linjc16/ctgov huggingface dataset:
Iressa Case Control Study in Japan

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment

Official Title
-----------------
A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens. Patients who are to be treated with gefitinib or chemotherapy Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study Exclusion Criteria: Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort
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 |
| --- | --- | --- |
Transcriptomic Study of IBD-associated Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Chronic inflammatory bowel disease (IBD) is associated with an increased risk of colorectal cancer (CRC) in historical cohorts. The pathways of oncogenesis of these CRCs, which are very different clinically from de novo CRCs, are currently unknown. The aim of our work is to identify specific molecular signatures of CRC occurring in the setting of IBD.

Official Title
-----------------
Transcriptiomic Analysis of Inflammatory Bowel Disease-associated Colorectal Cancer. A French Retrospective Study of 26 Cases Identified at the Nancy University Hospital

Conditions
-----------------
Colorectal Cancer, Genetics of

Intervention / Treatment
-----------------
* Genetic: transcriptomic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person 18 years of age or older Person with colorectal cancer in the context of IBD Person who has received complete information on the organization of the research and who has signed an informed consent Person affiliated to a social security plan or beneficiary of such a plan. Exclusion Criteria: Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code: Pregnant woman, parturient or nursing mother Minor (not emancipated) Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Person of legal age who is unable to express his or her consent Person deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: transcriptomic analysis|transcriptomic analysis on preserved tumor tissue|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBD associated CRC oncogenesis | Percentage of gene expression variation in CRC tumor tissue samples in the following groups patients with CRC and IBD | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory bowel disease
Non-Pharmacologic Patient Centered Pain Control Adjuncts During First Trimester Abortion

Study Overview
=================
Brief Summary
-----------------
This study will examine the use of non-pharmacologic pain control techniques and pain-management counseling as an additional tool for reducing pain during first trimester aspiration abortion.

Official Title
-----------------
Non-Pharmacologic Patient Centered Pain Control Adjuncts During First Trimester Abortion

Conditions
-----------------
Pregnancy Termination, Pain Management

Intervention / Treatment
-----------------
* Behavioral: Non-pharmacologic pain control adjuncts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking, able to read and understand consent form Age 18 + (minors eligible with parental consent) Seeking in-office aspiration termination of pregnancy Gestational age less than 14 weeks Exclusion Criteria: Not able to read or understand English Unable to understand consent Minors without parental consent Requesting narcotic or sedative analgesics Currently incarcerated Gestational age greater than 14 weeks Seeking medication abortion

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients in this group will participate in pain management counseling and choose non-pharmacologic pain control supports to use during their procedure in addition to the standard of care pain management offered in the office | Behavioral: Non-pharmacologic pain control adjuncts<br> <br> |
| No Intervention: Control group<br>Patients in this group will receive standard of care pain management offered in the office. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in overall pain score during procedure between control and intervention group | Patients will complete a visual analog scale to score their overall pain for the procedure. | Collected within 1 minute of procedure completion |
Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients regardless of the degree of iron overload. There is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.

Official Title
-----------------
Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C

Conditions
-----------------
Beta Thalassemia Major

Intervention / Treatment
-----------------
* Dietary Supplement: Spirulina


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multitransfused beta thalassemic children with and without super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction. Exclusion Criteria: liver decompensation child younger than 3 years patients with hepatitis B infection implantable cardiac device failure to obtain transient elastography (Fibroscan) results

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thalassemic children with hepatitis C<br>30 multitransfused beta thalassemic children infected with hepatitis C virus diagnosed by serological detection of HCV-antibodies and HCV RNA by polymerase chain reaction will be given Spirulina in a dose of 250 mg/kg/day orally for 3 months. | Dietary Supplement: Spirulina<br>* Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.<br>|
| No Intervention: thalassemic children without hepatitis C<br>30 multitransfused beta thalassemic children without hepatitis C virus infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver stiffness measurement using transient elastography (Fibroscan) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver function tests |  | 3 months | 
| aspartate aminotransferase to platelet ratio index (APRI) |  | 3 months |
Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to I. determine several skin parameters, for example natural moisturizing factor (NMF) and cholesterol, with Raman spectroscopy in vivo and II. compare the results with the corresponding cholesterol levels measured in venous blood.

Detailed Description
-----------------
In vivo Raman experiments will be carried out weekly on voluntary participants using a RiverDiagnostics gen2-SCA Skin Composition Analyzer (RiverDiagnostics, Rotterdam, Netherlands). All experiments will be carried out on the volar forearm. Semi-quantitative concentration profiles for several skin parameters will be determined, for example natural moisturizing factor (NMF) and cholesterol. Additionally the total cholesterol level will be detected by venous blood sample analysis. The blood samples will be taken weekly within two weeks, similar to the Raman measurements.

Official Title
-----------------
Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters - A Pilot Study

Conditions
-----------------
Dermatologic Disorders, Disorder of Cholesterol Metabolism

Intervention / Treatment
-----------------
* Procedure: Venous blood collection
* Procedure: Raman spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of subject informed consent Female or male aged between 18 and 65 years Exclusion Criteria: Pregnancy Chronic skin conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proband group<br>Raman spectroscopy and venous blood collection | Procedure: Venous blood collection<br>* weekly within two weeks<br>Procedure: Raman spectroscopy<br>* weekly within two weeks, on the volar forearm, using a RiverDiagnostics gen2-SCA Skin Composition Analyzer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the fasting total cholesterol levels measured in skin with confocal Raman spectroscopy and in venous blood collected by venipuncture |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration curves of various skin substances, such as NMF, urea and water as evidence for the eligibility of confocal Raman spectroscopy for the in vivo measurement of skin |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin parameters, cholesterol, Raman spectroscopy
Bifeprunox in the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia. Extension to study S154.3.001.

Official Title
-----------------
An Open-Label, Flexible-Dose, Long-Term Safety and Efficacy Study of Bifeprunox in the Treatment of Schizpohrenia (Extension of S154.3.001)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of schizophrenia, understand nature of study, able to be managed in out-patient setting for long-term bifeprunox treatment Exclusion Criteria: current primary diagnosis other than schizophrenia, suicide risk, diagnosis or history of substance abuse, uncontrolled hypertension

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


Arms and Interventions

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

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
-----------------
open-label study in the treatment of schizophrenia
Quality of Life After Surgery for Pancreatic Carcinoma

Study Overview
=================
Brief Summary
-----------------
Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured.

Official Title
-----------------
Quality of Life After Surgery for Pancreatic Carcinoma

Conditions
-----------------
Patients Suspected for a Pancreatic (Pre-)Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a suspected pancreatic malignancy eligible for surgery with curative intent being able to complete questionnaires in Dutch age >=18 years Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Health-related quality of life | To assess the influence of pancreatic surgery for patients with a pancreatic malignancy on health-related quality of life | 2 years |
The Prevalence of Sympathetic Overactivity in Primary Hypertensive Patients.

Study Overview
=================
Brief Summary
-----------------
The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients with newly diagnosed essential hypertension.

Detailed Description
-----------------
MC MD

Official Title
-----------------
A Non Interventional, Cross Sectional, Study on the Prevalence of Sympathetic Overactivity in Hypertensive Patients.

Conditions
-----------------
Essential Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed essential hypertension patients will be eligible for the study. Average of two or more systolic BP readings ≥ 140mmHg or diastolic BP readings ≥ 90mmHg Exclusion Criteria: History of coronary artery disease History of diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Prevalence of SO in newly diagnosed hypertensive patients |  | Visit 1-3: heart rate & Blood pressure, treatment presribed by physician. The interval between visit 1 and visit 2 is upto 4 weeks and interval between visit 2 & visit 3 is upto 4 weeks depending on Investigators discretion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of SO and heart rate. |  | Visits 1-3 | 
| Subjective symptoms noticed by the doctor. |  | 1st visit | 
| To record the drugs used in the treatment of patients diagnosed with hypertension. |  | Visits 1-3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The prevalence of sympathetic overactivity in hypertensive patients.
38 Week Extension Study to CAIN457C2303

Study Overview
=================
Brief Summary
-----------------
A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy

Official Title
-----------------
A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy (SHIELD Study)

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: AIN457
* Drug: AIN457
* Drug: Placebo AIN457


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: AIN457 300 mg every 2 weeks<br> | Drug: AIN457<br>* 300mg every 2 weeks<br>|
| Experimental: AIN457 300 mg monthly<br> | Drug: AIN457<br>* 300mg every 4 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo AIN457<br>* Placebo to AIN457<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. | The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section . | 62 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uveitis
Intraoperative Dexamethasone and Its Effect on Hyperglycemia

Study Overview
=================
Brief Summary
-----------------
To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients.

Official Title
-----------------
Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Other: No dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented history of Type I or Type II Diabetes Mellitus scheduled for surgery that requires patients to be admitted for at least 24 hours post-surgery Exclusion Criteria: Patients on steroid therapy Pregnant women Patients at low risk for nausea/vomiting

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br> | Drug: Dexamethasone<br>* Gluco-corticosteroid<br>Other: No dexamethasone<br>* Nothing<br>|
| No Intervention: Non-treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative blood sugar |  | 24 hour Post surgery |
Transplant Patient Registry of Liver, Kidney and/or Pancreas

Study Overview
=================
Brief Summary
-----------------
This is a registry of data collected from patient records, both of those who have a condition which may require transplantation and those who have undergone transplantation of the liver, kidney and/or pancreas.

Detailed Description
-----------------
Honest Broker arrangement.

Official Title
-----------------
Transplant Registry: Patients Who May Require Transplantation and Those Who Have Undergone Transplantation of Liver, Kidney and/or Pancreas

Conditions
-----------------
End Stage Renal Disease, End Stage Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients followed in the transplant clinic at Virginia Commonwealth University Health System
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 |
| --- | --- | --- |
| Data collection and maintenance | MAINTAIN A CURRENT, ACCURATE DATA BASE OF TRANSPLANT RECIPIENTS WITH REGARDS TO TRANSPLANT DATA AND OUTCOMES. | Ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transplant, transplantation of liver, kidney, pancreas