linjc16/ctgov huggingface dataset:
OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)

Study Overview
=================
Brief Summary
-----------------
OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register settled in Italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques in addition to the standard surgical procedures in 40 surgical wards. The availability of these data will allow for a better understanding of the therapeutic needs in the area of hemostatic supporting agents/techniques.

Official Title
-----------------
OSHES (Observational Study on Hemostasis in Surgery ). A Non Interventional Study on the Hemostasis Supportive Methods in Surgery

Conditions
-----------------
Blood Loss, Surgical, Hemostasis

Intervention / Treatment
-----------------
* Drug: Fibrinogen (human) + thrombin (human) (TachoSil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fibrinogen (human) + thrombin (human) (TachoSil)|Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures|

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
-----------------
Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
Safety Study of Abatacept to Treat Refractory Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.

Official Title
-----------------
Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Drug: Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Diagnosis of sarcoidosis for at least 1 year with lung disease Active disease despite current treatment On a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or hydroxychloroquine, for at least 90 days Primary Exclusion Criteria: Previous treatment with Abatacept Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) Currently receiving or received within the last 30 days the following: cyclosporine, tacrolimus or leflunomide Previous treatment of IVIg within the last 6 months History of chronic infection that has been active within last 60 days, or herpes zoster within last 6 months, or any infection requiring hospitalization or intravenous medication within last 60 days or oral medication within the last 2 weeks History of congestive heart failure HIV

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 |
| --- | --- |
| Other: Abatacept<br> | Drug: Abatacept<br>* 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.<br>* Other names: Orencia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Abatacept in Progressive Pulmonary Sarcoidosis. | Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept. | 24 weeks and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 6-minute Walk Distance. |  | 24 weeks and 52 weeks |
Optimizing the Ocular Surface Prior to Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.

Official Title
-----------------
Optimizing the Ocular Surface Prior to Cataract Surgery

Conditions
-----------------
Corneal Dystrophy, Epithelial Basement Membrane

Intervention / Treatment
-----------------
* Device: cryopreserved amniotic membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with significant EBMD that are contemplating cataract surgery. Age range: 50 years and older. Both Genders and all ethnic groups comparable with the local community. Subjects able to understand and willing to sign a written informed consent. Subjects able and willing to cooperate with the investigational plan. Subjects able and willing to complete postoperative follow-up. Exclusion Criteria: Subjects with known intolerance to PKS or known allergy to its preservative media. Subjects with symblepharon or lid abnormality preventing PKS placement. Ocular infection within 14 days prior to study entry. Previous ocular surgery or injury within 3 months before enrollment. Subjects with a history of non-healing epithelial defect or neurotrophic keratitis. Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study<br>prospective arm receiving cryopreserved amniotic membrane | Device: cryopreserved amniotic membrane<br>* placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD<br>* Other names: Prokera Slim (PKS);|
| No Intervention: Control<br>Retrospective review of debridement without cryopreserved amniotic membrane | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Lens Calculation | Assessed by corneal topography | Change from Baseline to 1 month | 
| Change in Intraocular Lens Power Calculation | Assessed using biometry and calculated using Holladay I formula | Change from Baseline to 1 month |
Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee

Official Title
-----------------
A Multicenter, Prospective Observational Study to Evaluate the Injection Site Reactions of Synovian® Inj. in Patients With Osteoarthritis in the Knee

Conditions
-----------------
Osteoarthritis in the Knee

Intervention / Treatment
-----------------
* Drug: Synovian®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female patient of over 19 years of age A patient diagnosed with knee osteoarthritis A patient who has been informed of the purpose, method of the study and signed the written informed consent form. Exclusion Criteria: A patient who shows hypersensitive reaction to the Synovian® Inj. or to the ingredients of Synovian® Inj. A patient with infection at the joint A patient with skin infection or skin disease at the injection area A patient diagnosed with osteoarthritis with the Kellgren & Lawrence Grade IV in X-ray within 12 months before enrollment of this study.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Synovian®|Synovian® Inj.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety endpoints | injection site reactions | Week 2 |
Indocyanine Green for Central Nervous System Tumors

Study Overview
=================
Brief Summary
-----------------
This study is a single center, open-label, two-part study to assess image guided surgery of intramolecular imaging in nervous system tumors. Subjects with a diagnosis of a resectable nervous system tumor who are at risk of recurrence are included. The primary goal is to observe what tissues fluoresce in the OR, and then to identify if that tissue is cancerous/tumor or normal when the histopathology is performed.

Official Title
-----------------
A Pilot/Feasibility Study of Intraoperative Image-Guided Surgery of CNS Tumors With Indocyanine Green and MR Spectroscopic Imaging

Conditions
-----------------
Suspected Central Nervous System Tumors

Intervention / Treatment
-----------------
* Drug: Indocyanine Green (ICG)
* Radiation: Intraoperative near-infrared (NIR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18 years of age and older Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment Good operative candidate as determined by the treating physician and multidisciplinary team Subject capable of giving informed consent and participating in the process of consent Exclusion Criteria: Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery Subjects with a history of iodide allergies Vulnerable patient populations Patients unable to participate in the consent process (children and neonates) Patients with non-MRI compatible implanted metallic foreign bodies Patients who due to severe claustrophobia cannot tolerate MRI scanning Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG Arm<br>Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization. | Drug: Indocyanine Green (ICG)<br> <br> Radiation: Intraoperative near-infrared (NIR)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity (SBR) | sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR) | 72 hours |
Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing

Study Overview
=================
Brief Summary
-----------------
Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.

Official Title
-----------------
Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: omeprazole
* Drug: omeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory Range of Age: 20-70 BMI: 20-30 Exclusion Criteria: Patients who are allergic to proton-pump inhibitors or show incompatibility Patients who have lactase deficiency Patients who have severe chronic disease Patients who participated in another study during the last three months Patients who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: control group<br>3 tablets, only 20 mg omeprazole, genotype independent | Drug: omeprazole<br>* 20 mg daily<br>|
| Active Comparator: intervention group<br>20 vs. 60 mg daily, genotype dependent | Drug: omeprazole<br>* 20 vs. 60 mg daily, genotype dependent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastro-oesophageal reflux disease
Microsurgery Using a Bioceramic Root End Filling Material

Study Overview
=================
Brief Summary
-----------------
Endodontic failures are not uncommonly encountered despite improvements in routine root canal therapy. Endodontic microsurgery is one way to manage such failure. The placement of a retrograde filling material is considered the most important prognostic factor in endodontic microsurgery. The aim of this study was to investigate the clinical and radiographic outcome of a fast set bioceramic root end filling material in human teeth.

Detailed Description
-----------------
Patients who were referred to the endodontic postgraduate clinics in the period between January 2017 till August 2017 were assessed for inclusion in the study according to preset criteria. Endodontic microsurgery was performed following modern techniques including magnification, root resection with minimal angle, ultrasonic root end preparation and placement of a fast set bioceramic putty as retrograde filling material. The case was subsequently evaluated clinically and radiographically at 3, 6 and 12 months. And will be followed subsequently at 2 years and 4 years post treatment.

Official Title
-----------------
Outcome of Periradicular Microsurgery Using a Bioceramic Root End Filling Material

Conditions
-----------------
Bone Resorption, Symptoms

Intervention / Treatment
-----------------
* Other: endodontic microsurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medically fit patient Tooth has adequate coronal seala nd judged restorable previously root filled tooth with persistent periapical lesion previously retreated tooth with persistent symptoms 5.previously tretaed tooth with inaccessable canal for retreatment 6. combined nonsurgical and surgical approach for teeth with large periapical lesions Exclusion Criteria: medically compromised patients nonrestorable teeth cracked roots

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| teeth with failed root canal treatement<br>endodontic microsurgery will be performed for teeth with failed root canal treatment | Other: endodontic microsurgery<br>* teeth with failed root canal treatment will be treated by endodontic microsurgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of signs of failure in the root treated tooth | symptoms should disappear and signs of bone healing should be evident on the radio graph | 6 months -1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rarifaction, root end filling, bioceramic, outcome
Electronic Warning Systems in Diagnosis and Treatment of AKI

Study Overview
=================
Brief Summary
-----------------
To set up electronic early warning system of AKI patients; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation. To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.

Detailed Description
-----------------
To set up electronic early warning system according to KDIGO AKI diagnosis standard, real-time monitoring of hospitalized patients with renal function data, real-time detection of AKI patients, notify the diagnosis of renal physician; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation. To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.

Official Title
-----------------
The Effect of Electronic Warning Systems in the Process of Diagnosis and Treatment of Patients With Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Device: electronic alerts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria. Exclusion Criteria: Exclusion criteria were initial hospital creatinine 4•0 mg/dL (to convert to μmol/L, multiply by 88•4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease.

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 |
| --- | --- |
| Hospital-acquired AKI<br>Adult patients with Hospital-acquired AKI | Device: electronic alerts<br>* electronic alerts for AKI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | death at 7 days after alert | at 7 days after alert | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dialysis | dialysis at 7 days after alert | at 7 days after alert | 
| change in creatinine | relative maximum change in creatinine | at 7 days after alert | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney Injury, Electronic alerts
Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI

Study Overview
=================
Brief Summary
-----------------
This study evaluated differences between men and women in the presentation, management and outcome of heart attacks within the GUSTO V study.

Detailed Description
-----------------
The Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO) V trial examined a large, contemporary cohort of women and men with ST elevation myocardial infarction (STEMI) treated with fibrinolytic therapy. The objective of the present study was to evaluate sex differences in presentation, management and outcome in GUSTO V.

Official Title
-----------------
Female Sex is an Independent Predictor of Death and Bleeding Among Fibrinolytic Treated Patients With AMI; Results of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries - V Trial

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: fibrinolytic therapy or combination reduced fibrinolytic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inclusion into GUSTO V Exclusion Criteria: lack of availability of data (database 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fibrinolytic therapy or combination reduced fibrinolytic therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | All cause mortality at 30 days after randomization. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcomes | Incidence of myocardial reinfarction as evidenced by new electrocardiographic changes or elevation in cardiac enzyme levels with recurrent chest pain within 7 days, bleeding, stoke, intracranial hemorrhage (ICH), and complications of MI. | 7 days |