linjc16/ctgov huggingface dataset:
Peer Enhanced Prolonged Exposure

Study Overview
=================
Brief Summary
-----------------
The investigators plan to develop and test an intervention using peer specialists (Veterans who have managed PTSD and completed PE) to provide support services for Veterans using prolonged exposure therapy.

Detailed Description
-----------------
The investigators will use qualitative data from Veterans and PE providers to revise the investigators' manualized intervention for peer support services, then complete a feasibility trial to assess the feasibility and acceptability of Peer Enhanced Prolonged Exposure

Official Title
-----------------
Peer Enhanced Exposure Therapy (PEET)

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Behavioral: Peer Enhanced Prolonged Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veteran participants will be individuals appropriate for PE, i.e., : Veterans who are currently seeking PE meet DSM-5 criteria for PTSD or subthreshold PTSD are competent to consent to research Exclusion Criteria: Veteran participants do not have levels of other types of psychopathology that would prevent successful participation in the intervention

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Peer specialist led individual education and support for veterans receiving Prolonged Exposure Therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEET<br>Peer support interventions as an adjunct to prolonged exposure | Behavioral: Peer Enhanced Prolonged Exposure<br>* Peer support interventions as adjunct to prolonged exposure<br>* Other names: PEET;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PE Sessions Attended | Number of PE Sessions attended during 10 weeks of participation in study. 10 is the maximum, 0 is the minimum. Higher numbers of sessions attended are an indication of better engagement in treatment. | 10 weeks | 
| Posttraumatic Stress Disorder (PTSD) Checklist-5 | Self-report measure of PTSD symptoms; score range is 0-80, with higher scores indicating more PTSD symptoms. | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Prolonged Exposure, Peer Support
Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals in China

Study Overview
=================
Brief Summary
-----------------
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Detailed Description
-----------------
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now. A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015. Eligibility criteria Patients who will use Shenfu injection in selected hospitals.

Official Title
-----------------
A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China

Conditions
-----------------
Shock, Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients using Shenfu injection from 2012 to 2014
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 |
| --- | --- | --- |
| Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction. |  | The registry procedure will last 3 years only for patients using Shenfu. |
Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used

Study Overview
=================
Brief Summary
-----------------
In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.

Official Title
-----------------
Evaluation of Systemic Leakage When a Heparin or Citrate Lock is Injected and Biological and Clinical Repercussions: Ancillary Study of the VERROU-REA Randomized Controlled Trial

Conditions
-----------------
Acute Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: citrate 4%
* Drug: unfractionated heparin
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged > 18 years Requiring dialysis for acute kidney failure In whom a first non-tunnelled catheter has been inserted In the jugular or femoral position Once informed consent has been obtained from the patient, a family member or a person of trust Exclusion Criteria: Patients with active and poorly-controlled bleeding Known allergy to citrate Liver failure (Factor V <30%) Thrombopenia < 30 000/mm3 in the absence of planned corrective measures at the time of randomization Known or suspected heparin-induced thrombopenia Positive blood cultures without treatment or with inappropriate treatment at the time of randomization Catheter inserted in the subclavian position Person without national health insurance cover Pregnant women Adults under guardianship

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrate lock<br> | Drug: citrate 4%<br> <br> Biological: blood sample<br> <br> |
| Active Comparator: Heparin lock<br> | Drug: unfractionated heparin<br> <br> Biological: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of calcaemia |  | through study completion an average of 28 days | 
| Level of haemostasis |  | through study completion an average of 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients
ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in patients with peripheral arterial occlusive disease (PAOD) requiring interventional procedures and to investigate if patients with resistance to ASA or Clopidogrel have an unfavourable outcome during long-term follow-up

Official Title
-----------------
Investigation of Laboratory Resistance to Aspirin and Clopidogrel and Its Clinical Relevance in Patients With Peripheral Arterial Occlusive Disease Requiring Interventional Procedures

Conditions
-----------------
Peripheral Arterial Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAOD patients Age 18-85 years Need for a catheter interventional procedure Antithrombotic therapy with aspirin or clopidogrel Exclusion Criteria: Comedication additionally compromising platelet function Known bleeding disorder Life expectancy < 6 months

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for peripheral arterial revascularisation |  | 1, 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI) |  | 1, 6, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral arterial occlusive disease, Aspirin, Clopidogrel, Resistance, Catheter interventional procedure, ASA and clopidogrel resistance
Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The patients from 12 centers were included into the study. pN2 patients received PORT, pN1 patients did not. PORT was 3D-planned and consisted in 54-56 Gy in 27-28 fractions. One month after surgery, all patients completed EORTC QLQ C-30 questionnaires and had pulmonary function tests (PFT); cardiopulmonary symptoms were assessed by modified LENT-SOM score. Two years after, all patients free of disease repeated the same examinations. Changes in QLQ, LENT-SOM score and the results of PFT were compared for patients receiving and not PORT.

Official Title
-----------------
Prospective Comparison of Quality of Life and Cardiopulmonary Morbidity After Surgery in Non-small Cell Lung Cancer Patients Treated With and Without Postoperative Radiotherapy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complete resection by lobectomy, bi-lobectomy or pneumonectomy of NSCLC, pN1 or pN2 disease, signed informed consent for participation in the study, Karnofsky Performance Status (KPS) higher than 70%. Exclusion Criteria: presence of distant metastases, N2 diagnosed before surgery in imaging and/or mediastinoscopy, previous radiotherapy to the chest, no or inadequate mediastinal nodal dissection , FEV1 after surgery lower than 1.0 liter, any active infectious process (including fistula formation) in the chest

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 |
| --- | --- |
| Stage II patients post surgery<br>Stage II patients treated with surgery alone | |
| Stage III patients post surgery<br>Stage III patients treated with surgery and PORT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded. | One month after surgery and two years after postoperative radiotherapy or surgery alone | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | For quality of life assessment, patients were asked to complete the Quality of Life Questionnaire Core 30 Items (QLC-C30) of the European Organization for Research and Treatment of Cancer (EORTC). | One month after surgery and two years after postoperative radiotherapy or surgery alone | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC,, PORT,, Quality of Life,, Pulmonary function after RT
Geriatric and Oncologic Assessment Before Treatment

Study Overview
=================
Brief Summary
-----------------
In a randomized controlled trial, the investigators wish to investigate, if oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in older frail patients with gynaecologic and urologic cancer is superior to standard assessment (PS and clinical assessment) in oncologic treatment decision.

Official Title
-----------------
Significance of Geriatric Assessment for Optimal Treatment of Older Cancer Patients

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: G8 screening
* Other: Geriatric assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified gynaecologic cancer (ovarian, uterine, or cervical cancer) or urologic cancer (prostate, bladder, or kidney cancer). Suited for first line medical oncologic treatment with chemotherapy and/or targeted therapy. Age ≥ 70 years. Understands, speaks, and writes Danish. Signed informed consent. Exclusion Criteria: Previous cancer diagnosis except for carcinoma in situ of the cervix or skin cancer other than malignant melanoma. Previous chemotherapy and/or targeted therapy for current cancer diagnosis. Previous radiation therapy or concomitant radiotherapy for current cancer diagnosis. Surgery within the last 4 weeks.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A (experimental group)<br>Oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in addition to standard assessment (ECOG Performance Status + clinical assessment). | Other: G8 screening<br> <br> Other: Geriatric assessment<br> <br> |
| No Intervention: B (control group)<br>Oncologic treatment decision based on standard assessment (ECOG Performance Status + clinical assessment). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Geriatric Assessment, G8 screening, Oncologic treatment
Evaluation of Discarded Laboratory Pathological Specimens and Media

Study Overview
=================
Brief Summary
-----------------
The researchers propose to investigate the causes, incidence, and time-related events of chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility drugs utilized, and in vitro laboratory culture conditions.

Detailed Description
-----------------
We propose to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We seek to test, standardize and implement better methods for the freezing of oocytes and sperm prior to these techniques being used in the clinical setting. We seek to develop new methods to optimize the determination of genes and chromosomes in gametes. We hope to develop new cell surgery or micromanipulation techniques (e.g. use of cell drills and lasers in order to enhance the efficiency of procedures such as ICSI, assisted hatching, biopsy) as well as other manipulations. We will test the safety and efficiency of micro fluidics and automation in the Embryology lab. This has the potential to reduce cost, human errors, temperature and physical changes. We hope to develop new methods and media and media supplements normally found in the reproductive tract that allow for higher survival of gametes in vitro. We will also test the proficiency of laboratory staff members on techniques and/or procedures performed in the in-vitro fertilization laboratory. We will perform Quality Control to review how changes in temperature and setting can effect specimens

Official Title
-----------------
Laboratory Evaluation of IVF Discarded Pathological Specimens and Media for Optimization of Techniques for Assisted Reproduction

Conditions
-----------------
Non-viable Oocytes, Extra Spermatozoa, Seminal Fluid, Granulosa Cells, Serum, Follicular Fluid, Conditioned IVF Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Methods for the freezing of ooyctes and sperm | To test, standardize and implement better methods for the freezing of ooyctes and sperm prior to these techniques being used in the clinical setting. | duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New methods of gene and chromosome analysis | The development of new methods to optimize the determination of genes and chromosomes in gametes. | duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
discarded pathological specimens, discarded media, IVF
Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.

Conditions
-----------------
HYPERNATREMIA

Intervention / Treatment
-----------------
* Device: INVOS 5100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestation week > 37 ve Na >150 mg/dl Dehydration Exclusion Criteria: Sepsis Intracranial Haemorrhagia Congenital Cardiac Diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Month

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cerebral oxygenation<br> | Device: INVOS 5100<br>* INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEREBRAL OXYGENATION | NIRS METHODS | 3 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEURODEVELOPMENT | NEURODEVELOPMENT EVALUATION | 12-18 MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CEREBRAL OXYGENATION, HYPERNATREMİA, NEWBORN, NA VALUES
Investigation of Cognitive Function Before and After Induced Ventricular Fibrillation in Electrophysiological (EP) Study

Study Overview
=================
Brief Summary
-----------------
In this study, changes in electroencephalogram (EEG) and the hemodynamic state during ventricular fibrillation or induced ventricular tachycardia are investigated.

Detailed Description
-----------------
Patients with a high risk of malignant tachyarrhythmia are routinely investigated by programmed electrophysiological study (EPS). To investigate the hemodynamic effects of ventricular arrhythmia to cerebral circulation an EEG and transcranial ultrasound are conducted simultaneously during the EPS. Before and after the EPS a neuropsychological test and an investigation of a specific blood sample (Neuron Specific Enolase, NSE) is done.

Official Title
-----------------
Change of EEG Activity and Cerebral Circulation During Induced Ventricular Fibrillation and Investigation of Cognitive Function Before and After Induced Ventricular Fibrillation in EP Study

Conditions
-----------------
Ventricular Fibrillation, Ventricular Tachycardia

Intervention / Treatment
-----------------
* Device: EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Positive agreement EPS for primary and secondary prophylaxis of a malignant ventricular tachyarrhythmia: primary prophylaxis: Brugada syndrome, long QT syndrome, cardiomyopathy, short QT syndrome secondary prophylaxis: Multicenter Automatic Defibrillator Implantation Trial (MADIT) criteria, syncope, documented ventricular tachycardia Exclusion Criteria: Severe neurological deficit Cardiopulmonary resuscitation

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EEG|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
-----------------
cerebral circulation