linjc16/ctgov huggingface dataset:
Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

Study Overview
=================
Brief Summary
-----------------
Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome. The benefit of faster and better recovery would be observed in fewer complications, less utilization of blood products and shorter hospital stay.

Detailed Description
-----------------
Patients with Class I HELLP Syndrome will be recruited for use os dexamethasone or placebo in the puerperium. Effects such as clinical course (blood pressure and diureses), laboratorial behaviour and complications will be compared. Duration of hospitalization will also be accessed.

Official Title
-----------------
Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial

Conditions
-----------------
HELLP Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postpartum women with Class I HELLP syndrome Exclusion Criteria: Chronic users of corticosteroids Patients with chronic conditions affecting the laboratory parameters involved in the HELLP syndrome Women who had received antenatal corticosteroids to treat HELLP syndrome were excluded

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 49 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline solution<br>Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours | Drug: dexamethasone<br>* Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours<br>Drug: Placebo<br>* Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours<br>|
| Active Comparator: Dexamethasone<br>Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours | Drug: dexamethasone<br>* dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe maternal morbidity | 42 days after delivery | postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay duration |  | postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HELLP syndrome, dexamethasone, postpartum period, class I HELLP syndrome
The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters

Study Overview
=================
Brief Summary
-----------------
Purpose: To find the correlation between hemogram parameters and Delta Neutrophil Index(DNI) and Serum PSA in patients presenting with the diagnosis of acute prostatitis. Material-Metod: Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.

Detailed Description
-----------------
Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively. WBC, neutrophil, lymphocyte, neutrophil-lymphocyte ratio, delta neutrophil index (DNI), PLT, RDW, and MPV values were determined in the Hemogram Parameters. Serum Total PSA and Free PSA values of the patients were also checked. Urine culture, urinary ultrasound, and antibiotic therapy

Official Title
-----------------
The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters

Conditions
-----------------
Prostate Infection, Prostate Disease, Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Serum PSA,Delta Neutrophil Index(DNI),WBC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute prostatitis Male - Exclusion Criteria: Prostate cancer Chronic prostatitis Other Urinary infections, -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>:PSA<4 ng/mL | Diagnostic Test: Serum PSA,Delta Neutrophil Index(DNI),WBC<br>* Urine culture, prostate volume<br>* Other names: MPV,NLR,RDW;|
| Group 2<br>PSA>4 ng/mL | Diagnostic Test: Serum PSA,Delta Neutrophil Index(DNI),WBC<br>* Urine culture, prostate volume<br>* Other names: MPV,NLR,RDW;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration Versus Time Curve (AUC) |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostatit
Clinical Outcomes After Acute Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
To investigate safety and effectiveness of PE treatment according to the decision of the multi-disciplinary pulmonary embolism response team (PERT) and to define and optimize treatment indications, institutional algorithms and interventional techniques for PE.

Detailed Description
-----------------
This single-center cohort study is designed to retrospectively and prospectively collect treatment and outcome data related to patients with PE and after activation of the PERT. Treatment information and outcomes after advanced treatment modalities, including systemic thrombolysis, catheter directed thrombolysis and surgical embolectomy, will be collected. Retrospective patient data will consist of treatment and health related outcomes of consecutive patients treated for acute and chronic PE between October 2017 and April 2020 (to assess the learning curve of the PERT) and of patients receiving surgical embolectomy between January 2001 and April 2020. The retrospective data will be derived from the local institutional dataset and will be transferred to the study database. Prospective patients will be included after May 2020.

Official Title
-----------------
Clinical Outcomes After Acute Pulmonary Embolism - The Bern Acute Pulmonary Embolism Registry

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT. Written informed consent Exclusion Criteria: High probability of non-adherence to the follow up requirements
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical Therapy / Anticoagulation<br> | |
| Systemic Lysis<br> | |
| Interventional Therapy for PE<br> | |
| Surgical Embolectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital death |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-procedural adverse events |  | 30 days | 
| Recurrent VTE during follow-up |  | up to 5 years | 
| Respiratory and functional deterioration after treatment |  | 6 months | 
| Development of chronic thromboembolic pulmonary hypertension (CTEPH) |  | up to 5 years |
Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.

Official Title
-----------------
The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy

Conditions
-----------------
Carotid Stenosis

Intervention / Treatment
-----------------
* Drug: Fasudil Hydrochloride
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with >= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy Age >= 18 years Agreement of the operating surgeon for patient to participate Exclusion Criteria: Surgery scheduled < 14 days after randomization Pregnancy ALT, GGT > 3x upper limit of normal (ULN) Creatinine > 3.5 mg/dL Prior intolerance to statins Reluctance to add or change dosage of statin therapy during study

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
Interventional Model Description: Randomized, placebo controlled, parallel arm design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Fasudil hydrochloride<br>Fasudil hydrochloride 40 mg three times a day X 14 days | Drug: Fasudil Hydrochloride<br>* Fasudil 40 mg three times a day x 14 days<br>* Other names: Fasudil;|
| Placebo Comparator: Drug: Placebo oral tablet<br>Placebo 1 tablet three times daily x 14 days | Drug: Placebo Oral Tablet<br>* Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens. | We were going to compare Rho/ROCK expression and eNOS expression/activity in carotid specimens obtained from patients treated with fasudil and compare those to specimens obtained from patients treated with placebo. We anticipated that Rho/ROCK expression and activity would be decreased in spcimens obtained from fasudil treated patients compared to specimens obtained from patients treated with placebo. We also anticipated that eNOS expression and activity would be increased in specimens obtained from patients treated with fasudil compared to specimens obtained from patients treated with placebo. | >= 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients scheduled for elective carotid endarterectomy
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors

Study Overview
=================
Brief Summary
-----------------
The differential diagnosis of gastric subepithelial tumors by endoscopic ultrasound is currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe nCLE interpretation criteria for the characterization of gastric subepithelial tumors, with histopathological correlation, and to perform the validation of these criteria.

Conditions
-----------------
Gastric Subepithelial Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Derivative study Inclusion Criteria: patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 2 cm Exclusion Criteria: Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function Extramural structures, vascular lesions or cystic masses were visible by EUS Pregnancy or breastfeeding Known allergy to fluorescein sodium Inability to provide informed consent Validation study Inclusion Criteria: patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 1 cm Exclusion Criteria: Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function Extramural structures, vascular lesions cystic masses or lipoma were visible by EUS Pregnancy or breastfeeding Known allergy to fluorescein sodium Inability to provide informed consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation |  | 24 months | 
| The feasibility, safety and diagnostic yield of nCLE for gastric subepithelial tumors |  | 24 months |
Colloid Osmotic Pressure During Heart Surgery in Children

Study Overview
=================
Brief Summary
-----------------
Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. The oedema formation is due to increased fluid transport from blood to tissue. This transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary bypass in children. The study hypothesis is that oedema developed during cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage and reduced colloid osmotic pressure gradient through the capillary membrane.

Official Title
-----------------
Colloid Osmotic Pressure During Heart Surgery in Children

Conditions
-----------------
Heart Defects, Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of a congenital heart defect scheduled for open heart surgery with the use of cardiopulmonary bypass under 13 year of age informed consent obtained from the parents Exclusion Criteria: renal failure liver failure

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 13 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 |
| --- | --- | --- |
| Interstitial colloid osmotic pressure |  | Before, during and after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital heart disease, Cardiopulmonary bypass, Capillary leak, Colloid osmotic pressure, Children
Treatment of Metastatic Cancer in Terminally Diagnosed Patients

Study Overview
=================
Brief Summary
-----------------
The objective is to provide terminally diagnosed patients with a last line of treatment while improving overall quality of life. Tempol can be added to any chemotherapy regimen to potentially reduce side effects and overcome chemoresistance.

Detailed Description
-----------------
The objective is to provide terminally diagnosed patients assigned to palliative care and palliative chemotherapy a last line treatment with Tempol. In vivo studies have shown Tempol to work synergistically with a number of chemotherapy agents increasing treatment response and reducing chemoresistance. Additionally, Tempol has been shown to provide protection to non-cancerous cells allowing for increased chemotherapy dosing by reducing side effects. Tempol inhibits HIF-1/VEGF among others in cancerous cells while upregulating GSH/NrF2 among others in non-cancerous cells.

Conditions
-----------------
Metastatic Cancer

Intervention / Treatment
-----------------
* Drug: Tempol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metastatic terminally diagnosed cancer Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tempol|Tempol will be given as an adjunct to chemotherapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
In order to optimize anti-cytomegalovirus (CMV) treatment with ganciclovir (GCV), in patients with multi organ failure treated with continuous renal replacement therapy (RRT), more information about ganciclovir pharmacokinetics in this setting is needed. The primary objective is to describe the pharmacokinetics of ganciclovir in critically ill patients with acute renal failure treated with continuous renal replacement therapy, with a special emphasis on the extra-renal clearance and distribution volume. Secondary objectives are to investigate if any co-factors, such as serum creatinine, weight, general hydration status, rest function of the native kidneys, etc. can help to describe the pharmacokinetics of GCV in these patients on continuous RRT as well as the relative influence of filtrations and dialysis on GCV elimination during different modalities of the treatment.

Official Title
-----------------
Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Conditions
-----------------
Acute Renal Failure, Cytomegalovirus Infections, Multi Organ Failure

Intervention / Treatment
-----------------
* Drug: intravenous (IV) ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in need of continuous RRT and GCV treatment 18 years of age or older. Exclusion Criteria: Concomitant treatment with acyclovir or valacyclovir. Patient does not give informed consent.

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: intravenous (IV) ganciclovir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing the total clearance with the RRT derived clearance of GCV |  |  | 
| comparing the volume of distribution with historic controls of non Intensive Care Unit (ICU) patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing GCV plasma concentration and population model derived estimates of these concentrations when including different relevant clinical co-factors such as: weight, S-creatinine, CL-creatinine, hydration, albumin, rest function of native kidneys etc. |  |  | 
| determine RRT derived GCV clearance during the different filtration/dialysis settings of the RRT machine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal replacement therapy, CMV disease
Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia

Study Overview
=================
Brief Summary
-----------------
In prospective, observational cohort study, changes in body temperature will be investigated before the procedure and during recovery in Radiotherapy patients aged 0-18 years who need sedation due to childhood malignancies. The aims of this study were to measure the incidence and magnitude of changes in body temperature in children undergoing sedation or general anesthesia for Radiotherapy, and to determine their effects on the recovery process.

Official Title
-----------------
An Observational Cohort Study of Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia

Conditions
-----------------
Hypothermia; Anesthesia, Hyperthermia, Anesthesia Related, Radiotherapy Side Effect, Childhood Cancer

Intervention / Treatment
-----------------
* Procedure: radiotherapy under anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing radiotherapy under anesthesia Exclusion Criteria: family refusal to participate, chronic nausea and vomiting complaints, active infection, apnea history, cardiac disease, kidney and liver failure, anomalies that may cause difficult airway, metabolic diseases, neurological or muscular diseases.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- |
| Radiotherapy under anesthesia<br> | Procedure: radiotherapy under anesthesia<br>* Body temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body temperature change among 2 time period | non-contact body temperature measured on forehead | time from before radiotherapy to the end of radiotherapy | 
| recovery time from anesthesia | Time from the end of the procedure until the Modified Steward score ≥ 8 in the patient recovery room | the time from end of radiotherapy to discharging | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypothermia; Anesthesia, Hyperthermia, Anesthesia Related, Radiotherapy Side Effect, Childhood Cancer