linjc16/ctgov huggingface dataset:
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when influenza is circulating in the community will receive treatment with Tamiflu syrup (or capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and influenza symptoms will be recorded throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: oseltamivir [Tamiflu]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or females, 1-12 years of age; candidate for seasonal prophylaxis; negative rapid diagnostic test for influenza at baseline. Exclusion Criteria: symptoms suggestive of influenza-like illness; positive rapid diagnostic test for influenza; antiviral treatment for influenza in 2 weeks prior to randomization.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: oseltamivir [Tamiflu]<br>* 30-75mg po daily for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, vital signs. |  | Throughout study | 
| Percentage of patients with laboratory confirmed clinical influenza |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness. |  | Throughout study |
Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea

Study Overview
=================
Brief Summary
-----------------
Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

Detailed Description
-----------------
Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood. A long term follow up will be recorded in a cohort of twenty SCA patients treated by Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. Also the mean hgb level and hgb F percentage will be summarized.

Official Title
-----------------
Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.

Conditions
-----------------
Sickle Cell Anemia, Sickle Cell Thalassemia

Intervention / Treatment
-----------------
* Other: Clinical follow up and laboratory analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated by Hydroxyurea in the Pediatric Hematology Unit.

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| 1<br>Patients with Sickle cell anemia treated by Hydroxyurea | Other: Clinical follow up and laboratory analysis<br>* Clinical follow up and laboratory analysis<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
-----------------
Sickle cell anemia, Sickle cell thalassemia, Hydroxyurea
Chemotherapy-induced Necrosis in Ewing Sarcoma

Study Overview
=================
Brief Summary
-----------------
This is single institution cases series review of histological and clinical data

Detailed Description
-----------------
Investigators will retrieve from the database of the Rizzoli institute all the cases with a histological diagnosis of Ewing sarcoma from 01 Jan 1982 to 31 Dic 2012

Official Title
-----------------
Chemotherapy-induced Necrosis in Ewing Sarcoma: Which is the Best Scoring Tool

Conditions
-----------------
Ewing Sarcoma of Bone

Intervention / Treatment
-----------------
* Behavioral: Scoring tool in Chemotherapy-induced necrosis in Ewing sarcoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients surgically treated at Rizzoli Institute from 01 Jan 1982 to 31 Dic 2012 Patients with diagnosis of Ewing sarcoma of bone who have had neo-adjuvant chemotherapy Diagnosis of Ewing sarcoma localized Exclusion Criteria: Metastatic disease at presentation Soft tissue origin Radiotherapy before surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Scoring tool in Chemotherapy-induced necrosis in Ewing sarcoma|The aim of the present study is to evaluate which is the best scoring tool to determine the histological response to chemotherapy in localized Ewing sarcoma of bone. The study will exam all the different systems to evaluate the histological necrosis after neo-adjuvant chemotherapy in all patients with localized Ewing sarcomas of bone surgically treated between 1982 and 2012.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retrospective analysis of cases of Ewing sarcomas | Investigators will exam the histological response to chemotherapy in localized Ewing sarcoma of bone and correlate it to clinical outcome. | at baseline (Day0) |
Serum Vancomycin Levels in Patients Receiving Enteral Vancomycin

Study Overview
=================
Brief Summary
-----------------
The study is based on the hypothesis that decreased creatinine clearance may be associated with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas) vancomyicn for CDAD. The objective of the study is to see whether enteral vancomycin is absorbed through the inflamed GI mucosa in CDAD, and if it is absorbed, does it achieve measurable serum concentration.

Detailed Description
-----------------
Vancomycin is a large glycopeptide compound with a molecular weight of about 1450 Da. It is not appreciably absorbed orally and is eliminated primarily via the renal route. Enteral vancomycin therapy (oral/intracolonic ) is used inpatients with severe Clostridium difficile associated colitis who are unable to take oral metronidazole or have failed treatment with metronidazole. Oral vancomycin is not detectable in serum of normal persons, but concentrations below therapeutic range may be found in patients with colitis. There are a few case reports of serum concentrations within the therapeutic range after oral/intracolonic administration of vancomycin, in association with renal failure. The use of enteral vancomycin in our geriatric population with variable creatinine clearance prompted us to measure the serum vancomycin levels in these patients.

Official Title
-----------------
Measurement of Serum Vancomycin in Patients Receiving Enteral ( Oral/Intracolonic) Vancomycin.

Conditions
-----------------
Clostridium Difficle Colitis, Clostridium Difficle Associated Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on enteral vancomycin therapy Exclusion Criteria: Coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.

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 |
| --- | --- | --- |
| Patients with detectable serum vancomycin levels during enteral vancomycin therapy |  | 5-7days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enteral vancomycin therapy, serum vancomycin levels, renal failure
Clinical Study to Evauate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers

Official Title
-----------------
Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2
* Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,
* Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 ≤ age ≤ 45 Health Volunteers Subject who agreeds to participate in this clinical trial voluntarily Exclusion Criteria: 1. Subject who cannot participate in a clinical trial based on the PI's judgment

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sequence A<br>CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 | Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2<br>* Subject of sequence A takes IP in the following order: Each tablet of CKD-828 and D097 and D337 be taken at once CKD-348 T1 1 tablet CKD-348 T2 1 tabet<br>* Other names: Sequence A;|
| Active Comparator: Sequence B<br>CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 | Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,<br>* Subject of sequence B takes IP in the following order: CKD-348 T1 1 tablet CKD-348 T2 1 tablet Each tablet of CKD-828 and D097 and D337 be taken at once<br>* Other names: Sequence B;|
| Active Comparator: Sequence C<br>CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 | Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337<br>* Subject of sequence C takes IP in the following order: CKD-348 T2 1 tablet Each tablet of CKD-828 and D097 and D337 be taken at once CKD-348 T1 1 tablet<br>* Other names: Sequence C;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration of the drug | 0 hour   144 hr | 
| AUCt | Area under the concentration time curve from time zero to time | 0 hour   144 hour |
Perioperative Observation of the Sublingual Microcirculation With SDF

Study Overview
=================
Brief Summary
-----------------
Does sublingual SDF-imaging results correlate with other haemodynamic parameters measured perioperatively and with postoperative morbidity/complications.

Official Title
-----------------
Visualisation of Changes in the Sublingual Microcirculation During Major Surgery Using Sidestream Darkfield Imaging (SDF).

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: major surgery > 3h requiring arterial cannulation and central venous access Exclusion Criteria: denied patient consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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
-----------------
perioperative sublingual microcirculation SDF
Impact of Five Love Languages on Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effectiveness of an intervention utilizing the Five Love Languages on quality of life (pain, depression, and anxiety) of cancer patients.

Official Title
-----------------
Impact of Five Love Languages on Cancer Patients

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: 5 Love Languages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with cancer with a significant other who attend a Texas Oncology couples support group will serve as the study population Exclusion Criteria: N/A

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer Patient and their significant other<br>The intervention will implemented in all cancer patients and their significant others | Behavioral: 5 Love Languages<br>* Emotional support will be given through utilizing the patient/partners specific Love Language (physical touch, words of affirmation, gifts, quality time, and acts of service).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be measured through the MD Anderson Cancer Center Brief Pain Inventory and improvement will be measured by change in pain scale score (ranging from 0=no pain to 10= pain as bad as you can imagine) from pre to post survey. | 6 weeks | 
| Depression | Depression will be measured through the Patient Health Questionnaire (PHQ-9) scoring from 0 being not at all to 3 nearly every day of depression symptoms and improvement will be measured in by change in total scoring. | 6 weeks | 
| Anxiety | Anxiety will be measured through the Generalized Anxiety Disorder 7-item (GAD-7) scoring from 0 being not at all to 3 nearly every day of anxiety symptoms and improvement will be measured in by change in total scoring. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Quality | This research study is also expected to measure improvement in the relationship of the cancer patient with their significant other. This improvement in relationship will be measured through the Funk and Rogge Couples Satisfaction Index which contains various scales from 0-6 or 0-5 with lowest satisfaction being 0 and highest being 5/6 and improvement will be measured in change in score from pre to post survey. | 6 weeks |
Carotid Atherosclerosis in Patients With Aortic Coarctation

Study Overview
=================
Brief Summary
-----------------
Despite aortic coarctation (CoA) repair these patients have cardiovascular complications and coronary artery disease is the most common cause of death.

Detailed Description
-----------------
The aim with this study was to measure intima-media thickness (IMT) and plaques in arteries compared to cardiovascular markers in controls and patients with CoA.

Official Title
-----------------
Carotid Atherosclerosis in Patients With Aortic Coarctation

Conditions
-----------------
Atherosclerosis, Aortic Coarctation

Intervention / Treatment
-----------------
* Other: Ultrasound measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sex and age-matched controls Exclusion Criteria: acute and chronic inflammation disease, underlying malignancies and diabetes mellitus.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with coarctation<br> | Other: Ultrasound measurement<br>* Ultrasound measurement<br>|
| Controls<br> | Other: Ultrasound measurement<br>* Ultrasound measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intima-media thickness | Measurement in mm | Intima-media thickness will be measured at one time point namely at inclusion. Data will be reported when study is completed, an average of 2 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular markers | A multiplex platform to analyze circulating blood levels biomarkers was used. | Blood samples will be taken at one time point namely at inclusion. Then biomarkers will be analysed when study is completed. Data will be reported when study is completed, an average of 2 year. |
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)

Study Overview
=================
Brief Summary
-----------------
This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment strategy for glaucoma patients. It is done with a laser device that can also be used for many other ophthalmic applications, thus reducing the economic burden of treatment.

Official Title
-----------------
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm) in Open Angle Glaucoma Patients

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Procedure: lasertrabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals over 18 years old willing to sign an informed consent and able to comply the requirements of the study having no other ocular diseases besides glaucoma Exclusion Criteria: history of ocular trauma intraocular surgery (except for phaco) pigment dispersion and exfoliation glaucoma

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lasertrabeculoplasty<br> | Procedure: lasertrabeculoplasty<br> <br> * Other names: Conventional (532nm);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the intraocular pressure reduction with the micropulse laser trabeculoplasty (532nm) versus the conventional laser trabeculoplasty (532nm) |  | one year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary the complication rate between the two techniques will be compared |  | one year of follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser trabeculoplasty, glaucoma
Brain Imaging in Babies Study

Study Overview
=================
Brief Summary
-----------------
The aims of the BIBS Study The Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby's brain develops from before birth, up until 3-4 years of age. Working with children from a variety of backgrounds and communities, the investigators use a combination of state-of-the-art diagnostic tools such as MRI scans alongside traditional behavioural assessments to capture the earliest information on infant brain development. The focus of the BIBS study MRI scanning is a safe way of producing detailed images using strong magnetic fields and radio waves. It does not use X-ray. Along with learning more about brain development in general, the investigators also try to identify features that may in future help predict whether a child will or will not develop traits of conditions such as Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this may help target useful interventions early on, helping children who are most in need. Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have been given ethical approval to include testing for this infection in the mothers and children participating in the study. This may provide an opportunity to better understand how mother and baby respond to infections. The investigators particularly welcome mothers who have had a positive COVID-19 test during their pregnancy to join the study.

Official Title
-----------------
Brain Imaging and Infant Development

Conditions
-----------------
Neurodevelopmental Conditions, COVID-19, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant mothers with and without confirmed COVID-19 Infants with and without an immediate family history of Autism Spectrum and neurodevelopmental conditions Based in England, UK Exclusion Criteria: based on further screening

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants a family history of ASD/ADHD<br> | |
| Infants without a family history of ASD/ADHD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental Outcomes |  | 3-4 years of age |