linjc16/ctgov huggingface dataset:
Integrative Analysis of CRC Liver Metastasis

Study Overview
=================
Brief Summary
-----------------
The investigators will perform integrative analysis of CRC liver metastasis

Detailed Description
-----------------
The investigators will analyzed proteomes of paired normal colorectal tissues and colorectal cancer (CRC) with or without liver metastasis, sequenced transcriptomes, performed whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal colorectal tissue, primary colorectal carcinoma, and its synchronous matched liver metastasis, as well as analyzed genomics of CRC characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Official Title
-----------------
Integrative Analysis of CRC Liver Metastasis

Conditions
-----------------
Metastasis

Intervention / Treatment
-----------------
* Other: normal colorectal tissues


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 75 years with histologically proven CRC No severe major organ dysfunction WHO performance status of 0 or 1 No prior cancer chemotherapy Exclusion Criteria: Age ≥ 76 Severe major organ dysfunction World Health Organization (WHO) performance status of >1 Prior cancer chemotherapy

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal colorectal tissues (PN)<br>normal colorectal tissues | Other: normal colorectal tissues<br>* The investigators will extract total protein, DNA and RNA from these groups.<br>* Other names: liver metastasis tissues;|
| primary colorectal carcinoma tissues<br>primary colorectal carcinoma tissues | Other: normal colorectal tissues<br>* The investigators will extract total protein, DNA and RNA from these groups.<br>* Other names: liver metastasis tissues;|
| liver metastasis tissues<br>liver metastasis tissues | Other: normal colorectal tissues<br>* The investigators will extract total protein, DNA and RNA from these groups.<br>* Other names: liver metastasis tissues;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years disease-free survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRC, liver metastasis
Whole Muscle Exercise Training (WHOLEi+12) in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this RCT is to study the effects of whole muscle training (inspiratory muscle training + aerobic training + muscle resistance training) on muscle power, VO2peak and gas-exchange variables obtained during cardiopulmonary exercise testing, QoL, functional capacity (eg, 6-min walking distance), and maximal inspiratory pressure in patients with pulmonary artery hypertension.

Official Title
-----------------
Exercise Training (WHOLEi+12) in Pulmonary Hypertension

Conditions
-----------------
Exercise Therapy

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed pulmonary hypertension, class II-III NYHA, no syncope in the last 3 months (stable clinical condition) or chronic thromboembolic pulmonary hypertension Exclusion Criteria: Not meeting the above

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Experimental: exercise<br>exercise intervention during 8 weeks | Other: exercise<br>* Exercise training for 8 weeks (aerobic exercise, resistance training and inspiratory muscle training thrice a week)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle power (upper and lower-body) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk distance test |  | 8 weeks | 
| maximal inspiratory pressure (PImax) |  | 8 weeks | 
| Short Form 36-Item Health Survey questionnaire version 2 (SF-36) |  | 8 weeks | 
| Physical activity levels objectively determined with accelerometry |  | 8 weeks | 
| Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT) |  | 8 weeks | 
| Other CEPT variables | Gas-exchange variables at the anaerobic threshold | 8 weeks | 
| NT-ProBNP |  | 8 weeks | 
| Performance in the 5-repetition sit-stand-test (5SST) |  | 8 weeks | 
| Safety assessment | Evaluation of adverse episodes, ie. syncopal/pre-syncopal episodes, severe dyspnea, arrhythmias, asthma, signs of poor peripheral perfusion or central nervous symptoms (ataxia, tremors). These episodes were be reported directly by the study researchers (in the exercise group) and by a telephone interview every 2 weeks in all participants. | 8 weeks |
COVID-19 - SARS-CoV-2 Community Contamination in Children and Adults - Impact of Variants (Dyn3CEA - Nosocor Phase 2)

Study Overview
=================
Brief Summary
-----------------
Unlike other respiratory viruses such as influenza and RSV where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of CoV2-CoRSA infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.

Official Title
-----------------
Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults - Impact of Variants

Conditions
-----------------
Infection Viral

Intervention / Treatment
-----------------
* Other: Review of medical file
* Other: Phone call interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Children hospitalized in the Pediatric department of the Hospices Civils de Lyon with PCR positive for a variant of the historical SARS-CoV2, 2) Adults hospitalized in the the Hospices Civils de Lyon, for a Covid-19 disease with documented infection by a variant of the SARS-CoV-2 and included in the NOSO-COR study with matching criteria described below. Exclusion Criteria: Any patient suspected of nosocomial infection. Any patient death during the Covid-19 infection. Any adult patient without children living home. Opposition to participate.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>Hospitalized children, 0 to 17 years of age, 30 subjects, consecutive sample survey, recruitment in quotas of five age ranges. | Other: Review of medical file<br>* Review of medical patient file, including patient tracing, brief summary of the disease course, barrier gestures, social distancing.<br>|
| Adults<br>Hospitalized adults, 18 years and above, 60 matched subjects | Other: Phone call interview<br>* less than 15 minutes phone call<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of possible contaminants, adults, adolescents and children with Covid-19 | To describe the age category of the 1st possible contaminant in the index case to show the preponderance of possible adult and adolescent contaminants in the SARS-Cov-2 contamination. Primary endpoint: Percentage of possible contaminants, adults, adolescents and children, in matched children and adults with Covid-19. | At inclusion |
LUME BioNIS: a Biomarker Study in Patients With NSCLC

Study Overview
=================
Brief Summary
-----------------
At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of this NIS is to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict OS in NSCLC patients eligible for treatment with Vargatef®. The investigations in this study are exploratory in nature and considered to be hypothesis generating. The results from these investigations may help to expand our understanding of the disease and the response to Vargatef®.

Detailed Description
-----------------
Purpose:

Official Title
-----------------
A Non-interventional Biomarker Study in Patients With Non-Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumour Histology Eligible for Treatment With Vargatef® According to the Approved Label.

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age = 18 years. Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma. Signed and dated written informed consent. Vargatef ® is initiated and administered in accordance with the SPC. Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or at re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5µm thickness). Exclusion criteria: Any contraindication to Vargatef® or docetaxel as specified in their respective labels. Vargatef® initiated more than 7 days prior to inclusion in this NIS. Patients participating simultaneously in a clinical trial.

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 |
| --- | --- | --- |
| Number of Participants With Overall Survival (OS) Event | Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS [days] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) [days] = date of last contact when the Patient was known to be alive - date of treatment start + 1. | From start of entering the study until death or last contact date, up to 42 months. |
An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.

Official Title
-----------------
An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Degarelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient Has completed the 000006 trial Exclusion Criteria: Has been withdrawn/discontinued from the 000006 trial.

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

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

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: Degarelix<br> | Drug: Degarelix<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of patients with Adverse Events (AEs) |  | Baseline to Month 26 | 
| Change in ECG parameters |  | Baseline to Month 26 | 
| Change in body weight and vital signs |  | Baseline to Month 26 | 
| Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis) |  | Baseline to Month 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in testosterone levels |  | Baseline to Month 26 | 
| Change in prostate-specific antigen (PSA) levels |  | Baseline to Month 26 | 
| Cumulative probability of no PSA failure | PSA failure is defined as two consecutive (at least two weeks apart) increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either trial 000006 or trial 000006A) | Baseline to Month 26 |
Closed Loop Insulin Therapy in Type 1 Diabetics Based on Blood Microdialysis, Online Sensors and an eMPC Algorithm

Study Overview
=================
Brief Summary
-----------------
The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose. It is the aim of this study to evaluate the feasibility to establish glycaemic control in type 1 diabetic subjects over a period of 30 hours by manually combining these three - previously tested - subsystems (ABS System, extracorporeal online glucose sensor and a laptop-based computer algorithm).

Official Title
-----------------
An Open, Mono-centre Pilot Study to Investigate a Novel Technique to Establish Glycaemic Control for Critically Ill Patients, Tested in Type 1 Diabetic Subjects for a Period of 30 Hours.

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent obtained before any trial-related activities Age of analysable subjects in the range from 18 to 65 years Type 1 diabetes (Treatment with multiple daily injection for more than 12 months) Exclusion Criteria: Severe acute and/or chronic diseases Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation Taking of any vasoactive substances or anticoagulation medication. Diseases of the skin which could interfere with application of the catheters. Pregnancy or breastfeeding Bleeding disorder Known heparin allergy or heparin intolerance

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood microdialysis, glucose monitoring, glucose control, automated blood sampling, online-sensor, algorithm, type 1 diabetes
Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy

Study Overview
=================
Brief Summary
-----------------
There are no solid treatment guidelines for idiopathic intractable epilepsy in children. The investigators propose that vitamin C being an antioxidant will improve seizure frequency and EEG in children with idiopathic intractable epilepsy.

Detailed Description
-----------------
Is vitamin C; being an antioxidant based on the hypothesis of oxidative stress as a provocation factor for idiopathic epilepsy low in those with idiopathic epilepsy, and is it lower in those with refractory than those with newly diagnosed? Will vitamin C supplementation for 1 month be efficient to raise the vitamin C level and will it improve seizures and EEG findings in those with idiopathic epilepsy?

Official Title
-----------------
Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy

Conditions
-----------------
Idiopathic Epilepsy

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal neuroimaging Exclusion Criteria: Developmental delay. Suspected metabolic problems.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin C supplemented<br>patients with refractory idiopathic epilepsy will receive vitamin C supplement according to age for 1 month | Dietary Supplement: Vitamin C<br>* those who are 2-3 years will receive 400 mg/day, 4-8 years will receive 500 mg/day, those who are 9-13 years will receive 1000 mg/day, and from 14-16 years will receive 1500 mg/day<br>|
| No Intervention: None supplemented<br>followed up for 1 month | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure severity and frequency, EEG findings | Seizure severity based on the Chalfont seizre severity scale and daily seizure frequency will be measured before and 30 days after vitamin C supplementation in children with intractable idiopathic epilepsy | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin C level in children with epilepsy | children with epilepsy will be recruited over a period of 6 months and we will measure vitamin C level in their blood | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin C, convulsions status, EEG, children
Biological Aspects of Depression and Antidepressant Drugs

Study Overview
=================
Brief Summary
-----------------
This study will be measuring changes in depressive symptoms over a 7 week time period. Double-blind placebo controlled trial using the pharmacologic agents Paroxetine or Desipramine.

Official Title
-----------------
Biological Aspects of Depression and Antidepressant Drugs

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: paroxetine
* Drug: Desipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of major depressive disorder Ham-D Score > 18 English speaking with ability to read and sign an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paroxetine|nan|
|Drug: Desipramine|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
-----------------
Depression