linjc16/ctgov huggingface dataset:
Effects of a Dipeptidyl Peptidase-4 Inhibitor Sitagliptininsulin on the Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

Detailed Description
-----------------
This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

Official Title
-----------------
Chinese PLA General Hospital Hainan Branch

Conditions
-----------------
Atherosclerosis Type 2 Diabetes Mellitus Dipeptidyl Peptidase-4 Inhibitor GLP-1

Intervention / Treatment
-----------------
* Drug: Sitagliptin
* Drug: Acarbose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18, < 80 years old, with type 2 diabetes mellitus and coronary heart disease. Exclusion Criteria: Allergy or hypersensitivity to any of the drug's components. Severe liver failure, moderate or severe kidney failure Malignant disease. Active infectious disease. Pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br> | Drug: Sitagliptin<br>* Sitagliptin 100mg QD<br>|
| Active Comparator: CONTROL<br>Acarbose | Drug: Acarbose<br>* Acarbose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary calcification score | Changes in coronary calcification score in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with Computed tomography angiography. To measure the changes in coronary calcification score at 18 months. | Changes from baseline in coronary calcification score at 18 months] |
Dose Linearity Study of Codeine Sulfate Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions

Official Title
-----------------
A Single Dose, 3-Period, 3-Treatment, 6-Sequence, 3-Way Crossover Study of the Dose Linearity of Codeine Sulfate Tablets Under Fasting Conditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Codeine Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Codeine Sulfate or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Codeine Sulfate|15 mg, 30 mg, and 60 mg tablets|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 21 Days |
Special Drug Use Surveillance of Irribow in Female Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.

Official Title
-----------------
Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients

Conditions
-----------------
Diarrhea-predominant Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with diarrhea-predominant irritable bowel syndrome Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ramosetron group<br>Female patients with diarrhea-predominant irritable bowel syndrome | Drug: Ramosetron<br>* Oral<br>* Other names: Irribow;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Adverse Drug Reactions |  | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in frequency of bowel movements | Frequency of bowel movements is recorded daily | Baseline to Week 52 | 
| Change from baseline in form of stool | Classified based on Bristol Stool Form Scale | Baseline to Week 52 | 
| Change from baseline in sensation of incomplete bowel evacuation | Assessment based on numerical rating scale | Baseline to Week 52 | 
| Change from baseline in defecation urgency |  | Baseline to Week 52 | 
| Change from baseline in abdominal pain or discomfort | Abdominal pain or discomfort assessed based on numerical rating scale | Baseline to Week 52 | 
| Change from baseline in melena |  | Baseline to Week 52 | 
| Overall improvement | Classified into the three scales (improved, no change or aggravated) or concluded as indeterminable. | Up to Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable bowel syndrome, YM060, Ramosetron, Survey
Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)

Study Overview
=================
Brief Summary
-----------------
This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.

Official Title
-----------------
An Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate Vs. a Single Dose of the Reference MK0974 Liquid Filled Capsule in Healthy Subjects

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: MK0974 tablet
* Drug: Comparator: MK0974 liquid filled capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Subject is a nonsmoker Subject is willing to comply with the study restrictions Exclusion Criteria: Subject has history of stroke, chronic seizures, or any major neurological disorder Subject has a history of cancer Subject is a nursing mother Subject has uncontrolled high blood pressure Subject has or has a history of any disease or condition that might made participation in the study unsafe or confound the study results

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0974 Tablet | Drug: MK0974 tablet<br>* MK0974 280 mg tablet in one of two treatment periods<br>|
| Active Comparator: 2<br>MK0974 Liquid filled capsule | Drug: Comparator: MK0974 liquid filled capsule<br>* MK0974 300 mg liquid filled capsule in one of two treatment periods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC(0 to infinity)) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation |  | Through 48 Hours Post Dose | 
| Peak plasma concentration (Cmax) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation |  | Through 48 Hours Post Dose |
Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy. The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Detailed Description
-----------------
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy. The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event. We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Official Title
-----------------
A Prospective Cohort Study of Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer

Conditions
-----------------
Breast Cancer, Adjuvant Chemotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically diagnosed stage I-III breast cancer; Plan to receive adjuvant chemotherapy in our hospital; Sign the informed consent; Good compliance and willing to follow up. Exclusion Criteria: Those who have started receiving adjuvant chemotherapy; Chemotherapy contraindications;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of chemotherapy related adverse reaction | chemotherapy related adverse reaction are assessed by CTCAE protocol | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | the length of time after surgery during which no breast cancer is found | 5years |
Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.

Detailed Description
-----------------
COPD is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling. Periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity, mortality and health care utilization. Currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations. Macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD. We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD. If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition.

Official Title
-----------------
Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Erythromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of COPD Clinically stable for 6 weeks Able to Swallow Tablets Exclusion Criteria: Clinically significant respiratory disease other than COPD Women of child bearing age Patients receiving existing Medication which may interact adversely with trial drug History of clinically significant liver disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erythromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation Frequency |  |  | 
| Airway Inflammation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Function |  |  | 
| Health Status |  |  | 
| Exacerbation Recovery Time |  |  | 
| Symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, EXACERBATIONS, AIRWAY INFLAMMATION
DNA Chip Based Prognosis of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous and large cell lung cancer).

Official Title
-----------------
DNA Chip Based Prognosis of Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A histological diagnosis of primary NSCLC stage Ia Surgical removal of the tumor Age between 18 and 75 years Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: A primary NSCLC stage Ia diagnosis that is changed to not primary NSCLC or NSCLC stage Ib-IV after surgery. Adjuvant treatment with chemotherapy. Prior history of cancer in the past 5 years or breast cancer at any time. Life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-related survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC
Prophylactic Ivermectin in COVID-19 Contacts

Study Overview
=================
Brief Summary
-----------------
asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms & diagnosis of COVID -19

Official Title
-----------------
Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: Ivermectin Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: family contact of confirmed COVID-19 case Exclusion Criteria: refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin group<br>Contacts who will receive prophylactic ivermectin | Drug: Ivermectin Tablets<br>* two doses 72 hours apart<br>|
| No Intervention: Control group<br>Contacts who will be only observed without prophylaxis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) | history taking and clinical examination | within 14 days after enrollement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of COVID | by swab | within 14 days after enrollement |
A Study on the Safety of Hakim Programmable Shunt System

Study Overview
=================
Brief Summary
-----------------
This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman & Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

Official Title
-----------------
A Multi-center, Retrospective Registry Study on the Safety of Hakim Programmable Shunt System

Conditions
-----------------
Hydrocephalus

Intervention / Treatment
-----------------
* Device: Hakim Shunt Programmable System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment. Subject had an indication suitable to use Hakim Shunt Programmable System. Subject received a Hakim Shunt Programmable System at least one year ago. Exclusion Criteria: Subject didn't have an indication suitable to use the product. Subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components. According to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection. Subject was simultaneously implanted with another shunt system different from Hakim Shunt Programmable System. Subject had a contraindication of the shunt operation. Subject had uncorrected coagulopathy or any bleeding disorder.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hakim Shunt Programmable System|patient accept Hakim Shunt Programmable System due to HCP|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Non-infection Within One Year | Non-infection rate of a subject within one year | 1 year |
Capsulotomy YAG Laser

Study Overview
=================
Brief Summary
-----------------
Study of refractive changes after capsulotomy with YAG laser in facectomized patients.

Detailed Description
-----------------
A retrospective, quantitative study was carried out by analyzing the medical records of a reference ophthalmologic hospital in Goiás. Data from the pre and post YAG laser refractive index data were collected from 67 eyes of 66 patients analyzed in the period from May to November 2016. We studied 67 eyes of 66 patients , both men and women , and 32 ( 47,7%) underwent myopia after the capsulotomy procedure with YAG laser and 25 ( 37.3%) hypermetropization and 10 (14.9%) maintained the refraction. The difference in refraction was found by the arithmetic mean of the spherical equivalent for the precapsulotomy procedure of -28.85D and post-capsulotomy of -31.75 D , giving a difference of -2.9 . It was concluded with this study that the use of posterior capsulotomy with YAG laser post facectomy caused changes in the refraction of the patients studied, presenting myopia with greater frequency in the results. With these data, we observed the need for other future studies with a large number of eyes to prove what happened in this study.

Official Title
-----------------
REFRACTIVE CHANGES AFTER CAPSULOTOMY WITH YAG LASER

Conditions
-----------------
Refractive and Accommodative Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete data information about refraction and the date of the YAG laser - Exclusion Criteria: Incomplete data -
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive changes after capsulotomy with YAG laser |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YAG laser