linjc16/ctgov huggingface dataset:
Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 as add-on therapy in subjects with Homozygous Familial Hypercholesterolemia

Official Title
-----------------
A Phase 2, Open-Label, Dose Escalation Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects

Conditions
-----------------
Hypercholesterolemia, Familial

Intervention / Treatment
-----------------
* Drug: ISIS 301012
* Drug: ISIS 301012
* Drug: ISIS 301012
* Drug: ISIS 301012


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight ≥ 40 kg for Cohorts A, B, & C; Weight ≥ 50 kg for Cohort D Diagnosis of Homozygous Familial Hypercholesterolemia. Female must be non-pregnant and non-lactating. On stable lipid lowering therapy for at least 4 weeks. Lipid values that meet the pre-specified criteria. Exclusion Criteria: Subject had heart problems in the prior 6 months. Subject has elevated ALT, AST, or CPK. History of renal disease, liver disease, or malignancy. Use of oral anticoagulants, unless the dose has been stable for 4 weeks Have any other conditions, which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Loading doses followed by weekly maintenance doses | Drug: ISIS 301012<br>* 50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36<br>|
| Experimental: Cohort B<br>Loading doses followed by weekly maintenance doses | Drug: ISIS 301012<br>* 100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36<br>|
| Experimental: Cohort C<br>Loading doses followed by weekly maintenance doses | Drug: ISIS 301012<br>* 200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36<br>|
| Experimental: Cohort D<br>Loading doses followed by extended weekly maintenance doses | Drug: ISIS 301012<br>* 300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64,71, 78, and 85<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in LDL-cholesterol from baseline |  | Week 7 (Cohorts A-C), Week 15 (Cohort D) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LDL-cholesterol, apoB-100, Homozygous Familial Hypercholesterolemia
Juvenile Inflammatory Rheumatism (JIR) Cohorte

Study Overview
=================
Brief Summary
-----------------
The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.

Detailed Description
-----------------
The JIR-cohort has to be filled by an authorized investigator during or after the consultation. Each patient much be followed at least once a year. Different data are requested in the JIR-cohort: diagnosis, treatment, adverse events and outcome.

Official Title
-----------------
Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases

Conditions
-----------------
Arthritis, Juvenile Rheumatoid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with juvenile inflammatory diseases Age at onset up to 18 years old Consent according national codes of ethics and current laws Exclusion Criteria: Non-consent from patients and/or legal representative
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Juvenile Inflammatory Rheumatism<br>Juvenile Inflammatory Rheumatism patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe and very severe adverse event as a mesure of safety and tolerability |  | 10 years | 
| Number of treatments prescribed off label |  | 10 Years | 
| Length in months of drug survival in patient treated with at least two consecutive biological agents |  | 10 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile, Inflammatory, Rheumatism, Pediatric-Onset inflammatory diseases
Expanded Access to Elezanumab

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Elezanumab

Conditions
-----------------
Acute Spinal Cord Injury (SCI), Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: Elezanumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The participant must not be eligible for an elezanumab clinical trial.

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: Elezanumab|Solution for intravenous (IV) infusion|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis

Study Overview
=================
Brief Summary
-----------------
Chronic Recurrent Multifocal Osteomyelitis (CRMO) is a rare autoinflammatory bone disease in children. Studies evaluating the quality of life of patients with CRMO are small and heterogeneous. A better understanding of the impact of the disease on the quality of life of adult patients with CRMO beginning in childhood would allow better long-term management of these patients. Our study aims are to assess the clinical and socio-professional outcomes of adult patients who started CRMO at pediatric age.

Official Title
-----------------
Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis

Conditions
-----------------
Chronic Recurrent Multifocal Osteomyelitis

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patient with a CRMO with pediatric-onset disease (> 18years) Patient who was informed and agreed to participate in this study Exclusion Criteria: Patients with Monogenic auto-inflammatory disease associated with osteolytic bone lesions (e.g. interleukin-1 receptor antagonist deficiency) Patient with Majeed syndrome Patient without sufficient imaging data to confirm the presence of one or more inflammatory lesions Patients with incomplete data. Patients placed under legal protection, guardianship or curatorship

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 |
| --- |
|Other: Questionnaire|Questionnaires concerning assesment of quality of life with 3 different questionnaires ( SF36, HAQ and pre-established questionnaire for the study) during a phone interview|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the disease on the quality of life of adult CRMO patients with pediatric-onset disease. | Result of the SF 36 (Short Form 36) quality of life questionnaire compared to data in the general population and other published data available in CRMO and inflammatory diseases in children. This questionnaire is composed of 36 questions which allow to calculate two scores of the quality of life of individuals: the physical composite score (SCP) and the mental composite score (SCM). The higher the score the higher the capacity. Range 0 to 100 | 20 minutes |
Comparison of Single vs Group Embryo Culture in Micro-well Group Culture Dish

Study Overview
=================
Brief Summary
-----------------
Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?

Official Title
-----------------
Randomized Controlled Comparison of Single Embryo Culture Versus Group Culture Using a Micro-well Group Culture Dish in Humans

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: micro-well group culture dish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female age uner 40, male age under 60 patients undergoing IVF-treatment with oocyte collection after ovarian hyperstimulation having signed the study-specific consent form patient fulfilling clinic's standard criteria for blastocyst culture minimum 5 normally fertilized oocytes at the time of fertilization check Exclusion Criteria: use of any type of surgically retrieved sperm cells patients undergoing any kind of genetic diagnosis at any developmental stage -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single embryo culture<br>single embryo culture in single drops inside micro-well group culture dish | Other: micro-well group culture dish<br>* an embryo culture dish containing nine micro-wells in the middle.<br>|
| Experimental: group embryo culture<br>group embryo culture in a single drop inside micro-well group culture dish | Other: micro-well group culture dish<br>* an embryo culture dish containing nine micro-wells in the middle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst development |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blastocyst, micro-well group culture dish
Electronic Chromoendoscopy for Polyp Characterization

Study Overview
=================
Brief Summary
-----------------
To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.

Official Title
-----------------
Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy

Conditions
-----------------
Colorectal Polyp

Intervention / Treatment
-----------------
* Diagnostic Test: Prediction of Histology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing screening or surveillance colonoscopy written informed consent Exclusion Criteria: inadequate bowel preparation polyposis syndromes history of colectomy use of anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| HD-WLE<br>Intervention: Prediction of polyp histology with HD-WLE | Diagnostic Test: Prediction of Histology<br>* The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC<br>|
| EC<br>Intervention: Prediction of polyp histology with EC | Diagnostic Test: Prediction of Histology<br>* The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of predicting histology with EC | Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared. | 1 year |
Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.

Official Title
-----------------
Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes Patients inadequately controlled by OAD Patients willing to sign informed consent Selection of study participants at the discretion of the physician Particular attention should be paid to the drug interactions that are listed within the product label Exclusion Criteria: Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit; Subjects who were previously enrolled in this study Subjects with a hypersensitivity to insulin detemir or to any of the excipients. Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycaemic control as measured by HbA1c. |  | For the duration of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5% |  | After 12 weeks and 24 weeks | 
| The effect on glycaemic control as measured by FPG |  | After 12 weeks and 24 weeks | 
| Change in body weight |  | After 12 weeks and 24 weeks | 
| Change in waist and hip perimeter |  | After 12 weeks and 24 weeks |
Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts

Study Overview
=================
Brief Summary
-----------------
KRANIOPHARYNGEOM Registry 2019 will prospectively collect and descriptively analyse data on diagnostics, treatment, and follow-up of patients with craniopharyngioma. In continuation of preceding studies also patients with xanthogranuloma, meningioma, pituitary adenoma, prolactinoma and cystic intracranial malformations will be registered.

Official Title
-----------------
KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts

Conditions
-----------------
Craniopharyngioma, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with craniopharyngioma for the first time Age at diagnosis 18 years or less of age Agreement from patient's parents or legal guardian as well as the patient Exclusion Criteria: Age at diagnosis over 18 years of age Diagnosis different from craniopharyngioma

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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 |
| --- | --- | --- |
| Overall Survival | Overall survival as measured by Kaplan Meyer analyses | 3 years follow-up | 
| Progression-free Survival (PFS) | Progression-free survival as measured by Kaplan Meyer analyses | 3 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QoL) | Domains of the PedQol instrument (questionnaire for assessment of health-related QoL in childhood cancer patients. | 3 years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Endocrinology, Oncology, Hypothalamus, Irradiation, Neurosurgery, Pediatric Brain tumors
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

Official Title
-----------------
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician Exclusion Criteria: Subjects who are unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for the final visit; Subjects currently being treated with insulin detemir; Subjects who previously enrolled in this study or studies related to NovoMix 30; Subjects with a hypersensitivity to insulin detemir or to any of the excipients; Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: Levemir®, NN304;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events |  | For the duration of the study (32 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events |  | For the duration of the study | 
| Number of all adverse events |  | For the duration of the study | 
| Number of all - daytime and nocturnal - hypoglycaemic events |  | In the 4 weeks before baseline compared to 4 weeks before interim and final visits | 
| Weight changes compared to baseline |  | At the end of the study | 
| HbA1c compared to baseline |  | At the end of the study | 
| Fasting glucose level control compared to baseline as measured by FBG |  | After 16 and 32 weeks of treatment |