linjc16/ctgov huggingface dataset:
Opioids Following ACL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).

Official Title
-----------------
The Utilization of Opioid Medication Following ACL Reconstruction

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

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: oxycodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair. Exclusion Criteria: Concomitant procedure other than meniscectomy or meniscal repair. ACL revision History of chronic pre-operative opioid use History of substance abuse Workmen's compensation claims Pregnancy

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 15 opioid tablets perscribed<br>For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain | Drug: Oxycodone<br>* Patients will be given a prescription for 15 opioid tablets for post-operative pain<br>|
| Active Comparator: 25 opioid tablets perscribed<br>For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain | Drug: Oxycodone<br>* Patients will be given a prescription for 25 opioid tablets for post-operative pain<br>|
| Active Comparator: 35 opioid tablets perscribed<br>For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain | Drug: oxycodone<br>* Patients will be given a prescription for 35 opioid tablets for post-operative pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable | 14 days post-operative |
Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
* Drug: UFT 250mg/m2, daily for 1 year


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: completely resected non small cell lung cancer no prior anti cancer treatment for thoracic malignancy exept for this operation pathological stage IB, II, and stage IIIA with only one station of n2 disease PS 0-1 age 20-75 adequate organ function for chemotherapy written informed consent Exclusion Criteria: small cell lung cancer or low grade malignancy of lung cancer incomplete resection apparent interstitial pneumonitis at chest rentogenogram inadequate condition for chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6|nan|
|Drug: UFT 250mg/m2, daily for 1 year|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 year survival rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  |  |
Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF

Study Overview
=================
Brief Summary
-----------------
Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. There is no report on whether AASI is associated with left ventricular diastolic dysfunction in patients with HFpEF.

Detailed Description
-----------------
Heart failure with preserved ejection fraction (HFpEF) is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. AASI is especially associated with left ventricular diastolic dysfunction in patients with hypertension. Patients with HFpEF have obvious left ventricular diastolic insufficiency. However, there is still no research investigating the the relationship between AASI and left ventricular diastolic dysfunction in patients with HFpEF.

Official Title
-----------------
Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged >=18years old; Diagnosed with HFpEF. Exclusion Criteria: LVEF less than 45% at any time; Severe liver failure; Other causes of shortness of breath, such as severe pulmonary disease or severe Severe valvular disease of the left heart; Chronically bedridden or incapacitated; Age <18 years old.

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 |
| --- | --- | --- |
| Left ventricular diastolic function | the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e') | 1 day On admission |
Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions

Study Overview
=================
Brief Summary
-----------------
This study aims to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions.

Official Title
-----------------
Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions

Conditions
-----------------
Elasticity Imaging Techniques

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with radiographic evidence of pleural lesions or effusion Exclusion Criteria: Age < 20 y/o Patients who cannot hold their breath for 5 seconds

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 |
| --- | --- | --- |
| Application of transthoracic shear-wave ultrasound elastography in pleural lesions | to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shear wave ultrasound elastography
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic abdominal scar.

Official Title
-----------------
A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transverse Hypertrophic Scars on the Lower Abdomen Resulting From Previous Surgeries in Healthy Adults

Conditions
-----------------
Hypertrophic Scar

Intervention / Treatment
-----------------
* Drug: RXI-109
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 21-55 years of age in general good health Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting in a transverse hypertrophic scar of ≥ 11 cm in length Scar to be revised must have been present for > 9 months Exclusion Criteria: Use of tobacco or nicotine-containing products Pregnant or lactating Post-menopausal or full hysterectomy

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RXI-109<br>Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery. | Drug: RXI-109<br>* surgery.<br>|
| Placebo Comparator: Placebo<br>Treatment with RXI-109 on one side of revised scar and a placebo comparator on the other side. Treatment to begin either immediately or 2 weeks following the scar revision surgery. | Drug: Placebo<br>* surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in recurrence of hypertrophic scarring after scar revision surgery | To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a hypertrophic abdominal scar | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of RXI-109 | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic abdominal scar | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scar prevention, Cicatrix, Scar revision, Hypertrophic scar
Infarction Register

Study Overview
=================
Brief Summary
-----------------
The Aachener Digitale Myokardinfarkt Register (ADMIRE) is a prospektive registry study which was designed in order to obtain data of patients with acute coronary syndrome and herewith control and optimize guideline conform therapy of these patients.

Detailed Description
-----------------
Aims of this registry stdy are documentation of the characteristics of all patients representing to the RWTH Aachen University Hospital (UKA) with STEMI or NSTEMI documentation of the invasive and adjuvant medicinal therapy of STEMI and NSTEMI at UKA documentation of the in-hospital mortality documentation of the procedure-associated complications documentation of therapeutic principals for patients with STEMI or NSTEMI at UKA and investigation conformity of treatment with already established guidelines

Official Title
-----------------
Aachen Digital Myocardial Infarction Register

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary syndrome Exclusion Criteria: under age or not able to give informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients representing to the hospital with acute coronary syndrome | Other: data collection<br>* The data of patients is collected from their hospital documentation The follow-up of all patients is done via phone calls in order to collect data about the outcome of each patient<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
-----------------
Acute coronary Syndrome, STEMI, NSTEMI, Registry
An Interaction Study With Digoxin and AZD1305

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to learn more about how digoxin is handled by the body, i.e. absorption, distribution, metabolism and excretion, when administered alone and in combination with AZD1305. Secondary purposes are to learn more about how AZD1305 is handled by the body when administered alone and in combination with digoxin and to learn more about how AZD1305 and digoxin administered alone and in combination affect the body.

Official Title
-----------------
A Phase I, Randomised, Open, Single-centre, Three-period Crossover Study to Evaluate the Effect of AZD1305 on the Pharmacokinetics of Digoxin After Repeated Oral Administration of AZD1305 and Digoxin to Young Healthy Male Volunteers

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: AZD1305
* Drug: Digoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A body mass index (BMI=weight/height2) of 19 to 30 kg/m2 Exclusion Criteria: Potassium outside normal reference values ECG findings outside normal range

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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: 1<br>AZD1305 tablet | Drug: AZD1305<br>* Extended Release tablet, repeated administration<br>|
| Experimental: 2<br>AZD1305 tablet + digoxin | Drug: AZD1305<br>* Extended Release tablet, repeated administration<br>Drug: Digoxin<br>* Tablet, repeated administration<br>|
| Active Comparator: 3<br>Digoxin | Drug: Digoxin<br>* Tablet, repeated administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | During all dosing visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event, vital signs, ECG, physical examination and laboratory variables. |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, interaction, pharmacokinetic
Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery

Study Overview
=================
Brief Summary
-----------------
This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures.

Detailed Description
-----------------
IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20 minutes after the cardiovascular bypass ends to calculate the difference between them and compare if there is any statistical difference between the proinflammatory markers with the two anesthesia techniques.

Official Title
-----------------
Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery

Conditions
-----------------
Cardiovascular Surgical Procedure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for cardiovascular surgery American Society of Anaesthesiologists (ASA) physical status classification II-IV BMI < 25 HbA1c < 7% Exclusion Criteria: Diabetic patients Known allergy to propofol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inhaled anesthesia (Sevoflurane)<br>Patients undergoing cardiovascular surgery with inhaled anesthesia with sevoflurane. | Drug: Sevoflurane<br>* Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)<br>* Other names: Sevorane;|
| Total Intravenous Anesthesia (Propofol)<br>Patients undergoing cardiovascular surgery with total intravenous anesthesia with propofol. | Drug: Propofol<br>* Propofol anesthesia Dose: 4-6mg/kg/h<br>* Other names: Diprivan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 | IL-6 will be compared between the groups. | The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNFα | TNFα will be compared between the groups | The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass | 
| Cortisol | Cortisol will be compared between the groups | The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhaled anesthesia, Total intravenous anesthesia
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This study is being done to see in B12 applied to the skin will improve the symptoms of eczema in children compared to a placebo creme

Detailed Description
-----------------
INTRODUCTION: Atopic dermatitis is a prevalent disease process in children, affecting up to 20% of children in the United States. Various treatment options are available to treat atopic dermatitis to include topical emollients, topical steroids, and topical calcineurin inhibitors. Each treatment option has benefits and potential risks. This study was done to determine if topical B12 could be a tolerable and efficacious alternative treatment option in this population. METHODS: The study was conducted as a placebo-controlled, double-blind, prospective, randomized clinical trial with intraindividual left ⁄ right comparison. Parents were given 2 containers of creams and instructed to apply the Vitamin B12 cream to one side of the body and the placebo cream to the contralateral side according to the randomization scheme.

Official Title
-----------------
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

Conditions
-----------------
Eczema

Intervention / Treatment
-----------------
* Drug: Topical B12 0.07%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children presenting to the Center for Family Medicine or Regional Pediatrics between the ages of 6 months and 18 years old with atopic dermatitis Exclusion Criteria: unwillingness of parent to consent to study protocol, pregnancy or lactation, eczema with superinfection present, known history of allergy to Vitamin B12 or components of the base cream, topical treatment with corticosteroids in the 4 weeks prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical B12 0.07%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in SCORAD at 2 and 4 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eczema, Pediatric, Vitamin B12