linjc16/ctgov huggingface dataset:
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Imipenem/Cilastatin For The Treatment Of Subjects With Nosocomial Pneumonia

Conditions
-----------------
Bacterial Pneumonia

Intervention / Treatment
-----------------
* Drug: Tigecycline
* Drug: Imipenem
* Drug: Cilastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age. Subjects known or suspected to have acute hospital-acquired pneumonia. Exclusion Criteria: Presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by Pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (Subjects with COPD are not excluded) Suspected or known Legionella infection Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tigecycline|nan|
|Drug: Imipenem|nan|
|Drug: Cilastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia
The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain

Study Overview
=================
Brief Summary
-----------------
Non-specific cronic low back pain is very common condition affecting 30-50% of adults. It is featured by neck muscles contractures which lead to pain and reduction of cervical spine mobility. High intensity laser therapy has been shown to be an effective treatment to improve symothoms in patient with non-specific neck pain. The aim of this study is to assess the effects of a multi-wave locked system laser therapy in patient with non-specif neck pain.

Official Title
-----------------
Pilot Study on the Effects of MLS (Multiwave Locked System) LASER Therapy in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial Versus Placebo

Conditions
-----------------
Chronic Non-specific Neck Pain

Intervention / Treatment
-----------------
* Other: Laser therapy
* Other: Sham laser therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic low back pain (> 3 months) Body mass index < 30 Preserved cognitive ability to fully understand and observe indications received by medical personnel Ability to understand and give an informed consent Exclusion Criteria: Spine surgery Spinal hernia spondylolisthesis Spinal infections Severe spine deformities Neural diseases Upper limbs radiculopathy Cervical rib Rotator cuff or other shoulder diseases Rheumatic diseases Diabetes Psychiatric diseases Vascular diseases Cancer Infectious diseases Skin abrasion Pregnancy or breastfeeding Recent injuries Known sensibility to Laser therapy Epilepsy Anticoagulant therapy Pacemaker hemorrhagic diathesis Photosensitizing drugs Known Photosensibility Neck Tattoos

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser therapy<br>Multiwave locked system laser therapy | Other: Laser therapy<br>* Multiwave locked system laser therapy<br>|
| Placebo Comparator: Sham laser therapy<br>Sham laser therapy | Other: Sham laser therapy<br>* Sham laser therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neck pain | Eleven point (0-10) visual analogue scale | Change from baseline neck pain at 3 and 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disability | Neck disability index questionnaire | Change from baseline disability at 3 and 7 weeks |
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.

Detailed Description
-----------------
OUTLINE: This is a multi-center study. Sample Collection: Tumor sample Serum sample Treatment Regimen: All registered patients must be planning treatment with lonafarnib

Official Title
-----------------
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study

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

Intervention / Treatment
-----------------
* Procedure: Tumor Sample
* Procedure: Serum Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Age > 18 years. Planned treatment with lonafarnib for metastatic breast cancer. Must consent to have a biopsy performed to obtain fresh tissue or be able to identify a formalin fixed paraffin embedded (FFPE) tissue block in which tumor samples can be obtained to complete the testing for this study. Exclusion Criteria: Planned treatment with any other treatment regimen

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 |
| --- | --- |
| Tumor and Serum Collection<br>Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block. Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib. | Procedure: Tumor Sample<br>* Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.<br>Procedure: Serum Sample<br>* Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate serum and tumor proteomic profiles with response to lonafarnib |  | 24 months | 
| To compare serum and tissue proteomic analyses |  | 24 months | 
| To compare genomic and proteomic profiles |  | 24 months | 
| To correlate toxicity and /or response with drug-specific pharmacogenomic parameters |  | 24 months |
Effect of Nafamostat on Postreperfusion Syndrome (PRS)

Study Overview
=================
Brief Summary
-----------------
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.

Official Title
-----------------
Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft

Conditions
-----------------
Liver Transplantation, Postreperfusion Syndrome

Intervention / Treatment
-----------------
* Drug: Nafamostat
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 year old scheduled to undergo liver transplantation Exclusion Criteria: Previous history of pulmonary, cardiovascular, or renal disease Previous history of allergic reactions to nafamostat

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nafamostat<br>The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft. | Drug: Nafamostat<br>* 0.2 mg/kg as bolus 1 minute before reperfusion<br>|
| Placebo Comparator: Control<br>The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft. | Drug: Normal saline<br>* 10 ml of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS) | Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. Moderate PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a severe form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs. | during 5 min after reperfusion of liver graft |
New Markers for Treatment Response to Radiotherapy in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The actual follow-up of patients undergoing definite radiotherapy for prostate cancer includes regular measurements of prostate specific antigen (PSA). Successful radiotherapy is critically dependent on local control of cancer; however, PSA takes 2-3 years to reach a nadir after therapy. We aim at collecting blood/urine after prostate massage before, and after radiotherapy in order to define new markers predicting local control earlier and more precisely than PSA.

Detailed Description
-----------------
Patients will be closely followed for 5 years (weeks 0, 2, 4, 6, and months 2, 3, 6, 9, 12, 18, 24, and then yearly). Each assessment includes PSA measurement, urine collection after prostatic massage, and blood collection.

Official Title
-----------------
New Markers for Treatment Response to Radiotherapy in Prostate Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing radiotherapy of biopsy confirmed clinically localised adenocarcinoma of the prostate Exclusion Criteria: patients with inflammatory processes of the rectum patients with no rectum due to previous surgery

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

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

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 |
| --- | --- | --- |
| Bio-repository |  | first assessment using predifined markers after recruitment of 15 patients followed for 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy, markers
Heart Rate Variability in Extracorporeal Membrane Oxygenation (ECMO) Patients

Study Overview
=================
Brief Summary
-----------------
National Taiwan University Hospital is the leading center for care of patients with extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes are still lacking in patients with the ECMO support. The aim of this study is to collect the electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability, including linear and non-linear analysis is calculated to address the association with outcomes of patients with ECMO. In addition, we collected the demographics, body temperature, respiratory rate, and blood pressure to investigate the causes of heart rate variability.

Detailed Description
-----------------
Inclusion criteria:Adults patients (aged older than 18 years; less than 90 years old) used ECMO for cardiopulmonary support Exclusion criteria: Patients used illicit drugs Patients received heart transplantation Patients have the history of arrhythmia

Official Title
-----------------
Clinical Application of Multimodal Physiological Signal Analysis in Critical Ill Patients Depending on Extracorporeal Membrane Oxygenation

Conditions
-----------------
Heart Rate Variability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients (aged > 18 years; less than 90 years old) used ECMO for cardiopulmonary support Exclusion Criteria: Patients used illicit drugs Patients received heart transplantation Patients have the history of arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart rate variability, extracorporeal membrane oxygenation
Epidemiology of Depression and Heart Failure in Aging

Study Overview
=================
Brief Summary
-----------------
To understand how depression leads to congestive heart failure (CHF) in older adults.

Detailed Description
-----------------
BACKGROUND: Depression is known to be associated with an increased risk of coronary heart disease (CHD), and with adverse outcomes among older adults with CHD. Recent evidence suggests that depression is also associated with an increased risk of congestive heart failure, and with adverse outcomes among older adults with congestive heart failure. However, the mechanisms by which depression leads to congestive heart failure are not known DESIGN NARRATIVE: To determine the mechanisms of association between depression and CHF, the investigators will use an existing cohort of 1024 older adults (mean age 67) with CHD (including 680 with no heart failure and 344 with clinical or subclinical heart failure) who were recruited between September 2000 and December 2002 for The Heart and Soul Study. The Heart and Soul Study was originally designed to understand the mechanism of association between depression and CHD. Since patients with CHD are at high risk for CHF, this well-characterized cohort will provide a unique opportunity to examine the relation between depression and CHF. At baseline, participants completed a depression interview (Diagnostic Interview Schedule); full exercise treadmill testing with stress echocardiography; 24-hour Holter monitoring for heart rate variability; 24-hour urine collection for cortisol and norepinephrine; venous blood measurements for lipids, platelet reactivity, and C-reactive protein; and an extensive questionnaire. Participants have been followed annually by telephone. The investigators will invite all participants to return for a 5-year examination, and will follow them for an additional 3 years thereafter, to determine (a) the independent association between baseline depression and CHF, and (b) the extent to which 5-vear changes in biological and behavioral factors associated with depression explain the relation between depression and CHF. By identifying the mechanisms that explain the relation between depression and CHF, this study will enable them to target specific areas for improving the treatment of these patients.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Heart Failure, Heart Failure, Congestive, Depression, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.

Official Title
-----------------
Department of Cardiology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Conditions
-----------------
Premature Ventricular Contraction

Intervention / Treatment
-----------------
* Procedure: Catheter Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-outflow tract PVCs Holter>10,000/24h or PVCs load>10% the first ablation procedure failure of at least one AAD to treat PVCs before ablation Exclusion Criteria: PVC ablation history HF with NYHA IV 3 months prior to AMI or PCI Cardiac thrombosi Hyperthyroidism Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote magnetic navigation group<br>PVC ablation with RMN | Procedure: Catheter Ablation<br>* Catheter Ablation with RMN and MCN<br>|
| Active Comparator: Mannual control navigation group<br>PVC ablation with mannual navigation | Procedure: Catheter Ablation<br>* Catheter Ablation with RMN and MCN<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom rate of PVC | Efficacy endpoint | one year | 
| Procedure-related Complications | Safety endpoint | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluoroscopic time |  | one day | 
| ablation time |  | one day | 
| procedure time |  | one day |
Enemas Before Elective Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Enemas are not anymore used routinely before vaginal deliveries.The intention of this study is to elucidate whether there is a benefit in routine use of enema before cesarean section.

Official Title
-----------------
Are Enemas Given Before Elective Cesarean Section Useful?

Conditions
-----------------
Complications After Cesarean Section

Intervention / Treatment
-----------------
* Procedure: enema


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean Section, Elective

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section | Procedure: enema<br> <br> |
| Active Comparator: Control Group<br>no preoperative intestinal preparation. | Procedure: enema<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Bowel Sounds | bowel sounds: present | On postoperative day 1 | 
| Number of Participants With Gas Passage | gas passage: present | On postoperative day 1 | 
| Number of Participants Had Spontaneous Feces | occurrence of spontaneous feces | On postoperative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean Section,, Enema