linjc16/ctgov huggingface dataset:
Resorbable Magnesium Scaffolds Registry

Study Overview
=================
Brief Summary
-----------------
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).

Official Title
-----------------
RMS (Resorbable Magnesium Scaffolds) Registry

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Magmaris


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to the IFU Exclusion Criteria: According to the IFU

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Magmaris|MAGMARIS is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry, Magmaris, Coronary Artery Disease, PCI, Resorbable Magnesium Scaffolds
Effect of Small Daily Doses of B-carotene on Breast Milk Retinol

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine whether breast milk retinol concentration increases in response to daily supplementation with small amounts of vitamin A ( 600 ug RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary purpose is to evaluate sampling methods for collecting breast milk samples in a community setting. The results of this pilot study will allow us to determine whether milk retinol is a useful indicator for evaluating the impact of food-based interventions on the vitamin A status of lactating women.

Official Title
-----------------
Effect of Small Daily Doses of B-carotene or Vitamin A on Breast Milk Retinol Concentration in Lactating Filipino Women.

Conditions
-----------------
Vitamin A Status

Intervention / Treatment
-----------------
* Dietary Supplement: b-carotene
* Dietary Supplement: retinyl palmitate
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lactating women breastfeeding a single infant 4-12 months of age Exclusion Criteria: chronic disease breastfeeding more than one infant severe anemia signs or symptoms of vitamin A deficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: b-carotene<br>600 ug RAE/d as b-carotene, 6 d/wk for 3 weeks | Dietary Supplement: b-carotene<br> <br> |
| Active Comparator: retinyl palmitate<br>600 ug retinol equivalent/d, 6 d/wk for 3 weeks | Dietary Supplement: retinyl palmitate<br> <br> |
| Placebo Comparator: placebo (corn oil)<br>0 ug RAE/d as corn oil | Dietary Supplement: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast milk retinol concentration | breast milk retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma retinol concentration | plasma retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
b-carotene, breastmilk, vitamin A
Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain

Official Title
-----------------
Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study

Conditions
-----------------
Arthritis, Psoriatic, Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate Children from 4 to 17 years old with JIA polyarticular Exclusion Criteria: Clinically significant abnormal screening lab values Patients who are planning to undergo elective surgery during the study period. Other current autoimmune connective tissue diseases

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine

Study Overview
=================
Brief Summary
-----------------
Intranasal dexmedetomidine has been studied and used in children for premedication before anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal Atomization Device (MAD®). Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and bioavailability would be better compares to simple dripping method. To date no pharmacokinetic information of intranasal dexmedetomidine delivered by either method is available. This investigation is designed to compare the bioavailablity of intranasal dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy adults.

Detailed Description
-----------------
This is a three-period crossover double-blinded study. 8 subjects will be recruited and they will attend 3 study sessions after informed written and verbal consent. They would have dexmedetomidine administered via different rout each time, intravenous, intranasal via dripping or intranasal via atomizer. Blood samples are collect to determine bioavailability of each mode of drug delivery.

Official Title
-----------------
Crossover Pharmacokinetic Study of Two Mode of Administration of Intranasal Dexmedetomidine in Healthy Adult Volunteers

Conditions
-----------------
Bioavailability, Dexmedetomidine

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteer ASA 1 age over 18 no other concomitant drug therapy no alcohol or smoking habit - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iv<br> | Drug: Dexmedetomidine<br>* blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.<br>|
| Active Comparator: drip<br> | Drug: Dexmedetomidine<br>* blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.<br>|
| Active Comparator: atomizer<br> | Drug: Dexmedetomidine<br>* blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of dexmedetomidine |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation score |  | 8 hours |
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.

Official Title
-----------------
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

Conditions
-----------------
Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8

Intervention / Treatment
-----------------
* Genetic: Genetic Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women participating in IRB:18-010601 Aged 35 and over with a negative routine mammogram within 3 months. Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8). Have an active email address for survey completion Exclusion Criteria: Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601) Known genetic cancer syndrome with test results available for review in Mayo EMR Known breast cancer Unable to understand or sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women at intermediate/high risk of breast cancer<br>Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing | Genetic: Genetic Testing<br>* A blood draw or saliva kit will be provided to collect subject cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic mutations | Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel) | One year | 
| Study Participants | Number of subjects who decide to undergo genetic panel testing | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
increased risk of breast cancer
The Impact of Point-of-Care Ultrasound

Study Overview
=================
Brief Summary
-----------------
Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness. In this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre- and post-ultrasound assessments are compared using a bioreactance monitor and passive leg raise test as the gold standard of fluid responsiveness in this study.

Official Title
-----------------
The Impact of Point-of-Care Ultrasound Performed by Trainees to Improve the Prediction of Fluid Responsiveness in Patients With Shock

Conditions
-----------------
Ultrasound, Shock

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 or older admitted to the MICU with a diagnosis of shock while a fellow was on duty. Exclusion Criteria: None

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shock<br> | Diagnostic Test: Ultrasound<br>* Point-of-care ultrasound examination by pulmonary and critical care fellow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid responsiveness | Increase of stroke volume index greater than 10% following passive leg raise testing | Immediately subsequent to performance of a point-of-care ultrasound exam |
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
the main objective of the study is to compare endoscopic transcanal tympanoplasty with attico-antrostomy with endoscopic assisted canal wall up mastoidectomy in treatment of limited attic cholesteatoma.

Official Title
-----------------
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial

Conditions
-----------------
Cholesteatoma

Intervention / Treatment
-----------------
* Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy
* Procedure: endoscopic assisted canal wall up mastoidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases of cholesteatoma limited to the middle ear and/or attic but not extending beyond the posterior end of the lateral semicircular canal (LSCC) proved radiologically with computed tomography (CT) scan Exclusion Criteria: Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: endoscopic transcanal tympanoplasty with attico-antrostomy<br> | Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy<br>* Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac<br>|
| Active Comparator: endoscopic assisted canal wall up mastoidectomy<br> | Procedure: endoscopic assisted canal wall up mastoidectomy<br>* traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication of attic cholesteatoma | number of participants with no recurrence documented by second look surgery or MRI diffusion | 6 months postoperative |
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

Study Overview
=================
Brief Summary
-----------------
Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. Follow-up will be done during 2 years.

Official Title
-----------------
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up

Conditions
-----------------
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint

Intervention / Treatment
-----------------
* Procedure: autograft tendon
* Procedure: allograft tendon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated rupture of the anterior cruciate ligament with instability of the knee joint meniscal tear possible to suture partial meniscectomies Exclusion Criteria: chronic laxity (more than 9 months) associated collateral laxity (grade III) subtotal or total meniscectomy infection or inflammatory disease of the knee joint large cartilage lesion

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Reconstruction with an autograft tendon (hamstrings) | Procedure: autograft tendon<br>* Reconstruction with an autograft tendon (hamstrings)<br>|
| Experimental: 2<br>Reconstruction with an allograft tendon (tibialis posterior) | Procedure: allograft tendon<br>* Reconstruction with an allograft tendon (tibialis posterior)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray, CT-scan, KT1000 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-rays, CT-scan, KT1000 |  | 24 months |
Study Evaluating Prevenar Immunogenicity in High Risk Children

Study Overview
=================
Brief Summary
-----------------
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

Detailed Description
-----------------
This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months

Official Title
-----------------
To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.

Conditions
-----------------
Vaccines, Pneumococcal Conjugate Vaccine

Intervention / Treatment
-----------------
* Biological: pneumococcus conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 2 months to 9 years old. Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease No history of seizures

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 9 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G1<br>G1: HIV+ | Biological: pneumococcus conjugate vaccine<br>* Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.<br>|
| Active Comparator: G2<br>G2: Sicle Cell disease | Biological: pneumococcus conjugate vaccine<br>* Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.<br>|
| Active Comparator: G3<br>G3: neprotic symdrome | Biological: pneumococcus conjugate vaccine<br>* Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.<br>|
| Active Comparator: G4<br>G4: Chronic pulmonary disease | Biological: pneumococcus conjugate vaccine<br>* Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate tolerability of Prevenar* in that population. |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumococcus conjugated vaccine