linjc16/ctgov huggingface dataset:
G8, VES-13 and CARG Scores in Predicting Chemotherapy Toxicity in Geriatric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. The suitability of G8, VES-13 and CARG chemotherapy risk assessment tools for elderly cancer patients was investigated.

Detailed Description
-----------------
All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. G8, VES-13 and CARG toxicity scores of all participating patients will be determined by two independent investigators before starting chemotherapy. The suitability of these practical chemotherapy risk assessment tools for cancer patients for elderly cancer patients was investigated.

Official Title
-----------------
The Predictive Value of G8, VES-13 and CARG Scores in Treatment-related Toxicity in Geriatric Cancer Patients

Conditions
-----------------
Predicting Chemotherapy Related Toxicity in Elderly Patients

Intervention / Treatment
-----------------
* Other: Older Patients Receiving Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥65 years Localized or metastatic solid carcinoma diagnosed by histology (any type, any stage) Starting a new-line (first-line, second-line or third-line) chemotherapy Exclusion Criteria: Concurrent radiotherapy; Simultaneous immunotherapy Impaired language Cognitive function leading to inability to complete assessments.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Older Patients Receiving Chemotherapy|No Intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G8 (Geriatric 8) screening tool measurement |  | 15-30 minutes | 
| CARG (Cancer and Aging Research Group) chemotherapy toxicity score measurement |  | 30-60 minutes | 
| VES-13 (Vulnerable Elders Survey-13) measurement |  | 30-60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
g8, ves-13, CARG, chemotherapy-related toxicity, Toxicity tool
Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks

Official Title
-----------------
A Multicenter, Single-Arm, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients in Treatment of Oral Antiviral Therapy for Hepatitis B Virus

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Experimental


Participation Criteria
=================
Eligibility Criteria
-----------------
1. Inclusion Criteria: Patients who show positive HBsAg Patients who show positive or negative HBeAg 2. Exclusion Criteria: Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV) Patients with a history of allergic reaction to Tenofovir Patients who are unable to participate in clinical trials based on investigator's decision.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Experimental group<br> | Drug: Experimental<br>* Experimental group are treated with TenofoBell®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of subjects with HBV DNA less than 20 IU/mL |  | change after 48 weeks compared to baseline |
Reduction of Remifentanil-related Complications

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate the effect of decreasing the maximum plasma concentration target of remifentanil of the Target Controlled Infusion system on the the incidence of major and minor side-effects.

Official Title
-----------------
Reduction of Remifentanil-related Complications by Limiting Maximum Plasma Concentration During Target-controlled Infusion

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Remifentanil (Limited) - Target Controlled Infusion system
* Drug: Remifentanil (Control) - Target Controlled Infusion system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 year old ASA class 1-3 scheduled for elective surgery Exclusion Criteria: history of neurologic or mental disorder uncontrolled pulmonary or cardiovascular disease history of adverse reactions to opioids history of drug abuse

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limited<br>Limit the maximum plasma concentration target to 9.8 ng/ml | Drug: Remifentanil (Limited) - Target Controlled Infusion system<br>* Limit max plasma concentration to 9.8 ng/ml<br>|
| Active Comparator: Control<br>Use 20 ng/ml as max plasma concentration | Drug: Remifentanil (Control) - Target Controlled Infusion system<br>* Use 20 ng/ml as max plasma concentration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypotension more than 25% from baseline |  | during remifentanil loading | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total intravenous anesthesia, Maximum plasma concentration of remifentanil
Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

Official Title
-----------------
Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for more than 1 year Subject treated by any kind of insulin regimen and whatever the number of injections HbA1c = 7.5% and = 10% Exclusion Criteria: Type 2 diabetes Treatment by oral anti-diabetic drugs Severe medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: insulin detemir|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean HbA1c |  | after 4 months of insulin detemir treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 
| Adverse events |  |  | 
| Insulin dose requirements during initial 4 months of treatment and during 3 months extension |  |  | 
| Weight |  |  | 
| Blood glucose |  |  | 
| Hypoglycaemia |  |  |
Turner Syndrome Prenatal Diagnosis Study

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the features of Turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason.

Detailed Description
-----------------
This is an observational study which will look at girls who are diagnosed with Turner syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed because of features seen on ultrasound which raised the question of Turner syndrome and 2) those diagnosed incidentally when their mother had an amniocentesis for another reason such as advanced maternal age. No clinical procedures nor interventions will be done as part of this data collection study which will occur for the first 3 to 6 years of the girl's life. The investigators will be looking to see if girls who are diagnosed incidentally have less features of Turner syndrome than those girls who are diagnosed because of fetal ultrasound.

Official Title
-----------------
National Collaborative Study of Girls Prenatally Diagnosed With Turner Syndrome Karyotypes

Conditions
-----------------
Turner Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Turner syndrome diagnosed prenatally Less than 4 months of age at time of enrollment Exclusion Criteria: Turner syndrome diagnosed postnatally Older than 4 months of age at time of enrollment

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fetal ascertainment<br>Girls who are diagnosed with Turner syndrome because of concerns raised by an abnormal fetal ultrasound. | |
| Maternal ascertainment<br>Girls who are diagnosed with Turner syndrome because their mothers had an amniocentesis for a reason other than an abnormal fetal ultrasound concerning for Turner syndrome. For example an amniocentesis was done because of advanced maternal age or because of an abnormal triple screen or because another condition was being screened for such as trisomy 21. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of signs of Turner syndrome | Girls diagnosed with Turner syndrome by fetal ascertainment will have more signs of Turner syndrome than girls diagnosed by maternal ascertainment | three to six years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Do girls with Turner syndrome ascertained by fetal ascertainment grow differently than girls ascertained by maternal ascertainment. | three to six years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turner syndrome, Diagnosis, prenatal
Evaluation of Sensitization to Peach and/or Cypress in Potato Sensitized Patients in a Large Cohort

Study Overview
=================
Brief Summary
-----------------
The aim of the study will be to investigate the prevalence of of sensitization to peach and/or cypress in potato sensitized patients, based on the collection of medical data from patient records consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital. Some Gibberellin-regulated protein (GRP) in fruits and pollens have been identified as allergen, and peach GRP (peamaclein) has recently emerged as a relevant food allergen in cypress pollen-hypersensitive patients. Multiple fruit allergies might be related to cross-reactivity between GRPs. Peamaclein shares 82% identity with snakin-1 from potato. Thus, because of this hight homology the investigators want to determine the prevalence of cosensitization between these 3 allergens potato, peach and cypress.

Official Title
-----------------
Prevalence of Sensitization to Peach and/or Cypress in Potato Sensitized Patients in Occitania

Conditions
-----------------
Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients evaluated at the Montpellier University Hospital, Allergy Unit children and adult with positive skin prick test to potato from february 2013 to december 2015 Exclusion criteria: Patients under legal protection Patients under guardianship or under curatorship Patients not capable of understanding French

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 99 Years

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 |
| --- | --- | --- |
| Rate of sensitization to peach and/or cypress in potato-sensitized patients | Rate of sensitization to peach and/or cypress in potato-sensitized patients | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of of sensitization to peach and/or cypress in potato-sensitized patients | Rate of sensitization to peach and/or cypress in potato-sensitized patients (cypress pollen-induced allergic rhinitis or food allergy to peach) | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cypress, gibberellin-regulated protein, peach, potato, rhinitis
Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)

Study Overview
=================
Brief Summary
-----------------
This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.

Official Title
-----------------
Vitamin K2 Supplementation and Effect on Arterial Stiffness Progression in the Renal Transplant Population

Conditions
-----------------
Arterial Stiffness, Vitamin K2 Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin K2 (MK7)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional renal graft Stable renal function for at least 3 months prior to enrollment Exclusion Criteria: History of thrombotic events Diagnosed coagulopathy Cardiovascular event in the past month prior to enrollment Current or planned pregnancy Lactation Soy allergy Concomitant or recent (past 6 months) use of supplements that contain vitamin K Warfarin treatment Known intestinal malabsorption or hypomotility syndromes

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin K2 (MK7)<br>Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks | Dietary Supplement: Vitamin K2 (MK7)<br> <br> * Other names: MenaQ7;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks |  | 8 weeks | 
| Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks |  | 8 weeks | 
| Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks |  | 8 weeks |
Staged Bilateral Percutaneous Nephrolithotomy

Study Overview
=================
Brief Summary
-----------------
To determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared.

Detailed Description
-----------------
The aim of the study is to determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. In our study, patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared. With the guidance of preoperative and postoperative data, it is aimed to determine the optimal time with the lowest complication and highest operational success.

Official Title
-----------------
Staged Bilateral Percutaneous Nephrolithotomy: When to Operate for a Contralateral Kidney?

Conditions
-----------------
Stone, Kidney, Urolithiasis

Intervention / Treatment
-----------------
* Procedure: Patients who underwent percutaneous nephrolithotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stones of 2 cm or more in each kidney Exclusion Criteria: Renal Failure Coagulopathy Pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Staged percutaneous nephrolithotomy group 1<br>Those who underwent percutaneous nephrolithotomy 2-4 weeks after percutaneous nephrolithotomy for stones in the other kidney | Procedure: Patients who underwent percutaneous nephrolithotomy<br>* Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the percutaneous nephrolithotomy operation<br>|
| Staged percutaneous nephrolithotomy group 2<br>Those who underwent percutaneous nephrolithotomy 4-6 weeks after percutaneous nephrolithotomy for stones in the other kidney | Procedure: Patients who underwent percutaneous nephrolithotomy<br>* Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the percutaneous nephrolithotomy operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI in kg/m^2 | BMI in kg/m^2 | 3 Months | 
| rates of intraoperative blood transfusion, operation time(minute) | rates of intraoperative blood transfusion, operation time(minute) | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mm size of the stone, | mm size of the stone, | 3 Months |
Study Evaluating CCI-779 in Relapsing Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Long-term Extension Study to Determine the Safety, Tolerability, and Preliminary Efficacy of CCI-779 in Subjects With Relapsing Multiple Sclerosis.

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: CCI-779


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with relapsing-remitting MS or secondary progressive MS with relapses. Successful completion of study 3066A2-205-WW with no major protocol violations. Exclusion Criteria: Pregnancy or lactation. Clinically important abnormalities on the physical examination, vital signs, or electrocardiogram (ECG) performed at the last visit of study 3066A2-205-WW (day 252). Any adverse events or findings observed in study 3066A2-205-WW that in the opinion of the investigators would preclude the subject's entry into the extension study. Please refer to section 16.2 'Discontinuation and Withdrawal of Subjects' regarding withdrawal of patients who have any clinical abnormalities in hematology or laboratory test results obtained at the last visit of the double-blind active phase of study 3066A2-205-WW.
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CCI-779|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety. |  |  | 
| Listing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy of long-term treatment. |  |  | 
| Lesions observed on MRI scans, clinical measures such as the EDSS scale, the 9-Hole Peg Test, the Paced Auditory Serial Addition Test and the Timed Ambulation 25-Foot Test, occurrence of relapse, will be analyzed at end -point (12 or 16 months). |  |  | 
| Only descriptive statistics will be performed. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis