linjc16/ctgov huggingface dataset:
Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers

Study Overview
=================
Brief Summary
-----------------
Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET, topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class III tubulin. These targets have been chosen because they are targets for chemotherapeutic agents that are currently used in clinical management of these diseases. In total 50 specimen will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt to establish a correlation between the pre-selected tumor markers and response to chemotherapy, and thus to be able to create a clinically useful classification that would provide clinical guidance for selection of the most effective chemotherapy for a individual patient, and thus be able to logically design more effective clinical trials for the future.

Official Title
-----------------
Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed lung cancer who received standard platinum-containing doublet chemotherapy followed by EGFR tyrosine kinase inhibitors. Exclusion Criteria: non
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer
Long Term Outcomes Of Hybrid Percutaneous Approach

Study Overview
=================
Brief Summary
-----------------
Bioresorbable vascular scaffolds (BVS) are considered as a new revolution in coronary intervention due to their potential advantages for long term follow up. However, current generation BVS have also some drawbacks that restrict the use for complex lesions. Using BVS and drug eluting stents (DES) together -implanting DES for BVS inappropriate segments -may be a feasible option to avoid the disadvantages of permanent foreign body and to reduce very late adverse events. In this context, we investigated the clinical outcomes following treatment with hybrid strategy with concomitant use of BVS and DES for complex lesions. A single center retrospective cohort was performed enrolling 40 patients with complex lesions treated with hybrid approach from February 2015 up to April 2017. Lesion segments with a large plaque burden and/or severe calcification, aorto-ostial and bifurcation lesions that may be unfavorable for BVS, treated with DES. BVS and DES were implanted with minimal overlap of DES and BVS struts. The primary end-point was target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization (TLR). During follow-up, coronary angiography was performed when patients had ischemic symptoms.

Official Title
-----------------
Long Term Outcomes Of Hybrid Percutaneous Intervention With Bioresorbable Vascular Scaffolds And Drug Eluting Stents For Complex Coronary Artery Lesions

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

Intervention / Treatment
-----------------
* Procedure: hybrid percutaneous intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treated with BVS in combination with DES Exclusion Criteria: treated with only DES or BVS
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hybrid percutaneous intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion failure | a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioresorbable vascular scaffold
A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Official Title
-----------------
A Phase 2B, Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging, Multicenter Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: pramlintide acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening. Usually consumes at least three major meals (morning, midday, and evening) each day. Exclusion Criteria: Is currently enrolled in a formal weight-loss program. Has had liposuction within 1 year before screening or is planning to have liposuction during the study. Has received any investigational drug within 3 months before screening. Has previously participated in a study using pramlintide.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Pramlintide Acetate<br> | Drug: pramlintide acetate<br> <br> * Other names: Pramlintide acetate injection (Pramlintide (0.6 mg/mL)) is a clear, colorless, sterile solution for SC injection;|
| Placebo Comparator: Placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of pramlintide on body weight in obese subjects |  | Approximately 16 weeks | 
| To examine the safety and tolerability of pramlintide in obese subjects |  | Approximately 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters |  | Approximately 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, weight loss, Amylin, pramlintide, Symlin
Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.

Study Overview
=================
Brief Summary
-----------------
From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).

Detailed Description
-----------------
A retrospective monocentre study of medical data (clinical, histological, molecular and imaging) contained in the medical records of patients operated on for Grade II or III incident glioma.

Official Title
-----------------
Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.

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

Intervention / Treatment
-----------------
* Other: Retrospective analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject 18 years of age or older, having been informed of the research Subject operated on with an incident glioma of grade II or III, histologically confirmed (WHO 2016 classification) Subject for which all preoperative imaging data is available (MRI, FDG and FDOPA PET-scan) Subject for which molecular data of the lesion are available Exclusion Criteria: Subject having signified his opposition to the use of his medical data Subject under safeguard of justice, guardianship or trusteeship Subject with incomplete or missing part of the molecular and/or imaging data

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 |
| --- | --- |
| Cohort<br>Retrospective cohort | Other: Retrospective analysis<br>* Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome | Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI). | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular profile | Evaluate the overall survival and progression-free survival of patients based on the molecular profile of gliomas. | 4years | 
| Imaging data | To evaluate the overall survival and progression-free survival of patients based on imaging data (PET-scan and MRI) of gliomas. | 4 years |
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Detailed Description
-----------------
Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Official Title
-----------------
A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-type KRAS With and Without Detectable EGFR Expression

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

Intervention / Treatment
-----------------
* Drug: Cetuximab, irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal adenocarcinoma, Wild KRAS, 18-75 yr Estimated life expectancy of more than 3 months ECOG performance status of 0 to 1 at study entry Adequate bone marrow function Adequate liver function Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit Informed Consent Exclusion Criteria: Central nervous system (CNS) metastases or prior radiation for CNS metastases. Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study. Evidence of gastrointestinal bleeding Exposure to Cetuximab Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment KRAS mutant Status Patients with serious toxicity to previous irinotecan-based chemotherapy Other serious illness or medical conditions

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: EGFR expression<br>Patients' accrual will be adjusted by EGFR expression (positive vs. negative) | Drug: Cetuximab, irinotecan<br>* cetuximab, irinotecan<br>* Other names: PharmDx kit for EGFR staining.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival, overall survival |  | every 8 weeks |
Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.

Official Title
-----------------
Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the New-Drug Re-examination

Conditions
-----------------
Hidradenitis Suppurativa (HS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant who are eligible to be treated with adalimumab for HS in accordance with the approved Korean label Participant must provide written authorization form to use their personal health data prior to the participating in the study. Exclusion Criteria: Participant who are contraindications to adalimumab as listed on the approved Korean label. Participant who is participating on other clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Participants with Hidradenitis suppurativa (HS)<br>Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing adverse events | Adverse event information is collected to assess prevalence of safety. | Up to 70 days following the last administration of Humira® | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Dermatology Life Quality Index (DLQI) | DLQI will be collected to evaluate effectiveness of adalimumab. DLQI has 10 quality of life domains scored from 0 (no effect) to thirty (very large effect). | Week 0 (baseline), Week 12, and Week 24 | 
| Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR) | The HiSCR measure is designed to assess treatment response in a binary manner, rather than being a continuous or ordinal scale. It includes a count of the total number of abscesses and inflammatory nodules (ANs), as well as recording the number of sinuses draining purulent fluid present in an individual. Treatment responders are defined as those who achieve at least a 50% reduction in ANs, with no increase in the number of abscesses or draining sinuses, relative to baseline. | Week 0 (baseline), Week 12, and Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adalimumab, Safety, Hidradenitis Suppurativa, Korean participants
Quality of Life in Juvenile Patients With Uveitis

Study Overview
=================
Brief Summary
-----------------
Data about psychodynamics in uveitis patients are scare. A negative impact of disease is described not only in adult patients with active, but also with quiescent disease. During adolescence even less is known about psychodynamics although this is an especially sensible and challenging stage of life. Given the assumption that juvenile patients with quiescent disease still could suffer from emotional distress, this would require special attention. In this study the investigators evaluate the impact of juvenile uveitis on HRQoL and attempted to identify clinical and demographic factors contributing to an impaired health status. The investigators limit the study to patients with quiescent uveitis and good visual function in at least one eye to exclude additional negative stressors. As there are no validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the investigators use age-appropriate generic instruments. This should allow obtaining an overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether psychological interventions should be offered to this sensitive patient group.

Official Title
-----------------
The Impact of Uveitis on Health-related Quality of Life in Adolescents

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

Intervention / Treatment
-----------------
* Other: Filling in a psychometric questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with uveitis aged 11-18 years willing to participate parent or legal guardian agrees with participation of adolescent Exclusion Criteria: not willing to participate parent or legal guardian does not agree with participation of adolescent

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum 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 |
| --- | --- |
| females, males<br>females: patients of female sex males: patients of male sex | Other: Filling in a psychometric questionnaire<br>* Juvenile patients attending the uveitis are asked to fill in a psychometric questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as assessed with the Inventory for Assessing the Quality of Life in Children and Adolescents | psychometric inventory | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as assessed with the Children Quality of Life Questionnaire | psychometric inventory | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood uveitis, health-related quality of life, gender
Lorazepam-Induced Toxicity in the Aged

Study Overview
=================
Brief Summary
-----------------
This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).

Detailed Description
-----------------
GAD is among the most common anxiety disorders in the elderly population. The drug lorazepam is widely utilized in the treatment of elderly individuals with GAD. However, single doses of lorazepam have been associated with cognitive toxicity that is typically evident between 1 and 2.5 hours after the drug is administered. The toxic effects include decreased memory and increased swaying, which has been associated with greater risk for falls. Patients have 4 study visits. A psychiatric evaluation and a memory test are given at the first visit. During the second study visit, patients have a physical exam, an electrocardiogram (ECG), a neuropsychological assessment, an optional magnetic resonance imaging (MRI) brain scan, and other laboratory tests. On the third and fourth visits, patients are randomized to receive either their highest daily dose of lorazepam or placebo. Performance effects and postural sway are determined before drug administration and at 1, 2.5, and 5 hours after the drug is given. Blood samples for the determination of drug levels are also obtained.

Official Title
-----------------
Long-Term Lorazepam Use and Acute Toxicity in the Aged

Conditions
-----------------
Anxiety Disorders, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Lorazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lorazepam treatment for at least 3 months Cognitively intact Note: Individuals who are unable or unwilling to have an MRI may be included Exclusion Criteria: Major psychiatric disorder other than GAD Significant medical illness which may increase the likelihood of adverse reactions to lorazepam Severe loss of hearing or vision Current or past history of alcohol dependence Substance abuse within the past 6 months MRI evidence of infection, infarction, or other lesions suggestive of intervening neurological disease Clinical symptoms that suggest neurological disease Dementia or other mental syndromes or disorders

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lorazepam|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
-----------------
Anxiety