linjc16/ctgov huggingface dataset:
A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.

Official Title
-----------------
An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: ELND002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug. Exclusion Criteria: Subject has no new medical contraindications to continue participation in the study.

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: ELND002<br>ELND002 sc injection | Drug: ELND002<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT). | Safety and tolerability will be assessed by frequency and severity of AEs. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the PK/PD/BM measurement of ELND002 in patients with MS. | Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)
Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

Study Overview
=================
Brief Summary
-----------------
Uncontrolled and prolonged oxidative stress plays an important role in the onset and progression of cardiovascular disease, hyperlipidemia, diabetes, and various cancers. Given that many diseases can start as early as childhood, eating patterns in childhood and preventing oxidative damage can have beneficial long-term health effects. Antioxidant-rich foods can slow down the progression of chronic diseases. In Slovenian kindergartens (and schools) children consume up to 70% of their daily energy and nutritional needs, so what is offered to them is very important. This study will evaluate the hypothesis that providing an antioxidant-rich diet in kindergartens can result in the reduction of biomarkers of oxidative stress.

Official Title
-----------------
The Effect of an Antioxidant-rich Kindergarten Diet on Oxidative Stress in Healthy Preschool Children

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Dietary Supplement: Antioxidant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Healthy children aged 5-6 who will attend the compulsory medical examination before entering primary school Exclusion Criteria: • Children with chronic conditions (e.g. diabetes, asthma) Children with allergies to food (e.g. gluten, egg, milk, lactose intolerance)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antioxidant rich diet<br> | Dietary Supplement: Antioxidant<br>* Antioxidant-rich diet (added selected types of fruits, vegetables, nuts, cereals and oils)<br>|
| No Intervention: Regular diet<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress biomarkers | Change in oxidative stress biomarkers of lipids (malondialdehyde (MDA), and four F2 - isoprostane isomers, namely 8 -iso-prostaglandin F2α (8-PGF2α), 11ß- prostaglandin F2α (11-PGF2α), 15 (R)-prostaglandin F2α (15-PGF 2α) and 8-iso, 15 prostaglandin F2α (8,15-PGF2α) ; proteins (o,o'-dityrosine (diY) and DNA 8-Hydroxy-2'-deoxyguanosine (8-OhdG) between day 1 and day 15 of the intervention diet, measured by HPLC-MS/MS | 2 weeks |
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for AF peri-CABG

Detailed Description
-----------------
In this double blind randomized study 240 consecutive patients underwent elective coronary artery bypass grafting, being randomized prospectively into three groups, propranolol (p) (n=80), amiodarone (A) (n=80) and amiodarone with propranolol (AP) (n=80). All groups received their medications from 7 days preoperatively and continued their medications for 5 days post CABG.

Official Title
-----------------
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft, A Prospective Double-Blind Randomized Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Amiodarone + Propranolol
* Drug: Amiodarone
* Drug: Propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who are going to have elective CABG Signing informed consent Exclusion Criteria: EF<35% Bradycardia<60 per min Hypotension< 100 mmhg

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P<br>Propranolol from 7 days pre-operation to 5 days post CABG | Drug: Propranolol<br>* Propranolol from 7 days pre-operation to 5 days post CABG<br>|
| Active Comparator: A<br>Amiodarone treated 7 days pre-operation to 5 days post CABG | Drug: Amiodarone<br>* Amiodarone treated 7 days pre-operation to 5 days post CABG<br>|
| Active Comparator: AP<br>Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG | Drug: Amiodarone + Propranolol<br>* Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of atrial fibrillation post CABG |  | 7 days post CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bradycardia, mortality, hypotension, morbidity |  | 7 days post CABG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, coronary bypass, Amiodarone, Propranolol, Coronary Artery Bypass Graft (CABG)
Jumping Gap Dimension at Maxillary Teeth: Cone-Beam Computed Tomography (CBCT) Study

Study Overview
=================
Brief Summary
-----------------
To assess the important anatomical structures involved in the treatment planning of immediate implants, particularly the jumping gap distance at the different maxillary teeth in the esthetic zone using CBCT analysis. Additional relevant radiographic aspects are evaluated as well to aid in decision making related to immediate implants.

Official Title
-----------------
Assessment of Jumping Gap Dimension at Maxillary Teeth in Addition to Selected Anatomical Landmarks Related to Immediate Implant Placement in the Esthetic Zone: Observational Cone-Beam Computed Tomography (CBCT) Study.

Conditions
-----------------
Jumping Gap Dimension at Maxillary Teeth

Intervention / Treatment
-----------------
* Other: Observational study no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: teeth at upper jaw including : incisors, laterals, canines and premolars Exclusion Criteria: teeth having: extensive restorations, crowns, implants CBCT scans showing scattering teeth showing bone loss around them indicative of periodontal disease

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study no intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jumping gap | Estimation of the jumping gap dimension at maxillary anterior and premolar teeth at different apico-coronal levels through CBCT analysis by linear measurements in mm. | 1 month |
A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin

Study Overview
=================
Brief Summary
-----------------
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.

Official Title
-----------------
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-DAILY RO6811135 IN TYPE 2 DIABETIC PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO6811135


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between the age of 18 and 65 Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks Hemoglobin A1c between 7.2 and 10.5% Fasting plasma glucose less than 250 mg/dL C-peptide greater than 1.5 ng/mL Body mass index (BMI) between 27 and 44 Exclusion Criteria: Pregnant or lactating women Type 1 diabetes Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator Significant kidney or liver disease as determined by the investigator

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* RO681135 placebo subcutaneously daily<br>|
| Experimental: RO6811135<br> | Drug: RO6811135<br>* Subcutaneously daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | from baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose (FPG) |  | from baseline to Week 12 | 
| Pharmacokinetics: Area under the concentration-time curve (AUC) |  | 12 weeks | 
| Safety: Incidence of adverse events |  | 19 weeks |
A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility of combined administration of different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated in future studies.

Official Title
-----------------
A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer

Conditions
-----------------
Prostate Cancer, Head & Neck Cancer, Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: panobinostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with age ≥18 years Confirmed diagnosis of prostate cancer, SCC esophageal cancer or head & neck cancer No evidence of distant spread of the disease Exclusion criteria: Patients who have severe and/or uncontrolled medical conditions Female patients who are pregnant or breast feeding Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBH589<br> | Drug: panobinostat<br> <br> * Other names: LBH589;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) |  | 1 to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of oral LBH589 when given in combination with standard Radiotherapy |  | min 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate,, Head & Neck,, Esophageal
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter

Study Overview
=================
Brief Summary
-----------------
Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.

Official Title
-----------------
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Yang Yin Fu Zheng Jie Du therapy
* Other: Routine medical care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the criteria of hepatocellular carcinoma Ages Eligible for Study: ≤75 years old; The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm) After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA) Surgery cannot be allowed; Informed consent from the patient. Exclusion Criteria: Serious problem of heart, lung, or kidney with severe dysfunction; Pregnant or child breast feeding women; Mental or cognitive disorders; Participating in other drug trials; Who are allergic to the study drug.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Yang Yin Fu Zheng Jie Du therapy<br> | Drug: Yang Yin Fu Zheng Jie Du therapy<br>* Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.<br>Other: Routine medical care<br>* Routine medical care<br>|
| Placebo Comparator: Routine medical care<br> | Other: Routine medical care<br>* Routine medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrance rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 1 year | 
| quality of life (QOL) questionnaire |  | 1 year |
Rare Tumor Case Review

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to do a literature review and combine all of the cases of the intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor in children.

Detailed Description
-----------------
We excised an intrapericardial teratoma tumor out of a child approximately one month ago. This is a very uncommon tumor overall, and even more uncommon in children. The majority of reports in the literature are single case reports I would like to report ours, as well as do a literature review to combine all of the cases and see if some conclusions can be made about this rare tumor in children.

Official Title
-----------------
Rare Tumor Case Review

Conditions
-----------------
Intrapericardial Teratoma Tumor, Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with intrapericardial teratoma tumors
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric health, rare tumor, children, cardiac
An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry

Study Overview
=================
Brief Summary
-----------------
Translational studies in cancer research can be impeded by the lack of high-quality clinical data that can be correlated with research questions. This is particularly true in the case of rare diseases, such as bone and soft tissue tumors. It is therefore the purpose of this study to create a prospective EHR-based clinical registry for individuals with bone and soft-tissue tumors.

Official Title
-----------------
An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry

Conditions
-----------------
Neoplasms, Connective and Soft Tissue, Bone Neoplasms

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a diagnosis or presumed diagnosis of bone or soft tissue tumor as defined by the WHO classification of tumors of soft tissue and bone (4th ed.) Patient, or his/her designated power of attorney, must be able to understand and approve of the consent to participate. Exclusion Criteria: Prisoners are excluded from participation in the Registry.

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: Observation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcoma, registry
An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.

Study Overview
=================
Brief Summary
-----------------
A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.

Official Title
-----------------
An 8-Week, Multi-Centre,Randomised Double-Blind, Placebo Controlled, Parallel Group Study To Evaluate The Efficacy,Toleration And Safety Of (+)- [S,S]- Reboxetine In The Treatment Of Stress Urinary Incontinence (SUI) In Women.

Conditions
-----------------
Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Drug: SS-RBX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically significant stress urinary incontinence Exclusion Criteria: History or evidence of any relevant confounding urological or neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SS-RBX|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX. |  |  |