linjc16/ctgov huggingface dataset:
Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative. Trial with surgical intervention

Official Title
-----------------
TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Procedure: Extracorporal shockwave lithotripsy
* Procedure: Retrograde intrarenal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size) male and female patients between 18 and 99 years informed consent signed by patient after explanation of the both treatment-modalities Exclusion criteria: - age < 18 or > 99 pregnancy breastfeeding mother disorders of blood clotting kidneystones > 15mm aneurysms of the aorta or renal artery severe skeletal deformations which hamper one of the treatment modalities synchronous stones of the ipsilateral ureter stones which can not visualized which X-ray or sonography

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: Extracorporal shockwave lithotripsy<br> | Procedure: Extracorporal shockwave lithotripsy<br>* Extracorporal shockwave lithotripsy<br>|
| Active Comparator: Retrograde intrarenal surgery<br> | Procedure: Retrograde intrarenal surgery<br>* Retrograde intrarenal surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stonefree-rates 3month after therapy |  | 3 month |
Mortality Reduction in Septic Shock by Plasma Adsorption

Study Overview
=================
Brief Summary
-----------------
The study objective is to clarify whether the application of high doses CPFA (Coupled Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).

Official Title
-----------------
Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Device: High Doses CPFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to the ICU in septic shock all patients that develop septic shock while in the ICU Exclusion Criteria: Age less than 18 years Pregnancy Estimated life expectancy (due to comorbidities) less than 90 days Presence of relative or absolute contraindications to CPFA Absence of informed consen

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High doses CPFA<br>High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization | Device: High Doses CPFA<br> <br> |
| No Intervention: Control Group<br>Standard practice | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time resolution of septic shock | normalization of lactate, and the decrease in vasoactive drugs | within the first 28 days |
Paracetamol for Intrapartum Analgesia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.

Official Title
-----------------
Efficacy of Intravenous Paracetamol as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial

Conditions
-----------------
Analgesia, Obstetrical

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Pethidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparity Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes) Maternal age between 20-30 years Singleton term pregnancy (37-42 weeks of gestation) Vertex-presenting fetus Exclusion Criteria: Clinical evidence of cephalopelvic disproportion Scarred uterus; previous cesarean section, hysterotomy or myomectomy Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment Fetal distress Receiving any regional or parenteral analgesia before recruitment in the study Known hypersensitivity to the drug family

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol<br>Patients will receive paracetamol intravenously (1 g in 100 mL) over 15 minutes (single dose), as an analgesic during the first stage of labor, given by a member of the study team. | Drug: Paracetamol<br> <br> |
| Active Comparator: Pethidine<br>Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team. | Drug: Pethidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of intravenous paracetamol to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale. | Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 [no pain] to 10 [worst possible pain]. | 4 hours |
VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)

Study Overview
=================
Brief Summary
-----------------
The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.

Detailed Description
-----------------
Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis.

Official Title
-----------------
VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway

Conditions
-----------------
Extrahepatic Cholangiocarcinoma

Intervention / Treatment
-----------------
* Procedure: surgical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma Child-Pugh A or B well preserved renal and hematopoietic Function receive surgical therapy achieve complete section accessed by contrast-enhanced CT Exclusion Criteria: incomplete section remote metastasis Child-Pugh C combination with other hepatobiliary disease suffer from other tumors concurrently or in last five years

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- |
| ECC patients<br>Extrahepatic cholangiocarcinoma patients treated by surgical treatment | Procedure: surgical treatment<br>* all the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis. | the sections would be collected as previously described.Western blot,immunohistochemistry,PCR would be conducted to find out the variation between the normal liver tissue and tumor,tumor and meta(if have). | the day when conducting surgery (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECC, Extrahepatic cholangiocarcinoma, VEGF signaling
Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries

Study Overview
=================
Brief Summary
-----------------
This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries

Official Title
-----------------
Comparison of the Efficacy of Bilevel Erector Spinae Plane Block and Single Level Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: Bilevel erector spinae plane block
* Procedure: Single level erector spinae plane block
* Drug: Intravenous morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Diagnosed with breast cancer Exclusion Criteria: Patient refusal coagulation defects bone metastases abnormal kidney and/or liver function tests

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Bilevel erector spinae plane block<br>Bilevel erector spinae block at 3rd and 5th thoracic vertebral levels | Procedure: Bilevel erector spinae plane block<br>* Bilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels<br>|
| Experimental: Single level erector spinae plane block<br>single level erector spinae plane block at 5th thoracic vertebral levels | Procedure: Single level erector spinae plane block<br>* Single level erector spinae plane block at 5th thoracic vertebrae<br>|
| Active Comparator: Intravenous morphine<br>Intravenous morphine 0.1 mg/ kg | Drug: Intravenous morphine<br>* Intravenous morphine 0.1 mg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total analgesic requisite | total postoperative morphine consumption | First 24 hours postoperatively |
Dual Source CT Angiography for Detection of Coronary Artery Stenoses

Study Overview
=================
Brief Summary
-----------------
The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.

Official Title
-----------------
Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected coronary artery disease chest Pain intermediate likelihood of coronary stenoses planned invasive coronary angiography age 30 to 80 years Exclusion Criteria: non sinus rhythm contrast allergy renal failure unstable clinical condition previous coronary revascularization calcium score exceeding 800 inability to perform 10 second breathhold possible pregnancy metformin medication that cannot be interrupted inability to establish antecubital iv access

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Accuracy for the detection of coronary artery stenoses | Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography | Patients will be monitored for one hour after injection of Ultravist 370 and Ultravist 300 intravenously to assess safety and detect side effects. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest Pain, Coronary Artery Disease, Computed Tomography
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.

Detailed Description
-----------------
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.

Official Title
-----------------
Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Cystic Fibrosis diagnosed with neo-natal screening Patients born between 01/01/1979 and 12/31/1984 (Cohort 1)and patients born between 01/01/1991 and 12/31/1996 (Cohort 2) Patients with at least 2 FEV1 yearly measurements from the age of 10 to 15 Exclusion Criteria: Patients with malignant tumor Patients with meconium ileus Patients with transplantation (pneumectomy or lobectomy) Patients involved in any other clinical trial Patients moved to another Clinical Center

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 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 |
| --- | --- |
| Cohort first decade<br>Patients born between 01/01/1979 and 12/31/1984 | |
| Cohort second decade<br>Patients born between 01/01/1991 and 12/31/1996 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients |  | 5 years | 
| To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period |  | 5 years | 
| To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis, Pseudomonas Aeruginosa
Influence of Corticosteroids on Heart Function

Study Overview
=================
Brief Summary
-----------------
This study will examine the effect of corticosteroid treatment on heart function.

Official Title
-----------------
Influence of Corticosteroid Therapy on Heart Function

Conditions
-----------------
Heart; Complications

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with good echogenic body structure Patients with sinus rhythm with no conduction disorder Exclusion Criteria: Patients with major medical condition Patients who are not hemodynamical stable Patients receiving long-term corticosteroid therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroid Therapy Patients<br>Corticosteroid therapy patients will be examined by echocardiography before, during and after receiving treatment | Diagnostic Test: Echocardiography<br>* Imaging of the heart using ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in heart function | Comparison of echocardiography performed before, during, and after corticosteroid administration will display changes in heart function | One month after completion of treatment |
Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules

Official Title
-----------------
A Phase III, Single Center, Open Label, Follow-up Immunogenicity Study in Subjects Who Previously Received Post-exposure Rabies Vaccine According to the Essen or 2:1:1 (Zagreb) Schedule

Conditions
-----------------
Rabies

Intervention / Treatment
-----------------
* Other: No vaccine administered; subjects only have blood sampling for immunogenicity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study Exclusion Criteria: Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study. Receipt of additional doses of rabies vaccine after completion of initial vaccine series. For additional entry criteria please refer to protocol.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br> | Other: No vaccine administered; subjects only have blood sampling for immunogenicity<br>* No vaccine administered; subjects only have blood sampling for<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL |  | 13 months, 3 years and 5 years after initial vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration |  | 13months, 3 years and 5years after initial vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rabies vaccine, Long-term Immunogenicity