linjc16/ctgov huggingface dataset:
Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.

Official Title
-----------------
A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.

Conditions
-----------------
Primary Immunodeficiency (PID)

Intervention / Treatment
-----------------
* Biological: Gammanorm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥ 18 years) Presenting with primary immunodeficiency Having received subcutaneous injections of immunoglobulin at home using an automatic pump for at least 1 month at the time of inclusion For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home Having signed an informed consent form Exclusion Criteria: Patient currently participating in another interventional study at the time of inclusion

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: Gammanorm® 165 mg/mL<br> | Biological: Gammanorm<br>* Sub-Q IgG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Quality Index (LQI) score (factor I: treatment interference) | Primary endpoint for assessment of patient's satisfaction regarding the treatment delivery device (pump or syringe) will be the Life Quality Index (LQI) score (factor I: treatment interference) at the end of each 3-month treatment period. | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Immunodeficiency, PID
Impact of the Diagnosis of Celiac Disease

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess the impact of the diagnosis of celiac disease on general health, healthcare resource utilization, quality of life and lifestyle. We hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these variables.

Detailed Description
-----------------
All new members with biopsy-proven celiac disease joining the Finnish Celiac Society will be categorized in three groups according to symptoms and signs leading to the diagnosis as classical symptoms, extraintestinal symptoms and screen-detected, the latest being further divided to those presenting with symptoms and those who are totally asymptomatic. Several parameters assessing general health and well-being, quality of life and healthcare resource utilization are evaluated at baseline and after one and five years on trial. Quality of life is compared to that of non-celiac controls.

Official Title
-----------------
Impact of the Diagnosis of Celiac Disease

Conditions
-----------------
Celiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis within one year biopsy-proven diagnosis Exclusion Criteria: Celiac disease diagnosis previously than within one year No biopsy-proven diagnosis
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 |
| --- | --- | --- |
| Psychological General Well-Being (PGWB) Index | Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healthcare resource utilization | Healthcare resuorce utilization measured as inpatient and outpatient visits and consumption of other medical services in addition to consumption of pharmaceutical agents | 5 years | 
| Gastrointestinal Symptoms Rating Scale (GSRS) | clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire | 5 years | 
| dietary compliance | self-assessed compliance to the dietary treatment | 5 years | 
| weight | effect of the dietary treatment in the weight of celiac disease patients | 5 years | 
| height | effect of the dietary treatment in the height of children with celiac disease | 5 years | 
| The Short Form (SF-36) Health Survey | Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac disease, Gluten-free diet, Screen-detected, Asymptomatic, Quality of life, Self-perceived health, Healthcare resource utilization
Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin

Study Overview
=================
Brief Summary
-----------------
Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily during the trial.

Official Title
-----------------
Complaints Associated With Use of Pre-Filled Pen B When Used by Patients With Type 2 Diabetes on Twice-Daily Insulin Therapy

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

Intervention / Treatment
-----------------
* Drug: insulin lispro injection [rDNA origin] Low Mix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Already on Lilly insulin or beginning insulin therapy 25 to 75 years old inclusive Exclusion Criteria: Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin lispro injection [rDNA origin] Low Mix|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia |  |  | 
| To assess overall patient perception of the device's performance through a patient questionnaire. |  |  |
Evaluation of Blood Flow Characteristics in Glaucoma Using Optical Coherence Tomography Angiography (OCT-A).

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based Angiography (OCT-A) softwares in the diagnosis and management of glaucoma.

Official Title
-----------------
A Cross-sectional, Prospective, Observational Study to Evaluate Blood Flow Characteristics in Glaucoma Patients Using Optical Coherence Tomography Based Angiography (OCT-A).

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography based Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma. Documented glaucomatous visual field damage (in the previous 12 months with mean defect (MD) > 2.0 dB) Structural and/or functional glaucomatous damage Have given written informed consent, prior to any investigational procedures Exclusion Criteria: Patients with allergy to corneal anesthetic Patients not able to understand the character and individual consequences of the investigation Participation in other clinical research within the last 4 weeks Other diseases that may cause visual field loss or optic disc abnormalities Refractive error of > +3.00D or < -7.00D

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 |
| --- | --- |
| Longitudinal arm<br>Evaluate optic nerve head blood flow using the new OCT-A software in surgically and medically treated glaucoma patients and in different types of glaucoma | Device: Optical Coherence Tomography based Angiography<br>* A contrast-free, noninvasive technology to identify blood vessels in the eye<br>|
| 24-h Intraocular pressure (IOP) arm<br>Evaluate the correlation between circadian IOP changes and optic nerve head blood flow using the new OCT-A software | Device: Optical Coherence Tomography based Angiography<br>* A contrast-free, noninvasive technology to identify blood vessels in the eye<br>|
| Surgery arm<br>Evaluate blood flow using the new OCT-A software in surgically treated glaucoma patients | Device: Optical Coherence Tomography based Angiography<br>* A contrast-free, noninvasive technology to identify blood vessels in the eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular and optic nerve head bloodflow, as measured by OCT-A macular and optic nerve head vessel density (%) |  | Up to 3 years |
Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon

Study Overview
=================
Brief Summary
-----------------
Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.

Official Title
-----------------
Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France

Conditions
-----------------
Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized for abdominal trauma diagnosis of splenic contusion confirmed by scanner or during surgery for hemodynamically unstable cases patient has signed a consent form patient is a beneficiary of or affiliated with a social security program Exclusion Criteria: Refuses to participate Pregnant or breastfeeding Patient under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Number of deceased participants | Mortality | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with certain morbidities | The occurrence of pulmonary, thrombo-embolic, hemorrhagic, pancreatic, splenic and infectious morbidities are recorded. | 3 months of follow up | 
| Days in hospital |  | 1 year of follow up | 
| Direct costs (euros per patient) | Costs are calculated as a function of hospitalisation, surgical procedures, interventional radiology. | 1 year of follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spleen
Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.

Detailed Description
-----------------
This is an open-label study to provide expanded access to TAS-120 prior to its commercial availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements who have failed standard therapy or who are unable to tolerate standard therapy.

Official Title
-----------------
An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Conditions
-----------------
Advanced Cholangiocarcinoma

Intervention / Treatment
-----------------
* Drug: TAS-120


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent. >18 years of age. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory. Patient has failed standard therapy or standard therapy is not tolerated. Has measurable or non-measurable lesion(s). Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Adequate organ function. Exclusion Criteria: History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis. History and/or current evidence of clinically significant ectopic mineralization/calcification. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination. A serious illness or medical condition(s) Pregnant or breast-feeding female

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TAS-120|Futibatinib 20mg QD orally on a 28 days cycle|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib
Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
(MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Detailed Description
-----------------
From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Official Title
-----------------
CT-guided Percutaneous Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: microwave ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unresectable pulmonary metastases from colorectal cancer. diagnosis by CT, and confirmed by percutaneous puncture biopsy. Age range 18-70 years old. Eastern Cooperative Oncology Group performance status 0-1. Life expectancy of more than 3 months. Adequate organ function. Exclusion Criteria: Resectable lung metastases. Life expectancy less than 3 months Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials. Coagulopathy with platelet count less than 50000. Active infectious disease. Age below 18 years. Pregnancy of breastfeeding.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated with microwave ablation<br>Patients undergoing MWA for pulmonary metastases from colorectal cancer. | Device: microwave ablation<br>* pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related adverse events |  | Eight weeks |
Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC

Study Overview
=================
Brief Summary
-----------------
To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.

Detailed Description
-----------------
The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.

Official Title
-----------------
Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Advanced Non-Small Cell Lung Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically proven non-small cell lung cancer no prior chemotherapy or only adjuvant chemotherapy which had been completed >6 months before registration ECOG performance status 0 to 2 measurable lesion(s) normal marrow, hepatic and renal functions provision of written informed consent Exclusion Criteria: active infection or severe comorbidities history of anaphylaxis of any origin

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Safety |  |  |
The Effect of Prednisone on Physical Exercise in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(COPD)

Detailed Description
-----------------
RCT study with 4 days of steroid

Official Title
-----------------
The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis.

Conditions
-----------------
Exercise Performance in Copd Patients

Intervention / Treatment
-----------------
* Drug: prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:FEV1< 60% FEV1/FVC ratio <70 % able to use a ergometer bike Exclusion Criteria: Haemodynamicaly unstable heart conditions exacerbations before 6 week entry of the study exacerbation during the study period treatment with beta blockers malignancy the last 5 years allergi toward IMP

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT study with steroid.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: prednisone and Solumedrol<br>placebo arm versus prednisone | Drug: prednisone<br>* similar size tablets<br>* Other names: placebo;|
| Placebo Comparator: solumedrol<br>placebo versus solu medrol | Drug: prednisone<br>* similar size tablets<br>* Other names: placebo;|
| Other: placebo<br>measurement of fitness | Drug: prednisone<br>* similar size tablets<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on muscle power | muscular strenght | jan 2013 to july 2013 (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the inflammatory response | hsCRP | jan 2013 to july 2013 (6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD exercise inflammation prednisone