linjc16/ctgov huggingface dataset:
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.

Official Title
-----------------
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: rectal resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria patients with a histologically proven low rectal adenocarcinoma, no previous or synchronous colorectal disease, UICC stage I-III patients who underwent neoadjuvant chemoradiotherapy or chemotherapy, followed by total mesorectal excision (TME), and a complete pathological response defined as ypT0N0 Exclusion Criteria: - all patients with metastatic tumors or missing 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

| Intervention/Treatment |
| --- |
|Procedure: rectal resection|total mesorectal excision|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence rate | A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease. | From date of surgery until the date of first documented local progression assessed up to 100 months | 
| Distant recurrence rate | A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease. | From date of surgery until the date of first documented distant progression assessed up to 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors of disease free survival | Disease free survival was defined as the period between the day of surgery and the date of recurrence or the last date of follow-up | From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low rectal cancer, Neoadjuvant treatment, Complete pathological response, ypT0N0, disease free survival, Predictive factors
Assessing Movement Disorder Patients P1A4

Study Overview
=================
Brief Summary
-----------------
Non-randomized data collection, excepting participants completing the Implanted DBS Structured Data Collection, who will be randomized to one of two conditions.

Detailed Description
-----------------
Patients with movement disorders, for example Parkinson's disease (PD), essential tremor (ET) and dystonia, will be assessed using appropriate clinical and (sensor) quantified measures in order to obtain quantitative and qualitative data that is not consistently obtained in clinical exams. This data will aid in assessing trends and outcomes in motor and non-motor signs, side effects and symptoms that correlate with deep brain stimulation (DBS) lead location, stimulation parameters, and other variables, for those that have received this treatment, in order to inform neurosurgical and neurological practices aimed at optimizing treatment and therapy for movement disorders. For those patients that have received DBS lead implant(s), this study will include the analysis of patient's clinical and/or research-related intraoperative neurophysiological recordings collected during the microelectrode recording portion of the DBS lead implant surgery. Additionally, researchers may analyze trends and outcomes by gathering data from retrospective and prospective chart review

Official Title
-----------------
Assessing Movement Disorder Patients

Conditions
-----------------
Movement Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia Aged: 10+ Exclusion Criteria: History of dementia Patients with post-operative complications or adverse effects that affect patient safety or confound the experiment will be excluded from further study. Pregnant women Lactating women

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale | pre-to-post DBS lead implantation changes in sign and symptom severity | 6 months | 
| Burke-Fahn-Marsden Dystonia Rating Scale | pre-to-post DBS lead implantation changes in sign and symptom severity | 6 months | 
| Tremor Research Group Essential Tremor Rating Scale | pre-to-post DBS lead implantation changes in sign and symptom severity | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dystonia, Parkinsons disease, essential tremor
An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

Study Overview
=================
Brief Summary
-----------------
This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.

Official Title
-----------------
An Observational Cohort Study of Treatment Patterns and Outcomes in Patients With HER2 Positive (HER2+) Metastatic Breast Cancer (SystHERs Registry (Systemic Therapies for HER2+ Metastatic Breast Cancer Study)).

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years of age Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment Availability of cancer-specific historical data points in the patient's medical records Exclusion Criteria: Any inability to provide informed consent

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> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of patients receiving unique treatment regimen/sequence of treatment regimens |  | Up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | Up to 8 years | 
| Overall survival (OS) |  | Up to 8 years | 
| Post-progression survival (PPS) |  | Up to 8 years | 
| Time-to-treatment failure (TTF) |  | Up to 8 years | 
| Response rate (RR) |  | Up to 8 years | 
| Safety: Incidence of adverse events |  | Up to 8 years | 
| Patient-reported outcome assessment (PRO) |  | Up to 8 years |
Alcohol Consumption and Stress at Patients Alcohol-dependants

Study Overview
=================
Brief Summary
-----------------
This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.

Detailed Description
-----------------
This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving.

Official Title
-----------------
Alcohol Consumption and Stress at Patients Alcohol-dependants

Conditions
-----------------
Alcohol Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Males or Females aged 18-65 years Alcohol use disorder defined by DSM 5 criteria Fluent in French Hospitalized for alcohol withdrawal for at least 7 days Viable (working) telephone number Exclusion criteria: Participants without social care insurance Any DSM Axis I disorder not defined in the inclusion criteria Mandatory psychiatric treatment

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stress and craving<br>This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress level | correlation between stress and alcohol related craving using a prospective ecological design | 3 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic association with stress level | Correlation between stress and alcohol related craving using a prospective ecological design stratified for CRHR1 variant | 3 weeks follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress- correlation, alcohol dependence, genetic, CRHR1
Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease (PHARM-ageing)

Study Overview
=================
Brief Summary
-----------------
A registry study on drug therapy and clinical outcomes in elderly patients with coronary heart disease

Official Title
-----------------
Registry Study of Pharmacotherapy and Clinical Outcomes in Elderly Patients With Coronary Heart Disease

Conditions
-----------------
Elderly Patients, Coronary Heart Disease, Drug Therapy, Clinical Outcomes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent has been signed Patients diagnosed in our hospital with coronary heart disease Age ≥65 years Exclusion Criteria: Severe lack of important information such as history of previous medication, history of previous disease, history of surgery. Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| main adverse cardiovascular and cerebrovascular events (MACCE) | MACCE will be defined as all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reaction | Adverse drug reaction will be defined as any adverse reactions in the patients | up to 3 years |
Multiplex Analysis of Circulating Tumor DNA

Study Overview
=================
Brief Summary
-----------------
Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients

Detailed Description
-----------------
Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying. Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.

Official Title
-----------------
The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients

Conditions
-----------------
Lung Neoplasm, Carcinoma, Non-small-cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent and consent to participate in this study; Found small nodules in pulmonary by CT and prepare for surgery; Exclusion Criteria: Malignant tumor history within the past 5 years; Receiving chemotherapy, radiotherapy or targeted therapy before surgery; No matching tissue or blood samplesUnqualified blood samples Lesion is pure ground glass opacity.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer |  | 12 months | 
| The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection |  | 36 months | 
| Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early diagnosis, Surveillance, Methylation, Circulating Tumor DNA, Somatic mutation
Effectiveness of Modafinil in Improving Cognitive Performance of University Students

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether modafinil is effective in the improvement of mnesic performance and executive functions of university students from high academic performance.

Official Title
-----------------
Effectiveness of Modafinil in Improving Mnesic Performance and Executive Functions of University Students From Careers of High Academic Performance

Conditions
-----------------
Memory, Short-Term, Attention, Executive Function

Intervention / Treatment
-----------------
* Drug: Modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medicine, Psychology, Obstetrics, Nursing and Kinesiology students of the Universidad de Valparaiso. Exclusion Criteria: Patients with Mental Disorders. Patients with physical diseases. Patients using any psychotropic substances. History of chronic diseases. Pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control Group | Drug: Modafinil<br>* Modafinil 200mg<br>* Other names: Modafinilo;|
| Experimental: Modafinil 200mg<br>Modafinil 200mg taken orally. | Drug: Modafinil<br>* Modafinil 200mg<br>* Other names: Modafinilo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Correct Answers in Biber Cognitive Estimation Test |  | 2 hours after pill ingestion | 
| Average response latency in Stroop Effect test |  | 2 hours after pill ingestion | 
| Average Score in Digit Span test |  | 2 hours after pill ingestion | 
| Average Score in Backwards Digit Span test |  | 2 hours after pill ingestion | 
| Average percentage of correct answers in Stroop Effect test |  | 2 hours after pill ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biber Cognitive Estimation Test, Modafinil, Memory, Executive Functions, Memory, Short-Term, Attention, University Students, Stroop Effect, Digit Span, Backwards Digit Span
Simvastatin in Patients With Isolated Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether combined therapy with simvastatin and hypotensive drugs (ACEI or ARB) may decrease the blood pressure. Moreover, we would like to assess the influence of isolated hypertension on endothelial injury, and on the development of atherosclerosis.

Detailed Description
-----------------
Hypertension is one of the most important predictors of cardiovascular diseases (CVD). Due to the fact that hypertension frequently coexists with hypercholesterolemia and diabetes which increase the risk of CVDs development, it is advisable to use the optimal combined therapy (hypotensive + hypolipidemic + hypoglycemic)in this group of patients. Statins are the most effective and widely used drugs for the treatment of hypercholesterolemia. According to the available experimental and clinical data they may decrease the blood pressure (BP) in normotensive and hypertensive patients. However, it is still difficult to determine to what degree the reduction of both blood pressure and cardiovascular risk is due to hypotensive or hypolipidemic/pleiotropic effects of statins.

Official Title
-----------------
Simvastatin in the Treatment of Isolated Arterial hyPertension and Prevention of cARdiovascular Events

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated hypertension (I or II class according to ESH guidelines 2009) Exclusion Criteria: ischemic heart disease, prior percutaneous coronary intervention (PCI), prior coronary artery bypass grafting (CABG), heart failure, diabetes, hyperlipidemia, active smokers

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 |
| --- | --- |
| statin treatment, isolated hypertension<br>treatment with statins, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking | |
| placebo treatment, isolated hypertension<br>treatment with placebo, patients with isolated hypertension, with no hyperlipidemia, no diabetes, no smoking | |

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
-----------------
statins, isolated hypertension, atherosclerosis, lipid profile
Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in a change in patient management.

Official Title
-----------------
A Post-authorization, Observational Study to Assess the Impact of Blue Light Cystoscopy After Administration of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer.

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Hexaminolevulinate (Hexvix)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age. Patients of either sex. Patients with documented or highly suspected non-invasive bladder cancer. Exclusion Criteria: Patients with hypersensitivity to the drug substance or any excipient of Hexvix. Patients with porphyry. Women of childbearing age. Patients at a high risk of suffering extensive bladder inflammation e.g. patients after intravesical BCG treatment, patients with moderate or severe leukocyturia or patients undergoing recent bladder surgery.

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

| Intervention/Treatment |
| --- |
|Drug: Hexaminolevulinate (Hexvix)|Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. | Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®. | Day 0 (Post contrast administration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level. | The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy. | Day 0 (Post contrast administration) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder, Cancer, Cystoscopy, Hexaminolevulinate, Hexvix