linjc16/ctgov huggingface dataset:
Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate and define the mean number, degree of confluence, and depth of penetration of melanocytes in chronically sun exposed skin of the head and neck using Mart-1 immunostains on frozen sections. The study was conducted to confirm whether similar results were found using permanent sections. The present study used hematoxaline and eosin (H&E) staining as well as Mart-1 staining, and included patients from both Mayo Clinic Jacksonville and Rochester.

Detailed Description
-----------------
For each study participant we recorded their age, sex, state they lived in, tumor type, tumor location, recent sun exposure (during the two weeks prior to the surgery), whether or not a follicle was present on the slide, and if so the follicular extension (mm) from the granular layer, presence of atypia, nesting, pagetoid spread. Two slides were obtained; one stained with Mart-1; the other with H&E. For both, melanocyte counts per high power field (400 X HPF magnification) were obtained in three locations of the slide. The mean of the 3 counts was used for analysis, though the individual counts were considered in some data summaries (see below). Classification of photo-aging according to the Glogau scale was noted by the surgeon as type1: no wrinkles; type II wrinkles in motion; type III wrinkles at rest and type IV only wrinkles. Confluence was categorized by the number of adjacent melanocytes as none, mild (2 side-by-side), moderate (3-6), or severe (7 or more).

Official Title
-----------------
Immunohistochemical Analysis of Melanocytes in Sun-Exposed Skin

Conditions
-----------------
Carcinoma, Basal Cell, Carcinoma, Squamous Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants undergoing Mohs and reconstructive surgery for basal cell and squamous cell carcinoma of the face and neck Exclusion Criteria: Participants with a history of radiation to the head and neck were excluded.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| The mean number of melanocytes per high power field for Mart-1 was 12.7 in FL and 11.2 in MN. Using H&E, the means were 10.3 and 8.3 for FL and MN respectively. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of higher means in FL than in MN after adjusting for age and gender (p<0.001 for H&E, p=0.08 for Mart-1) and strong evidence of an increase in observed numbers of melanocytes with use of the Mart-1 stain compared to the H&E stain (p<0.001) |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanocytes
Consequences of At-risk Alcohol Consumption in ICU Patients

Study Overview
=================
Brief Summary
-----------------
At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.

Detailed Description
-----------------
Alcohol-use disorder has a significant impact on morbidity in surgical intensive care units and is known to cause alcohol withdrawal syndrome which mortality can reach 50% if left untreated. The aim of the study was to assess the impact of alcohol use disorder on one-year mortality and adverse ICU outcomes such as agitation in a Medical Intensive Care Unit.

Official Title
-----------------
Consequences of At-risk Alcohol Consumption in ICU Patients : the Impact OH Study.

Conditions
-----------------
Alcohol Abuse, Alcoholism

Intervention / Treatment
-----------------
* Other: no interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients aged 18 years old or more admitted in ICU Exclusion Criteria: No exclusion criteria

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no interventional study|no interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-Year Mortality | Assessment of mortality at one year after ICU discharge | The primary outcome measure was assessed at one year after ICU discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
agitation, restlessness, alcohol withdrawal syndrome, alcohol-dependence, heavy drinking, Alcohol use disorders, intensive care unit
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients

Study Overview
=================
Brief Summary
-----------------
Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients

Detailed Description
-----------------
Prospective clinical monocentric study in ICU with sedated ventilated obese patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Official Title
-----------------
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Sedation with sevoflurane during 48-hr in ICU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line BMI >30 Exclusion Criteria: Acute kidney injury BMI <30 Sevoflurane anaphylaxia

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane<br>Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients | Drug: Sedation with sevoflurane during 48-hr in ICU<br> <br> * Other names: Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of sevoflurane before using AnaConda® system |  | at 5min, 60 min, 24 hrs and just before the end of sedation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system |  | at 5min, 60 min, 24 hrs and just before the end of sedation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Sevoflurane, Obesity, Sedation, ICU patients
Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of selective COX-II inhibitor in patients with regionally disseminated stomach cancer treated by palliative resection (so called R1 or R2 gastrectomy).

Detailed Description
-----------------
Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which expresses excessively when there are stimuli such as inflammation or hypergastrinaemia. Up to 40% of patients with stomach cancer are found to have disseminated disease during surgical exploration. While palliative resection could offer a marginal benefit in the survival of these patients, almost all patients will die of progression of disease within a short time span. Palliative chemotherapy has been used in the past. However, there is no evidence that the chemotherapy can confer any survival advantages, and the side-effects and toxicity of the treatment may indeed compromise the quality of life of these patients. With a better understanding of the relation between COX-II and stomach cancer, it may be possible to suppress the progression of the residual cancer cells after the palliative resection by giving the patients selective COX-II inhibitors.

Official Title
-----------------
Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial

Conditions
-----------------
Cancer of Stomach

Intervention / Treatment
-----------------
* Drug: Vioxx (Rofecoxib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stomach cancer with peritoneal or lymphatic spread beyond the scope of curative resection Palliative resection can be performed Normal RFT Exclusion Criteria: Solid organ metastases Poor performance status On long-term aspirin or NSAID Renal or hepatic dysfunction Bleeding disorder Hypersensitive to COX-II inhibitors/aspirin/NSAID No history of myocardial infarct or stroke

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vioxx (Rofecoxib)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom-free susrvival and the quality of life score within the two years of study period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in long-term. |  |  |
Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery

Study Overview
=================
Brief Summary
-----------------
Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anaesthetic drug is run between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes

Official Title
-----------------
Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery

Conditions
-----------------
Rhomboid Intercostal Block

Intervention / Treatment
-----------------
* Drug: Rhomboid Intercostal and Sub-Serratus block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Adult patients between 18-60 years. Genders eligible for study: both sexes ASA physical status I and II Undergoing open nephrectomy surgery Exclusion criteria Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding disorders Use of any anti-coagulants Inability to provide informed consent ASA III-IV

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control group<br>patients will receive sham block. | Drug: Rhomboid Intercostal and Sub-Serratus block<br>* Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance<br>|
| Active Comparator: RISS group<br>will receive Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance | Drug: Rhomboid Intercostal and Sub-Serratus block<br>* Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nalbuphine consumption i | Postoperative nalbuphine consumption | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nalbuphine consumption. | intraoperative nalbuphine consumption. | 2 hours | 
| Patient's satisfaction | using 1-4 scales (1, bad; 2, moderate; 3, good; 4, excellent; | 24 hours |
Retinal Detachment - Demographic and Clinical Survey

Study Overview
=================
Brief Summary
-----------------
Background: Rhegmatogenous retinal detachment is an ophthalmic emergency that, without surgical repair, often leads to blindness. The incidence is about 1/10000/year. The leading causes are myopia and aging which cause retinal tears often resulting in retinal detachment. Patients commonly experience photopsia, floaters, and peripheral visual field loss. Two different general surgical treatment options exist for retinal detachment; scleral buckling or vitrectomy. However, the precise indications for each approach have not been well established. Correct classification of the retinal detachment is important. The first step is to decide whether an intra- or extra-ocular surgical approach is more appropriate. Simple rhegmatogenous retinal detachments are usually treated extraocularly with scleral buckling surgery, whereas more complicated cases require intraocular primary pars plana vitrectomy and one or more of gas, silicone oil, laser therapy, or cryotherapy. Study objectives: The purpose of this study is to evaluate different surgical techniques for the treatment of retinal detachment. Data relating to retinal status before treatment, surgical treatment, post-operative anatomy and visual acuity, post-operative OCT, and intra- and post-operative complications will be collected. Vitreous cytokines will also be analyzed to monitor intravitreal inflammation as a result of retinal detachment.

Official Title
-----------------
Long-term Anatomic and Funcional Succes After Surgery in Eyes With Retinal Detachment

Conditions
-----------------
Rhegmatogenous Retinal Detachment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received surgery due to retinal detachment between January 2008 and Decemebr 2012. Surgery was performed by either Ass.Prof.PD.Dr. Stefan Sacu or Prof.Dr. Michael Georgopoulos Exclusion Criteria: If patients had prior vitrectomy or scleral buckel. If patients had no adequate follow-up.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retinal detachment group<br>400 patients patients, who received surgery due to retinal detachment exclusion: if patients had prior vitrectomy or scleral buckel if patients have no adequate follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision |  | 2 years | 
| Aqueous cytokine Levels |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT |  | baseline | 
| Surgical Data |  | 2 years |
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)

Study Overview
=================
Brief Summary
-----------------
This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.

Official Title
-----------------
Dialysis Patients' Response to IV Iron With Elevated Ferritin

Conditions
-----------------
Anemia, Iron-Deficiency, Kidney Failure, Chronic, Hemodialysis

Intervention / Treatment
-----------------
* Drug: Sodium ferric gluconate,


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hemodialysis Elevated serum ferritin with low to normal transferrin saturation (TSAT) Moderate to severe anemia Receiving epoetin alfa treatment Exclusion Criteria: Known sensitivity to Ferrlecit® Medical conditions that would confound the efficacy evaluation Recent blood transfusion

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 |
| --- | --- |
| Experimental: Ferric gluconate<br> | Drug: Sodium ferric gluconate,<br>* Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions<br>|
| No Intervention: standard of care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin and anemia medications |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in various iron indices |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron deficiency anemia, ferritin, hemodialysis, sodium ferric gluconate, epoetin alfa
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

Study Overview
=================
Brief Summary
-----------------
Implantation of fiducial markers in the prostate and daily check of the positioning during radiotherapy based on the implanted fiducial markers

Official Title
-----------------
The Implantation Under Echography of Fiducial Markers in the Intraprostatic Lesion and Prostate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Goldlock
* Device: Visicoil smallest size
* Device: Visicoil larger size
* Device: Bard goldmarker smallest size
* Device: Bard goldmarker larger size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological proven adenocarcinoma of the prostate T1-T4 tumors Radiotherapy as primary therapy +/- androgen deprivation Presence of an intraprostatic lesion (IPL) on MRI/MRS Presence of an intraprostatic lesion (IPL) on ultrasound WHO 0-2 Exclusion Criteria: Other primary tumor, except non-melanoma skin cancer No written informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Goldlock | Device: Goldlock<br>* Insertion of Goldlock marker<br>|
| Active Comparator: 2<br>Visicoil smallest size | Device: Visicoil smallest size<br>* Insertion of Visicoil, smallest size, marker<br>|
| Active Comparator: 3<br>Visicoil larger size | Device: Visicoil larger size<br>* Insertion of Visicoil, larger size, marker<br>|
| Active Comparator: 4<br>Bard goldmarker smallest size | Device: Bard goldmarker smallest size<br>* Insertion of Bard goldmarker, smallest size<br>|
| Active Comparator: 5<br>Bard goldmarker larger size | Device: Bard goldmarker larger size<br>* Insertion of Bard goldmarker, larger size<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity after implantation of the fiducial gold markers |  | 1 week after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of insertion 1 fiducial gold marker in the intraprostatic lesion combined with extra gold markers in the rest of the prostate upto 3 goldmarkers in total |  | 1 week after implantation | 
| Visualization of the implanted gold markers by ultrasound |  | After implantation |