linjc16/ctgov huggingface dataset:
Fluid Status and T1-mapping by CMR

Study Overview
=================
Brief Summary
-----------------
It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging. In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.

Official Title
-----------------
Fluid Status Assessed by Bioelectrical Impedance Spectroscopy and Its Association With T1-mapping by Cardiovascular Magnetic Resonance Imaging

Conditions
-----------------
Heart Diseases, Heart Failure, Valvular Heart Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Bioimpedance spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent patient undergoing cardiovascular magnetic resonance imaging Exclusion Criteria: Unwillingness to participate pregnancy

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 |
| --- | --- |
| Fluid overload (Liters) ≥ median<br> | Diagnostic Test: Bioimpedance spectroscopy<br>* Fluid overload will be assessed by bioimpedance spectroscopy<br>* Other names: BCM measurement;|
| Fluid overload (Liters) < median<br> | Diagnostic Test: Bioimpedance spectroscopy<br>* Fluid overload will be assessed by bioimpedance spectroscopy<br>* Other names: BCM measurement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Native T1-mapping | Association of fluid overload and native T1 values of left ventricular myocardium | baseline | 
| Extracellular Volume by Cardiovascular magnetic resonance imaging | Association of fluid overload and extracellular volume of left ventricular myocardium | baseline |
Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia

Study Overview
=================
Brief Summary
-----------------
Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.

Detailed Description
-----------------
A dosage climbing for the safety and efficacy studies for the neutropenia induced by chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the neutropenia.

Official Title
-----------------
Phase 1 Study of rHSA/GCSF in Neutropenia After Chemotherapy of Cancer Patients

Conditions
-----------------
Underdose (Unintentional), Cancer, Tumor

Intervention / Treatment
-----------------
* Drug: rHSA/GCSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - chemotherapy induced neutropenia Exclusion Criteria: - treated with other biological drugs or other neutropenia therapy drugs

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: rHSA/GCSF for injection<br>rHSA/GCSF Start from 300mcg | Drug: rHSA/GCSF<br>* for treatment of neutropenia<br>* Other names: Long acting rhG-CSF fusion protein;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Number of participants with adverse events as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | AUC after single and multiple dose of rHSA/GCSF | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neutropenia, chemotherapy, rHSA/GCSF
A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

Official Title
-----------------
A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: ASP1941
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients for at least 12 weeks HbA1c value between 7.0 and 10.0% at screening Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening Body Mass Index (BMI) 20.0 - 45.0 kg/m2. Exclusion Criteria: Type 1 diabetes mellitus patients Serum creatinine > upper limit of normal Proteinuria（albumin/creatinine ratio > 300mg/g） Dysuria and/or urinary tract infection Significant renal, hepatic or cardiovascular diseases Severe gastrointestinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1941 high dose group<br>oral | Drug: ASP1941<br>* oral<br>|
| Experimental: ASP1941 low dose group<br>oral | Drug: ASP1941<br>* oral<br>|
| Placebo Comparator: Placebo group<br>oral | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma glucose levels |  | On day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary glucose excursion |  | On day 14 | 
| Pharmacokinetic parameter of ASP1941 |  | On day 14 | 
| Safety by adverse events, routine safety laboratories and vital signs. |  | During treatment | 
| Change in serum insulin levels |  | On day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1941, Diabetes mellitus, Blood glucose
The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella

Study Overview
=================
Brief Summary
-----------------
Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis.

Detailed Description
-----------------
Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis. in order to investigate the collagen synthesis potential and the influence of growth hormone, 12 elderly males age > 50 year, is enrolled in this study.

Official Title
-----------------
The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella

Conditions
-----------------
Growth Hormone, Elderly

Intervention / Treatment
-----------------
* Drug: Growth Hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18.5 - 25.0 Exclusion Criteria: earlier knee injury

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth hormone<br>The effect of Growth hormone on the collagen synthesis rate | Drug: Growth Hormone<br>* infusion of Growth hormone in the patella tendon.<br>* Other names: infusion of Saline in the patella tendon.;|
| Placebo Comparator: Saline<br> | Drug: Growth Hormone<br>* infusion of Growth hormone in the patella tendon.<br>* Other names: infusion of Saline in the patella tendon.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Fraktionele collagen protein synthesis in human patella tendon |  | 01122010 |
Postoperative Temperature Monitoring In Brain Trauma

Study Overview
=================
Brief Summary
-----------------
This prospective observational study is designed to investigate the relationship between brain temperature, axillary temperature, rectal temperature, and bladder temperature of postoperative patients with brain trauma, and the relationship between brain temperature and prognosis. This study is conducted based on the following important assumptions. First, brain temperature of postoperative patients with brain trauma should be higher than the axillary temperature, rectal temperature and bladder temperature. Second, the consistency of brain temperature and bladder temperature is better than the consistency of brain temperature and axillary temperature, as well as that of brain temperature and rectal temperature. Third, brain temperature can help clinicians to predict the prognosis of patients with brain trauma. Therefore, brain temperature monitoring is significant in postoperative intensive care and treatment of patients with brain trauma.

Official Title
-----------------
A Muti-centre Prospective Observational Study on Postoperative Temperature Monitoring In Patients With Brain Trauma

Conditions
-----------------
Brain Injuries, Traumatic, Body Temperature Changes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical or radiological diagnosis is brain trauma; The patient has surgical indications, and the patient or his/her family are willing to undergo operation including brain temperature monitoring probe implantation; Informed consent is obtained from the patient's family. Exclusion Criteria: At the time of admission there are serious systemic diseases, including severe infections, immune system diseases, blood system diseases, infectious diseases, severe liver and kidney dysfunction, malignant tumors, etc; Pregnant or lactating women; There are other brain tumors or cerebrovascular disease in the brain at the same time; There is a history of drug or alcohol abuse; Within 3 months before admission, live vaccines were inoculated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Change of Brain Temperature |  | Change from Baseline Brain Temperature at 1 week | 
| Change of Axillary Temperature |  | Change from Baseline Axillary Temperature at 1 week | 
| Change of Rectal Temperature |  | Change from Baseline Rectal Temperature at 1 week | 
| Change of Bladder Temperature |  | Change from Baseline Bladder Temperature at 1 week | 
| Glasgow Outcome Scale | An objective assessment of the recovery of patients with brain trauma | 1 month |
Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents

Official Title
-----------------
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Drug: Temozolomide, Cisplatinum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 4th birthday and younger than 21st birthday Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours Measurable and evaluable disease by the imaging criteria (MRI) Patient not previously treated by either of the two drugs Exclusion Criteria: Malignant brain stem tumours are excluded

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 21 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Temozolomide, Cisplatinum|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological response after two courses of Temozolomide-Cisplatinum |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Health status and quality of life |  |  | 
| Toxicity |  |  |
Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to use a tea-based mouthwash to relieve pain and discomfort in patients with stomatitis and ulcers.

Detailed Description
-----------------
The objective of this study is to use tea as a base, supplemented with licorice to reduce bitterness and astringency, to make mouthwash, and use tea's antioxidant and anti-inflammatory properties to relieve the pain and discomfort of stomatitis and ulcer patients. This study will observe the difference between saliva and oral mucosal cells before and after treatment, to find the mechanism of effective treatment of stomatitis.

Official Title
-----------------
Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers

Conditions
-----------------
Stomatitis

Intervention / Treatment
-----------------
* Combination Product: mouthwash with tea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 20 years old, male or female Exclusion Criteria: patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tea mouthwash group<br> | Combination Product: mouthwash with tea<br>* Using tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis.<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Xerostomia questionnaire (XQ) | Questionnaires for symptoms relief of dry mouth | 4 weeks | 
| Xerostomia Inventory (XI) | A multi-item approach to measuring dry mouth | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+) | Immunohistochemistry stain for ACE2 protein | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomatitis; oral ulcers; oral mucosa; tea; mouthwash
p-AKT Expression on Clinical Outcomes in Malignant Lymphoma

Study Overview
=================
Brief Summary
-----------------
PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway. However, clinical information about the significance of p-AKT expression in malignant lymphoma is not fully understood yet. In this study, we investigated the overexpression of p-AKT and its prognostic implication in malignant lymphoma.

Detailed Description
-----------------
Recently, among diverse oncogenic signaling pathways, a number of studies have focused on the significance of oncogenic PI3K/AKT (phophatidylinositol 3-kinase/serine-threonine kinase, also known as protein kinase B [PKB]) pathway. PI3K(phosphatidylinositol 3-kinase)/AKT pathway phosphorylates and activates AKT as phosphorylated AKT (p-AKT) and plays a critical role promoting malignant phenotype and has prognostic significance in various solid cancers. However, a systematic approach on the impact of p-AKT overexpression on clinical outcomes has not been performed in malignant lymphoma.

Official Title
-----------------
The Impact of Activated p-AKT Expression on Clinical Outcomes in Malignant Lymphoma : A Clinicopathological Study

Conditions
-----------------
Malignant Lymphoma, P13K-AKT Pathway Deregulation

Intervention / Treatment
-----------------
* Other: p-AKT immunohistochemical staining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients were pathologically confirmed of malignant lymphoma, according to the World Health Organization classification; the patients had adequate paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT. Exclusion Criteria: 1. Primary central nervous system lymphoma was excluded in this study

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| p-AKT<br>p-AKT immunohistochemical staining,high p-AKT expression (upper quartile), low p-AKT expression (lower 3 quartiles) | Other: p-AKT immunohistochemical staining<br>* p-AKT staining on the adequate paraffin-embedded biopsy specimen or unstained slides<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of overall survival according to p-AKT status in malignant lymphoma |  | study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subgroup analysis of overall survival according to histologic subtypes (GCB vs non GCB) |  | study entry |
MRD-directed Therapy for Low-risk and Intermediate-risk AML.

Study Overview
=================
Brief Summary
-----------------
Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

Official Title
-----------------
Minimal Residual Disease-directed Therapy for Low-risk and Intermediate-risk Acute Myeloid Leukemia.

Conditions
-----------------
Acute Myeloid Leukemia, Minimal Residual Disease

Intervention / Treatment
-----------------
* Combination Product: MRD-directed therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: MRD-directed therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRD-directed therapy<br> | Combination Product: MRD-directed therapy<br>* The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival (DFS) |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leukemia relapse rate |  | 3 year | 
| disease-free survival (DFS) |  | 3 year | 
| overall survival (OS) |  | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRD, Acute myeloid leukemia