linjc16/ctgov huggingface dataset:
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium

Study Overview
=================
Brief Summary
-----------------
Anesthesia induction with sevoflurane is not associated with an increased incidence or severity of laryngeal injuries compared with an anesthesia induction with a muscle relaxant.

Official Title
-----------------
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium. A Randomized, Prospective, Controlled Trial

Conditions
-----------------
Laryngeal Injuries

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ear-nose-throat surgery orotracheal intubation for surgery of the ear Exclusion Criteria: obesity allergy against the study drugs patients with a known or suspected difficult airway (Mallampati score 3 or 4 and a mouth opening < 3.5 cm). all patients were examined by stroboscopy one day before surgery and were excluded from the study when preexisting pathologies of the vocal cords were found

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sevoflurane<br>anesthesia induction with propofol, remifentanil and sevoflurane | Drug: Sevoflurane<br>* anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation<br>|
| Active Comparator: rocuronium<br>anesthesia induction with propofol, remifentanil and rocuronium | Drug: Rocuronium<br>* anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of vocal cord injuries |  | 24 h after tracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hoarseness |  | 24h, 48 h, and 72 h after tracheal intubation | 
| incidence of soar throat |  | 24h, 48h, and 72 h after tracheal intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laryngeal injuries, vocal cord injuries, hoarseness, sore throat
Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

Study Overview
=================
Brief Summary
-----------------
Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with RDEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.

Detailed Description
-----------------
We will obtain a detailed medical history and will perform a skin examination and brief physical exam. Photographs may be taken. We will ask questions about the size and duration wounds. LAB TESTS We will draw blood to determine overall health status to include Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV) testing. Genetic testing may also be performed. BIOPSIES Biopsies may be collected to check for Collagen 7 and for antibodies to Collagen 7. Based on the results obtained, it may be possible to identify patients who would qualify to participate in current or future clinical trials.

Official Title
-----------------
Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

Conditions
-----------------
Epidermolysis Bullosa Dystrophica

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of RDEB by local dermatologist 7 years of age or older Exclusion Criteria: -Medical instability limiting ability to travel to Stanford University Medical Center
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 |
| --- | --- | --- |
| Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa | Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa for future studies | 4 years |
Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.

Detailed Description
-----------------
Assessment of efficacy, tolerance and acceptability of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers: multicenter trial, conducted in France.

Official Title
-----------------
Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers

Conditions
-----------------
Ulcers, Leg

Intervention / Treatment
-----------------
* Device: Urgo 310 3166 dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female over 18 years old who has provided his/her written informed consent Patient who can be monitored by the same investigation team throughout the whole duration of the study Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 Ulcer area between 3 and 20 cm2 Ulcer duration between 3 and 18 months, Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue Moderately or heavily exudative ulcers. Exclusion Criteria: A. Clinical infection on the wound bed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Urgo 310 3166 dressing<br>Urgo 310 3166 dressing | Device: Urgo 310 3166 dressing<br>* Experimental: Urgo 310 3166 dressing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - % of Wound Area Regression (WAR | % of Wound Area Regression (WAR), as a measure of efficacy | at week 12 |
NAtional TUnisian REgistry of Heart Failure

Study Overview
=================
Brief Summary
-----------------
NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.

Detailed Description
-----------------
The NATURE-HF is a national clinical non-interventional registry of heart failure, carried out in Tunisia at cardiology departments in hospitals and in liberal cardiology consultations. 100 cardiologists participate in the enrollment of the eligible patients as investigators. A Committee of Experts validates the protocol methodology and supervises the data-management. A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Official Title
-----------------
National Tunisian Registry of Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with chronic heart failure Patient with acute heart failure (new onset or not) The diagnosis of heart failure is at the discretion of the investigator Informed and signed consent Exclusion Criteria: Life expectancy <12 months for extra cardiac disease Isolated Right Heart Failure Pregnant woman Renal failure with creatinine clearance < 15 ml / min Hemodialysis patients Cardiac surgery planned within 3 months Congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Cardiovascular death | Incidence of cardiovascular death including sudden death, death from refractory heart failure and death from stroke | Time-To-Event measure up to 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Readmission | Incidence of heart failure readmissions | At 1, 3 and 12 months from patient enrollment | 
| Global Death | Incidence of death of all causes (cardiovascular death and non-cardiovascular death) | Time-To-Event measure up to 12 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Acute Heart Failure, Chronic Heat Failure, Cardiovascular diseases, Heart diseases, Registry, Tunisia
Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).

Official Title
-----------------
Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia

Conditions
-----------------
Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia

Intervention / Treatment
-----------------
* Biological: CD34-positive cells
* Biological: CD34-positive cells
* Biological: Saline and 5% autologous plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21-80 years of age moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5) unsuitable for conventional revascularization Exclusion Criteria: advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene advance AV block or NYHA Class III or Class IV heart failure myocardial infarction within 3 months of treatment successful coronary or lower extremity revascularization within 3 months of study enrollment arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease) co-morbidity associated with life expectancy of less than 1 year

Ages Eligible for Study
-----------------
Minimum Age: 21 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Dose<br> | Biological: CD34-positive cells<br> <br> |
| Active Comparator: High Dose<br> | Biological: CD34-positive cells<br> <br> |
| Placebo Comparator: Saline<br> | Biological: Saline and 5% autologous plasma<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Intramuscular Injection of CD34-positive cells |  | 6 months and 1 year | 
| Change in Rest Pain |  | 6 months | 
| Ulcer Healing |  | 6 months | 
| Functional Improvement |  | 6 months | 
| Limb Salvage |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Severity |  | 6 months | 
| Assessment of Co-morbidity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD, PVD, CLI, Stem Cells
Hereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers

Study Overview
=================
Brief Summary
-----------------
Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or pheochromocytoma. The main objective of our national clinical research project is to test different screening methods to detect presymptomatic tumors in order to establish guidelines for the work-up and the follow-up of SDH mutation carriers.

Official Title
-----------------
Evaluation Des méthodes de dépistage du Paragangliome héréditaire Chez Les Sujets prédisposés génétiquement

Conditions
-----------------
Paraganglioma, Pheochromocytoma

Intervention / Treatment
-----------------
* Procedure: diagnosis methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: identification of an SDH (SDHD, SDHD, SDHC) germline mutation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: diagnosis methods|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Spirulina on Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Hyaluronic acid serum levels correlate with histological stages of liver fibrosis in hepatitis C patients, so it has a good diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.

Official Title
-----------------
Effect of Spirulina on Serum Hyaluronic Acid as a Marker for Liver Fibrosis in Beta Thalassemic Children With Hepatitis C

Conditions
-----------------
Beta Thalassemia Major

Intervention / Treatment
-----------------
* Dietary Supplement: Spirulina


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multitransfused beta thalassemic children with and without super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction. Exclusion Criteria: liver decompensation child younger than 3 years patients with hepatitis B infection

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thalassemic children with hepatitis C<br>30 multitransfused beta thalassemic children infected with hepatitis C virus diagnosed by serological detection of HCV-antibodies and HCV RNA by polymerase chain reaction will be given Spirulina in a dose of 250 mg/kg/day orally for 3 months. | Dietary Supplement: Spirulina<br>* Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.<br>|
| No Intervention: thalassemic children without hepatitis C<br>30 multitransfused beta thalassemic children without hepatitis C virus infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum hyaluronic acid levels |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver function tests |  | 3 months | 
| aspartate aminotransferase to platelet ratio index (APRI) |  | 3 months |
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Drug: Ursodeoxycholic acid, thiamine, riboflavin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CIS greater than or equal to 76, HADS less than or equal to 10 ALT greater than upper limit of normal OR fatty liver on US Exclusion Criteria: Subjects who have diseases that can cause fatigue Subjects who are taking medication that can cause fatigue

Ages Eligible for Study
-----------------
Minimum Age: 19 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: udca003<br>udca003 | Drug: Ursodeoxycholic acid, thiamine, riboflavin<br> <br> |
| Placebo Comparator: placebo<br>placebo of udca003 | Drug: Ursodeoxycholic acid, thiamine, riboflavin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of subjects whose CIS score has improved under 76 at week 8 |  | 8 weeks |
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections

Study Overview
=================
Brief Summary
-----------------
This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.

Detailed Description
-----------------
The study is an open label controlled efficacy trial of Aionx patented antimicrobial surface for the prevention of healthcare-associated infections (HAIs). It will take place at Penn State Hershey. Half of the single occupancy rooms of the 5th and 7th floor will be assigned to contain the antimicrobial surface at five locations: bed rails, overbed table, door handles, counter, and arm rests of bedside chair. The remaining rooms will serve as controls. Data on HAIs will be gathered for all the patients admitted to the rooms during the duration of the study. After 45 days the rooms will be flipped so that test rooms become controls and control rooms become test rooms. The duration of the study will be for a minimum of 90 days.

Official Title
-----------------
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections

Conditions
-----------------
Healthcare Associated Infection

Intervention / Treatment
-----------------
* Device: Antimicrobial Surface


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to a single occupancy room in a participating floor at Hershey Medical Center Exclusion Criteria: Refusal to participate 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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Use of antimicrobial surface | Device: Antimicrobial Surface<br>* Antimicrobial Surface<br>|
| No Intervention: Control<br>No antimicrobial surface | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare-Associated Infections | Healthcare-Associated Infections | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Readmission for infection |  | 90 days |
Role and Outcome of Endovascular Revascularization of Chronic Limb Ischaemia

Study Overview
=================
Brief Summary
-----------------
identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases

Detailed Description
-----------------
patients with chronic kidney diseases are at higher risk of developing peripheral artery diseases needing revascularization of diseased arteries via endovascular transluminal angioplasty

Official Title
-----------------
Role and Outcome of Endovascular Revacularization of Chronic Limb Threatening Ischaemia in Patients With Chronic Kidney Diseases

Conditions
-----------------
Limb Ischemia, Critical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with chronic kidney diseases on medical treatment or on dialysis and have critical limb ischaemia Exclusion Criteria: patients with acute renal failure and lower limb ischaemia. chronic kidney diseased patients underwent previous intervention or surgery for lower limb ischaemia. patients presented with acute limb ischaemia

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one year evaluation for maintaining vessel patency without restenosis or need for re intervention in 100 participants | all patients will be scheduled for follow up visits every 3 months for 1 year assessing primary patency and major adverse limb events. duplex scanning will be performed for all patients | baseline |