linjc16/ctgov huggingface dataset:
Prophylactic Photodynamic Therapy to Organ Transplant Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate a possible prophylactic efficacy of photodynamic therapy on the incidence of non-melanoma skin cancer, actinic keratoses, warts and keratoses in recently organ transplanted recipients.

Conditions
-----------------
Organ Transplants

Intervention / Treatment
-----------------
* Procedure: Photodynamic Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Organ transplant recipients. Age 40 years or older. Exclusion Criteria: Patients younger than 40 years and older than 70 years. Clinical signs of skin cancer, actinic keratoses or warts at the time of inclusion. Previous photodynamic therapy to the skin areas investigated. Pregnancy or breast feeding patients. Patients with porphyria. Patients with a tendency to produce hypertrophic scars or keloids. Patients with known allergy to Metvix. Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients etc.).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Photodynamic Therapy|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
-----------------
Organ transplant patients receiving immunosuppressive therapy
Constrictive Pericarditis in the Adult Congenital Cardiac Population

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.

Detailed Description
-----------------
Constrictive pericarditis is a notoriously difficult diagnosis to reach. There are no signs, symptoms or pathognomonic diagnostic tests for pericardial constriction. In the adult congenital patients, it is also difficult. In addition, with pulmonary insufficiency, constrictive pericarditis may mask the findings of progressive right sided ventricular dilation and heart failure. The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis. Study Design and Methodology: Retrospective chart review - approximately 15 patients Preoperative data: ECHO and cath findings Operative data: Operative findings Postoperative data: ECHO and cath findings

Official Title
-----------------
Constrictive Pericarditis in the Adult Congenital Cardiac Population

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in the adult congenital heart disease clinic who have been diagnosed or operated on with constrictive pericarditis Exclusion Criteria: those who do not meet the inclusion criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constrictive pericarditis, adult congenital patients, pulmonary insufficiency
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.

Official Title
-----------------
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients with a current or new diagnosis of major depressive episode (MDE) according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR); diagnosis will be confirmed through the Mini International Psychiatric Interview (MINI) questionnaire (depression module) Outpatients starting an antidepressant treatment in monotherapy at baseline (treatment initiation or first treatment switch) as decided by the treating physician The patient will present within the normal course of care, for either a first or subsequent episode of depression Exclusion Criteria: Schizophrenia or other psychotic disorders Bipolar disorder Dementia or other neurodegenerative disease significantly impacting cognitive functioning Mood disorder due to a general medical condition or substances Acute suicidality Patient treated for depression by a combination of different antidepressant treatments at the time of the consultation Other exclusion criteria may apply.

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 |
| --- | --- |
| Major Depressive Disorder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score |  | At baseline | 
| Patients' functioning assessed by the SDS total score |  | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations between the patients' clinical condition measured as score on Clinical Global Improvement Severity scale (CGI-S) and of patients' functioning measured as total score on SDS |  | At baseline | 
| Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS |  | At 12 months | 
| Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS |  | At 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Non-interventional study, Observational study
Estimation of Perioperative Atelectasis

Study Overview
=================
Brief Summary
-----------------
This study will compare an oxygenation test based on arterial blood gas analysis with computed tomography for estimating the extent of atelectasis.

Detailed Description
-----------------
Computed tomography of the lungs is the gold standard for investigating the extent of atelectasis, which is common in the perioperative setting. Atelectasis increase the risk of postoperative pulmonary complications and result in pulmonary shunt, which is one of the two major causes of impaired oxygenation. The other cause is admixture of venous blood from poorly ventilated regions of the lungs. The investigators have developed an oxygenation test utilizing arterial blood gas analysis at different inspired fractions of oxygen, which may be used to distinguish between these two causes. This observational study aims to establish the agreement between computed tomography and the oxygenation test for estimating the extent of atelectasis.

Official Title
-----------------
A Comparison Between Two Methods for Estimating the Extent of Perioperative Atelectasis

Conditions
-----------------
Atelectasis, Oxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology (ASA) class I-II. Non-abdominal day case surgery under general anesthesia. Patients enrolled in study registered in ClinicalTrials with NCT ID. Exclusion Criteria: Arterial oxygen saturation (SpO2) <90 % with 40% Venturi mask. Unstable postoperative condition needing immediate treatment.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Atelectasis area | Atelectasis area as studied by computed tomography | 30 min after emergence from anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary shunt estimated by a standardised oxygenation test | Pulmonary shunt estimated by a standardised oxygenation test using | 30 min after emergence from anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atelectasis, Oxygenation, Venous admixture, Computed Tomography, Oxygenation test
Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Advanced Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The combination of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor has shown efficacy in many cancers.The purpose of this study is to confirm that the combination of these two drugs can benefit patients with advanced esophageal cancer.

Official Title
-----------------
Containing Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Anti-tumor Treatment of Chinese Patients With Unresectable Locally Advanced / Recurrent or Metastatic Esophageal Cancer: a Real World Study

Conditions
-----------------
Esophageal Neoplasms

Intervention / Treatment
-----------------
* Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Esophageal cancer confirmed by histopathology or cytology Unresectable locally advanced/recurrent or metastatic esophageal cancer, or progression after neoadjuvant or adjuvant therapy Esophageal cancer patients who benefit from the use of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor evaluated by the researchers Patients who sign informed consent and voluntarily join the study Exclusion Criteria: Patients who are recommended not using an anti-PD-1/PD-L1 antibody or an angiogenesis inhibitor in the instructions, or other patients who are judged by the investigators to be unsuitable in the study Patients who are undergoing treatment regimen of blind trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor group<br> | Drug: an anti-PD-1/PD-L1 antibody plus an angiogenesis inhibitor<br>* This is an observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | From date of admission until the date of death from any cause, assessed up to 24 months |
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.

Official Title
-----------------
A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

Conditions
-----------------
Colon Cleansing

Intervention / Treatment
-----------------
* Drug: Polyethylene glycol
* Drug: Oral sodium phosphate solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 70 years of age, inclusive Scheduled for colonoscopy within 21 days of the screening visit Able to swallow tablets the size of a multivitamin without difficulty Exclusion Criteria: History of biopsy-proven acute phosphate nephropathy Known allergy or hypersensitivity to treatment arms History of gastric stapling or bypass procedure or history of gastric retention History of any other sodium phosphate preparation within 6 months prior to colonoscopy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OsmoPrep Tablets<br> | Drug: Oral sodium phosphate solution<br>* OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L<br>|
| Active Comparator: HalfLytely and Bisacodyl Tablet<br> | Drug: Polyethylene glycol<br>* HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bowel Prep, Colon Cleansing, Colonoscopy
Antimicrobial Stewardship Reduces MDRO Isolates in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms. Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria detection. However, to the investigators knowledge, there is few data to support the concept that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities. Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly recommended in clinics. As the investigators know, antimicrobial overuse, which occurs commonly in China, induces a severe antibacterial resistance. China's Ministry of Health (MOH) has established a policy about the antimicrobial stewardship. To date, the investigators do not have published documentation the effects of this policy on multidrug-resistant organism (MDRO) in critically ill patients.

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized in the ICU Exclusion Criteria: Patients who were readmitted to the ICU during a single hospital stay
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients before and after intervetion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participates infection or colonization with MDRO in critically ill patients at ICU admission and discharge as a measure of effect of antimicrobial stewardship | MDRO isolation from inclusion to the date of discharge of hospital, access up to 90 days | up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimicrobial stewardship
I-125 Versus Pd-103 for Low Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication. Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Detailed Description
-----------------
Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication. Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy). Methodology: Patients will be randomized by the method of random permuted blocks. Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. Patients with serum PSA above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Official Title
-----------------
I-125 Versus Pd-103 for Low Risk Prostate Cancer

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

Intervention / Treatment
-----------------
* Procedure: Radioactive seed implant to prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males age 40-80 PSA 4-10 Gleason score 5-6 Exclusion Criteria: Lymph node positive

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Radioactive seed implant to prostate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer control (biochemical and survival) |  | final analysis 2008(?) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, cancer, radiation, brachytherapy
Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas

Study Overview
=================
Brief Summary
-----------------
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

Detailed Description
-----------------
High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years

Official Title
-----------------
Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: CEEP regimen
* Procedure: Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged from 15 to 60 years previously untreated histologically proven aggressive NHL high aa-IPI (equal to 3) proper underlying organ function Exclusion Criteria: transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Drug: CEEP regimen|cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals|
|Procedure: Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)|The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4. The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response |  | end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival disease free survival |  | 10 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-dose chemotherapy, aggressive NHL, high-risk, PBSC