linjc16/ctgov huggingface dataset:
Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.

Official Title
-----------------
Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM) Exclusion Criteria: Participants who use Empliciti for therapeutic indications which are not approved for Empliciti combination therapy in Korea Patients in whom treatment with Empliciti (as clarified in the Korean label) is contraindicated Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Empliciti combination therapy<br>Adult patients with a confirmed diagnosis of MM who have received, are currently receiving, or will begin Empliciti combination therapy | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AE's and SAE's |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response of Empliciti treatment with lenalidomide and dexamethasone |  | 24 Months | 
| Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone |  | 24 Months |
Effect of Topical Dexmedetomidine on Intraocular Pressure

Study Overview
=================
Brief Summary
-----------------
Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.

Official Title
-----------------
The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: a Randomized Controlled Trial

Conditions
-----------------
Glaucoma, Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Balanced salt solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with healthy eyes and no history of glaucoma Exclusion Criteria: history of glaucoma, IOP > 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised control trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: BSS<br>Balanced salt solution | Drug: Balanced salt solution<br>* instillation of eyedrop<br>|
| Active Comparator: Dexmedetomidine<br>dexmedetomidine (0.0055%) | Drug: Dexmedetomidine<br>* Instillation of eyedrops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure change | Taken by aplanation tonometry | at presentation, 30 minutes, 4 hours and 24 hours after instillation |
Eszopiclone Treatment & Cortisol Responsivity

Study Overview
=================
Brief Summary
-----------------
This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to assess cortisol reactivity before and after long-term (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone would result in a significant reduction in plasma cortisol response to the DEX/CRH test following treatment of insomnia with standard dose of eszopiclone.

Detailed Description
-----------------
see above

Official Title
-----------------
Eszopiclone Treatment & Cortisol Response to HPA Axis Tests

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: eszopiclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to Moderate Insomnia Exclusion Criteria: Any acute or chronic medical condition involving function of HPA axis (e.g., Cushing's or Addison's Disease, adrenal or pituitary gland disorders) Currently taking, or unable to be free of, antidepressant, neuroleptic, anxiolytic, or thymoleptic drugs for at least 2 weeks preceding the DEX/CRH test (free of fluoxetine for at least 6 weeks) Current use of psychotropic medication or medication (prescribed or over the counter) thought to affect HPA axis function or glucocorticoid synthesis/release (e.g., prednisone, anabolic steroids, DHEA, ketoconazole, metyrapone) History of a significant adverse reaction to eszopiclone Meets DSM-IV criteria for any Axis I psychiatric disorder, including substance abuse presently, or substance dependence within the past 6 months Pregnancy, lactation, or unable/unwilling to use reliable methods of contraception during the study procedures Limited mental competency and the inability to give informed, voluntary, written consent to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label Eszopiclone<br>Standard dosing of drug for 6 weeks for insomnia | Drug: eszopiclone<br>* 6 weeks standard oral therapy<br>* Other names: Lunesta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) | Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT). | post drug (6 weeks oral eszopiclone) |
Outcomes of Uterine Rupture

Study Overview
=================
Brief Summary
-----------------
Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated with an increased risk of maternal and perinatal morbidity and mortality, particularly in developing countries compared to developed countries. UR occurs mainly as a consequence of poorly managed labour

Official Title
-----------------
Uterine Rupture: Prevalence and Feto-maternal Outcomes in Assiut Women Health Hospital

Conditions
-----------------
Maternal Mortality

Intervention / Treatment
-----------------
* Procedure: repair of rupture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with ruptured uterus accept to share in the study Exclusion Criteria: women refuse to participate

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: repair of rupture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of women undergoes repair |  | 1 hour |
Observational Study Comparing the Efficacy of Ganciclovir as a Function of Blood Exposure to the Drug During a Curative or Preemptive Treatment

Study Overview
=================
Brief Summary
-----------------
This study aims to better define the target range of ganciclovir trough concentrations by investigating the relationship between ganciclovir concentration and the time to undetectable CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.

Detailed Description
-----------------
The primary objective of the study is to determine whether higher concentrations of ganciclovir can reduce the time of negation of the CMV-DNA load. Secondary objectives are to determine the concentration-toxicity relationship of ganciclovir and the relationship between concentrations of ganciclovir and apparition of CMV gene mutations responsible of drug resistance. Each week, trough concentrations of ganciclovir are measured, associated with control of CMV-DNA load and all biological analysis currently necessary for the monitoring of the infection.

Official Title
-----------------
Etude Observationnelle Comparant l'efficacité du GANciclovir en Fonction de l'EXposition Sanguine au médicament

Conditions
-----------------
Solid Organ Transplantation

Intervention / Treatment
-----------------
* Drug: Therapeutic Drug Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years-old Solid organ transplanted patients needing a treatment by oral or intravenous (val)ganciclovir Non-opposition to participate in the study. Exclusion Criteria: pregnancy opposition to participate in the study incapable person

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 |
| --- |
|Drug: Therapeutic Drug Monitoring|Trough concentration of ganciclovir and viral load measurement at each follow-up visit.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to CMV viral load negativity as a function of the median of trough concentrations of ganciclovir | Duration of patient follow-up for the CMV infection | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ganciclovir, trough concentrations, CMV viral load, safety, Solid organ transplantation (heart, kidney or liver)
Transforming ED Throughput With AI-Driven Clinical Decision Support System

Study Overview
=================
Brief Summary
-----------------
The aims of this study is to integrate real-time data flow infrastructure between hospital information system and AI models and to conduct a cluster randomized crossover trial to evaluate the efficacy of the AI models in improving patient flow and relieving ED crowding.

Official Title
-----------------
Transforming ED Throughput With AI-Driven Clinical Decision Support System (TEDAI): The Impact on the Delivery of Care and Patient Experience

Conditions
-----------------
Critical Care, Emergency Treatment, Triage, Readmission

Intervention / Treatment
-----------------
* Other: AI-assisted models providing diagnosis and prognostic information
* Procedure: Critical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ED patients aged 20 years or older Patients were treated by the recruited 16 ED attendings. Exclusion Criteria: Patients aged less than 20 years. Patients were not treated by the recruited 16 ED attendings.

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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AI-assisted<br>AI-assisted models providing diagnosis and prognostic information | Other: AI-assisted models providing diagnosis and prognostic information<br>* AI-assisted models providing diagnosis and prognostic information in the ED, including triage, ICD coding, chest x ray alerts, critical event alerts, readmission prediction, and post-cardiac arrest prognostication.<br>|
| Placebo Comparator: Usual care<br>usual care without AI-assisted models providing diagnosis and prognostic information | Procedure: Critical treatment<br>* Critical treatment of the emergency room<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ED length of stay |  | From ED arrival to 3 days after ED discharge. For hospitalized patients with cardiac arrest, the outcome ascertainment continues until hospital discharge. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Care, Emergency Treatment, Triage, Readmission
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

Study Overview
=================
Brief Summary
-----------------
The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.

Official Title
-----------------
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

Conditions
-----------------
Immune System Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Food proteins
* Drug: Omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old. Sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility. Exclusion Criteria: No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers). Subjects with a total IgE at screening of >2,000 kU/L Previous reaction to omalizumab Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 55 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: One<br> | Dietary Supplement: Food proteins<br>* Food proteins<br>Drug: Omalizumab<br>* Drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events in the treatment population |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who reach 2g or more of food flour |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple food allergies
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient

Study Overview
=================
Brief Summary
-----------------
to identify the effect of omega-3 plus vitamin E cosupplementation on mastalgia in patients with FCC and to compare its effect with that of vitamin E only.

Detailed Description
-----------------
120 patients will be enrolled in the study and divided into three groups each group consisted 40 patient then the severity of mastalgia in the three groups before, through and after intervention. Radiological assessment was done before and after the intervention.

Official Title
-----------------
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient

Conditions
-----------------
Mastalgia

Intervention / Treatment
-----------------
* Drug: Omega 3 fatty acid
* Drug: VitaE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all females with mastalgia aged 18 to 55 Exclusion Criteria: Pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin E supplementation before the trial and postmenopausal women. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: group a<br>will receive omega 3 plus vitamin E | Drug: Omega 3 fatty acid<br>* omega 3 1000 mg<br>Drug: VitaE<br>* vitamin e 400 mg<br>|
| Active Comparator: Group b<br>will receive vitamin E | Drug: VitaE<br>* vitamin e 400 mg<br>|
| No Intervention: Group c<br>no intervention just reassurance and analgesics on need | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of pain severity | improvement of pain on visual analogue scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of radiological finding |  | 3 months |
Perceptions of Health Professionals Confronted With Palliative Situations

Study Overview
=================
Brief Summary
-----------------
Hospitals, doctors and caregivers, who take care of increasingly heavy patients, are faced with ever more complex situations, particularly in the case of severe, progressive, and incurable pathologies. Thanks to their willingness and expertise, these care providers try to guarantee the continuity and quality of care for both patients and patients in a palliative situation. Nevertheless, these same actors testify to the complexity they encounter in the care of patients in advanced or terminal stages, especially since the concept of palliative care, which was often erroneously reduced during the Any end of life and therefore death, remains a source of questions, contradictions, even resistances. In this context, how do physicians and caregivers appropriate palliative care? How do they react to the complexity and intensity of certain situations? Do they have specific expectations of help or support in the face of certain difficulties? Are there actions to be carried out and developed to make the aid given to these actors of the palliative approach more efficient? These are the topics that the HUS palliative care service proposes to explore through a study of physicians and caregivers working in HUS services for adult patients with LISP.

Official Title
-----------------
Preliminary Study: Perceptions of Doctors and Caregivers Confronted With Adult Patients in Advanced or Terminal Stage of a Severe, Progressive and Incurable Pathology in the Services of the Hospitals University of Strasbourg Including Beds Identified Palliative Care

Conditions
-----------------
Incurable Pathologies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major hospitals, doctors and caregivers, who take care of increasingly heavy patients Exclusion Criteria: Patient under 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 |
| --- | --- | --- |
| Questionnaire |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incurable pathologies, palliative care