linjc16/ctgov huggingface dataset:
Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

Study Overview
=================
Brief Summary
-----------------
No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

Detailed Description
-----------------
Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Official Title
-----------------
PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.

Conditions
-----------------
Locally Advanced Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Pancreatic resection after preoperative chemotherapy
* Procedure: Pancreatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of pancreatic cancer Preoperative chemotherapy Pancreatic resection Exclusion Criteria: Metastatic disease ASA score 4

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preoperative chemotherapy (PCHT)<br>Patients who underwent pancreatic resection after PCHT. | Procedure: Pancreatic resection after preoperative chemotherapy<br>* Pancreatic resection after preoperative chemotherapy<br>|
| Active Comparator: Control<br>Patient who underwent pancreatic resection without preoperative therapy | Procedure: Pancreatic resection<br>* Pancreatic resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity rate |  | Postoperative. From 0 to 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative mortality |  | Postoperative. From 0 to 30 days after discharge | 
| Length of hospital stay (LOS) |  | Postoperative. From 0 to 30 days after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, neoadjuvant chemotherapy
Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics

Study Overview
=================
Brief Summary
-----------------
adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and evaluating care.

Detailed Description
-----------------
During the intervention period, the pharmacist attended daily unit rounds with ICU intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative services were also available by phone calls 24 hours x 7 days if needed. For every patient surgical prophylactic antibiotic initiated immediately before surgery and continued for 48 hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed therapy was defined as treatment of a documented infection based on culture and sensitivity. Empiric therapy was defined as any antibiotic therapy administered when no documented infection was present, and the patient had clinically suspected infection following surgery. Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics had given after exclusion of allergy by history and intradermal sensitivity test.

Official Title
-----------------
Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Other: Clinical pharmacy sharing in the patient care regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all admitted patients to the ICU between age 18-80 years old Exclusion Criteria: Patient admitted for less than 24 hours (including deaths and transfers) will be excluded from the study. Pediatric patients weighted less than kilograms.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Group c<br>Patients admitted from June 9, 2020 to june 31, 2021. | Other: Clinical pharmacy sharing in the patient care regimen<br>* antibiotic regimens will be directed by a trained clinical pharmacist recommendation and supported by intensivist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotics consumption | consumption will be counted as number of defined daily doses (DDD), expressed as DDD per 100 patient-days | 1 year | 
| Average length of stay | the average number of days that patients spent in SICU. | 1 year | 
| Mortality rate | The number of deaths of patients admitted to SICU, divided by the number of admissions. | 1 year |
ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

Study Overview
=================
Brief Summary
-----------------
HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.

Detailed Description
-----------------
Procedures in all patients: Digital anorectal evaluation Colonoscopy with retroflection and visualization of the anal squamocolumnar junction After identification of this area 5% acetic acid will be applied. Visualization under NBI/BLI. Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).

Official Title
-----------------
PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)

Conditions
-----------------
AIN3, AIN2, HSIL, High Grade Squamous Intraepithelial Lesions

Intervention / Treatment
-----------------
* Procedure: Detection of anal HSIL in a routine colonoscopy.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-positive patients Solid transplanted recipients Crohn's disease patients under immunosuppression: steroids, thiopurines, biologics Patients with lupus under immunosuppression Women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva. Exclusion Criteria: Previous anal/perianal cancer history Previous known history of anal/perianal intraepithelial neoplasia Pelvic radiation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Detection of anal HSIL in a routine colonoscopy.|Detection of anal HSIL in a routine colonoscopy by using acetic acid and NBI/BLI.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy. |  | through study completion, an average of 3 years |
Effect of Casodex on Tumour Hypoxia - Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.

Official Title
-----------------
A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: hypoxia measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project informed consent Exclusion Criteria: Coagulopathy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypoxia measurement<br>Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy | Procedure: hypoxia measurement<br>* transrectal oxygen measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours | Trans-rectal ultrasound and measurement of tumor oxygenation | 8 weeks | 
| Correlate level of tumor oxygenation with PSA level | PSA test (ug/L) | 8 weeks | 
| Correlate level of tumor oxygenation with hemoglobin level | hemoglobin test (g/L) | 8 weeks | 
| Correlate level of tumor oxygenation with prostate volume | prostate volume measurement | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study of the effect of neoadjuvant anti-androgen therapy on prostate tumour histopathology and gene expression, and correlation of these effects with changes in oxygenation. |  | 8 weeks |
Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to analyze the effects of strength training on sleep quality and daytime sleepiness in institutionalized adolescents (14 to 19 years of age). Thirty-one adolescents were randomly assigned in two sample groups: intervention group (IG, n = 19) and control group (CG, n = 12). Anthropometric measures were performed (height and body mass) and BMI was determined. Sleep quality and daytime sleepiness were assessed using the questionnaires, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESE), and total sleep time by accelerometer. Physical training (2x / week) was performed for 12 weeks. The OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES) scale was used to control the effort intensity and the exercises followed an alternate pre-follow-up.

Official Title
-----------------
Effect of Strength Training on the Quality and Duration of Sleep and Daytime Sleepiness of Institutionalized Adolescents: A Randomized Study

Conditions
-----------------
Adolescent Behavior, Sleep Disorder

Intervention / Treatment
-----------------
* Behavioral: Physical training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Institutionalized adolescents (14 to 19 years of age) Exclusion Criteria: refuse to participate, incomplete evaluation

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 |
| --- | --- |
| Experimental: Intervention group<br>Physical training (2x / week) was performed for 12 weeks | Behavioral: Physical training<br>* Physical training (2x / week) was performed for 12 weeks<br>|
| No Intervention: Control Group<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality | improvement in Pittsburgh Sleep Quality Index (PSQI) | 12 weeks | 
| Daytime sleepiness | improvement Epworth Sleepiness Scale (ESE) | 12 weeks |
Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: single trans-septal puncture
* Procedure: conventional bilateral groin puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients agreement of consent Patients who age more than 19 patients who undergoing catheter ablation of atrial fibrillation Patients who are not vascular disease Exclusion Criteria: patients who do not agree with study inclusion persistent AF Patients with vascular disease or venous anomaly Patients with structural abnormality of the heart

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single puncture group<br>single trans-septal puncture | Procedure: single trans-septal puncture<br>* The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.<br>|
| Active Comparator: conventional group<br>conventional bilateral groin puncture | Procedure: conventional bilateral groin puncture<br>* Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's subjective discomfort |  | 6month after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time |  | 1day | 
| Procedure related complication rate |  | 1 month after procedure | 
| Long-term AF recurrence rate |  | 12 month after procedure |
An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Official Title
-----------------
An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)

Conditions
-----------------
Non Small Cell Lung Cancer, Cancer of the Head and Neck

Intervention / Treatment
-----------------
* Drug: ZD1839


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have received at least one course of standard systemic chemotherapy or radiation therapy Are ineligible for chemotherapy or radiotherapy Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H&NC Are, in the investigators opinion, not medically suitable for chemotherapy. Exclusion Criteria: Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients. Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission Incomplete healing from prior oncologic or other major surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ZD1839|250mg administered daily for patients with NSCLC and500mg daily for patients with H&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H&NC will take two tablets at each dose administration.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Progression of Untreated Pulmonary Ground Glass Opacity

Study Overview
=================
Brief Summary
-----------------
In this study, about 2000 GGO patients will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion and provide evidence for GGO treatment.

Official Title
-----------------
Progression of Untreated Pulmonary Ground Glass Opacity

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

Intervention / Treatment
-----------------
* Other: No intercention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35-80 years' old found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains Diameter of GGO > 5mm and < 3cm Solid component of GGO in pulmonary window < 5mm signed informed consent form Exclusion Criteria: receiving immunosuppressor or steriods receiving chemo- or radio- therapy can not receive regular follow-up

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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 |
| --- | --- |
| pulmonary GGO<br>Patients with pulmonary GGO. | Other: No intercention<br>* No intercention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline GGO diameter | Changes from baseline GGO diameter | 6 months, 1year, 2 years, 3 years, 4 years and 5 years | 
| Changes from baseline GGO CT index. | Changes from baseline GGO CT index. | 6 months, 1year, 2 years, 3 years, 4 years and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ground glass opacity