linjc16/ctgov huggingface dataset:
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones

Study Overview
=================
Brief Summary
-----------------
Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.

Conditions
-----------------
Common Bile Duct Gallstones

Intervention / Treatment
-----------------
* Procedure: laparoscopic common bile duct exploration
* Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preoperatively diagnosed common bile duct stones Exclusion Criteria: liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 90 Years

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

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 |
| --- | --- |
| Placebo Comparator: laparoscopic common bile duct exploration<br> | Procedure: laparoscopic common bile duct exploration<br> <br> |
| Active Comparator: laparoscopic cholecystectomy with intraoperative ES<br> | Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success/failure of common bile duct removal |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
common bile duct stones, laparoscopic common bile duct exploration, intraoperative ercp, Preoperatively diagnosed common bile duct stones
Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase

Study Overview
=================
Brief Summary
-----------------
To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with local anaesthetics in patients with hip fracture immediately after arrival in the emergency department.

Detailed Description
-----------------
Hip fracture patients have severe pain in the acute phase. Traditional analgesic treatment have consisted of intramuscular morphine with its associated side effects. The trial evaluates the Fascia iliaca compartment compared to regular opioid pain therapy in hip fracture patinets immediately after arrival at the emergency department.

Official Title
-----------------
Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Procedure: Fascia Iliaca Compartment Blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip fracture suspected able to give informed consent no substance abuse no regular opioid therapy no opioid treatment within the last 6 hours morphine intolerance allergies to local anaesthetics Exclusion Criteria: Fracture ruled out on x-ray

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fascia Iliaca Compartment Blockade|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief within 3 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea |  |  | 
| Pain on transfer |  |  | 
| Discomfort with block placement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip fracture, pain, regional anaesthesia, analgesia
Nephrocare mHealth Project: Telemonitoring of Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The Nephrocare mHealth project supports patients with Chronic Kidney Disease with a mobile application and telemonitoring. The application includes the follow-up of blood pressure.

Detailed Description
-----------------
Patients that are included in the Nephrocare mHealth project send their blood pressure results through an app or online website. The clinical decision support system will alert the patient, as well as the general practitioner and the hospital when the blood pressure is too high or low. In addition the clinical decision support will calculate monthly averages and all the data are connected with the electronic patient files.

Official Title
-----------------
Nephrocare mHealth: Improvement of Patient Empowerment and Self-management by the Use of Telemonitoring.

Conditions
-----------------
Chronic Kidney Diseases, Blood Pressure

Intervention / Treatment
-----------------
* Other: Telemonitoring of blood pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dutch-speaking Signed and approved informed consent Follow-up by nephrology at the University Hospitals Leuven or General Hospital Groeninge Exclusion Criteria: No Dutch-speaking Impaired cognitive condition or medically unstable

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Telemonitoring of blood pressure<br>Patients measure their blood pressure and register their results on the app or website. | Other: Telemonitoring of blood pressure<br>* Blood pressure monitoring at least once a week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure under control | Percentage of patients with blood pressure within target limits | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adaptations of treatment | Percentage of change in hypertension therapy | 6 months |
Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if tumor cells can be detected in the peripheral blood and/or bone marrow of patients with melanoma.

Detailed Description
-----------------
Patients with melanoma can succumb to subclinical metastatic disease, not detectable at presentation by conventional physical examination, hematologic and biochemical screening, or radiologic evaluation. More intensive radiologic evaluation with CT or radioisotope scanning has not proven to be useful. What may be useful is a more sensitive method of staging melanoma patients at presentation, specifically evaluating them for subclinical systemic disease.

Official Title
-----------------
Study of Peripheral Blood and/or Bone Marrow, Including Detection of Occult Metastases, in Patients With Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MSK Patients with histologically confirmed melanoma of any site and at least one of the following: Primary tumor > 4.0 mm thick (AJCC Stage IIB) Clinically or histologically positive regional nodes (AJCC Stage III) Any in transit disease (AJCC Stage III) Any systemic metastases (AJCC Stage IV)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Melanoma patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the sensitivity of RT-PCR to detect evidence of melanoma cells in bone marrow and/or peripheral blood and estimate sensitivity separately for each of the different stage groupings for melanoma |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
histologically confirmed melanoma of any site
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.

Official Title
-----------------
A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: MK0476, Montelukast Sodium /Duration of Treatment : 14 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms. Exclusion Criteria : Anemia or history of any significant illness that will pose additional risk to the patient.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 3 Months

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476, Montelukast Sodium /Duration of Treatment : 14 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the single-dose population pharmacokinetics, (maximum plasma concentration, time to maximum plasma concentration, and apparent half-life) of montelukast 4-mg oral granules in children aged 1 to 3 months. |  |  |
Prevalence of HBV in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The most common mode of HBV transmission is materno-fetal transmission mainly during labor. This study aims to estimate the seroprevalence of HBV infection and the possible risk factors of HBV acquisition in pregnant women in Upper Egypt and to evaluate the predictive value of HBeAg and quantitative HBsAg as surrogate markers for high viremia in pregnant women.

Detailed Description
-----------------
Hepatitis B virus (HBV) is a cause of a vaccine-preventable life-threatening infection of the liver. Worldwide, the estimated number of cases of chronic HBV infection is 296 million cases with about 820 000 deaths, mostly due to liver cirrhosis and hepatocellular carcinoma. The prevalence of HBV infection among pregnant women is estimated to be 1.5-9.5%. The most important risk factor of materno-fetal transmission is high viremia. Other factors include hepatitis B e antigen (HBeAg) seropositivity, HBV S variant, and threatened preterm labor. Quantitative hepatitis B surface antigen (HBsAg) was postulated as a surrogate marker for HBV high viremia in pregnant women by many authors. This study aims to estimate the seroprevalence of HBV infection and the possible risk factors of HBV acquisition in pregnant women in Upper Egypt and to evaluate the predictive value of HBeAg and quantitative HBsAg as surrogate markers for high viremia in pregnant women.

Official Title
-----------------
Prevalence of Hepatitis B Virus Infection in Pregnancy

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pregnant women Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| HBsAg | HBsAg prevalence in pregnancy | 6 months | 
| Risk factors of HBV in pregnancy | Operations, blood transfusion, dental procedures, tattooing, family history of HBV | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between HBeAg and quantitative HBsAg with viral load | to evaluate the predictive value of HBeAg and quantitative HBsAGg as surogate markers for high viraemia in pregnant women hbe ag | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, Pregnancy, Prevalence
Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the treatment. Clinical symptoms were also observed simultaneously.

Official Title
-----------------
Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites

Conditions
-----------------
Liver Cirrhosis, Refractory Ascites

Intervention / Treatment
-----------------
* Radiation: Infrared ray heat treatment
* Other: conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged 18 60 years inpatient Diagnosed with liver cirrhosis and liver stubborn ascites. Exclusion Criteria: Severe problems in other vital organs(e.g.the heart,renal or lungs). combined with malignant tumour. combined with endocrine diseases. combined with high fever. infected with the AIDS virus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Treatment and Infrared ray heat treatment group<br>conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine. | Radiation: Infrared ray heat treatment<br>* Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy.<br>|
| Active Comparator: conventional treatment group<br>conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine. | Other: conventional treatment<br>* Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ascites pressure | use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment. | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infrared ray heat treatment, liver cirrhosis, refractory ascites
Thromboelastogram During Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.

Detailed Description
-----------------
The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.

Official Title
-----------------
Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid

Conditions
-----------------
Orthopedic Procedures, Tranexamic Acid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthrosis TKR operation elective ASA I-III Exclusion Criteria: TKR due to any reason but osteoarthrosis known coagulation problems platelets < 100,000/DcL Hb < 12 g% past thrombo-embolic event treatment with aspiring during last week treatment with NSAID's during last 48 hours malignancy known allergy to tranexamic acid general anesthesia

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 |
| --- | --- | --- |
| Change in coagulation status during and after surgery compared to pre-surgery |  | During and after surgery compared to pre-surgery | 
| Change in fibrinolytic activity during and after surgery compared to pre-surgery |  | During and after surgery compared to pre-surgery |
A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
This observational study follows subjects who have been exposed to a traumatic event and are at risk of developing PTSD symptoms. Participants are recruited within six hours of a traumatic event, and, starting from the recruitment session, are then examined on six set points of time within a period of thirteen months. The examinations include both biological studies of cortisol in hair, blood and saliva, and psychological examinations and questionaires that assess the development and severity of PTSD symptoms. The novel method of sampling hair cortisol allows investigators to retroactively estimate the mean levels of blood cortisol during the tree months prior to the sampling. The study aims at further illuminating the correlation between cortisol levels both prior and following a traumatic event, and the development and severity of PTSD symptoms

Official Title
-----------------
A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)

Conditions
-----------------
Post Traumatic Stress Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70. Experienced a traumatic and were at risk (or perceived risk) of serious injury to themselves or others in their surroundings. Signed an informed consent form. Exclusion Criteria: Age under 18 or over 70. Severe or complex physical injury, such as severe head trauma, massive burns or injuries that require surgery under full anesthesia. A personal history of Psychotic state or PTSD. Pregnancy Weight below 45 Kg or over 120 Kg. Hair shorter than 1.5 cm.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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 |
| --- | --- |
| Participants exposed to tramautic event<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS). |  | 13 months |
Doxazosin and Ramipril in Hypertension

Study Overview
=================
Brief Summary
-----------------
Randomized double-blind parallel group study in patients with mild-to-moderate hypertension to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.

Detailed Description
-----------------
This study aims to answer the following questions: 1) Does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension? 2) Are the potential antithrombotic effects of doxazosin different to the effects of an ACE inhibitor? 3) Is there a relation between the antihypertensive effect and the antithrombotic effect of these antihypertensive agents? The co-primary outcomes are changes in endothelial function assessed by flow mediated vasodilatation, and in haemostatic function measured by the generation of thrombin-antithrombin complex.

Official Title
-----------------
On the Antithrombotic Effects of Doxazosin and Ramipril in Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Ramipril
* Drug: Doxazosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary mild-to-moderate hypertension Exclusion Criteria: Pregnancy and lactation Recent (6 months) malignant disease or ongoing treatment for malignancy No absolute indication or contraindication for any of the study drugs

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACE inhibitor<br>Ramipril tablets 10 mg od for 12 weeks | Drug: Ramipril<br>* Antihypertensive therapy<br>* Other names: Tiratec;|
| Active Comparator: Alpha receptor blocker<br>Doxazosin tablets 8 mg od for 12 weeks | Drug: Doxazosin<br>* Antihypertensive therapy<br>* Other names: Alfadil ,Cardura;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombin generation | Thrombin-Antithrombin complex (TAT) | 12 weeks | 
| Endothelial function | Forearm post-ischemic flow mediated dilatation | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Blood pressure, Hemostasis, Endothelial function