linjc16/ctgov huggingface dataset:
Staining in a Healthy, Non-Dry Eye Population

Study Overview
=================
Brief Summary
-----------------
The clinical objective of this study is to quantify the levels of corneal and conjunctival staining in a healthy, non-dry eye population. This is a descriptive study without test article administered.

Conditions
-----------------
Normal Healthy Eyes

Intervention / Treatment
-----------------
* Other: No intervention required


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy eyes Exclusion Criteria: Age related

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Other: No intervention required<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal fluorescein staining scores |  |  |
A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Detailed Description
-----------------
This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Official Title
-----------------
A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Abraxane and Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female between 18 and 70 years old; Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery; ECOG (Eastern Cooperative Oncology Group) 0 1; Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L; Got ICF (Informed Consent Form) before enrollment; Life expectancy more than 12 weeks Exclusion Criteria: Pregnant or breast-feeding women or positive serum pregnancy test; Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling; Participation in any investigational drug study within 4 weeks preceding treatment start; Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer; Serious uncontrolled intercurrent infections; Poor compliance

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abraxane and Gemcitabine<br>Abraxane and Gemcitabine | Drug: Abraxane and Gemcitabine<br>* ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15 GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15<br>* Other names: Combined Chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse events |  | 6 months |
Isentress Re-examination Study (MK-0518-115)

Study Overview
=================
Brief Summary
-----------------
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Isentress through collecting the safety and efficacy information in usual practice according to the Re-examination Regulation for New Drugs. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice

Conditions
-----------------
HIV Infection, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 Infected Adults Treated with Isentress 400 mg tablet within local label during the enrollment period Exclusion Criteria: Contraindication to Isentress according to the local label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>HIV-1 Infected patients treated with Isentress | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment |  | up to 14 days after last treatment | 
| Proportions of patients with HIV-1 RNA levels of less than 50 milliliter |  | 6 months after treatment +/- 2 weeks | 
| Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter |  | 6 months after treatment +/- 2 weeks | 
| Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible) |  | 6 months after treatment +/- 2 weeks |
Dynamic CT Imaging After Nellix Endoprosthesis Implantation

Study Overview
=================
Brief Summary
-----------------
The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.

Official Title
-----------------
Dynamic CT Imaging After Nellix Endoprosthesis Implantation

Conditions
-----------------
Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Nellix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nellix implantation Exclusion Criteria: Use of chimneys or combined with other stent graft material
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment group<br>Patients eligible for AAA repair using Nellix and willing to participate in this trial. | Device: Nellix<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic changes in neck morphology after EVAS |  | 1 month | 
| Dynamic changes in common iliac artery morphology after EVAS. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nellix, EVAS, EVAR, Dynamic CT, Dyna CT
A Systematic Echography During Intubation Procedure to Predict Cardiovascular Collapse

Study Overview
=================
Brief Summary
-----------------
In the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily available in most ICUs for several years. Echocardiography enables to perform a noninvasive hemodynamic evaluation (cardiac function and volemia status). We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse and its components.

Official Title
-----------------
A Systematic Ultrasound Assessment During Intubation Procedure to Predict Cardiovascular Collapse Related to Intubation in the Intensive Care Unit: a Prospective, Multiple-center Study

Conditions
-----------------
Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requiring endotracheal intubation Exclusion Criteria: Age < 18 yrs Pregnancy Amputation of a lower limb Passing leg raising contraindication: intracranial hypertension with invasive monitoring, fracture of the pelvis or limbs Patients under administrative protective measures Severe cardiovascular collapse before intubation Severe cardiogenic pulmonary oedema

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Subsequent cardiovascular collapse related to intubation | Mean arterial pressure drop < 60 mmHg | Within 15 minutes of intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound parameters to predict fluid responsiveness | Transthoracic echocardiography parameters to predict fluid responsiveness | 30 minutes before intubation, less than 30 minutes after intubation, 1 minutes after lifting legs and 3 hours after intubation |
Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
This study is to analyze the relationship between brain structure, the heart rate variability and the serum fatty acid component of the irritable bowel syndrome patients.

Detailed Description
-----------------
Several studies showed that the gray matter and white matter of the brain related to the symptoms of irritable bowel syndrome patients. The investigators study is to analyse the relationship between thickness of cortex of irritable patients, the sympathetic tone and the serum fatty acid component of the irritable bowel syndrome patients. It is to clarify the mechanism of irritable bowel syndrome, whether the symptoms of irritable bowel syndrome are related to the thickness of cortex or inflammation status of the body.

Official Title
-----------------
Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female between 20 and 50 years old meet Rome III criteria Exclusion Criteria: colon and small intestinal disease psychiatric disease patients patients received major surgery in the past 5 years diabetic patients patients with metal implant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Irritable bowel syndrome, Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between brain structure, heart rate variability and fatty acid of the irritable bowel syndrome patients. |  | Patients who suffered from IBS for more than 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between thickness of brain cortex and the symptoms of irritable bowel syndrome |  | Patients who suffered from IBS for more than 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Heart rate variability, Fatty acid
Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

Official Title
-----------------
Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Hylastan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with OA of the knee Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications Exclusion Criteria: Prior or concomitant treatments that would impede measurement of safety and efficacy

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hylastan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
musculoskeletal, osteoarthritis of the knee
Four Methods of Pre-oxygenation

Study Overview
=================
Brief Summary
-----------------
Four methods of preoxygenation will be compared in healthy volunteers

Detailed Description
-----------------
After informed consent, each volunteer will undergo the following techniques: Simple mask at flush flow (40-60 L/min) Non-rebreather mask at 15 L/min Non-rebreather mask at 60 L/min Bag valve mask with one way exhalation valve at 15 L/min After 3 minutes, the exhaled oxygen will be measured with an oxygen sensor

Official Title
-----------------
Comparison of Emergency Department Preoxygenation Techniques in Healthy Volunteers

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: Preoxygenation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Exclusion Criteria: Any active respiratory pathology (asthma, chronic obstructive pulmonary disease, other lung disease, smoking history more than 5 years) pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoxygenation<br>All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 15 L/min for 3 min 3) Non-rebreather at 60 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes | Device: Preoxygenation<br>* After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed below, the exhaled oxygen content will be measured. All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 60 L/min for 3 min 3) Non-rebreather at 15 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Oxygen Concentration | Subjects will blow into an oxygen sensor after each method (arm). The primary outcome will be a non-inferiority test between bag valve mask and non-rebreather at 60 L/min. The remaining tests will be completed for comparison, but not part of formal statistical testing. | Immediately after 3 minutes of oxygen supplementation |
Bone Health in Hyperemesis Gravidarum

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether maternal bone resorption would be seen in Hyperemesis Gravidarum and could be detected in early period using serum vitamin D levels, serum calcium (Ca) levels, serum parathormone (PTH) levels and urine N- telopeptide levels in the patients with Hyperemesis Gravidarum.

Official Title
-----------------
Urine N-telopeptide, Serum Vit D, Parathormone and Calcium Levels in Hyperemesis Gravidarum

Conditions
-----------------
Hyperemesis Gravidarum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 7. and 20. weeks of gestation pregnant women in both groups İn hyperemesis group; 5% weight loss with regard to pre-gestation vomiting more than 3 times 3-5 % weight loss with ketonuria. Exclusion Criteria: Other pathologies that cause nausea and vomiting in pregnancy gastroenteritis gastroparesis gall duct diseases hepatitis peptic ulcers appendicitis pyelonephritis ovarian torsion urinary tract stones diabetic ketoacidosis hyperthyroidism hyperparathyroidism migraine pseudo tumor cerebra vestibular diseases Additionally some situations causing to rise of Ntx levels osteoporosis paget disease bone tumors Furthermore some of conditions resulted in pre-menopausal osteoporosis or decreasing in Bone Mineral Density Malignancy Smoking Celiac Disease Depression Inflammatory Bowel Disease Pre-gestational Diabetes Chronic Kidney or Liver Disease Drug Use such as steroids, anticonvulsants, antiepileptic, heparin or low molecular weight heparin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hyperemesis gravidarum<br>hyperemesis gravidarum group consisting of 30 pregnant women between 7-20 weeks of gestation with diagnosed hyperemesis gravidarum. | |
| Control group<br>control group consisting of 30 health pregnant women between 7-20 weeks of gestation with excluded hyperemesis gravidarum. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine N- telopeptide levels in Pregnant Women with Hyperemesis Gravidarum |  | 4 months | 
| Serum Vitamin D Levels in Pregnant Women with Hyperemesis Gravidarum |  | 4 months | 
| Serum Calcium Levels in Pregnant Women with Hyperemesis Gravidarum |  | 4 months | 
| Serum Parathormone Levels in Pregnant Women with Hyperemesis Gravidarum |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperemesis Gravidarum, Bone Health, Urine N-telopeptide, Serum calcium, Serum parathormone, Serum vit D
Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.

Detailed Description
-----------------
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.

Official Title
-----------------
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug C in Healthy Adult Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: DWP16001 Drug A
* Drug: DWP16001 Drug C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 ☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2 Exclusion Criteria: musculoskeletal diseases mental diseases hemato-oncologic diseases

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Intervention: DWP16001 Drug A<br>1 tablet, Oral, once daily single dose | Drug: DWP16001 Drug A<br>* DWP16001 Drug A<br>|
| Experimental: Intervention: DWP16001 Drug C<br>1 tablet, Oral, once daily single dose | Drug: DWP16001 Drug C<br>* DWP16001 Drug C<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of DWP16001 | Peak Plasma Concetration of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. | 
| AUClast of DWP16001 | The area under the plasma drug concentration-time curve of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of DWP16001 | Time at Cmax of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. | 
| T1/2 of DWP16001 | Half life of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. | 
| CL/F of DWP16001 | Apparent total clearance of the drug from plasma after oral administration of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. | 
| Vd/F of DWP16001 | Volume of distribution of DWP16001 | At pre-dose (0 hour), and post-dose 0.25 to 72 hour. |