linjc16/ctgov huggingface dataset:
PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

Study Overview
=================
Brief Summary
-----------------
Skin melanoma is a common form of skin cancer. Its diagnosis is usually clinically suspected and then affirmed by histopathological examination. In some cases, the histopathological analysis of these lesions is equivocal, and the malignant or benign nature of the proliferation is difficult to determine with certainty. In these cases, the use of expensive ancillary tests, which are hardly accessible and take a long time to set up (FISH - CGH-array), is usually required. Anti-PRAME immunostaining, an inexpensive and readily available technic, has recently been described as highly sensitive and specific for diagnosing malignant melanocytic proliferations. Knowledge on its utility for evaluating ambiguous melanocytic neoplasms remains limited. Our study aims to improve the current body of knowledge on the utility of PRAME immunohistochemistry for evaluating challenging samples of melanocytic proliferation. The secondary objective is to determine the PRAME immunoreactivity profile for each histological subtype of melanocytic proliferations (spitzoid tumors, cellular blue nevi, dysplastic nevi ...)

Official Title
-----------------
PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

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

Intervention / Treatment
-----------------
* Other: Immunomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient at the time of diagnosis (> = 18 years). histopathological diagnosis of ambiguous melanocytic proliferation or atypical melanocytic proliferation made between January 2016 and December 2020. Histological slides archived in the CRB biobank available Formalin-fixed paraffin-embedded tissue block archived in the CRB biobank available Informed patient Exclusion Criteria: Patient who has expressed opposition to participating in the 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Immunomarkers|immunohistochemical expression profile of ambiguous melanocytic proliferation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunomarkers | Correlation of melanocytic lesions' histopathological diagnosis concerning benignity or malignancy with anti-PRAME immunohistochemical expression profile | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunohistochemistry, Histopathology
Improving Compliance With Metformin

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial of adherence. The study involves monitoring and managing focused intervention in patients prescribed metformin.

Detailed Description
-----------------
The active intervention, MEMS Feedback, involves review of patients' medication-taking over the preceding weeks

Official Title
-----------------
Improving Compliance With Metformin

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: MEMS caps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metformin has been prescribed Willing to use medication containers with MEMS caps Capable of giving informed consent 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Behavioral: MEMS caps<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
compliance, MEMS, metformin
A2 to O Lung Transplants

Study Overview
=================
Brief Summary
-----------------
Blood group A2 to blood group O kidney and liver transplants have been shown to be safe and successful, especially in recipients with low pre-operative anti-A antibody titers and with the use of peri-operative antibody-depleting therapies. Since blood group O lung transplant candidates tend to have longer wait times and a higher waitlist mortality compared to other blood groups, we propose to conduct a prospective study of lung transplantation from blood group A2 donors to eligible blood group O recipients in an effort to increase the available donor pool. The aim of this study is to determine both the feasibility and safety of this specific type of ABO-incompatible lung transplant, and the impact of this practice on reducing transplant wait times among blood group O lung transplant candidates. This would represent the first prospective study of ABO-incompatible lung transplants worldwide.

Official Title
-----------------
Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation

Conditions
-----------------
Lung Transplant, ABO Incompatibility

Intervention / Treatment
-----------------
* Procedure: Blood group A2 donor to blood group O recipient lung transplant surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first lung transplant blood group O recipient low pre-operative anti-A antibody titers consent to study participation Exclusion Criteria: re-transplant multiorgan transplant positive virtual crossmatch at time of transplant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A2 donor transplant to O recipient<br> | Procedure: Blood group A2 donor to blood group O recipient lung transplant surgery<br>* Suitable blood group A2 donor lung transplant to a consented blood group O recipient who has acceptably low levels of anti-A antibody titres and a negative virtual cross-match at time of transplant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-transplant anti-A antibody titers |  | post-op day 5 or day 12 | 
| Primary graft dysfunction grade |  | post-op day 0, 1, 2, 3 | 
| Incidence of hyperacute antibody-mediated rejection |  | post-op day 1, 2 | 
| C4d positivity on transbronchial biopsy samples |  | 1 year | 
| Incidence and severity of acute cellular rejection |  | 1 year | 
| Bleeding |  | post-op day 1-7 | 
| Infection |  | 10 years | 
| Graft function |  | 10 years | 
| Incidence of malignancy |  | 10 years | 
| Chronic lung allograft dysfunction |  | 10 years | 
| Time to death or re-transplantation |  | 10 years |
PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0

Detailed Description
-----------------
The first clinical experience with AMS was in infrapopliteal arteries and demonstrated safety and acceptable patency rates up to 12 months post implantation. These encouraging results led to the initiation of the first trial to treat human coronary lesions with AMS named Clinical Performance and angiographic Results of Coronary Stenting with Absorbable Metal Stents (PROGRESS AMS-1). Although an ischemic driven target lesion revascularization rate of 26.7% (16/60) was observed during the PROGRESS AMS-1 study, it demonstrated that biodegradable magnesium stents can be implanted safely in coronary arteries, and the stents degraded as intended without causing stent thrombosis, myocardial infarction or death at one year. No adverse device effects from the absorbable nature of the stents or its constituents were detected. The continued clinical follow-up and retrospective evaluation of all angiographies and IVUS films on all eligible patients enrolled in the PROGRESS-AMS 1.0 will give important information on the long term safety of absorbable metal scaffolds and thus can support improvement of the device.

Official Title
-----------------
Clinical Performance and Angiographic Results of Coronary Stenting With Absorbable Metal Stents, Clinical Long Term Follow-Up

Conditions
-----------------
Long Term Safety of the AMS 1.0

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form available prior to clinical long term follow-up Exclusion Criteria: Patent did not sign the informed consent form prior to clinical long term follow-up
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 |
| --- | --- | --- |
| Target Lesion Failure (TLF) | Composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization | up to 7 years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical follow-up, up to 7 years, all patients enrolled in the main study
Effect of Alveolar Recruitment Maneuver on Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O

Detailed Description
-----------------
After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds

Official Title
-----------------
Effect of Alveolar Recruitment Maneuver on Postoperative Pain After Bariatric Surgery

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Alveolar recruitment maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who scheduled for elective bariatric surgery Exclusion Criteria: uncontrolled cardio-vascular disease, active pulmonary disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>no applying alveolar recuritment maneuver | Procedure: Alveolar recruitment maneuver<br>* Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery<br>* Other names: High pressure alveolar recruitment maneuver;|
| Active Comparator: Low ARM<br>Applying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec | Procedure: Alveolar recruitment maneuver<br>* Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery<br>* Other names: High pressure alveolar recruitment maneuver;|
| Active Comparator: High ARM<br>Applying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec | Procedure: Alveolar recruitment maneuver<br>* Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery<br>* Other names: High pressure alveolar recruitment maneuver;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale for postoperative pain | score (0 no pain-10 severe pain) | up to postoperative 24 hour | 
| Quality of recovery (QoR40) for Postoperative comfort | score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery) | up to postoperative 24 hour |
Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

Detailed Description
-----------------
This study was conducted in India.

Official Title
-----------------
Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Propylene Glycol 0.6% eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent and willing and able to attend all study visits; Dry eye in both eyes diagnosed by an ophthalmologist; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential who are pregnant or breastfeeding; Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study; Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening; Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening; Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening; Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Balance<br>Propylene Glycol 0.6% eye drops, 1 drop QID (with the last dose of each day at bedtime) in each eye for 90 days | Other: Propylene Glycol 0.6% eye drops<br> <br> * Other names: Systane® Balance;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Corneal Staining Total Score | The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15). | Baseline (Day 0), Day 45, Day 90 |
Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

Study Overview
=================
Brief Summary
-----------------
to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula

Detailed Description
-----------------
congenital Recto vestibular fistula represents the commonest type of anorectal malformation in females. The treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. Several perioperative factors may affect the outcome. One of major postoperative complications is the occurrence of wound infection. Purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence. Patients and methods: A prospective randomized trial included 55 infants with recto-vestibular fistula. All infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. Patients were divided into two groups. group A included infants who started oral intake on the 5th postoperative day and group B included infants who started oral intake on the 2nd postoperative day. The primary outcome was the onset of perineal wound infection. Group A infants were kept on peripheral parenteral nutrition during fasting period.

Official Title
-----------------
Early Versus Delayed Postoperative Enteral Feeding to Reduce the Incidence of Perineal Wound Infection Following Anterior Sagittal Anorectoplasty of Congenital Recto-vestibular Fistula

Conditions
-----------------
Onset of Perineal Wound Infection

Intervention / Treatment
-----------------
* Other: enteral feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All female infants with congenital rectoperineal fistula Exclusion Criteria: patients with major anomalies, patients who have staged repair

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: delayed enteral feeding ingroup 1 early enteral feeding in group 2
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: delayed enteral feeding<br>delayed enteral feeding | Other: enteral feeding<br>* to intake oral feeding or delay it<br>|
| Active Comparator: early enteral feeding<br>early enteral feeding | Other: enteral feeding<br>* to intake oral feeding or delay it<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perineal wound infection | the occurrence of wound infection after ASARP | WITHIN TWO WEEKS POST OPERATIVE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recto-vestibular fistula,, early enteral feeding, peripheral parenteral nutrition, perineal wound infection
High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy

Study Overview
=================
Brief Summary
-----------------
Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.

Official Title
-----------------
Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy

Conditions
-----------------
Diabetic Kidney Disease

Intervention / Treatment
-----------------
* Drug: High dose ACE-I vs ARB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR&gt;50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease. Controlled blood pressure (&lt;150/&lt;90) Able to give informed consent Between the ages of 18 and 75 Must be capable of providing a 24 hour urine collection Negative BHcG test for ruling out pregnancy in women of childbearing age Currently taking an angiotensin converting enzyme inhibitor - Exclusion Criteria: Creatinine clearance &lt;50ml/min or 24hour protein excretion &gt;3gm/d. Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp &lt;100mmHg. Serum potassium &gt;5.5 on two separate occasions in the previous six months Previous adverse reaction to angiotensin receptor antagonist medication Use of NSAIDS including COX2 inhibitors Pregnant or nursing women will be excluded Currently taking an angiotensin receptor antagonist -

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: High dose ACE-I vs ARB|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducing proteinuria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glomerular filtration rate |  |  | 
| side-effects of hypotension, postural symptom |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Proteinuria, Angiotensin converting enzyme inhibitors, Angiotensin receptor antagonists