linjc16/ctgov huggingface dataset:
RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

Study Overview
=================
Brief Summary
-----------------
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer

Official Title
-----------------
A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

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

Intervention / Treatment
-----------------
* Biological: RV001V


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prostatectomised (PT) due to histologically verified adenocarcinoma of the prostate gland who currently are not being treated, or expected within the next 8 months to be treated, with any anti-cancer treatment. ECOG performance status 0 or 1. Exclusion Criteria: Patient has been treated with Androgen Deprivation Therapy (ADT), or expected to receive such treatment within the next 8 months from enrolment. Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.

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: RV001V<br>RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. | Biological: RV001V<br>* Sc injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of Participants With Treatment-related Adverse Events | Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 8 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological Response | RV001-specific immunological response after treatment from baseline to each treatment and follow-up | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatectomised cancer patients
The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the use of Edi in patients under the endotracheal tube and tracheostomy, and analysis of cardiopulmonary parameters in adult patients.

Detailed Description
-----------------
Tracheostomy is a utilitarian surgical procedure of access; therefore, it should be discussed in light of the problem it addresses: access to the tracheobronchial tree. The trachea is a conduit between the upper airway and the lungs that delivers moist warm air and expels carbon dioxide and sputum. Failure or blockage at any point along that conduit can be most readily corrected with the provision of access for mechanical ventilators and suction equipment. In the case of upper airway obstruction, tracheostomy provides a path of low resistance for air exchange.

Official Title
-----------------
The Application and Analysis of Diaphragm Electrical Impulse in Adult Patients With Spontaneous Breathing Trial: Before and After Tracheostomy

Conditions
-----------------
Tracheostomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patents under planning tracheostomy will enroll to this study. Exclusion Criteria: Pregnant women, age under 18 and unable to insert nasogastric tube

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 |
| --- | --- | --- |
| The electrical activity of the diaphragm (Edi) | Edi is the primary requirement for NAVA to function and the main source for ventilator trigger. This study will find the difference of data of Edi after surgery | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary function parameters | heart rate (HR) | one year | 
| Cardiopulmonary function parameters | blood pressure (BP) | one year | 
| Cardiopulmonary function parameters | stroke volume (SV) | one year | 
| Cardiopulmonary function parameters | cardiac output (CO) | one year | 
| Cardiopulmonary function parameters | total peripheral resistance (TPR) | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tracheostomy, diaphragm electrical impulse, diaphragm activity, endotracheal tube
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Study Overview
=================
Brief Summary
-----------------
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.

Detailed Description
-----------------
Eosinophilic fasciitis (EF)is a fibrosing skin disorder extensively involving the deep fascia. The aim of this pilot study is to evaluate the effect of high dose MTX on skin induration in patients with EF. In addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function. By administering high dose MTX intravenously every four weeks with a Leukovorin rescue, we hope to induce a more pronounced and sustained effect on the involved skin with less (long-lasting) side effects.

Official Title
-----------------
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Conditions
-----------------
Fasciitis

Intervention / Treatment
-----------------
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eosinophilic fasciitis as defined by clinical judgement of an expert, Histologically confirmed with a skin-fascia-muscle biopsy, and in additon: Either the presence of a modified skin score according to Zachariae of 8 or higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence of severe contractures due to eosinophilic fasciitis lesions. Exclusion Criteria: Age < 18 yrs Contraindications to MTX: AST/ALT level > 2 times upper limit of normal, WBC count < 3.5 x 109/l or platelet count < 150 x 109/l, serum creatinine > 130 micromol/l or clearance < 50 ml/min, confirmed by two repeated tests within one month. Chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse Restrictive pulmonary disease (total lung capacity or vital capacity < 40% of predicted) or interstitial lung disease (KCO < 60% of predicted) Pregnancy or child bearing potential without adequate contraception The presence of any serious co-morbidity or malignancy Use of other anti-folate drugs than MTX

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: methotrexate|methotrexate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy is evaluated after 6 months. |  | December 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eosinophilic fasciitis, Shulman's syndrome, methotrexate
Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most common and most serious complications of thyroid surgery. Neuromonitoring of the inferior laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle which is stimulated electrically at the location of ILN, producing an acoustic and visual signal. This is a basic electromyographic technique whose diagnostic and prognostic potential for the entire neuromuscular system has not yet been fully explored. The study of action potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis during the course of surgery making it possible to diagnose lesions of the nerve and guide the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent paralysis. It could also enable the surgeon to give a prognosis for functional recovery.

Official Title
-----------------
Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy

Conditions
-----------------
Recurrent Laryngeal Nerve

Intervention / Treatment
-----------------
* Device: perioperative monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a total thyroidectomy or a thyroid lobectomy Exclusion Criteria: History of mobility disorder of the vocal cords

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 |
| --- |
|Device: perioperative monitoring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrophysiologic state of the inferior laryngeal nerve | To study electrophysiologic state of the inferior laryngeal nerve with a neurostimulator during thyroidectomies in order to validate its diagnostic usefulness for ILN impairment of vocal cord movement. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroidectomy, Electrophysiologic, vocal cord movement
Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery

Study Overview
=================
Brief Summary
-----------------
The study compares the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and aims to discover the essential microbes and their metabolites that highly associate with the repair of myometrium through metagenomics and metabolomics. It verifies that flora disorder in the endometrium is the important cause of poor uterine repair after cesarean section. Then these patients with uterine diverticula receive the transvaginal repair surgery. Through the follow-up with them, we gain the microbiome differences of the endometrium before and after the surgery and show the validity of transvaginal repair surgery in the level of microbiome and metabolism.

Official Title
-----------------
Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have one cesarean delivery, have intermenstrual spotting after the cesarean section or Residual muscle thickness was less than 3.0 mm at the preoperative stage underwent magnetic resonance imaging and transvaginalultrasound to evaluate the size of the defect and the Residual muscle thickness before surgery have vaginal repair of Cesarean Section Diverticula write consent for operation. Exclusion Criteria: have a history of endocrine disorders have coagulation disorders use of intrauterine devices have sub-mucous myoma have endometrial diseases have endometrial cysts, uterine fibroids, and adenomyosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| Change of Endometrium Microbiome | analysis the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and after vaginal repair surgery | In the 7th day of the period |
Mental Health Symptoms and Intimate Partner Violence

Study Overview
=================
Brief Summary
-----------------
Using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues.

Detailed Description
-----------------
Using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues. The researchers are looking to see if those who participate in a computer screen and are given referral lists as well as having the computer printout placed on the physician clipboard, will increase physician awareness and recognition as well as patient use of resources compared to usual care.

Official Title
-----------------
Mental Health Symptoms and Intimate Partner Violence

Conditions
-----------------
Depression, Domestic Violence, Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Procedure: Computer screen with community resource printout


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients between the ages of 18-55 who present to the waiting room of the emergency department during study time periods Exclusion Criteria: Psychotic Acutely intoxicated Too ill to participate Unable to read Not English speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female ED patients<br>All eligible African American female patients were approached in the ED waiting room during study periods. Patients participated in the screening process via a computer kiosk. Questions regarding IPV and mental health symptoms were asked using validated tools | Procedure: Computer screen with community resource printout<br>* Patients participated in the screening process via a computer kiosk. Questions regarding IPV and mental health symptoms were asked using validated tools<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased levels of PTSD |  |  | 
| Increased levels of suicidality |  |  | 
| Increased levels of depression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suicidality, PTSD, depression
Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).

Conditions
-----------------
Gram-Negative Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Beta-Lactams
* Drug: Beta-Lactams


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 years) Admitted on the intensive care unit Starting a treatment with beta-lactams antibiotics Signed informed consent Expected to live > 3 days Exclusion Criteria: renal insufficiency (estimated clearance < 20 ML /MIN) renal replacement therapy ANC < 1000 103 µl pregnancy drug abuse

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intermittent infusion<br> | Drug: Beta-Lactams<br>* infusion time: 30 mins or 1 hr<br>|
| Experimental: extended infusion<br> | Drug: Beta-Lactams<br>* infusion time 4 hrs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum concentrations of beta-lactams | Determination of serum concentrations of beta-lactams | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
focus of study
Stress, Diurnal Cortisol, and Breast Cancer Survival

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression.

Detailed Description
-----------------
The purpose of this study is to investigate stress and tonic activation of diurnal cortisol in aging metastatic breast cancer patients; feedback inhibition & activation of cortisol; and stress-induced phasic activation of cortisol.

Official Title
-----------------
Stress, Diurnal Cortisol, and Breast Cancer Survival

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

Intervention / Treatment
-----------------
* Drug: Sandostatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of recurrent or metastatic breast cancer. Karnofsky of 70% or greater. Proficient enough in English to be able to take questionnaires and participate in the required tasks. Living within the Greater Bay Area. Age 35 or older . Exclusion Criteria: Positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis. Active cancers within the past 10 years other than breast cancer, basal cell or squamous cell carcinomas of the skin, or in situ cancer of the cervix. Any other serious medical condition that will effect short term survival History of major psychiatric illness for which patient was hospitalized or medicated, with the exception of depression or anxiety A diagnosis of diabetes.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sandostatin|Calculated per patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

Study Overview
=================
Brief Summary
-----------------
The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Patients With Coronary Heart Disease (CHD) to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of APL180

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: APL180
* Drug: APL180
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female CHD or CHD equivalent patients Body mass index (BMI) must be within the range of 20 to 35 kg/m2, Patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients. Exclusion criteria: Pregnancy Significant illness within two weeks prior to dosing. Triglycerides ≥ 500 mg/dl (5.65 mmol/l) Uncontrolled hypertension Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety. Presence of NYHA Class III or IV chronic heart failure MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/exclusion criteria may apply

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APL180 (first dose level)<br> | Drug: APL180<br> <br> |
| Experimental: APL180 (second dose level)<br> | Drug: APL180<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of APL180 |  | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of APL180 |  | Throughout the study | 
| Evaluate effects of APL180 biomarkers |  | Throughout the study | 
| Pharmacokinetic-pharmacodynamic relationship of APL180 |  | Throughout the study | 
| Effect of APL180 on exploratory biomarkers, |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary heart disease, APL180