linjc16/ctgov huggingface dataset:
Clinical Research on Retinal Neovascularization of Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Retinal neovascularization of diabetic retinopathy might be associated with genetic risk factors and environmental risk factors.

Conditions
-----------------
The Mechanism of Retinal Neovascularization of Diabetic, Retinopathy.

Intervention / Treatment
-----------------
* Genetic: genetic analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T2DM was diagnosed according to the World Health Organization Expert Consultation Report 1999 and consisted of one of the following: fasting blood glucose (FBG) ≥7.0 mmol/L (≥126 mg/dL), blood glucose ≥11.1 mmol/L (≥200 mg/dL) 2 hours after an oral glucose tolerance test (OGTT); or a random blood glucose ≥11.1 mmol/L (≥200 mg/dL). DR was clinically graded in accordance with the International Clinical Diabetic Retinopathy guidelines based on fundus fluorescence angiography. All participants with PDR underwent a comprehensive dilated fundus examination to detect DR by indirect ophthalmoscopy and were diagnosed by fundus fluorescence angiography. Exclusion Criteria: Patients were excluded if they had acute complications of diabetes mellitus, type 1 diabetes mellitus, other types of diabetes, serious cardiovascular, hepatic, nephritic or other complications, other serious primary diseases or mental illness.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 74 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 |
| --- | --- |
| No Intervention: Lifestyle counseling<br> | Genetic: genetic analyzer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hemostatic Profiles of Endocrine Therapies for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective cohort study is to evaluate the modifications of the biological hemostatic profile associated with the use of endocrine therapy in women with breast cancer (tamoxifen or aromatase inhibitors).

Detailed Description
-----------------
In this cohort study, women with breast cancer and an indication for endocrine therapy will be prospectively enrolled. At the 1st visit (before the start of endocrine therapy (tamoxifen or aromatase inhibitor)) and at the 2nd visit (at  3 months after the start of treatment), demographical / clinical data and blood samples will be collected. We will evaluate the hemostatic biological profiles associated with the use of endocrine therapy by comparing hemostatic biomarkers before and during its use.

Official Title
-----------------
Hemostatic Profiles Associated With Use of Aromatase Inhibitors and Tamoxifen in Women With Breast Cancer : a Prospective Cohort Study

Conditions
-----------------
Breast Neoplasms, Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult women with a diagnosis of non-metastatic breast cancer and an indication for adjuvant endocrine therapy Exclusion Criteria: lack of consent planned chemotherapy personal history of venous thromboembolism ongoing anticoagulant treatment

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aromatase inhibitors<br> | |
| Tamoxifen<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in thrombin generation, including APC sensitivity ratio |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of coagulation factors | Levels of the following coagulation factors will be measured and compared before and after use of endocrine treatments: antithrombin, protein C, protein S, D-dimer, fibrinogen, F VII, F VIII | three months | 
| Change in fibrinolytic time |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tamoxifen, aromatase inhibitors, breast cancer, venous thromboembolism
Inherited Myokymia: A Clinical and Genetic Study of a Family

Study Overview
=================
Brief Summary
-----------------
Neuromyotonia (NMT), so called Isaac's syndrome, is a rare disorder in which hyperexcitability of peripheral motor nerves leads to intermittent muscle contractions. It is characterized by muscle twitching at rest (visible myokymia), cramps, hyperhidrosis, paraesthesiae, mild muscle weakness. and impaired muscle relaxation, or pseudomyotonia. Electromyographic recording is a key diagnostic tool in detecting myokymia and neuromyotonia. Pathophysiology of neuromyotonia is claimed to be related immune disorder, autoimmune anti-voltage-gated potassium-channel antibodies and genetic mutation in potassium channel. KCNA1 (Kv1.1) mutation was mostly reported in a autosomal dominant trait. In the present study, we report a family affected with myokymia，worsening with elevated body temperature, febrile illness or spicy food. How the change in temperature influence clinical features of channelopathies is an interesting topic. Variant clinical severity of family members are recorded. The index patient has possible autoimmune mechanism involvement because of his clinical feature of myasthenia gravis with thymoma and hyperthyroidism. Further analyzing the genetic mutation in potassium channelopathy may provide researchers some pathophysiological insight into the Isaac's syndrome.

Official Title
-----------------
Inherited Myokymia: A Clinical and Genetic Study of a Family

Conditions
-----------------
A Study of Clinical and Genetic Mutations in a Family of Neuromyotonia, so Called Isaac's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The disease was initially diagnosed of Isaacs syndrome by two neurologist(Dr Tsai and Dr Yang). We will recruit family members of diseased patient and normal subjects for clinical, electromyographic and genetic studies. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Neuromyotonia, Isaac's syndrome; Peripheral nerve hyperexcitability; Myokymia; Potassium channelopathy
The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide important information on the potential health benefits of isomaltulose consumption in Asian population. It will also reveal how the three main ethnicities in Singapore respond to isomaltulose and whether the response differs from the Caucasians.

Detailed Description
-----------------
The objective of the present study is to investigate the glycaemic effect of isomaltulose in Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians completed data sets, aged between 21 and 40 years will be recruited from the general public in Singapore. Participants will be asked to attend two test sessions for this study. Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50 g of available carbohydrate).

Official Title
-----------------
The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Isomaltulose
* Other: Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese, Indian, Malay or Caucasian ethnic origin Exclusion Criteria: People with major chronic disease such as heart disease, cancer or diabetes mellitus Individuals with food intolerances or allergies to isomaltulose or sucrose Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution People with a major medical or surgical event requiring hospitalization within the preceding 3 months Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isomaltulose<br>50g of isomaltulose dissolved in 250ml of water | Other: Isomaltulose<br>* Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.<br>|
| Experimental: Sucrose<br>50g of sucrose dissolved in 250ml of water | Other: Sucrose<br>* Sucrose is normal table sugar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in post prandial Blood glucose for 180 minutes period | Blood glucose obtained through finger pricks using Hemocue Glucose Analyser | 180 minutes |
German Lactat Clearance in Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate if there is a correlation between lactate clearance and the course at patients with severe sepsis and septic shock at german intensive care units.

Official Title
-----------------
German Lactat Clearance in Severe Sepsis

Conditions
-----------------
Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe sepsis or septic shock signed informed consent Exclusion Criteria: severe sepsis or septic schock within 4 weeks before inclusion of study shock of other genesis persons being accomondated in an institution because of court or official order persons being interdependet to the investigator employees of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| severe sepsis or septic shock<br>patients with severe sepsis or septic shock | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate Clearance | Determination of lactate clearance within 6 hours after diagnosis of severe sepisis and septic shocik | Within 6 hours after diagnoses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA Score |  | Day of hospitalization, day 7, day 8 |
Effect of Palm Sugar on Blood Glucose Concentrations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine by how much, the ingestion of palm sugar increases blood glucose concentrations and what the corresponding glycaemic index is. The investigators estimate that the glycaemic index will be 68 (equal to that of sucrose).

Official Title
-----------------
Investigation of the Glycaemic Index of Arenga Pinnata Palm Sugar

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Other: Arenga Pinnata Sugar
* Other: Glucose
* Other: Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy: as judged by the participant; Age: 18 to 35. Exclusion criteria: Pregnant or lactating females Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome 18.5 < BMI < 25 Allergy or intolerance to palms or coconuts Weight loss or gain of more then 5 kg in the last two months Fasting blood glucose levels <100 mg/dl or 5.6 mmol/l Smokers Use of medications other then birth control Previous problems with blood sampling

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: glucose<br> | Other: Glucose<br>* 50 g glucose given orally 3 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.<br>|
| Active Comparator: sucrose<br> | Other: Sucrose<br>* 50 g sucrose given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.<br>* Other names: table sugar;|
| Experimental: palm sugar<br> | Other: Arenga Pinnata Sugar<br>* 50 g palm sugar given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.<br>* Other names: palm sugar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose concentrations | During the labratory visits subjects will ingest glucose (control), sucrose or palm sugar. At time points 0, 15, 30, 45, 60, 90 and 120 minutes post ingestion blood glucose concentrations will be measured by finger prick blood samples. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycaemic index, arenga pinnata sugar, palm sugar, diabetes
Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3

Official Title
-----------------
Phase I-II Vaccination Clinical Trial in Patients With Chronic Hepatitis C by Administration of Autologous Dendritic Cells Transduced With an Adenoviral Vector Encoding NS3 Protein

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Biological: Autologous dendritic cells transduced with Ad encoding NS3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment Exclusion Criteria: Liver cirrhosis HBV-coinfection Bilirubin >1.5 times ULN or ALT >7 ULN Hepatocellular carcinoma Immunodeficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: Single arm<br>Autologous dendritic cells transduced with Ad encoding NS3 | Biological: Autologous dendritic cells transduced with Ad encoding NS3<br>* Patients will receive 3 different dosis of the vaccine via subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound. | Safety assessment will be determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy on viral load and immune response |  | 6 months |
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.

Official Title
-----------------
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma

Conditions
-----------------
Metastatic Melanoma

Intervention / Treatment
-----------------
* Drug: Cisplatin, Vindesine, Dacarbazine (drugs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological diagnosis of metastatic melanoma (stage IV) progressive disease after first-line chemotherapy or immuno-chemotherapy Karnofsky-index > 60% informed consent Exclusion Criteria: Uvea melanoma another primary malignancy except basal cell carcinoma or cervical carcinoma in situ severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cisplatin, Vindesine, Dacarbazine (drugs)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life analysis |  |  | 
| Objective tumor response rate in study arm B |  |  | 
| Time to tumor progression |  |  | 
| Cost analysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignant Melanoma, Chemotherapy, Metastasis, standard palliative care, best supportive care
Impact of Culture Medium on Embryo Quality

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two culture media.

Conditions
-----------------
Embryo Development

Intervention / Treatment
-----------------
* Other: embryo culture medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Embryos of patients younger than 36 years old Exclusion Criteria: Embryos of patients older than 36 years old

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sequential medium<br> | Other: embryo culture medium<br>* comparison between two types of embryo culture medium<br>|
| Active Comparator: single medium<br> | Other: embryo culture medium<br>* comparison between two types of embryo culture medium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryo quality: number and size of blastomeres, degree of fragmentation |  | day 1 -day 3 |