linjc16/ctgov huggingface dataset:
Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation

Study Overview
=================
Brief Summary
-----------------
Patients treated with radiation therapy for lung tumors can experience inflammation after treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in the composition of exhaled breath in patients undergoing radiotherapy. If changes can be detected, this may ultimately serve as biomarkers for identifying patients at highest risk for radiation-induced lung injury (radiation pneumonitis).

Official Title
-----------------
Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation: A Feasibility Study

Conditions
-----------------
Lung Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Exhaled Breath Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of any type of lung tumor Medical recommendation (independent of the study) that the patient undergo thoracic radiation therapy. Radiation therapy may be either fractionated or hypofractionated (i.e. radiosurgery) Age >= 18 years old Any gender and any ethnic background will be recruited Capable of giving written informed consent Exclusion Criteria: Inability of giving written informed consent Pregnancy or breast-feeding

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: Exhaled Breath Sampling|Standard of care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements |  | Every 3 months for 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and post-radiation CO (carbon monoxide), CO2 (carbon dioxide), and N2O (nitrous oxide) measurements and feasibility as the fraction of patients unable to give a breath sample. Adverse events are not expected but any that appear related to the breath |  | 1 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC)
Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

Official Title
-----------------
Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

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

Intervention / Treatment
-----------------
* Radiation: Hypofractionated radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >18 years Histologically confirmed prostate adenocarcinoma Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL Exclusion Criteria: Prior pelvic radiotherapy Anticoagulation medication (if unsafe to discontinue for gold seed insertion) Diagnosis of bleeding diathesis Presence of a hip prosthesis Pelvic girth >40cm - Large prostate (>90cm3) on imaging Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

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: SBRT<br>SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT | Radiation: Hypofractionated radiotherapy<br>* 40 Gy / 5 fractions / 29 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 3+ rectal toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Acute period (<3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 3+ urinary toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Acute (<3 months) and Late (>6 months) | 
| Quality of Life | Expanded Prostate Cancer Index Composite (EPIC) | 5 years | 
| Biochemical (ie. prostate specific antigen) disease free survival |  | 5 year | 
| Incidence of grade 3+ rectal toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Late (>6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatic Neoplasms, Radiotherapy, Hypofractionation, Low and Intermediate Risk Prostate Cancer
Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Detailed Description
-----------------
rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Official Title
-----------------
Phase II Pilot Study of Hyper-CVAD Plus Rituximab for Previously Untreated Mantle Cell Lymphoma

Conditions
-----------------
Mantle Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: modified Hyper-CVAD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated mantle cell lymphoma Exclusion Criteria: Pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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: modified Hyper-CVAD|rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response Rate to Induction Therapy | Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999). | Median follow up of 37 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
untreated mantle cell lymphoma
Effect of Location of Tetanic Stimuli on Photoplethysmogram

Study Overview
=================
Brief Summary
-----------------
The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.

Detailed Description
-----------------
A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order in patients who are under general anesthesia. Tetanic stimuli are used routinely during general anesthesia to assess effectiveness of neuromuscular blockade. These tetanic stimuli are noxious stimuli that elicit a stress response which can be quantified using photoplethysmography. This study investigates if the magnitude of the tetanus induced stress response is dependent on the location of the tetanic stimulus as measured by photoplythysmography.

Official Title
-----------------
Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia

Conditions
-----------------
Stress Reaction

Intervention / Treatment
-----------------
* Device: Tetanic Stimulus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical patients general anesthesia able to consent in english Exclusion Criteria: regional anesthesia unable to consent in english under 18 yrs of age

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

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

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: intervention<br>all participants receive the same intervention | Device: Tetanic Stimulus<br>* 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photoplethysmography (PPG) | Change in the PPG signal in response to tetanic stimulus. A tetanic stimulus will cause vasoconstriction which can be recorded as a decrease in PPG AC/DC. The outcome measure is the maximum decrease in AC/DC from baseline. Maximum decrease happens typically in 30-60 seconds after the stimulus. Thus, data was collected immediately before (baseline) and for 2 min after the stimulus. After the stimulus AC/DC values return to baseline in a few minutes. Baseline AC/DC measures a relative state of blood vessel tone. In anesthetized patients the AC/DC values can range from close to 0 to above 10. The higher the value, the more vasodilated the subject is. | 1-2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
photoplethysmography, stress response
The Use of Optical Oximetry in Determining Gastrointestinal Complications After the Hybrid Procedure

Study Overview
=================
Brief Summary
-----------------
This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Device: Regional saturation monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of single ventricle and undergoing the hybrid procedure pathway. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regional saturation monitor<br>Patients undergoing surgical repair of hypoplastic left heart syndrome. | Device: Regional saturation monitor<br> <br> * Other names: Casmed;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal perfusion |  | Immediate post-op period (24 - 96 hours) |
Association With Spinal Needle-puncture Pain and Menstrual Phase

Study Overview
=================
Brief Summary
-----------------
This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and spinal needle-puncture pain during spinal anesthesia in female patients of reproductive age.

Detailed Description
-----------------
Before the spinal anesthesia procedure, the anxiety and depression levels of the patients will be evaluated with the 14-scale 'hospital anxiety and depression scale.' The spinal anesthesia procedure will be performed by the anesthesiologist responsible for the patient. At the end of the spinal anesthesia procedure, a researcher with no knowledge of the patient's menstrual phase information will ask rate the spinal needle-puncture pain felt during spinal anesthesia with a numerical rating scale (NRS), which is graded from 1 to 10 (0: no pain, 10: very severe pain).

Official Title
-----------------
Does the Menstrual Phase Affect Skin Puncture Pain During Spinal Anesthesia? Prospective, Observational Study

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female volunteers of reproductive age have had a regular menstrual cycle for at least six months Exclusion Criteria: Pregnancy ASA physical status III and IV Patients with psychiatric disorders, Emergency surgeries Mentally retarded patients, Patients with multiple spinal anesthesia trials Patients with previous spinal surgery experience

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spinal needle-puncture pain | A numerical rating scale (NRS) will be used to assess spinal needle-puncture pain during spinal anesthesia, graded from 1 to 10 (0: no pain, 10: very severe pain). | 10 minutes |
Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
Several studies have highlighted the cardioprotective effects of acute normovolemic hemodilution during cardiac surgery. The aim of our study is to show that an increase in endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute normovolemic hemodilution against ischemia-reperfusion phenomena.

Detailed Description
-----------------
The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium. Several studies have demonstrated that acute normovolemic hemodilution before aortic cross clamping decreases perioperative myocardial damage. We hypothesized that the onset of acute anemia increases the endogenous EPO concentration, which explains the cardioprotective effects of acute normovolemic hemodilution.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: acute normovolemic hemodilution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients between 18 and 80 years old undergoing CABG with or without cardiopulmonary bypass Exclusion Criteria: emergencies redo operations combined surgery men with Hb< 120g/dL and women with Hb< 110g/ dL patients with preoperative creatinine> 2.2 mg/dL poor ventricular function (EF < 50%) subjects with a pulmonary disease, hepatic disease subjects with carotid stenosis

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: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo, hemodilution<br> | Procedure: acute normovolemic hemodilution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Troponin -I values |  | 4 h |
Cardiac Allograft Vasculopathy and Dobutamine Stress Echocardiography / Brain Natriuretic Peptide Coupling

Study Overview
=================
Brief Summary
-----------------
Primary purpose :To early detect cardiac allograft vasculopathy and to identify patients with high risk of cardiac events, by coupling the analysis of the kinetics of the brain natriuretic peptide ( BNP) with that of the left ventricle (LV) during a dobutamine stress echocardiography. Hypothesis : Plasma BNP elevation and abnormalities of LV kinetic during the ESD, will be associated with the presence of allograft vasculopathy and the arisen of cardiovascular events.

Official Title
-----------------
Allograft Vasculopathy After Heart Transplantation : Diagnostic Interest of Dobutamine Stress Echocardiography and Brain Natriuretic Peptide Coupling

Conditions
-----------------
Vasculopathy, Allograft

Intervention / Treatment
-----------------
* Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Heart transplant recipients Exclusion criteria: No respect of inclusion criteria Pregnancy Severe renal failure (creatinin clearance < or equal to 30 ml/min) Dobutamine stress echocardiography contraindication

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

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

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 |
| --- | --- |
| Other: Cardiovascular events vs Dobutamine stress echocardiography<br> | Procedure: Dobutamine stress echocardiography, coronarography, brachial arterial echography<br>* DSE: cumulative doses of dobutamine (max = 40 µg/kg/min) and atropine (max = 1.5 mg), to reach a maximal heart rate under clinical, electrocardiographic and echocardiographic surveillancesCoronarography: invasive injection into coronary arteries of a radiological product showing a contrast visible on an x-ray. FMD: Flow-mediated dilatation of the brachial artery induced by 5-min forearm arterial occlusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events vs Dobutamine stress echocardiography each 2 years |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated humeral dilatation each 2 years |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
-Heart Transplant, Allograft Vasculopathy, Dobutamine Stress Echocardiography, Brain Natriuretic Peptide, Vasculopathy
Does Green Tea Affect Postprandial Glucose, Insulin and Satiety in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Green tea consumption could lower the risk of type II diabetes, as suggested by epidemiological studies. There is also evidence from intervention studies that green tea can decrease blood glucose levels and contribute to weight loss. The aim with this study is therefore to examine the postprandial effects of green tea on glycemic index, insulin levels and satiety in healthy individuals after the consumption of a meal.

Detailed Description
-----------------
The study was conducted on 14 healthy volunteers, with a crossover design. Participants were randomized to either green tea or water. This was consumed together with a breakfast consisting of white bread. Blood samples were drawn at 0, 15, 30, 45, 60, 90 and 120 minutes. Participants completed two different satiety scores at the same time intervals.

Conditions
-----------------
Diabetes Type 2, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Diabetes

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose and insulin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial satiety |  |  |