linjc16/ctgov huggingface dataset:
Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis

Study Overview
=================
Brief Summary
-----------------
Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries

Detailed Description
-----------------
Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries with no toxicity and no adverse reaction or complications we targeted under echography each nerve to be blocked alone either to put around all the nerves a big volume

Official Title
-----------------
Ropivacaine for Ultrasound-guided Interscalene Block: 3mL Provide Similar Analgesia to 5mL With Less Diaphragmatic Paralysis in Shoulder Arthroscopy Surgeries

Conditions
-----------------
Diaphragmatic Paralysis

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.5% Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA1-2 Exclusion Criteria: ASA3-4 anticoagulant
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3 ml ropivacaine<br>interscalene block using 3 ml under ultrasound put medication on each nerve | Drug: Ropivacaine 0.5% Injectable Solution<br>* Is to put 3 ml or 5 ml and show the difference<br>* Other names: interscalene;|
| Active Comparator: 5 ml ropivacaine<br>interscalene block using 5 ml under ultrasound put medication on each nerve | Drug: Ropivacaine 0.5% Injectable Solution<br>* Is to put 3 ml or 5 ml and show the difference<br>* Other names: interscalene;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic paralysis | on x ray we look if there is an elevated diaphragm | Up to 48 hours | 
| Pain relief | pain scale 1-10 score 1 no pain and 10 severe pain first by visiting patient before discharge twice and thereafter on the phone | up to day 2 after operation |
Remote Ischemic Preconditioning in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to ameliorate the effect of reperfusion injury in recipients.

Detailed Description
-----------------
Upper arm ischemia will be induced by elevation of NIBP cuff pressure to 200 mm Hg for 5 minutes repeated four times 5 mniutes apart, aiming to decrease the effect of ischemia reperfusion in the graft liver.

Conditions
-----------------
Liver Transplanatation

Intervention / Treatment
-----------------
* Procedure: Ischemia preconditioining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All candidates for living donor liver transplantation Exclusion Criteria: Donors with peripheral vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P group<br>Elevation of Cuff pressure to 200 mm Hg for 5 minutes four times 5 minutes apart | Procedure: Ischemia preconditioining<br>* Elavate blood pressure cuff pressure to 200<br>|
| No Intervention: C group<br>no intervention will be added to routine anesthetic mangement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver enzymes ( SGOT and SGPT) as indicator of graft injury | Hemodynamic effects of reperfusion ijury | 30 minutes |
Phase1, Single Dose, Crossover Study to Determine Bioequivalence

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).

Official Title
-----------------
A Phase 1, Open-Label, Randomized, Single-Dose, 2-Way Crossover Study To Determine Bioequivalence Of 4 Mg Fesoterodine SR Tablet Between Formulation D And Formulation E(1) In Healthy Subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Fesoterodine
* Drug: Fesoterodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female Chinese or Japanese subjects Exclusion Criteria: Evidence or history of clinically significant findings at screening

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Fesoterodine<br>* Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)<br>|
| Experimental: B<br> | Drug: Fesoterodine<br>* Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions |  | Day 1 and 2 | 
| AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions |  | Day 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions |  | Day 1 and 2 | 
| Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions |  | Day 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence, Therapeutic Equivalency
Fusariosis in Solid-Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.

Detailed Description
-----------------
This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.This will help determine prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.

Official Title
-----------------
Fusariosis in Solid-Organ Transplant Recipients

Conditions
-----------------
Solid Organ Transplant, Fusariosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid-organ transplants (liver, kidney, lung, heart, pancreas, small bowel transplant) diagnosed with fusariosis or infections due to Fusarium, species in our institution Exclusion Criteria: Those subjects that do not meet inclusion 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?
-----------------
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
-----------------
fusariosis, solid organ transplants
A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.

Official Title
-----------------
A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children

Conditions
-----------------
Growth Hormone Disorder, Growth Hormone Deficiency in Children

Intervention / Treatment
-----------------
* Drug: NNC126-0083
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml Pre-pubertal children Growth hormone replacement treatment for at least three months Exclusion Criteria: Evidence of tumour growth or malignant disease Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC126-0083<br> | Drug: NNC126-0083<br>* One single dose administered in four dose levels in an escalating order<br>|
| Active Comparator: Norditropin NordiFlex®<br> | Drug: somatropin<br>* A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse events (AEs) |  | 0-10 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration |  | Measured 10 days after dosing | 
| IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration |  | Measured 10 days after dosing |
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events

Study Overview
=================
Brief Summary
-----------------
MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.

Official Title
-----------------
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study

Conditions
-----------------
Breast Cancer Female, Acute Coronary Events, Cardiac Complications

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female breast cancer patients; Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS); Age between 40-75 years at time of start RT; WHO performance status 0-1; Planned for RT alone to the breast, the chest wall and/or the lymph node areas; Start of RT is between 01-01-2015 and 31-12-2013; Available planning CT scan and dose distribution; Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed; Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion; Written informed consent. Exclusion Criteria: Male breast cancer patients; Women with metastatic breast cancer (M1 disease); Any prior malignancy other than non-melanoma skin cancer; Previous thoracic or mediastinal radiation; Women treated with neoadjuvant chemotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy|Breast cancer patients treated with radiotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with an Acute Coronary Event after completion of RT treatment |  | First 10 years after RT treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with other cardiac complications after completion of RT treatment |  | First 10 years after RT treatment | 
| Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors) |  | First 10 years after RT treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Radiotherapy, Cardiac complications, Acute coronary events, NTCP model
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.

Official Title
-----------------
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of rheumatoid arthritis Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis Active disease despite treatment with at least one disease modifying anti-rheumatic drug Treatment with adalimumab indicated according to the the patient's rheumatologist At least six swollen joints in 28-joint index CRP > 8 mg / L within the last three months Exclusion Criteria: Treatment with anti-TNF drugs in the last three months Treatment with intravenous corticosteroids within fourteen days Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion Severe bleeding disorder Extensive or refractory leg ulcers Severe peripheral vascular disease

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: Adalimumab<br> | Drug: Adalimumab<br>* 40 mg IV every 14 days<br>* Other names: Humira;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial expression of HLA-DQ in muscle biopsies | Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis | 3 months | 
| Endothelial expression of interleukin-1 alpha in muscle biopsies | Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis | 3 months | 
| Carotid artery intima-media thickness | Thickness of the intima and media of the common carotid artery, measured by ultrasound. Mean of two measures of the right and left common carotid artery. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, cardiovascular disease, adalimumab
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia

Study Overview
=================
Brief Summary
-----------------
This study evaluates the current situation and follow-up of chronic hepatitis C virus (HCV) infection in patients co-infected with human immunodeficiency virus (HIV) in Andalusia.

Detailed Description
-----------------
In subjects co-infected with HIV, treatment of chronic HCV infection is particularly complex and requires considerable resources, including a very high cost is likely to increase with new antivirals. A precise knowledge of the situation in each hospital would facilitate adequate provision of personal and material resources needed to adequately address this disease in each center and in the Community as a whole. Because all or the vast majority of patients coinfected HIV / HCV are staffed by specialists who are part of Hepavir group and / or Sociedad Andaluza de Enfermedades Infecciosas (SAEI), they are ideal for carrying out this study.

Official Title
-----------------
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia

Conditions
-----------------
Chronic Hepatitis C, Human Immunodeficiency Virus (HIV)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 with HIV infection and active chronic hepatitis or SVR after treatment. Exclusion Criteria: None

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 |
| --- | --- | --- |
| Sustained virological response | This variable will be collected as follow at each clinical visit: i) yes; ii) not valuable (patients still on treatment); or, iii) no (patients who has not initiated treatment in the corresponding visit). | Up to twelve months |
Anidulafungin PK in Infants and Toddlers

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.

Official Title
-----------------
Anidulafungin PK in Infants and Toddlers

Conditions
-----------------
Invasive Fungal Infections

Intervention / Treatment
-----------------
* Drug: Anidulafungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 24 months at the time of enrollment Patient must have sufficient venous access to permit administration of study medication Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry Availability and willingness of the parent/legally authorized representative to provide written informed consent. Exclusion Criteria: Patients with a history of anaphylaxis attributed to an echinocandin Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study Previous participation in this study Previous exposure to an echinocandin in the month prior to study.

Ages Eligible for Study
-----------------
Minimum Age: 48 Hours
Maximum Age: 24 Months

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: Treatment<br>Treatment | Drug: Anidulafungin<br>* Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.<br>* Other names: Eraxis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. | Area under the curve at steady state | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. | Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug. | During and up to 10 days after last dose of study drug. |