linjc16/ctgov huggingface dataset:
Safety of Xeloda in Solid Tumours

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.

Official Title
-----------------
Safety of Xeloda in Solid Tumours

Conditions
-----------------
Metastatic Breast Cancer, Colon Cancer

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Xeloda


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic Breast Cancer: women >=18 years of age Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. Female patients with histopathologically proven metastatic breast cancer Adequate bone marrow, liver, renal and cardiac functions Colon Cancer: Patients >18 years of age Patients with histologicaly confirmed colon cancer Patients with potential curative tumor resection within 8 weeks before enrolment in the study Patients previously not treated with chemiotherapy Exclusion Criteria: Metastatic Breast Cancer: Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda) Patients with contraindications for any of study drugs as listed in approved SmPC Colon Cancer: Patients previously treated with chemiotherapy Patients with contraindications for study drug as listed in approved SmPC

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 |
| --- | --- |
| Adjuvant therapy<br>Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer | Drug: Xeloda<br> <br> |
| Combination Therapy<br>Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression | Drug: Docetaxel<br> <br> Drug: Xeloda<br> <br> |
| Monotherapy<br>Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer | Drug: Xeloda<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | within 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival (DFS) |  | within 18 months |
What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?

Study Overview
=================
Brief Summary
-----------------
Foreign body (FB) ingestion is a very common domestic accident in children. The prevention of the recurrence by securing child's environment is mandatory. The study will study whether the advices of follow-up at home and recurrence prophylaxis were given to parents after a foreign ingestion by their child.

Detailed Description
-----------------
Foreign body ingestion (FB) is a very common domestic accident in children. When the FB is not dangerous or it is inaccessible after crossing the pylorus, the child should be monitored. In all cases, recurrence should be prevented by securing the environment of the swallowing child. The information on monitoring and securing the environment should be communicated during hospital care. This prospective study will analyze whether advices were correctly given to the families concerning the follow-up at home and the prophylaxis of FB ingestion.

Official Title
-----------------
What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?

Conditions
-----------------
Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child

Intervention / Treatment
-----------------
* Other: telephone interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children under 18 years Foreign body ingestion Exclusion Criteria: Refusal to participate in the study Non-French speaking parents

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum 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: telephone interview|telephone call to parents to know the information given following the ingestion of foreign body by their child|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child. |  | 1 year |
Knowledge-based Iterative Model Reconstruction at Low-kilovoltage (kV) Cardiac Computed Tomography (CT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures.

Official Title
-----------------
Value of Knowledge-based Iterative Model Reconstruction at Low-kilovoltage Cardiac 256-slice CT: A Comparison of Filtered Back Projection-, Hybrid-, and Iterative Model Reconstruction

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A BMI of 27 kg/m2 or less and a coronary calcium score of less than 1,000 Agatston units. Exclusion Criteria: BMI exceeded 27 kg/m2 renal dysfunction (serum creatinine level > 1.5 mg/dl) atrial fibrillation prior coronary artery bypass grafting heart failure (New York Heart Association class III-IV)

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Contrast to noise ratio of coronary arteries |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Computed tomography
MRI Predictors of Response to Tumor Treating Fields

Study Overview
=================
Brief Summary
-----------------
Patients with glioblastoma, an aggressive brain tumor, are recommended to undergo treatment with tumor treating fields using the Optune device as part of standard of care therapy. While undergoing treatment, patients are monitored regularly with brain MRI scans to look for tumor progression, but there are currently no means to predict which, or when, patients will progress. The purpose of the current study is to prospectively analyze these MRI scans to look for subtle imaging markers that can predict for future brain tumor progression while undergoing tumor treating field therapy.

Detailed Description
-----------------
The proposed trial involves the prospective collection of imaging data at standard clinical time points before and during treatment with TTFields. All patients who are offered treatment with TTFields will also be offered enrollment in this non-randomized, observational study. Imaging data will include the standard battery of MRI sequences, which includes DWI and ADC reconstruction. These data will be collected at standard time points and the proposed study will not rely on any additional imaging or tests outside of the clinical standard of care.

Official Title
-----------------
Imaging Biomarkers to Predict Responsiveness to Tumor Treating Fields in Patients With High Grade Glioma

Conditions
-----------------
Glioblastoma Multiforme

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 or older with newly diagnosed WHO grade IV glioblastoma or patients with recurrent glioblastoma not previously treated with TTFields. Patients may have undergone surgical resection or biopsy. Residual tumor, absence of treatment with temozolomide or radiation therapy will not be an exclusion criteria for the study. Exclusion Criteria: Patients previously treated with TTFields will not be included in the study. Patients will also be excluded if they are undergoing active treatment with systemic agents, including bevacizumab, during treatment with TTFields.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glioblastoma<br>Patients with a diagnosis of newly diagnosed or recurrent glioblastoma who have been treated with radiation and temozolomide and are being offered tumor treated fields. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of disease | Clinical or radiographic disease progression | Until discontinuation of tumor treating fields, progression or death. This will be evaluated by imaging and clinical exam from the time of trial enrollment until up to 36 months at approximately three-month intervals. |
Effects of Romantic Affection on Blood Chemistry and Immune Parameters

Study Overview
=================
Brief Summary
-----------------
This trial tests the hypothesis that increasing nonverbal affection in romantic relationships will improve blood lipid parameters (total cholesterol, high and low density lipoproteins, triglycerides), blood glucose, and immune parameters (C-reactive protein and antibodies to latent Epstein-Barr virus). 52 healthy cohabiting romantic couples took part. In half of the couples, one partner increased the frequency of romantic kissing with the other partner during the six-week trial. The other couples received no such instruction. Blood tests performed before and after the trial were used to assess the health outcomes.

Official Title
-----------------
Study of the Effects of Romantic Affection on Blood Lipids, Blood Glucose, C-Reactive Protein, and Antibodies to Latent Epstein-Barr Virus

Conditions
-----------------
Stress, Hypercholesterolemia

Intervention / Treatment
-----------------
* Behavioral: Romantic kissing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years of age; English-speaking; Current co-habitation with romantic partner Exclusion Criteria: History of hypercholesterolemia; Current pregnancy; Current use of blood-thinning agents; Greater than moderate anxiety about giving capillary blood; Weight of less than 110 pounds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Romantic kissing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study on Bladder and Sexual Function Change After Simple Hysterectomy

Study Overview
=================
Brief Summary
-----------------
To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring after simple hysterectomy and to analyze the influence of bladder symptoms and sexual function change on quality of life of patients.

Official Title
-----------------
Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy

Conditions
-----------------
Benign Uterine Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who is planed to undergo simple hysterectomy due to benign uterine disease Uterine leiomyoma Uterine adenomyosis Endometrial hyperplasia Cervical intraepithelial neoplasia (including carcinoma in situ, FIGO stage IA1 cancer) Dysfunctional uterine bleeding Other benign uterine disease requiring hysterectomy Exclusion Criteria: Patients who are taking medication for overactive bladder Patients who underwent incontinence surgery due to urinary incontinence Acute or chronic infectious disease of urinary tract Neurologic disease causing urinary abnormality Previous pelvic radiation therapy Patients who are undergoing incontinence surgery with hysterectomy Pregnant woman

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Simple hysterectomy group<br>Patients will undergo simple hysterectomy due to benign uterine disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bladder symptoms |  | within 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern change of bladder symptoms after surgery |  | Baseline and within 6 months after surgery | 
| Sexual function change |  | Baseline and within 6 months after surgery | 
| Quality of life |  | within 6 months aftr surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder symptoms, Sexual function, Quality of life, Simple hysterectomy
Effect of Empagliflozin on Body Composition and Ketones

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).

Detailed Description
-----------------
Sodium-glucose cotransporter-2 (SGLT2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. However, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. The purpose of this study is to evaluate changes of body composition induced by SGLT2 inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).

Official Title
-----------------
Decrease in Body Fat and Increase in Ketone Body After 6-month Treatment of Empagliflozin in Korean Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Fat; Intolerance, Pancreas

Intervention / Treatment
-----------------
* Drug: Empagliflozin 10 MG
* Drug: Hypoglycemics Oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45 Exclusion Criteria: Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI < 20 kg/m2 eGFR < 45 Malignancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor | Drug: Hypoglycemics Oral<br>* dose escalation of hypoglycemics oral<br>* Other names: Oral antidiabetic medication escalation;|
| Experimental: Study group<br>addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents | Drug: Empagliflozin 10 MG<br>* addition of empagliflozin 10 MG<br>* Other names: SGLT2 inhibitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | glycemic control | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical parameters | Ketone body concentration | 6 months | 
| Body weight | Weight change | 6 months | 
| Body fat | fat change | 6 months | 
| Systolic and diastolic blood pressures | blood pressure change | 6 months | 
| Lipid profile | Triglyceride | 6 months | 
| Insulin resistance | HOMA-IR | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sodium-glucose transporter 2 inhibitor
Salivary Cortisol in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
In critical illness, patients are highly stressed and should have elevated cortisol (stress hormone) secretion to adapt to stress. Dysfunction of this system is referred to as critical illness-related corticosteroid insufficiency. Free cortisol (unbound form) which is mainly responsible for its physiologic function is difficult to measure. We hypothesized that the salivary cortisol, which can be obtained by noninvasive methods, can more accurately evaluate adrenal function of critically ill patients.

Official Title
-----------------
Association of Salivary Cortisol Levels and Outcome of Critically Ill Patients in the Intensive Care Unit

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Other: Salivary cortisol test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who agreed to participate Exclusion Criteria: Known adrenal or pituitary disease oral bleeding currently on systemic or inhaled corticosteroids

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 |
| --- | --- |
| MICU patients<br> | Other: Salivary cortisol test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU days |  | 28 days | 
| ventilator-free days |  | 28 days |
Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail

Study Overview
=================
Brief Summary
-----------------
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic nasopharyngeal carcinoma

Conditions
-----------------
Recurrent and Metastatic Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: nedaplatin and gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs. Exclusion Criteria: allergic to nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nedaplatin combined with gemcitabine<br> | Drug: nedaplatin and gemcitabine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 years |
Pediatric Distal Radius US Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound will be compared to x-ray diagnosis under routine conditions in the investigator's injury and fracture treatment evening clinic. Data will be collected and recorded during the duration of the 12 week study. Through the literature review and experience with ultrasound, the investigators anticipate that diagnostic ultrasound will provide very high sensitivity and specificity in diagnosing distal radius fractures in children.

Official Title
-----------------
Pediatric Distal Radius US Study

Conditions
-----------------
Distal Radius Fractures

Intervention / Treatment
-----------------
* Device: Diagnostic Ultrasound
* Radiation: X-ray imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patient with a wrist injury. Exclusion Criteria: Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 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 |
| --- | --- |
| Diagnostic ultrasound and radiographic imaging<br>- The diagnostic musculoskeletal ultrasound and x-rays will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis. | Device: Diagnostic Ultrasound<br> <br> * Other names: Sonosite Ultrasound;Radiation: X-ray imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Fracture | Diagnostic ultrasound will be used to determine if the bones do or do not have a fracture. Fractures will be based on the presence or absence of cortical disruption or irregularity on the ultrasound. | Duration of office visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic ultrasound