linjc16/ctgov huggingface dataset:
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites

Study Overview
=================
Brief Summary
-----------------
This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions.

Official Title
-----------------
A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D (FS VH S/D) in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites

Conditions
-----------------
Breast Cancer, Lumpectomy, Mastectomy Plus Axillary Lymph Node Dissection, Lymphatic Leakage

Intervention / Treatment
-----------------
* Drug: Fibrin Sealant VH S/D
* Procedure: Surgical intervention alone without Fibrin Sealant VH S/D application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent has been obtained from the subject prior to FS VH S/D administration Female subjects >= 19 years of age Subjects with breast cancer scheduled to undergo lumpectomy of the breast and level I and II axillary lymphadenectomy with two separate incisions Exclusion Criteria: Subjects with known hypersensitivity to aprotinin or other components of the product Subjects with immunodeficiency Subjects with increased red cell production (e.g., in hemolytic anemia) Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes. Subjects having previously had axillary surgery Subjects having undergone irradiation therapy to the axillary tissue Subjects having ever received chemotherapy before the surgery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fibrin Sealant VH S/D|nan|
|Procedure: Surgical intervention alone without Fibrin Sealant VH S/D application|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axillary wound, Seroma, Fistulae
Study Evaluating Approach to Treatment of Haemophilia A and B in Spain

Study Overview
=================
Brief Summary
-----------------
Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain.

Detailed Description
-----------------
Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis. Assess haemophilia A or B patient profile, study different kinds of hanitual clinical treatment of haemophilia A and B patients, and estimate the kind of treatment and dosage units used per year in patients under habitual clinical practice conditions.

Official Title
-----------------
Actual Approach to Treatment of Haemophilia A and B in Spain

Conditions
-----------------
Hemophilia A, Hemophilia B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Haemophilia A or B patients of any age Written informed consent
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> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the clinical and therapeutic approach to treament of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess haemophilia A or B patient profile, study different kinds of habitual clinical treatment of haemophilia A and B patients, and estimate the dosage units used per year in patients under habitual clinical practice conditions. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Approach Haemophilia A and B
Physiologic Variables in Healthy Women in Shuttle Walk Test

Study Overview
=================
Brief Summary
-----------------
To analyze the alterations of physiologic variables in healthy sedentary women in the Shuttle Walk Test, verify the distance reached and interruption causes of the test.

Detailed Description
-----------------
The Shuttle Walk Test requires patients to walk at a gradually increasing speed, up and down a 10 meter corridor identified by two marker cones, until they reach a symptom limited maximum. The walking speed was externally paced and controlled by a series of beeps played on a compact disk.

Official Title
-----------------
Analysis of Physiologic Variables in Healthy Women in Shuttle Walk Test

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Shuttle walk test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: female gender; sedentary; aged 20 to 30 years. Exclusion criteria: pregnancy; enrolment in any regular physical activity program; diagnosed health conditions.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 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 |
| --- | --- |
| Exercise Capacity<br>Individuals from the female gender; age range of 20 to 30 years old; considered healthy (i.e. with no diagnosed health condition; considered sedentary (i.e. performing less than 150 minutes of moderate intensity physical activity per week); will be asked to volunteer in the research and perform a exercise capacity test. | Other: Shuttle walk test<br>* the test requires patients to walk at a gradually increasing speed, up and down a 10 m course identified by two marker cones, until they reach a symptom limited maximum. The walking speed was externally paced and controlled by a series of beeps played on a compact disk.<br>* Other names: Exercise Capacity Test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shuttle Walk Test Distance | The distance achieved in the test in meters | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate at baseline | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy sedentary women
Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients

Study Overview
=================
Brief Summary
-----------------
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.

Official Title
-----------------
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Treating Inflammation in Cataract Surgery Patients

Conditions
-----------------
Ocular Inflammation

Intervention / Treatment
-----------------
* Drug: IBI-10090


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation. Exclusion Criteria: Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening. Patients with any signs of intraocular inflammation in either eye at screening. Patients who have received any prior intravitreal injections in the study eye.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>513ug | Drug: IBI-10090<br> <br> |
| Experimental: Dose 2<br>776ug | Drug: IBI-10090<br> <br> |
| Experimental: Dose 3<br>1046ug | Drug: IBI-10090<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment | This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant. | 8 days post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, inflammation
Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride

Official Title
-----------------
A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Lanthanum carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving haemodialysis for ESRD Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months Exclusion Criteria: Pregnant or lactating women Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma Patients who are HIV+ Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lanthanum carbonate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pre-dialysis serum phosphate level |  | The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pre-dialysis serum calcium product |  | The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8) | 
| Mean pre-dialysis calcium-phosphate product |  | The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8) | 
| Average daily pill burden |  | Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit. | 
| Treatment emergent adverse events | Treatment-emergent adverse events (TEAEs) were defined as AEs that had an onset date and time on or after the date and time of the first dose of study medication. | Throughout the study period of approximately 7.5 months. |
Clinical Pharmacology of FYU-981 (Elder Subjects)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.

Official Title
-----------------
Clinical Pharmacological Study of FYU-981 Administered to Male and Female Elder or Non-elder Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: FYU-981, (Oral single dosing)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese adult subjects 20-35 Years (non-elder groups) 65- Years (elder groups) Body mass index: >=18.5 and <25.0 Exclusion Criteria: Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male elder subjects<br>Male 65- Years | Drug: FYU-981, (Oral single dosing)<br> <br> |
| Experimental: Male non-elder subjects<br>Male 20-35 Years | Drug: FYU-981, (Oral single dosing)<br> <br> |
| Experimental: Female elder subjects<br>Female 65- Years | Drug: FYU-981, (Oral single dosing)<br> <br> |
| Experimental: Female non-elder subjects<br>Female 20-35 Years | Drug: FYU-981, (Oral single dosing)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax: Maximum plasma concentration) |  | 48 hours | 
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |  | 48 hours | 
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) |  | 48 hours | 
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) |  | 48 hours | 
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (kel: Elimination rate constant) |  | 48 hours | 
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed |  | 48 hours | 
| Pharmacokinetics (MRT: Mean residence time) |  | 48 hours | 
| Pharmacokinetics (Ae: Amount of drug excreted in urine) |  | 48 hours | 
| Pharmacokinetics (fe: Fraction of dose excreted in urine) |  | 48 hours |
Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus. This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.

Official Title
-----------------
Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Other: ophthalmologic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes type I or type II follow-up with fluorescein angiography Exclusion Criteria: known allergy to fluorescein contra-indication to fluorescein angiography pregnant or breast-feeding patient technical impossibility to analyse retinal ischemic areas on fluorescein angiography or OCT-A.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ophthalmologic examination|ophthalmologic examination including optical coherent tomography with angiography module|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection and measure of ischemic territories in central and peripheral retina |  | immediate |
Biomarkers in Pulmonary Hypertension Associated to Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of patients with interstitial pulmonary disease. The aim of this study is to estimate the frequency of an increased blood pressure in the lungs among patient with interstitial pulmonary disease, and to evaluate the use of different biomarkers in diagnosis of the condition.

Detailed Description
-----------------
The presence of increased pulmonary blood pressure is established by echocardiography and confirmed by right heart catheterization. The ability of NT-proBNP, vWf, troponin-t, D-dimer and exhaled NO to predict the presence of increased pressure in the pulmonary circulation is evaluated.

Official Title
-----------------
The Prevalence of Pulmonary Hypertension and the Significance of Different Biomarkers in Chronic Interstitial Lung Disease

Conditions
-----------------
Interstitial Lung Disease, Pulmonary Hypertension, Biomarkers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Interstitial pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>Patients with interstitial pulmonary disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interstitial lung disease, pulmonary hypertension, biomarkers, NT-pro-BNP, von Willebrand factor, D-dimer, Exhaled NO, Troponin-t
Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether insulin sensitivity and insulin resistance of the human brain is comparable in all insulin sensitive parts of the brain and whether correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of the study participants.

Official Title
-----------------
Insulinsensitivität Des Menschlichen Zentralnervensystems: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin

Conditions
-----------------
Obesity, Diabetes

Intervention / Treatment
-----------------
* Drug: Human Insulin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal routine blood works for women: negative pregnancy test healthy Exclusion Criteria: Type 2 diabetes pregnancy acute or chronic diseases Pacemakers Artificial heart valves Metal prostheses Implanted magnetic metal parts (screws, ...) Metal fragments Braces insulin pumps Tattoos claustrophobia reduced temperature sensation and / or increased sensitivity to warming of the body Ear disease or an increased sensitivity to loud noises

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Human Insulin<br>Nasal spray | Drug: Human Insulin<br>* 160 U of insulin<br>|
| Placebo Comparator: Placebo solution<br>Nasal spray | Drug: Placebo<br>* Insulin dilution medium without insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin effect on regional brain activity assessed by fMRI |  | Change from Baseline to 15 minutes and 60 minutes post spray application |