linjc16/ctgov huggingface dataset:
Lactobacillus Brevis CD2 Preventing Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT. Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.

Official Title
-----------------
A Pilot Study on the Efficacy of Lactobacillus Brevis CD2 Lozenges in Preventing Oral Mucositis by High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Mucositis

Intervention / Treatment
-----------------
* Drug: Lactobacillus brevis CD2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65 years Karnofsky Performance Score ≥ 70%. Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy Patients eligible to receive high-dose chemotherapy as part of conditioning regimen Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on) Serum creatinine < 1.8mg/dl Total bilirubin < 2mg/dl Liver enzymes within three times of normal limit Expected survival > 6 months. Exclusion Criteria: Pregnant women and lactating mothers Patients with history of HIV infection Patients who have taken any other investigational product in last 4 weeks Patients having untreated symptomatic dental infection Patients with WHO Grade 3 or 4 oral Mucositis Other serious concurrent illness Inconclusive hematological diagnosis Patients with signs and symptoms of systemic infections Patient's/guardian's refusal to sign informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus brevis CD2 lozenges<br> | Drug: Lactobacillus brevis CD2<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis |  | days -14;-7; 0;+7;+14;+21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM |  | days -14;-7; 0; +7;+14; +21 |
N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

Study Overview
=================
Brief Summary
-----------------
The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation. Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.

Detailed Description
-----------------
Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment. The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.

Official Title
-----------------
Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2

Conditions
-----------------
Non-small-Cell Lung Carcinoma, Surgery, Stage IIIA-N2, Chemoradiation, Survival

Intervention / Treatment
-----------------
* Other: Overall survival


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IIIA (N2) disease Potentially resectable disease Stage Lung Cancer with CT scan or PET-CT. N2 involvement: it is not necessary pathological proof. No progression after induction treatment. Exclusion Criteria: T4 or N3 stage. Bulky disease or not resectable.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemoradiation Group<br>Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (>/= 60 Gy) plus Platinum-based Chemotherapy | Other: Overall survival<br>* Compare overall survival between both groups.<br>|
| Neoadjuvant treatment plus Surgery Group<br>Analyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus >/= 45Gy) followed by Surgery | Other: Overall survival<br>* Compare overall survival between both groups.<br>|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 5 years | 
| Patterns of Relapse |  | 5 years | 
| Mortality |  | 5 years |
Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft

Study Overview
=================
Brief Summary
-----------------
Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

Official Title
-----------------
A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Remodulin in Patients With Critical Limb Ischemia Following an Autogenous Vein Infrainguinal Bypass Graft

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Drug: Remodulin (treprostinil sodium) Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remodulin (treprostinil sodium) Injection|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
-----------------
Critical Limb Ischemia, Autogenous Bypass Graft, CLI
An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Several large adjuvant trastuzumab trials have demonstrated improved overall survival, in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%). At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment. At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as standard of care.

Official Title
-----------------
An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer

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

Intervention / Treatment
-----------------
* Procedure: LVEF 3 month
* Procedure: LVEF 4 month


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed early stage HER2-positive breast cancer Planned trastuzumab therapy for early stage breast cancer ≥18 years of age Able to provide verbal consent Normal LVEF (>53%) before trastuzumab therapy Exclusion Criteria: • Contraindication to transthoracic echocardiography or MUGA

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LVEF 3 month<br>cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months | Procedure: LVEF 3 month<br>* cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months<br>|
| Active Comparator: LVEF 4 month<br>cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months | Procedure: LVEF 4 month<br>* cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF results | Changes in LVEF results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy | at year one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac toxicities
Glucose Monitor Accuracy Investigation (Ⅱ)

Study Overview
=================
Brief Summary
-----------------
According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of fingertips as samples to evaluate the accuracy of portable BGM.

Detailed Description
-----------------
The clinical medical technologists collected blood samples from 319 volunteers including 90 diabetics and 229 healthy people. The range of the blood glucose concentration was from 30.2mg/dL to 577.5mg/dL. The result of clinic evaluation shows that the accuracy of BGM matches the requirement of ISO15197(2003).

Official Title
-----------------
Glucose Monitor Accuracy Investigation (Ⅱ)

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteers with diabetes and non-diabets Exclusion Criteria: hypertension,fever,AIDS,hemophilia

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| glucose |  | 10 min |
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

Official Title
-----------------
A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Telbivudine (LdT)
* Drug: Adefovir Dipivoxil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B Detectable serum HBsAg at the Screening visit Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding. Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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 |
| --- |
|Drug: Telbivudine (LdT)|nan|
|Drug: Adefovir Dipivoxil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Desflurane and Propofol on Quality of Recovery in Patients Undergoing Robotic or Laparoscopic Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether propofol can improve quality of recovery compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy.

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Drug: Desflurane
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged over 20 yrs who are scheduled for laparoscopic or robotic gastrectomy, ASA 1 or 2. Exclusion Criteria: patients with allergy to anesthetic agents body mass index more than 35 kg/m2 pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desflurane<br>Anesthesia is maintained with desflurane during surgery. | Drug: Desflurane<br>* Anesthesia is maintained with desflurane in Desflurane group according to the randomly allocated groups.<br>|
| Experimental: Propofol<br>Anesthesia is maintained with propofol during surgery. | Drug: Propofol<br> <br> * Other names: Anesthesia is maintained with propofol in Propofol group according to the randomly allocated groups.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery | The quality of recovery will be assessed with QoR-40 score. | Within 24 hours after the end of surgery |
Asthma Control and Clinical Practice in Hungary 2009

Study Overview
=================
Brief Summary
-----------------
A prospective study led amongst pulmonologists. Patients asthma control level will be evaluated based on GINA guideline criteria. HRQoL measured by Visual analogue scale. Clinical practice: non controlled patients therapy assessed.

Official Title
-----------------
Asthma Control and Clinical Practice in Hungary 2009

Conditions
-----------------
Asthma Control Level

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma patients treated with ICS or bronchodilators Exclusion Criteria: COPD pulmonary cancer pulmonary tuberculosis

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 |
| --- | --- |
| 1<br>Asthmatic patients above 18 y, treated with ICS or bronchodilators | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control level |  | 3 times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | 3 times | 
| Routine Therapeutical habits in control maintenance |  | 3 times | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma control level, visual analogue scale
Abatacept Pregnancy Exposure Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth.

Official Title
-----------------
Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: No Interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Currently pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants Exclusion Criteria: Women who come in first contact with the project after prenatal diagnosis of a fetal abnormality
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant RA patients with abatacept exposure during pregnancy<br> | Drug: No Interventions<br>* No Interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major structural birth defects of newborns |  | Throughout pregnancy and up to 1 year of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 or more minor structural defects |  | at dysmorphological exam | 
| Spontaneous abortion |  | throughout pregnancy | 
| Premature delivery |  | throughout pregnancy | 
| Small for gestational age |  | at birth | 
| Postnatal growth deficiency |  | throughout pregnancy and up to 1 year of life | 
| Postnatal serious infections, hospitalizations or malignancies |  | 1st year of life |
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia

Conditions
-----------------
Hypertriglyceridemia, Hyperlipoproteinemia Type IV

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Fredrickson Type IV Hypertriglyceridemia Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDL-C and non-HDL-C levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of other lipid and biomarkers. |  |  |