linjc16/ctgov huggingface dataset:
ACZ885 in Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.

Official Title
-----------------
A Randomized, Double-blind, Multiple-dose, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ACZ885 in Patients With Newly Diagnosed Type-1 Diabetes Mellitus (T1DM)

Conditions
-----------------
Diabetes Mellitus, Diabetes Type 1

Intervention / Treatment
-----------------
* Drug: ACZ885
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen presence of at least one diabetes-related autoantibody qualifying C-peptide value in a mixed meal test at visit 1 willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug body weight of at least 30 kg Exclusion Criteria: women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc) immunodeficiency active infections or febrile illness within 3 days before visit 1 major dental work within 8 days before visit 1 positive test for tuberculosis at visit 1 use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 35 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACZ885<br> | Drug: ACZ885<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months |  | at 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months |  | 36 months | 
| Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months |  | 36 months | 
| Measure: number of hypoglycemic events |  | 36 months | 
| Measure: daily insulin dose |  | 36 months | 
| Measure: anti-ACZ885 antibodies |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACZ885, diabetes, type 1, C-peptide
Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia. II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients. III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days. Patients are followed every 3 months for at least 2 years and annually thereafter.

Official Title
-----------------
High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria

Conditions
-----------------
Aplastic Anemia, Paroxysmal Hemoglobinuria, Nocturnal

Intervention / Treatment
-----------------
* Drug: cyclophosphamide
* Drug: filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria Not a candidate for allogeneic bone marrow transplantation Must meet one of the following criteria: Severe aplastic anemia Less than 25% bone marrow cellularity and depression in two of three blood counts (reticulocytes less than 40,000/mm3 platelet count less than 20,000/mm3 and granulocytes less than 500/mm3) Life-threatening paroxysmal nocturnal hemoglobinuria Absolute neutrophil count less than 500/mm3 platelet transfusion dependent thrombotic disease No Fanconi anemia No abnormal cytogenetics --Patient Characteristics-- Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 45% Other: Not preterminal or moribund Not pregnant

Ages Eligible for Study
-----------------
Maximum Age: 70 Years

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: cyclophosphamide|nan|
|Drug: filgrastim|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
-----------------
aplastic anemia, hematologic disorders, paroxysmal nocturnal hemoglobinuria, rare disease
Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.

Official Title
-----------------
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: SBI-087


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit. Must meet criteria for rheumatoid arthritis with functional class I to III. Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age Exclusion Criteria: Any significant health problems other than rheumatoid arthritis. Treatment of greater than 10 mg of prednisone per day. Treatment with cyclophosphamide.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: 1<br>SBI-087 | Drug: SBI-087<br>* Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ascending Single Dose, Safety, Pharmacokinetics, Open-label
Intraocular Pressure (IOP) Assessed by Dynamic Contour Tonometer (DCT) and Goldman Applanation Tonometry (GAT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate an assessment of the intraocular pressure with the dynamic contour tonometry and the Goldmann applanation tonometry in patients with active anterior uveitis.

Detailed Description
-----------------
Keratoprecipitates are often found in anterior uveitis. Also elevation of the IOP can be seen in these patients. Goldmann applanation tonometry is the standard technique to assess the IOP but depends on the corneal thickness. Therefore IOP is measured by Goldmann and dynamic contour tonometry and corneal thickness is quantified by Orbscan at active uveitis and after the keratoprecipitates have disappeared.

Official Title
-----------------
Inflammatory Changes of Corneal Thickness and Influence on Assessment of Intraocular Pressure

Conditions
-----------------
Uveitis, Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active anterior or panuveitis with keratoprecipitates Exclusion Criteria: corneal endothelial dystrophy

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 |
| --- | --- | --- |
| IOP by GAT and DCT |  | 3 months after treatment start |
Diabetic Patients Needs in Therapeutic Education About Work. TE-DIW (Therapeutic Education of DIabetic Working People)

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.

Official Title
-----------------
Exploratory Study of the Needs of Type 1 Diabetic Patients in Therapeutic Education in Order to Reconcile Diabetes and Work.

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Other: Interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old To be diagnosed with type 1 diabetes according to the criteria of the French High Authority of Health and confirmed by an endocrinologist To have paid employment with an employment contract during the study to be informed and having no opposition to the study Exclusion Criteria: self-employed person to be unemployed To be diagnosed with an other disease wich could damage cognition or motricity and could interfere with work (cancer, neurodegenerative disorder, etc) To have legal guardian.

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Interviews|An interview will be realized with each patient in order to precise the issues they have to reconcile their diabetes and their work. Some questions will be posed to the patients and they respond as they wish.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of the needs of type 1 diabetic patients in therapeutic education in order to reconcile diabetes and work. | It is a qualitative study consisting of type 1 diabetic patients semi-structured interviews in order to identify and describe their needs in therapeutic education in order to reconcile diabetes and work. | Expected duration of interviews is around 1 hour, when no new idea appear in an interview. |
Oral Care Protocol for Preventing Ventilator- Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The Nosocomial Pneumonia remains to be a major complication for patients who were incubated with ventilation. Most cases are attributed to increased bacteria flora in oropharyngeal secretion and aspiration of those organisms. Research indicates that the Gram-Negative Bacteria grows in upper air way and trachea rapidly during the initial 2-4 hospital days and the dental plague also increased dramatically at the first 5 days. About 50% cases with prolonged intubation experienced temporal swallowing disorders and majority of them recovered 7 days post weaning. Some evidence exist suggesting that oral care could reduce bacterial flora, prevent aspiration, and subsequently decrease the incidence of ventilation-associated pneumonia for this group of high risk patients. This study aims to evaluate the effectiveness of a standardized oral care protocol in improving oral hygiene and reducing the incidence of pneumonia on a sample of surgical patients at intensive care unit.

Official Title
-----------------
The Effectiveness of an Oral Care Protocol in Preventing Ventilator- Associated Pneumonia for Intensive Care Unit Patient

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Other: standardized oral care protocol - electronic toothbrush
* Other: mimic protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients newly admitted to SICU who were under ventilator support for 48 72 hours Exclusion Criteria: With pneumonia present

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br>received a 7 day standardized oral care protocol | Other: standardized oral care protocol - electronic toothbrush<br>* a standardized 20-minute oral care protocol using an electronic toothbrush to clean and moisturize oral cavity twice daily.<br>|
| Placebo Comparator: C<br>received a 7 day mimic protocol | Other: mimic protocol<br>* a mimic 20-minute protocol involving moisturizing and attention control was performed for the same intervals.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the oral hygiene status measured by the oral assessment guide and plague index |  | every 3 4days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of VAP defined by the Clinical Pulmonary Infection Score |  | a 7 day oral care protocol duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral hygiene
Genetic Examination of Patients With Primary Multiple Hernia

Study Overview
=================
Brief Summary
-----------------
The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's). The hypothesis is that patients with multiple hernias have different expression of specific genes compared to the healthy control group.

Detailed Description
-----------------
Other examinations performed on the patients enrolled in this study: Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms. Beightons score to evaluate the degree of joint hypermobility.

Official Title
-----------------
Genetic Differences Between Patients With Multiple Hernia and a Healthy Control Group

Conditions
-----------------
Multiple Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with minimum 3 primary hernias Exclusion Criteria: Patients under 18 years

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 |
| --- | --- |
| Multiple hernia<br>Patients with more than 3 primary hernias | |
| Control group<br>Patients without hernias | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic expression of relevant genes between the groups |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of serological biomarkers (MMP's) correlated to gene expression |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple hernia
Fusion UltraSound Imaging Of the Thyroid GlaNd With I-124 PET. Evaluation of Nodule Allocation.

Study Overview
=================
Brief Summary
-----------------
Regular thyroid diagnostics versus augmented thyroid work-up with additional I-124 PET/US fusion for metabolic-sonographic nodule allocation in patients with benign thyroid diseases

Official Title
-----------------
I-124 PET/US for Benign Thyroid Diseases - Blinded, Multicentric Assessment of Augmented Thyroid Work-up Versus Regular Thyroid Diagnostics

Conditions
-----------------
Thyroid Nodule, Thyroid Diseases, Thyroid Goitre

Intervention / Treatment
-----------------
* Other: Assessment of already preacquired I-124 PET/US


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with thyroidal nodules, euthyroidism Uptake >0,5% on Tc-99m-pertechnetate- scintigraphy Exclusion Criteria: thyroid medications in the last 6 months Iodine exposition in the last 6 months thyroid surgery or radioiodine therapy

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 |
| --- | --- |
| Regular Thyroid Work-up<br>Nuclear Medicine physicians evaluate up to 34 cases of patients who have received regular thyroid diagnostics. Data and images of patient characteristics, laboratory results, ultrasonography loops and planar 99mTcO4 scintigraphy are provided and the physicians are asked to assign the function (hypo-, iso-, hyperfunctional) to predefined thyroid nodules visible on ultrasonography. | |
| Regular Thyroid Work-up and I-124 PET/US<br>Nuclear Medicine physicians evaluate up to 34 cases of patients who have received regular thyroid diagnostics and additional I-124 PET/CT, followed by I-124 PET/US (administration of I-124 was not subject of this study). Data and images of patient characteristics, laboratory results, ultrasonography loops, planar 99mTcO4 scintigraphy as well as I-124 PET/US loops are provided and the physicians are asked to assign the function (hypo-, iso-, hyperfunctional) to predefined thyroid nodules visible on ultrasonography. | Other: Assessment of already preacquired I-124 PET/US<br>* Assessment of preacquired I-124 PET/US by review of anonymous digital case files<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic-sonographic nodule allocation | The number of correct assignments of metabolic function of each nodule will be assessed for each group seperately. A three-point scale will be used for evaluation of the nodule's function and the degree of the physicians certainty will be investigated using a four-point scale. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fusion, Hybrid Imaging, Mapping, Iodine, Ultrasound
One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma

Study Overview
=================
Brief Summary
-----------------
This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.

Official Title
-----------------
Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the 2-79-52030-207 study and received 12 injections of lanreotide Autogel 120 mg, regardless of efficacy at the end of this period. Subject or in case of subject's death next of kin having given their written informed consent prior to collection of the data by the sponsor (if locally required)

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 |
| --- | --- | --- |
| Proportion of patients maintained on medical treatment with lanreotide Autogel |  | 1 year | 
| Proportion of patients receiving other medical treatments |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with at least one pituitary surgery |  | 1 year |