linjc16/ctgov huggingface dataset:
To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

Study Overview
=================
Brief Summary
-----------------
To collect clinical response data with the use of ertapenem in approved indications.

Official Title
-----------------
Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy

Conditions
-----------------
Infection, Pneumonia, Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, 20 years of age or older Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment Patients who required therapy prior to identification of cause of infection Exclusion Criteria: Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem Patient has an apache ii > 30. Patient has an infection caused by pathogens resistant to ertapenem Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  |  |
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to detect the presence of autoantibodies and autoantigens in cerebrospinal fluid early (<48 hours) following spinal cord trauma. The study also aims to define the central or peripheral origin of autoantibodies by looking for their simultaneous presence at the blood level and to evaluate the prognostic value of the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial clinical severity than on the recovery potential.

Official Title
-----------------
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma

Conditions
-----------------
Bone Marrow Failure, Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with spinal cord injury dating back less than 48 hours Men or women over 18 years of age Patients benefiting from social protection Surgery performed within 48 hours of the trauma Informed and signed consent by the patient or trusted person Exclusion Criteria: Contra-indication to ensure surgical decompression within the first 48 hours following the trauma Coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery) Severe cranial trauma associated History of autoimmune pathology Immunosuppressive therapy or long-term corticosteroid therapy Patients unable to comply with protocol requirements Person benefiting from legal protection (guardianship / curator) Person deprived of liberty Patient unable to express consent Pregnant women

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 |
| --- | --- | --- |
| Level of anti glial fibrillary acid protein antibodies | Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid | The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood level of anti glial fibrillary acid protein antibodies | Anti glial fibrillary acid protein antibodies measured into the blood | The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours. | 
| Severity of Neurological Impairment | Measured using the American Society Injury Association score | in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, spinal cord, autoimmunity, antibody
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method

Study Overview
=================
Brief Summary
-----------------
This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii (a newer device also created by Monica Healthcare) using the same technology with different monitor placement.

Detailed Description
-----------------
This study has one arm, in which Both the FDA - Approved AN24 (Fetal Monitoring device marketed by Monica Healthcare) and the new device (Novii, being investigated in this clinical trial) will be placed on the patient's abdomen. After delivery of the patient's infant, the data will be abstracted from the second device. This data will be compared to the data from the first device for accuracy.

Official Title
-----------------
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method

Conditions
-----------------
Labor Fetal Anoxia

Intervention / Treatment
-----------------
* Device: Novii
* Device: AN24


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term Laboring Patients Exclusion Criteria: Preterm Labor Fetal Anomaly Imminent cesarean

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AN24 in addition to new device (Novii)<br>FDA-cleared device (The AN24 device) used in conjunction with the new device (Novii). Both devices will be placed on the patient's abdomen. Hence the patient acts as their own control. | Device: Novii<br>* The Novii is a modified device with similar technology to the AN24 device already being used in the USA.<br>Device: AN24<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the Novii when compared to the AN24 | Both the AN24 device and the Novii device will be placed on the patient's abdomen at the same time. After the patient has delivered their infant, the data from the Novii will be downloaded and checked against that from the AN24 to assess for accuracy of fetal monitoring. | duration of the patient's labor | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECG, Fetal monitoring
Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China

Study Overview
=================
Brief Summary
-----------------
To understand 295 gene mutation mutation status (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect) by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Detailed Description
-----------------
This study is prospective to identify biomarkers to resistant to afatinib，gefitinib and erlotinib in non-small cell lung cancer patients. Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with non-small cell lung cancer and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Official Title
-----------------
Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years,both male and female Histologically confirmed patients with pulmonary adenocarcinoma (Stage I-IV) ECOG 0-2 Patients with enough paraffin tissue specimens or fresh tissue for detection Quality of the DNA extracted from the tissue samples ensures that the DNA can be used in DNA sequencing Subjects who provide detailed clinical and follow-up information Exclusion Criteria: Patients with other tumors Patients suffering from other serious diseases like infectious diseases (viral hepatitis, HIV,etc) Pregnant women shall be excluded

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 |
| --- | --- | --- |
| Potential predictive biomarker to resistant to afatinib | Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with NSCLC and their relationships with the patients' clinical features , specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs | baseline |
Fingolimod in COVID-19

Study Overview
=================
Brief Summary
-----------------
Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).

Official Title
-----------------
Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)

Conditions
-----------------
Coronavirus Disease (COVID-19)

Intervention / Treatment
-----------------
* Drug: Fingolimod 0.5 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia; Aged 18 to 85 years; Patients or authorized family members volunteered to participate in this study and signed informed consent. Exclusion Criteria: Patients with any history of bradyarrhythmia or atrioventricular blocks Patients who are participating in other drug clinical trials; Pregnant or lactating women; ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50; Definite diagnosis of rheumatic immune-related diseases; Long-term oral anti-rejection or immunomodulatory drugs; Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.

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 |
| --- | --- |
| Experimental: Treatment group<br> | Drug: Fingolimod 0.5 mg<br>* Each patient in the fingolimod treatment group was given 0.5 mg of fingolimod orally once daily, for three consecutive days<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of pneumonia severity on X-ray images | The lesion change on X-ray images from day 5 to baseline | 5 day after fingolimod treatment |
Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)

Study Overview
=================
Brief Summary
-----------------
Viability assessment remains a clinical challenge in patient with coronary artery disease and left ventricular dysfunction. Several imaging modalities are available for evaluating myocardial viability, based either on perfusion or on contractile reserve analysis. Briefly, perfusion analysis is highly sensitive and contractile reserve highly specific. A combined analysis of both perfusion and contractile reserve has been proposed to improve the diagnostic accuracy in patient referred for a revascularization procedure. However, the value of this combined analysis has not been validated in unselected patients referred for viability assessment. The patients enrolled in the study will undergo a nitrate enhanced rest gated SPECT using a Tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated SPECT acquired during a low-dose dobutamine infusion (10 mcg/kg/mn). All patients will have a 6-month clinical and imaging follow-up, including physical examination and a nitrate enhanced rest gated SPECT using the same radiopharmaceutical. All treatments received during this 6-month period will be recorded, including medical therapy and coronary revascularization (angioplasty, stenting and CABG). Finally, the value of baseline perfusion and contractile reserve analysis in predicting left ventricular ejection fraction changes at 6-month follow-up will be evaluated.

Official Title
-----------------
Prediction of Left Ventricular Function Changes Using Low Dose Dobutamine Gated SPECT in Patients Referred for Viability Assessment: The DOGS (DObutamine Gated Spect)Study.

Conditions
-----------------
Coronary Arteriosclerosis, Heart Failure, Congestive, Myocardial Infarction, Myocardial Ischemia, Myocardial Stunning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented coronary artery disease Left ventricular dysfunction (LVEF < 50%) Patients referred to the Nuclear Medicine department for myocardial viability assessment Sinus Rhythm Acceptance of a 6-month follow-up Signed informed consent Exclusion Criteria: Recent acute coronary syndrome (< 21 days) Atrial Fibrillation or significant arrhythmias Implanted pacemaker Contra indication to dobutamine Non ischaemic cardiomyopathy Pregnancy

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?
-----------------
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
-----------------
Coronary Arteriosclerosis, Heart Failure, Congestive, Myocardial Infarction, Myocardial Revascularization, Tomography, Emission-Computed, Single-Photon, Dobutamine, Myocardial Stunning, Myocardial Hibernation
Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia

Study Overview
=================
Brief Summary
-----------------
Trial to use GABA mimetic action of midazolam to ameliorate the severe preeclampsia induced neuronal excitotoxicity using middle cerebral artery transcranial doppler resisitive vasculer indices to evaluate . Secondery goal is to study end organ injury

Official Title
-----------------
Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia

Conditions
-----------------
Midazolam in Preeclamptic Patients

Intervention / Treatment
-----------------
* Drug: intrthecl midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All parturients with severe preeclampsia for urgent C.S Exclusion Criteria: Ladies refusal to participate. Refusal to have spinal anesthsia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: Midazolam group<br>Midazolam group will receive 1 mg intrathecal midazolam once during induction for anethesia | Drug: intrthecl midazolam<br>* midazolm as as adjuvant in spinal anesthesia<br>|
| No Intervention: control group<br>control group will receive placebo ( 0.5cm of sterile saline | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Pulsatality index and resistive index of maternal middle cerebral artery | Resistive vasculer indices outcome after intrthecal midazolam injection | 2 months |
Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.

Official Title
-----------------
A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions

Conditions
-----------------
Allergic Transfusion Reaction

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Chlorpheniramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 65 years old. Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions. Subject can fully understand and voluntarily sign informed consent forms. Exclusion Criteria: Subject with a history of allergic diseases. Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past. Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion. Subject transfused with washed RBC. Received allo-HSCT transplantation before. Subject with heart failure. Subject suffered from sequelae of cardiovascular or cerebrovascular diseases. Pregnant or nursing women. Inability to understand or to follow study procedures.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion. | Drug: Placebo<br>* The tablet resembles chlorpheniramine but has no therapeutic value.<br>|
| Active Comparator: Chlorpheniramine<br>Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion. | Drug: Chlorpheniramine<br>* An antihistamine that reduces the natural chemical histamine in the body.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of allergic-transfusion reactions |  | within 4 hours from the start of the transfusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pretransfusion medication, Chlorpheniramine, blood transfusion, allergic transfusion reaction