linjc16/ctgov huggingface dataset:
Practicability and Acceptability of Stylomax® in Children

Study Overview
=================
Brief Summary
-----------------
Primary objective: to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.

Official Title
-----------------
Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children over 3 years of age with growth hormone deficiency, requiring treatment with MAXOMAT® according to the criteria of the MA. Exclusion Criteria: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: somatropine<br> | Drug: somatropine<br>* subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| practicability/acceptability of the Stylomax pen |  | at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerability : pain (evaluation on pain scale) |  | at each visit |
Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

Study Overview
=================
Brief Summary
-----------------
To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID_19 related disease in pediatric patients with cardiac involvement.

Official Title
-----------------
Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

Conditions
-----------------
COVID-19 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with cardiac MRI or cardiac CT scan or thoracic CT scan admitted for acute inflammatory syndrome and cardiac compromise Patient with PCR or antibodies test for COVID 19 (positive of negative) Patient or parents of minor patients informed about collection of personal data for the study Exclusion Criteria: Patient or parents refusing personal data collection

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Imaging data at Baseline | Description of imaging data from MRI ans CT scan and associated clinical data. | Baseline | 
| Imagine data at Follow-up | Description of imaging data from MRI ans CT scan and associated clinical data. | During the 2 years follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 Infection, Children, Acute Myocarditis, Kawasaki-like-syndrome
Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT

Study Overview
=================
Brief Summary
-----------------
Increasing radiation exposure by medical examinations is getting more concerns. For optimal medical imaging, reducing radiation exposure with preservation image quality is important. One of the solutions is use of iterative recontruction of CT examination. In this study, the investigators aimed to investigate the clinical feasibility of ultralow dose abdominopelvic CT with iterative reconstruction in patients with intraabdominal abscess. Patients with intrabdominal abscess usually undergo multiple CT examinations to evaluate treatment response. Therefore, ultralow dose CT can reduce unnecessary radiation exposure in these patients.

Official Title
-----------------
Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT

Conditions
-----------------
Abdominal Abscess

Intervention / Treatment
-----------------
* Other: ultralow dose abdominopelvic CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent standard dose CT for suspected intraabdominal abscess patients who need follow-up CT to evaluate treatment response of abscess 3) Adult patient, 4) patients who agreed this study protocol Exclusion Criteria: pregnancy patients with poor renal function (GFR < 30 mL/min/1/73m2) Patients who have allergy to CT contrast media Patients who are not cooperative (e.g., dementia)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| Abscess<br>Patients group with abdominal abscess | Other: ultralow dose abdominopelvic CT<br>* In the patient cohort with abdominal abscess, ultralow dose abdominopelvic CT will be performed as a follow-up protocol. Ultralow dose CT has approximately 80 90% reduced radiation dose compared to standard dose CT.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of subjective image quality of CT image | Score of subjective image quality of CT images consists of overall subjective image quality, noise, diagnostic ability, and artifact. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective radiation dose: CTDIvol(volume CT dose index), DLP(dose length product), effective dose(DLPx0.015) | Effective radiation dose between standard dose CT and ultra-low dose CT will be compared | 1 month |
Young Breast Cancer Cohort Study

Study Overview
=================
Brief Summary
-----------------
This study is prospective cohort study to investigate and identify comprehensively the clinicopathological features and long-term outcome of young breast cancer (YBC). We have enrolled Breast cancer patients under 40 year-old and collected their baseline characteristics including tumor character, familiar history and other background information. Moreover, we have collected breast cancer tissue/blood sample for analyzing genetic characteristics, if patient agree to genetic analysis.

Official Title
-----------------
Prospective Cohort Study for Development of Personalized Treatment Strategy Based on Biologic Tumor Behavior and Clinical Characteristics in Young Breast Cancer (YBC) Patients

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis with breast cancer Age under 40 year-old or diagnosis with breast cancer at pregnancy or within 1year after delivery Obtained informed consent form Exclusion Criteria: 1) Cannot understand or disagree to informed consent form

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

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

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 |
| --- | --- | --- |
| Progression free survival | Time to detect disease recurrence from surgery date | From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours

Study Overview
=================
Brief Summary
-----------------
Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer.

Official Title
-----------------
A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTIN™), in Patients With Advanced Solid Tumours

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: cediranib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Prostate cancer), which is refractory to standard therapies or for which no standard therapy exists. Estimated life expectancy of at least 8 weeks WHO performance status (PS) 0-2. Exclusion Criteria: Unstable brain/meningeal metastases Biochemistry/haematology results outside of required ranges History of significant GI impairment Inadequate bone marrow reserve

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone. | Drug: cediranib<br>* 45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce.<br>* Other names: RECENTIN;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin |  | PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of cediranib in the presence of rifampicin, by assessment of Adverse events (AEs) Laboratory findings, Vital signs, physical examination and Electrocardiogram. |  | Until study drug is discountinued | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced cancer, metastatic, rifampicin, pharmacokinetics, Phase I, Advanced solid tumours
Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

Detailed Description
-----------------
This is a non-randomized cohort, multi-center study. The eligible subjects will be asked to use the FORESEE HOME device daily and the tests results will be automatically transmitted to the Data Monitor Center for analysis.

Official Title
-----------------
Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Device: FORESEE HOME


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who successfully completed participation in ForeseeHome-US2 study Patients with ability to comprehend and sign the informed consent/authorization Exclusion Criteria: Subjects who failed to complete participation in ForeseeHome-US2 study

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Dry AMD<br>subjects diagnosed as intermediate AMD in at least one eye | Device: FORESEE HOME<br>* Home Monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject compliance with Foresee HomeTM device |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Telemedicine infrastructure |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermediate AMD
An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya

Study Overview
=================
Brief Summary
-----------------
This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.

Official Title
-----------------
Breast Cancer Care (BRECC) Registry - Development of a Breast Cancer Registry to Determine the Magnitude of Breast Cancer and Current Clinical Care Patterns in Kenya

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed breast cancer No previous interventional therapy for breast cancer Ability to provide written informed consent as per GCP and local regulations Exclusion Criteria: Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of breast cancer in Kenya |  | 5 years | 
| Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 5 years | 
| Overall survival |  | 5 years | 
| Patient demographics of breast cancer patients in Kenya |  | 5 years | 
| Pathology: Prevalence of tumour types |  | 5 years | 
| Correlation between risk factors and clinical outcome |  | 5 years | 
| Therapy duration/compliance |  | 5 years | 
| Safety: Incidence of adverse events |  | 5 years |
Immunobiology of Cancer

Study Overview
=================
Brief Summary
-----------------
To learn whether or not an Interferon defect in cell signaling, recently discovered in immune cells from melanoma patients as well as breast cancer patients, is common to all cancers.

Detailed Description
-----------------
BACKGROUND We have previously demonstrated that tumor-specific T cells could be identified in >50% of patients with metastatic melanoma and these cells appeared to be rendered anergic in vivo [Nature Medicine 5:677, 1999]. Recently we discovered that there is a signaling defect in the Interferon (IFN) pathway in immune cells from melanoma patients [PLOS Medicine 4:897 2007]. Interestingly, preliminary studies are showing the same defect in immune cells from breast cancer patients (unpublished). We would like to expand our research to all types of cancer to determine whether these phenomena occur in different cancer types. OBJECTIVES Our primary objective is to determine whether there is an IFN signaling defect in different types of cancers and to determine what is causing this defect. The second objective is to determine whether these PBMCs are rendered anergic. INVESTIGATIONAL PLAN The study population will consist of patients who have been diagnosed with cancer, regardless of sex or ethnicity. Blood will be collected during the subjects regularly scheduled laboratory appointment and peripheral blood mononuclear cells (PBMCs) will be isolated for research purposes. These PBMCs will undergo studies, i.e. phosflow, qPCR, proliferation, survival, etc., to determine immune responses for T cells (CD4 and CD8), B cells (CD19), natural killer cells (CD16), and possibly monocytes (CD14).

Official Title
-----------------
Immunobiology of Cancer

Conditions
-----------------
Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over. Exclusion Criteria:Participants who have an autoimmune disorder and/or are under the age of 18 years.

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 |
| --- | --- | --- |
A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.

Official Title
-----------------
A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: eletriptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of migraine with or without aura according to the recent IHS criteria. Migraine headaches must have been present for more than one year. History in the last 3 months of 1 to 4 acute attacks of migraine headache per month. Exclusion Criteria: Subjects with current or past history of coronary artery disease. Pregnant or breastfeeding women. Subjects who have chronic daily headaches.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: eletriptan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence |  |  |
Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification

Study Overview
=================
Brief Summary
-----------------
Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions

Official Title
-----------------
A Single-center, Multi-scanner, Observational Study to Investigate the Impact of Reduced Radiation Dose and Iterative Reconstruction Algorithms on Coronary Calcium Score in Comparison to the Standard Normal Radiation Dose -Filtered Back Projection Method

Conditions
-----------------
Atherosclerotic Plaque

Intervention / Treatment
-----------------
* Device: Iterative reconstruction at reduced radiation dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania Exclusion Criteria: Patients found to have no coronary calcium on full dose FBP reconstructions
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Iterative reconstruction at reduced radiation dose|Evaluating Agatston coronary calcium score using reduced dose acquisitions reconstructed using iterative reconstruction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium score | Calcium score compared to FBP full dose recon | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk stratification | Cardiovascular risk stratification group of reduced dose IR vs. full dose FBP | immediate |