linjc16/ctgov huggingface dataset:
Creon After Pancreatic Surgery

Study Overview
=================
Brief Summary
-----------------
This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA

Official Title
-----------------
One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year

Conditions
-----------------
Pancreatic Insufficiency

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria: Direct or indirect pancreatic function test (except stool fat excretion) and Steatorrhoea: stool fat > 15 g/day (using van de Kamer method) Proven chronic pancreatitis Females of child-bearing potential must agree to continue using a medically acceptable method of birth control Exclusion Criteria Subjects in an unstable situation (catabolic) after pancreatic surgery Ileus or acute abdomen Current excessive intake of alcohol or drug abuse Hypersensitivity vs porcine proteins / pancreatin Subjects taking digestive enzyme preparations have to stop them before start of the run-in period

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Creon<br>* 3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CFA from baseline to the end of double blind treatment |  | 7 days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI |  | 7 days after baseline, and end of open-label period (1 year of open label treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Exocrine Insufficiency After Pancreatic Surgery
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of GH therapy.The assessment by specific questionnaires of quality of life and of parental stress index.Parameters will be evaluated at the time of the diagnosis and after 12 months of GH therapy.

Detailed Description
-----------------
Observational longitudinal study in children affected by idiopathic growth hormone deficiency (GHD): lung function parameters assessment; quality of life assessment; stress parenting assessment (Pneumo GHD). The aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of GH therapy.The assessment by specific questionnaires of quality of life and of parental stress index.Parameters will be evaluated at the time of the diagnosis and after 12 months of GH therapy.

Official Title
-----------------
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD): Lung Function Parameters Assessment; Quality of Life Assessment; Stress Parenting Assessment (Pneumo GHD)

Conditions
-----------------
Growth Hormone Deficiency

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GH deficiency Exclusion Criteria: Respiratory infections 4 weeks before the recruitment Children with autoimmune diseases Therapy with drugs able to modify the lung function

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| GHD Children<br>Treatment with Growth Hormone-Releasing Hormone in children affected by idiopathic growth hormone deficiency (GHD) | Drug: Growth Hormone-Releasing Hormone<br>* From Baseline Visit (T0) to 6th Month Visit 0,025 mg/kg Growth Hormone/die. From 6th Month Visit to 12th Month Visit 0,030 mg/Kg Growth Hormone/die.<br>* Other names: GH;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the developmental patterns of lung function before and after GH by spirometry | Assessment of lung function before and after administration of GH in children with growth hormone deficiency by spirometry | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GHD
Teriflunomide Male Transmission Study

Study Overview
=================
Brief Summary
-----------------
It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be found in low concentrations in semen. Because the drug has been associated with teratogenicity in laboratory animals, the question is raised as to whether the drug can be detected in female partners of sexually active males who are taking the drug to treat their multiple sclerosis.

Detailed Description
-----------------
A total of 10 couples were enrolled in the study. Females partners had undetectable or borderline levels of teriflunomide.

Official Title
-----------------
Assay of Teriflunomide Concentrations in Males Taking Teriflunomide for Treatment of Multiple Sclerosis and Their Female Sexual Partners

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males with relapsing forms of multiple sclerosis appropriately treated with teriflunomide 14 mg po daily; Continuous treatment for three months with good compliance as assessed by the investigator Age between 18 and 55 Penile-vaginal intercourse with a female partner at least twice a month with unimpeded ejaculation. Compliance with safety assessments, e.g., regular bloodwork for complete blood count and liver function testing as recommended in the Package Insert Able to give informed consent Females Regular sexual intercourse with a male partner who is actively taking teriflunomide Age between 18 and 55 Able to give informed consent Negative urine pregnancy test at the time of blood sampling Reliable contraception that does not involve barrier methods Exclusion Criteria: Use of barrier methods of contraception For males, contraindications to the continued use of teriflunomide Couples that are actively trying to conceive For males, noncompliance with teriflunomide therapy Inability or unwilling to give consent or comply with the protocol Pregnancy of the female sexual partner.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Serum levels of teriflunomide in males and their female partners | single laboratory evaluation | Up to one year |
Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation

Study Overview
=================
Brief Summary
-----------------
Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.

Official Title
-----------------
Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation - A Pilot Study on 10 Patients With Histological Assessment

Conditions
-----------------
Bone Augmentation

Intervention / Treatment
-----------------
* Other: block perforation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single tooth gap in need of lateral bone augmentation prior to implant installation Exclusion Criteria: untreated periodontal disease systemic disease and/or medication intake with significant effect on bone healing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 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: block perforation<br> | Other: block perforation<br>* The bone block used for lateral bone augmentation will be perforated several times.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphometry | % of new bone formation | at implant installation (approximately 6 months after augmentation) | 
| Radiographic | Volume gain (mm3) after block augmentation at the buccal aspect | 6 months after block augmentation | 
| Radiographic | Volume gain (mm3) after block augmentation at the buccal aspect | 12 months after block augmentation |
Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism

Study Overview
=================
Brief Summary
-----------------
Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid metabolism, however, whether DFPP can improve platelet function and recover Endothelial function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve endothelial function in hyperlipidemia patients.

Official Title
-----------------
Double Filtration Plasmapheresis (DFPP) Improves Lipid Profile and Platelet Function in Hyperlipidemia Patients

Conditions
-----------------
DFPP and Platelet Function

Intervention / Treatment
-----------------
* Device: DFPP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hyperlipidemia Exclusion Criteria: Severe liver and kidney dysfunction Severe cardiopulmonary insufficiency tumor 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DFPP group<br>self contrast (before and after DFPP) | Device: DFPP<br>* Lipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid levels | reduce in lipid levels | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet RNA sequencing | whether the RNA sequencing of platelet changed ? | 1 year |
Awareness About Breast Cancer Screening

Study Overview
=================
Brief Summary
-----------------
Breast cancer is the most common cancer in French women, with 52000 new cases each year. Shift work and night work is recognized by International Agency for Research on Cancer as a potential risk factor. Epidemiological studies find, for most of them, an increased risk of breast cancer compared with general population. Physiological hypothesis rely on the melatonin role in defense against tumorigenesis. According to High Authority of Health clinical good practice guidelines, the risk does not justify more screening than the organized screening. We do not have information about awareness level of workers in health structures, specially in the Hospices Civils de Lyon. Investigators would like to know how employees take part to breast cancer screening, specially in night workers. This study, as a survey, is a first step to evaluate the need for specific actions to increase the participation to breast cancer screening.

Official Title
-----------------
Study of Awareness of Hospices Civils de Lyon Workers About Breast Cancer Screening

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: employees HCL women Exclusion Criteria: <18 years old

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaire on the level of awareness of this risk among health sector employees, and more specifically the Lyon Civilian Hospices, and on participation in breast cancer screening for HCL employees, particularly among night shift staff.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation of HCL female staff in mammography screening for breast cancer | One question of the questionnaire is about this participation | 5 minutes |
Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors

Study Overview
=================
Brief Summary
-----------------
While performing a primary TKA in consecutive patients, a constrained insert may be necessary when adequate stability and soft tissue balance are not obtained. In this retrospective study, The investigators aim to identify the prevalence and risk factors that associate with the use of a constrained insert in primary TKA.

Official Title
-----------------
Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors

Conditions
-----------------
Constrained Insert in Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: constrained polyethylene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary knee osteoarthritis primary total knee replacement Exclusion Criteria: secondary knee osteoarthritis revision total knee replacement previous knee surgery post-traumatic knee history of previously infection comorbidity;rheumatoid arthritis, connective tissue disease, neuromuscular disease, lumbar spinal stenosis, neuropathy severe osteoporosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: constrained polyethylene|constrained polyethylene insert|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence to use constrained insert in primary total knee arthroplasty | to identify the prevalence that associate with the use of a constrained insert in primary total knee arthroplasty | intraoperative | 
| risk factors to use constrained insert in primary total knee arthroplasty | to identify the risk factors that associate with the use of a constrained insert in primary total knee arthroplasty such as degree of preoperative deformity, degree of preoperative instability | intraoperative |
Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.

Detailed Description
-----------------
Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing. After patients received docetaxel combination thiotepa for two cycles, response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups-sensitive and resistant tumours. The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups Statistical analysis is performed using unsupervised hierarchical cluster.

Official Title
-----------------
Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

Conditions
-----------------
Breast Neoplasms, Neoplasm Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be histologically confirmed with metastatic breast cancer; Patients who had completed the planned chemotherapy regimen with no major protocol violation; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; At least one measurable lesion; Normal cardiac, hepatic, renal and bone marrow functions; Life expectancy ≥3 months; Discontinuity of previous chemotherapy for a minimum of 4 weeks. Exclusion Criteria: previous history of other malignancies; previous surgery history on the needle biopsy organ; Central nervous system metastases; Serious or uncontrolled concurrent medical illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
| Chemotherapy response | Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines | four-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression. | six months | 
| Overall survival | Overall survival is measured from the date therapy is initiated to the date of death or final follow-up. | one year | 
| clinical benefit response | clinical benefit response include CR,PR,SD | six months to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Breast Neoplasms, Gene Expression Profiling, Drug Therapy
Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.

Detailed Description
-----------------
Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.

Official Title
-----------------
Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Conditions
-----------------
Metastatic Liver Cancer

Intervention / Treatment
-----------------
* Radiation: SIRT
* Drug: capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adequate liver function Adequate performance status Exclusion Criteria: Significant extrahepatic disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (SIRT and capecitabine)<br>Patients receive capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo SIRT on day 2 and may undergo a second course of SIRT on day 58. | Radiation: SIRT<br>* Undergo SIRT<br>* Other names: selective internal radiation therapy;Drug: capecitabine<br>* Given PO<br>* Other names: CAPE, Ro 09-1978/000, Xeloda;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer. |  | ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | response rate |