Test BCVA before and after the treatment of methylprednisolone pulse therapy, and calculate the change value | 3 day after the treatment of methylprednisolone pulse therapy |
Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings

Official Title
-----------------
Drug Use Results Survey of Tiotropium Bromide

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Spiriva (tiotropium bromide) inhalation capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with COPD Exclusion Criteria: -There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with COPD<br> | Drug: Spiriva (tiotropium bromide) inhalation capsules<br>* Survey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | Up to 4 weeks after start of treatment | 
| Number of patients with adverse drug reactions |  | Up to 4 weeks after start of treatment | 
| Number of patients with serious adverse events |  | Up to 4 weeks after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable |  | Up to 4 weeks after start of treatment |
Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

Study Overview
=================
Brief Summary
-----------------
Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm : Colonoscopy Only Group Artificial intelligence only group (IA GI GENIUS ™ alone) Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)

Official Title
-----------------
A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone

Conditions
-----------------
Adenoma Colon, Colorectal Cancer, Colorectal Polyp, Colonic Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : 18 years < Patient < 85 years Need to perform a primary and / or secondary screening colonoscopy for colorectal cancer Patients candidates for outpatient care Exclusion Criteria : History of inflammatory digestive tract disease Failed previous colonoscopy Known familial polyposis Biopsy / polypectomy contraindication (coagulation disorder, treatment with CLOPIDOGREL / Anticoagulant)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonoscopy Only Group<br> | |
| Artificial intelligence GI GENIUS ™ only Group<br> | |
| Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software | number of colonoscopies with the discovery of at least 1 colonic adenoma out of the total number of colonoscopies according to the use of colonoscopy alone / artificial intelligence alone / artificial intelligence combined with the endoscopic cap. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenomas Rate according to their morphology | according to Paris classification | 4 months | 
| Adenomas Rate according to their size | < 0,5mm / 0-5-10mm / > 10mm | 4 months | 
| Adenomas Rate according to their histology | according to Vienne classification | 4 months | 
| Caecal Intubation Rate | Complete colonocopy rate | 4 months | 
| Withdrawal time |  | 4 months | 
| Adverse effects | Haemorrhages, Perforation | 4 months |
WALK Study: Women's Active Living for Koreans Study

Study Overview
=================
Brief Summary
-----------------
The prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and older women. Thus, the investigators propose to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women.

Detailed Description
-----------------
The purpose of this pilot study is to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women. The investigators will assess feasibility and acceptability of the WALK Study and potential efficacy of the WALK Study on outcomes including sedentary behavior and PA.

Official Title
-----------------
Development of a Lifestyle Intervention for Korean American Women at Risk for Metabolic Syndrome

Conditions
-----------------
Physical Activity, Metabolic Syndrome, Lifestyle, Sedentary

Intervention / Treatment
-----------------
* Behavioral: WALK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identified Korean-speaking Korean American women Sedentary lifestyle at work and/or during leisure time Aged between 40 and 69; 4) intention to be physically active KakaoTalk user Exclusion Criteria Medical conditions or physical problems requiring a special care exercise program Known bone or join problems that impair the ability to do moderate physical activity Participating in a lifestyle modification program or research study Planning a trip out of the U.S. during the next 2 months Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>Participants will receive an in-person session and an activity monitor | |
| Experimental: Group 2<br>Participants will receive an in-person session, an activity monitor, and social support through BAND | Behavioral: WALK<br>* Walking program<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Time spent in moderate and vigorous activity | Last 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary behavior | Time spent in sedentary activity | Last 7 days |
Study of Cryotherapy for Renal Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the change of tumor size and serum cytokine in the patients who received cryotherapy for the renal tumors.

Official Title
-----------------
Study of Cryotherapy for Renal Tumors

Conditions
-----------------
Renal Tumors

Intervention / Treatment
-----------------
* Procedure: cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who have renal tumor less than 7 cm and receive cryotherapy Exclusion Criteria: The tumor size is larger than 7 cm The patients do not approve the surgery
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryotherapy<br>The patients who receive cryotherapy for their renal tumors | Procedure: cryotherapy<br>* Placing 4-6 cryotherapy probes into the renal tumors and conducting two cycles of freezing and thawing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor size |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal tumor, cryotherapy, cytokine
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Drug: ONO-6950
* Drug: ONO-6950


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking male or female subjects (18-55 inclusive) Body mass index (BMI) of 19-35kg/m2 (inclusive) For females, postmenopausal, non-lactating, and non-pregnant Exclusion Criteria: History or presence of clinical significant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br> | Drug: ONO-6950<br>* 1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study<br>|
| Placebo Comparator: P<br> | Drug: ONO-6950<br>* 1mg, 3mg, 10mg, 30mg, 100mg, 300mg, 1000mg at a single dose; 30mg, 100mg and 300mg for food effect study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations |  | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects |  | up to 7 days | 
| Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions |  | up to 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-6950, Healthy Adult Subjects
An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.

Official Title
-----------------
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors

Conditions
-----------------
Small Cell Lung Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer, Gastric Cancer (Inoperable and Recurrent)

Intervention / Treatment
-----------------
* Drug: CPT-11
* Drug: Platinum analogues


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer Has UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28 Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents) Exclusion Criteria: Has contraindication for CPT-11 Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UGT1A1 genotyped patients<br>UGT1A1 genotyped patients receive CPT-11 with platinum analogues | Drug: CPT-11<br>* CPT-11 blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog.<br>* Other names: Topotecin;Drug: Platinum analogues<br>* Platinum compounds produce changes in DNA structure, which causes cancer cell death (apoptosis). They are typically used alone or in combination with other chemotherapy drugs.<br>* Other names: Nedaplatin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues |  | within 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues |  | within 6 months | 
| Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype |  | within 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UGT1A1, irinotecan