linjc16/ctgov huggingface dataset:
Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH for intermediate risk patients with localised disease in 1997. This technique provides a much smaller margin of error for treatment set-up and delivery than with conventional techniques. One way to ensure the accuracy of treatment delivery is to image the prostate position daily, prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are implanted into the prostate under guided ultrasound (a standard procedure at PMH). However, there are disadvantages in using imaging markers which include added time to the treatment planning process, and an invasive procedure with a potential for discomfort, bleeding and infection. This study will investigate and compare X-ray volume imaging to the gold standard imaging markers.

Official Title
-----------------
A Clinical Study of X-ray Volume Imaging to Evaluate the Daily Set-up Accuracy of Conformal Prostate Radiotherapy

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: daily Xray volume imaging for planning radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate Patient undergoing escalated dose conformal external beam radiotherapy. Patient has low or intermediate risk prognostic factors: all of PSA <21, Gleason score <8, clinical T category <T3, clinical N category 0 or X, M category 0 or X. Informed consent Exclusion Criteria: No diagnosis of adenocarcinoma of the prostate Patient not undergoing escalated dose conformal radiotherapy Patient does not have low or intermediate risk prognostic factors

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: daily Xray volume imaging for planning radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate he feasibility of daily X-ray volume imaging during conformal radiotherapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide preliminary data concerning the relative utility of daily X-ray volume image matching compared to fiducial marker image matching. |  |  |
Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies : A Pilot Study

Study Overview
=================
Brief Summary
-----------------
5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight.

Official Title
-----------------
Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies: A Pilot Study

Conditions
-----------------
Macrosomia

Intervention / Treatment
-----------------
* Other: 5D ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 37 to 42 weeks gestation macrosomic fetuses maternal diabetes Exclusion Criteria: intrauterine fetal death multiple pregnancy congenital anomaly nonvisualized fetal parts

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women with macrosomia<br>Pregnant wo.en between 37 and 42 weeks with fetal macrosomia as suspected by clinical estimation and 2D ultrasound. | Other: 5D ultrasound<br>* Measure the femur length by 5DLB to calculate fetal weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of 5D ultrasound in predicting actual birth weight in comparison to 2D ultrasound. (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight) |  | 72hours |
Early or Late Foley Removal After Thoracotomy

Study Overview
=================
Brief Summary
-----------------
Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?

Detailed Description
-----------------
We hypothesis that removing the foley catheter within 48 hours after a thoracotomy in patients that have an epidural catheter will result in an increase in the rate of urinary infections and the need for reinsertion of the foley. We have designed a randomized trial to test this hypothesis.

Official Title
-----------------
Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial

Conditions
-----------------
Urinary Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epidural catheter after thoracic surgery foley in place Exclusion Criteria: < 18 years of age death in hospital within 30 days of the operation length of hospital stay is less than 48 hours epidural catheter is removed before the 3rd postoperative day patients who have a suprapubic catheter or no bladder patients who require a urologist or a urologic technician to insert the Foley catheter at the time of surgery patients who were being intermittently catheterized before surgery patients with a known urinary tract infection preoperatively patients required to keep Foley in since they required close monitoring of urinary output

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Early (within 48 hours of surgery)<br>Patients will have their urinary catheter removed within 48 hours of surgery | |
| Late (6 hours after epidural removal)<br>Patients will have their urinary catheter removed 6 hours after their epidural is removed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for insertion of catheter after Foley removed. |  | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of urinary tract infection |  | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary bladder, urinary catheterization, epidural analgesia, catheters, indwelling
Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

Study Overview
=================
Brief Summary
-----------------
To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

Detailed Description
-----------------
the minimally invasive procedure contain laparoscopic or robotic surgery

Official Title
-----------------
Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

Conditions
-----------------
Colorectal Liver Metastasis

Intervention / Treatment
-----------------
* Procedure: laparoscopic and robotic liver resection
* Procedure: open surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients were diagnosed with colorectal cancer liver metastases without extra-hepatic liver metastases age were within 18-75 yeas the numbers of metastases more than 3 the maximal tumor size of liver metastases more than 10 cm Exclusion Criteria: liver metastases were unresectable.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm A: minimally invasive surgery Arm B: open
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally Invasive surgery<br>the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection | Procedure: laparoscopic and robotic liver resection<br>* laparoscopic and robotic procedure for liver resection<br>|
| Other: Open surgery<br>the open surgery means traditional open surgery for liver resection | Procedure: open surgery<br>* using open surgery procedure for liver resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival (DFS) | DFS was calculated from the date of liver resection to the date of death or recurrence or new tumors developing | 3 years disease-free survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS was calculated from the date of liver resection to the date of death with any reason | 5 years overall survival | 
| Sugical complications | According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery | 1 months after sugery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal liver metastasis, Minimally invasive surgery, Robotic surgery, Laparoscopic surgery
Characterize Metzker Pigmentary Disorders

Study Overview
=================
Brief Summary
-----------------
Metzker pigmentary disorders are frequent cause of consultation in pediatric dermatology. The investigators can describe 4 patterns. They must be differentiated from mosaicisms because they aren't associated with neurologic disorders and don't require any follow up.

Official Title
-----------------
Characterize Metzker Pigmentary Disorders

Conditions
-----------------
Pigment Dispersion, Mosaicism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Metzker pigmentary disorder, age between birth and 18 years old Exclusion criteria: None

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metzker pigmentary disorder pattern | Plume of smoke/ Cloud/Flag/ Linear | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Evolution | Stability/ partial regression/aggravation | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metzker pigmentary disorder
Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels. The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Other: Food supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012. Exclusion Criteria: Patients on chronic antibiotic treatment Patients with immune disorders Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia. Patients who experienced myocardial infarction within less than two months. Patients who consume probiotics.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIO 25 (food supplements)twice a day for 8 weeks<br>BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule. | Other: Food supplement<br> <br> * Other names: BIO-25;|
| Placebo Comparator: Placebo twice a day for 8 weeks<br>Placebo twice a day for 8 weeks | Other: Food supplement<br> <br> * Other names: BIO-25;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-Cholesterol levels. | The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia
Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Study Overview
=================
Brief Summary
-----------------
Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.

Detailed Description
-----------------
Phase II study of radiochemotherapy for elderly patients with oesophagus cancer with Radiotherapy = 50 Gy, 2Gy/f ans chemotherapy with 2 arms arm Cisplatin = Cisplatin 75mg/m2 J1J22 or arm Oxaliplatine = oxaliplatine 85mg/m2 every 2 weeks.

Official Title
-----------------
Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Conditions
-----------------
Esophagus Cancer

Intervention / Treatment
-----------------
* Drug: Cisplatin
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat Exclusion Criteria: previous radiotherapy no fit to treat

Ages Eligible for Study
-----------------
Minimum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm Cisplatin<br>Radiotherapy 50 Gy with cisplatin 75 mg/2 Day 1 and day 22 (2) | Drug: Cisplatin<br>* Arm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f<br>* Other names: Arm Cisplatin;|
| Experimental: Arm Oxaliplatin<br>Radiotherapy 50Gy Oxaliplatin 85mg/m2 every 2 weeks, (6) | Drug: Oxaliplatin<br>* 85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f<br>* Other names: Arm Oxaliplatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of treatment: Number of patients with completed treatment | number of patient with completed treatment | 6 weeks after end of the radiochemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumoral response | tumoral evaluation at 6 weeks after the treatment | 6 weeks after end of the radiochemotherapy | 
| Quality of life | QLQC30 | 6 weeks after end of the radiochemotherapy | 
| Quality of life | ELD14 | 6 weeks after end of the radiochemotherapy |
Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To validate the inter-rater and intra-rater reliability of a new scale for the assessment of ataxia and neurologic dysfunction (STAND) To assess common constructs and correlation between STAND subscale items.

Detailed Description
-----------------
There are few validated, comprehensive rating scales for the assessment of ataxia severity. The development of a Scale To assess Ataxia and Neurologic Dysfunction (STAND) would examine and measure as many facets of ataxia as possible. Scale items to be measured include parkinsonism, timed gait analysis, dystonia, neuropathy and peripheral nerve weakness, as well as other areas of clinical manifestation for ataxia. This brief but thorough scale should yield a thorough measurement of ataxia.

Official Title
-----------------
Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)

Conditions
-----------------
Spinocerebellar Ataxia - All Sub-types, Friedreich's Ataxia

Intervention / Treatment
-----------------
* Other: Ataxia rating scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ataxia. Male or female between 18 and 80 years of age. Subject has voluntarily signed an IRB approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject. Exclusion Criteria: Any illness that in the investigator's opinion preclude participation in this study. Subjects with a cardiac pacemaker Legal incapacity or limited legal capacity.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Subjects with Ataxia<br>Patients with a diagnosis of ataxia (Friedreich's ataxia or Spinocerebellar ataxia type 1-30) aged 18-80 years old will be recruited for the study. | Other: Ataxia rating scale<br>* Administer new rating scale for ataxia. This will be administered by two different raters on two separate occassions, 4 to 6 weeks apart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter- and intra-rater agreement | Assess agreement between raters (inter-rater agreement) and within raters (intra-rater agreement) through the evaluation of STAND total score, subtotals and individual variables using intraclass correlation coefficients (ICCs). | 4 to 6 weeks |
Occurence of Pain and Use of Analgesic Treatment in Multi-trauma Patients of Intermediate Seveity

Study Overview
=================
Brief Summary
-----------------
To register the perceived pain score during 0-14 days after multitrauma in conscious patients and to register the use (type and dose) of analgesic treatment in the same period.

Official Title
-----------------
The Incidence and Strenght of Pain in Conscious Multitrauma Patients, 0-14 Days After Multitrauma

Conditions
-----------------
Post Traumatic Pain, Post Traumatic Analgesic Treatment

Intervention / Treatment
-----------------
* Drug: analgesic drugs and methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient With trauma, ISS > 8 Exclusion Criteria: Unconscious patients at admission patients due for major surgery within 3 hrs of admission patients primary admitted to other hospitals not able to communicate in Norewegian

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: analgesic drugs and methods|the patient will receive analgesic treatment at the discretion of the physician in charge|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst pain | NRS scale, 0-10 | 0-14 days | 
| Average pain | NRS scale, 0-10 | 0-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic methods | list of drugs (dose and duration) and other analgesic measures | 0-14 days |