linjc16/ctgov huggingface dataset:
Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study

Study Overview
=================
Brief Summary
-----------------
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world. NAFLD is associated with a lot of comorbidity, such as diabetes, metabolic syndrome, coronary heart disease and chronic kidney diseases. However, the correlation between the NAFLD and cardiovascular disease (CVD) events remains controversial. This study is an observational study based on a big retrospective cohort in china to explore the prevalence of NAFLD in China, the risk factors associated with NAFLD, as well as whether patients with NAFLD are more prone to experience CVDs and CVD events.

Official Title
-----------------
Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study

Conditions
-----------------
NAFLD, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or females aged 18-75 Exclusion Criteria: malignancy except primary liver cancer pregnancy or breastfeeding liver diseases of other etiology including hepatitis C virus infection ,autoimmune hepatitis,Wilson's disease,hemachromatosis,drug-induced hepatitis,parenteral nutrition excessive alcohol consumption cases missing crucial data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| NAFLD group<br>those with NAFLD | |
| Control group<br>those without NAFLD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of NAFLD in China |  | June，2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the risk factors associated with NAFLD |  | August，2020 | 
| to indicate the prevalence of CVDs and CVD events in people with and without NAFLD |  | October，2020 |
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

Study Overview
=================
Brief Summary
-----------------
This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.

Official Title
-----------------
Randomized, Double-blind, Parallel-group, Phase 3 Study

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

Intervention / Treatment
-----------------
* Drug: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with active rheumatoid arthritis at least 3 months of treatment with methotrexate Exclusion Criteria: have allergies to infliximab serious infection

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-P13<br> | Drug: Infliximab<br>* Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.<br>* Other names: remicade;|
| Active Comparator: Remicade<br> | Drug: Infliximab<br>* Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.<br>* Other names: remicade;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK equivalence to remicade |  | PK sampling at week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy endpoint | -ACR criteria comparison with Baseline at Weeks 14,30,54 | up to week 54. | 
| efficacy endpoint | - Time to onset of ACR20 response | Up to week 54. | 
| efficacy endpoint | - Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30 | Up to week 54. | 
| efficacy endpoint | - Proportion of patients with a good response, defined according to the EULAR response criteria | Up to week 54. | 
| efficacy endpoint | - ACR20 at weeks 14 and 54 | Up to week 54. | 
| efficacy endpoint | - ACR50 and ACR70 at weeks 14, 30, and 54 | Up to week 54. | 
| efficacy endpoint | - Hybrid ACR response at weeks 14, 30, and 54 | Up to week 54. | 
| efficacy endpoint | - SDAI and CDAI at weeks 14, 30, and 54 | Up to week 54. | 
| efficacy endpoint | - Joint damage progression at week 54 | Up to week 54. | 
| efficacy endpoint | - SF-36 at weeks 14, 30, and 54 | Up to week 54. | 
| efficacy endpoint | - Fatigue | Up to week 54. | 
| efficacy endpoint | - Number of patients requiring salvage retreatment at weeks 30 and 54 | Up to week 54. |
A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
To evaluate the mechanism whereby thymopentin appears to retard the progressive immune suppression attributable to HIV infection.

Detailed Description
-----------------
Patients are randomized to receive subcutaneous thymopentin or placebo thrice weekly for 4 weeks.

Official Title
-----------------
Double-Blind Study of the Effect of Timunox (Thymopentin) on Lymphoproliferative Responses and Virus Load in HIV-Infected Subjects Receiving Nucleoside Analog Antiretroviral Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Thymopentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Asymptomatic or minimally symptomatic HIV infection (no evidence of AIDS). CD4 count <= 400 cells/mm3 within 6 weeks prior to study entry (CD4 count changed to 100 - 400 cells/mm3 per amendment). Tolerated the current nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to thymopentin or any component of the formulation. Significant chronic underlying medical illness that would impede study participation. Grade 2 or higher peripheral neuropathy related to nucleoside analog antiretroviral treatment. Concurrent Medication: Excluded: Any antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine. HIV vaccines or any investigational or non-FDA approved medication or immunomodulatory or experimental therapy within 30 days prior to study entry. Patients with the following prior condition are excluded: Abnormal chest x-ray consistent with active opportunistic infection within 6 weeks prior to study entry. Prior Medication: Excluded: Any prior antiretroviral agents other than zidovudine, didanosine, or dideoxycytidine within 30 days prior to study entry. Required: Current nucleoside analog antiretroviral treatment. Required: Nucleoside analog antiretroviral treatment for at least 4 weeks prior to study entry. Significant active alcohol or drug abuse sufficient to prevent study compliance.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymopentin|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
-----------------
Thymopentin, AIDS-Related Complex
Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Dyslipidemic Patients Deemed Appropriate for Further Lipid Modification.

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: niacin (+) laropiprant
* Drug: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older and on a stable dose of lipid therapy Exclusion Criteria: Patients lipid level is outside the recommended range Patients that are HIV positive

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Patients will remain on existing lipid-modifying therapy throughout the study. Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study. | Drug: niacin (+) laropiprant<br>* Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.<br>* Other names: MK0524A;|
| Placebo Comparator: Group 2<br>Patients will remain on existing lipid-modifying therapy throughout the study. Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study. | Drug: placebo (unspecified)<br>* Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks. |  | 3 months |
Feasibility of Supportive Care Needs in Patients With Advanced Solid Cancer in a Therapeutic Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.

Detailed Description
-----------------
All patients included in a therapeutic trial will be offered an analysis of their supportive care needs from the following options: dietetics psychological pain management Palliative medicine consultation or day hospital onco-geriatrics social assistance Physiotherapist care If an intervention(s) is selected, it will be offered in addition to the patient's participation in the therapeutic trial.

Official Title
-----------------
Prospective, Observational Study Evaluating the Feasibility of a Systematic and Standardized Assessment of Supportive Care Needs in Patients With Advanced Solid Cancer at the Inclusion in a Therapeutic Trial at the Institut Curie

Conditions
-----------------
Supportive Care, Metastatic Cancer, Clinical Trial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metastatic cancer patient included in a clinical trial Exclusion Criteria: - patient deprived of his freedom

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) | Descritive results with validated questionnaire for the assessment of Quality of life in patient with cancer. 30 Questions | 3 months | 
| National Comprehensive Cancer Network (NCCN) Distress thermometer | Descritive results with validated questionnaire for distress assessment (scale from 0 to 10 and list of problems to be ticked by the patient | 3 months | 
| Questionnaire G8 oncodage | Descritive results with validated questionnaire for the identification of geriatric frailties in 70 year old cancer patients. Score on 17 points: > 14 = standard care, <14 = specialized geriatric evaluation | 3 months |
Comparison of White Light, PDD and NBI in Detection of Flat Dysplasia and CIS at TURB - a Study of Trimodality

Study Overview
=================
Brief Summary
-----------------
All patients planned for PDD guided TURB can be included in this study. Two different optics with PDD and NBI are applied to the resectoscope in addition to regular WL. First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with registration of any additional findings. To adjust for bias introduced by photo bleaching, the second part of the study will be performed with PDD as the second modality. Any flat lesions will be biopsied if they appear suspicious in one of the modalities. The registration form is completed by the surgeon, once the pathology results are known. A total number of 152 patients is planned to be included.

Official Title
-----------------
Trimodalitets-studie Hvidt Lys vs. NBI vs. PDD Ved Detektion af Flad Dysplasi og CIS Ved TURB

Conditions
-----------------
Narrow Band Imaging and PDD in Cystoscopy

Intervention / Treatment
-----------------
* Device: NBI and PDD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing PDD according to the Danish guidelines Exclusion Criteria: Patients not fulfilling the inclusion criteria

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 |
| --- |
|Device: NBI and PDD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of CIS |  | Baseline |
Imaging With a New Agent That Finds a Cancer Protein Called HER2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.

Official Title
-----------------
First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies

Conditions
-----------------
HER2-positive Carcinoma, HER2-positive Primary Malignancy

Intervention / Treatment
-----------------
* Drug: Zr-DFO-pertuzumab PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21 years or greater Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate. At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment ECOG performance of 0-2 Exclusion Criteria: Life expectancy < 3 months Pregnancy or lactation Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT<br>Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT will be performed in patients with known HER2-positive malignancy. Patients with multifocal disease, as demonstrated on cross-sectional imaging studies, will be preferentially recruited. | Drug: Zr-DFO-pertuzumab PET/CT<br>* Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0 | Patients will be monitored closely for evidence of adverse events, including vital signs before and after tracer administration. The day after tracer administration, a physician will screen for any side effects requiring treatment. If a severe adverse effect (Common Terminology Criteria for Adverse Events grade 3 or 4) attributable to 89Zr-DFO-pertuzumab occurs in any patient, then further use of 89Zr-DFO-pertuzumab will be suspended and the protocol reviewed with the MSKCC Data Safety Monitoring Committee. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
17-059, Zr-DFO-pertuzumab
A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.

Conditions
-----------------
Primary Total Hip Replacement

Intervention / Treatment
-----------------
* Device: Delta TT acetabular cup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI< 40 kg/m2 Indication suitable to the implantation of Delta TT acetabular cup (First implant) Idiopathic osteoarthritis Avascular necrosis Post-traumatic arthritis Presence of sufficient periacetabular bone stock Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups Written informed consent Exclusion Criteria: Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision) Patients aged 76 or older Haemophilic disease Femur neck fracture Insulin Dependent Diabetes Mellitus (IDDM) Severe kidney failure (grade 4) Not responder Hypo- or Hyperthyroidism Paget's disease Tumours Active or suspicious infections Neurosensory deficits or neuromuscular diseases Severe and impairing vascular diseases Known incompatibility or allergy to products materials Woman with pregnancy or childbearing capacity or breast-feeding Subjects already enrolled in other clinical trials

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DELTA TT<br> | Device: Delta TT acetabular cup<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan |  | From baseline to 5 year Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) |  | From baseline to 5 year Follow-up | 
| SF-36 score |  | From baseline to 5 year Follow-up |
ULnar Nerve ECHographic Observation (ULNECHO)

Study Overview
=================
Brief Summary
-----------------
There is currently no consensus on the normal ultrasound surface of the ulnar nerve at the elbow. The goal of this study is to study the ulnar nerve surface at the elbow in a population of asymptomatic subjects

Detailed Description
-----------------
100 elbows from 50 patients will be included, from a population of asymptomatic subjects, in order to measure the frequency of ulnar nerve which surface is >8,3 mm². The measures will be realized centered on the epicondyle : 2 cm higher, and 2 cm lower with 2 echographs (ESAOTE) and 2 observers. An inter and intra observer study will also be realized to determine the reproducibility and reliability of the measurements.

Official Title
-----------------
ULnar Nerve ECHographic Observation (ULNECHO)

Conditions
-----------------
Ulnar Neuropathies

Intervention / Treatment
-----------------
* Diagnostic Test: Ulnar nerve Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 -to 80 years or older Patient without any current or previous pathology on the ulnar nerve Patients would be able to consent Exclusion Criteria: Patient under administrative supervision or legal guardianship

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulnar nerve ultrasound<br> | Diagnostic Test: Ulnar nerve Ultrasound<br>* No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach by measure of ulnar nerve surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of ulnar nerve surface > 8,3 mm ² frequency by Ultrasound |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation ulnar nerve surface measure of by two doctors |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulnar Neuropathies, Ultrasound