linjc16/ctgov huggingface dataset:
Study on the Risk of Allergy-like Reactions After Intra-arterial or Intra-venous Injection of the Marketed X-ray Contrast Medium Iopromid

Study Overview
=================
Brief Summary
-----------------
Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.

Official Title
-----------------
Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration

Conditions
-----------------
Contrast Medium

Intervention / Treatment
-----------------
* Drug: Iopromide (Ultravist, BAY86-4877)


Participation Criteria
=================
Eligibility Criteria
-----------------
The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

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 |
| --- | --- |
| Intra-arterial administration<br>Patients with intra-arterial administration of Iopromide | Drug: Iopromide (Ultravist, BAY86-4877)<br>* Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.<br>|
| Intravenous administration<br>Patients with intravenous administration of Iopromide | Drug: Iopromide (Ultravist, BAY86-4877)<br>* Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with anaphylactoid reactions of Iopromide after administration |  | Retrospective analysis from 31 Aug 2010 to 30 Sep 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide |  | Retrospective analysis from 31 Aug 2010 to 30 Sep 2011 | 
| Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide |  | Retrospective analysis from 31 Aug 2010 to 30 Sep 2011 |
Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Study Overview
=================
Brief Summary
-----------------
Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as well. Hyperpigmented plaques will be changed. We assess objective measurement by using spectroscopic and colorimetric analysis.

Conditions
-----------------
Acanthosis Nigricans, Hyperinsulinemia, Spectroscopic Analysis

Intervention / Treatment
-----------------
* Drug: Metformin
* Behavioral: Dietary Modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state. Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may be taken to document dermatopathology consistent with acanthosis nigricans. Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up. Agree to abide by the investigator's guidelines Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form Agree to follow and undergo all study-related procedures Exclusion Criteria: Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states. Women who are lactating, pregnant, or planning to become pregnant. Any reason the investigator feels the patient should not participate in the study. -

Ages Eligible for Study
-----------------
Minimum Age: 11 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metformin|Dosage to be determined by Endocrinologist|
|Behavioral: Dietary Modification|To be determined by Endocrinologist|

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
-----------------
diffuse reflectance spectroscopy
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.

Official Title
-----------------
A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: CTP-543


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial Exclusion Criteria: Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication Donation of blood at any point throughout the study and for 30 days after last dose of study medication

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-543<br>Patients who previously completed a qualifying CTP-543 clinical trial | Drug: CTP-543<br>* Twice daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety |  | 108 weeks | 
| Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT) | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). | 108 weeks |
Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews

Study Overview
=================
Brief Summary
-----------------
The tools to measure safety culture (CS) have recently become available. No study has focused on the measure in France, apart from pilot studies. intensive services are particularly at risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or therapeutic strategies have report risk-benefit narrow. They may well be complicated by EIG.Safety of care is a priority in the field of health in general, and especially in intensive care. CS measure in this context seems particularly relevant. The main objective is to describe the CS intensive care units in France. The study will explore the development of the CS level for the units investigated. This study will also describe the main features of RMM practiced in intensive care units in France.

Official Title
-----------------
Study on the Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews

Conditions
-----------------
Emergency

Intervention / Treatment
-----------------
* Behavioral: Measure the culture of safety in the reanimation units


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: practicing resuscitation activity (this practice is medical or surgical, pediatric or adult, in public or private sector) volunteer to participate in the study (agreement of the head of the unit) for which at least 2 matching / references for the study were identified: a medical officer, caregiver responsible (Health Framework). Exclusion Criteria: measurement safety culture done in a period of significant change during a period where the staff and activities of the respondent unit of work is relatively stable. the responses of professionals to the questionnaire can be influenced by internal factors in their work unit (recent accident occurred, change of close supervision, personnel changes ...) and by factors external to their unit work (establishment certification period, arrival of a new director, recent media coverage of medical accidents ...).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Measure the culture of safety in the reanimation units|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measure of the CS of intensive care units in France using a validated questionnaire |  | The planned project duration is 12 months |
Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the usefulness of 64 slice multi-detector computed tomography as a first diagnostic approach in acute chest pain patients in emergency room

Detailed Description
-----------------
We prospectively enrolled the patients with acute chest pain who visited ED. Exclusion criteria were myocardial infarction (MI) with ST elevation, unstable vital sign, uncontrolled arrhythmia, renal dysfunction, hypersensitivity to contrast media and pregnancy. Patients were allocated into 3 categories based on history, physical exam, and electrocardiogram: 1) definite angina with uncertainty of regarding MI (high risk), 2) probable angina (intermediate risk), 3) low likelihood of angina (low risk), and then randomized to either receive MDCT immediately (MDCT group), or not (control). We compared diagnostic accuracy, length of stay in ER, admission rate, and major adverse cardiac events (MACE) and clinical diagnosis in 1 month after discharge from ED.

Official Title
-----------------
Usefulness of 64 Slice Multi-Detector Computed Tomography as a First Diagnostic Approach in Acute Chest Pain Patients

Conditions
-----------------
Chest Pains

Intervention / Treatment
-----------------
* Procedure: 64 multi-detector computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute chest pain patient visiting emergency room Exclusion Criteria: unstable vital sign renal failure ST elevation myocardial infarction uncontrolled arrhythmia hypersensitivity to contrast dye clinically no possibility of angina

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 64 multi-detector computed tomography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission rate |  |  | 
| Unnecessary admission rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stay time in emergency department |  |  | 
| Diagnostic accuracy |  |  | 
| MACE |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest pains, Computed tomography, Emergency
Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.

Detailed Description
-----------------
Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those patients. Tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy. Based on the encouraging results reported from the SLCG phase II study reported the efficacy of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would prolong overall survival, delay disease progression and be well tolerated, mOS reached 27 months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo, Tarceva may provide an important treatment alternative for local advanced pts with EGFR mutation.

Official Title
-----------------
A National, Multi Center, Randomized, Open-label, Phase II Trial of Tarceva Versus Combination of Gemcitabine Plus Cisplatin as Neoadjuvant Treatment in Stage IIIA-N1,N2 NSCLC With Activating EGFR Mutation in Exon 19 or 21

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically diagnosed of non-small cell lung cancer Diagnosed as stage IIIA-NI, N2, except for T4N1M0 The diagnosis standard of N1 or N2 is as below: The short axis of N1 lymph node of Stage IIIA-N1 must be ≥ 10 mm on Computed Tomography, and the Standard Uptake Value (SUV) on PET-CT of N1 lymph node must be > 2.5 Exclusion Criteria: Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab) Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy) Resection of primary malignancy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erlotinib|150mg/qd, on day 15-28 of each 28 day cycle.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in Greece. II. Assess the safety of tin mesoporphyrin in high-risk newborns.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are stratified by gestational age and sex, and randomly assigned in pairs per stratum. One group receives a preventive dose of tin mesoporphyrin. Another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration. Patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated.

Conditions
-----------------
Glucosephosphate Dehydrogenase Deficiency, Hyperbilirubinemia, Hemolytic Disease of Newborn

Intervention / Treatment
-----------------
* Drug: tin mesoporphyrin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Hyperbilirubinemia associated with either of the following: Direct Coombs' test-positive ABO hemolytic disease of the newborn Glucose-6-phosphate dehydrogenase deficiency --Prior/Concurrent Therapy-- No maternal phenobarbital in last month of pregnancy --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No congenital renal abnormality Cardiovascular: No congenital heart abnormality Pulmonary: No asphyxia requiring assisted ventilation at delivery Other: Gestational age more than 210 days Birth weight at least 1500 g No other major congenital abnormality, i.e.: Central nervous system Chromosomal Gastrointestinal No evident or suspected congenital infection, e.g.: Cytomegalovirus Herpes Rubella Syphilis

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 24 Hours

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tin mesoporphyrin|nan|

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
-----------------
glucose-6-phosphate dehydrogenase deficiency, hematologic disorders, hemolytic disease, hyperbilirubinemia, neonatal disorders, rare disease
Swedish External Support Study

Study Overview
=================
Brief Summary
-----------------
Randomized study to evaluate the effect of adding external support to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage.

Official Title
-----------------
Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Procedure: External support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critical limb ischemia Need for bypass surgery Exclusion Criteria: Can participate in follow-up Has suitable saphenous vein

Ages Eligible for Study
-----------------
Minimum Age: 20 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: External support<br>Bypass graft with external support | Procedure: External support<br>* Bypass surgery with externally supported graft<br>|
| Experimental: No external support<br>Bypass with graft without external support | Procedure: External support<br>* Bypass surgery with externally supported graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary graft patency |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| limb salvage |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTFE bypass, femoro-popliteal, femoro-crural, popliteal arteries, crural arteries, external support, crtical limb ischemia
A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants

Study Overview
=================
Brief Summary
-----------------
The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain when given at tracer levels (microdose) in healthy young men.

Official Title
-----------------
Interventional, Open-Label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88370 Investigating Blood-Brain Barrier Penetration of Lu AF88370 in Healthy Men

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Drug: [11C]-Lu AF88370


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m^2) at the Screening Visit. The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical and neurological examination, vital signs, an ECG, and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests. Exclusion Criteria: The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken. The participant has received a COVID-19 vaccination within the last 30 days before receiving first dose of study drug. The participant has had surgery or trauma with significant blood loss <6 months prior to the first dose of the study drug. The participant is exposed to significant levels of ionising radiation at work. Note: Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [11C]-Lu AF88370<br>Participants will receive [11C]-Lu AF88370 via an intravenous cannula on Day 1. | Drug: [11C]-Lu AF88370<br>* PET ligand in a single intravenous bolus injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370 |  | Day 1 | 
| VT of [11C]-Lu AF88370 in Regions of Interest (ROI) |  | Day 1 |