linjc16/ctgov huggingface dataset:
Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions

Study Overview
=================
Brief Summary
-----------------
To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.

Detailed Description
-----------------
The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.

Official Title
-----------------
Study of Single And Double Bundle ACL Graft Cross-sectional Dimensions Compared With Native ACL

Conditions
-----------------
Rupture of Anterior Cruciate Ligament

Intervention / Treatment
-----------------
* Procedure: single bundle ACL reconstruction
* Procedure: double bundle ACL reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACL rupture patients aged between 10 to 50 years Exclusion Criteria: combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation) any injury or surgery to the contralateral knee any inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 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: single bundle ACLR<br>patients undergo single bundle ACL reconstruction | Procedure: single bundle ACL reconstruction<br>* anterior cruciate ligament reconstruction using single bundle technique<br>|
| Active Comparator: double bundle ACLR<br>patients undergo double bundle ACL reconstruction | Procedure: double bundle ACL reconstruction<br>* anterior cruciate ligament reconstruction using double bundle technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cross-sectional area of the reconstructed ACL |  | 3-6 weeks | 
| long to short axis ratio of the cross-sectional area of the reconstructed ACL |  | 3-6 weeks | 
| long axis of the cross-sectional area of the reconstructed ACL |  | 3-6 weeks | 
| short axis of the cross-sectional area of the reconstructed ACL |  | 3-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Cruciate Ligament Reconstruction
Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment

Study Overview
=================
Brief Summary
-----------------
This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.

Official Title
-----------------
A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function

Conditions
-----------------
Advanced Melanoma and Normal or Impaired, Hepatic Function

Intervention / Treatment
-----------------
* Drug: Genasense® (G3139, oblimersen sodium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of malignant melanoma Metastatic Stage IV disease, or Stage III disease that is not surgically resectable ECOG Performance status of 0,1,or 2 Adequate venous access Agreement to practice effective methods of birth control Hepatically impaired consistent with Child-Pugh classification Grade B Exclusion Criteria: Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites Prior organ allograft Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy Known hypersensitive to DTIC Prior treatment with Genasense

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Genasense® (G3139, oblimersen sodium)|Genasense 7 mg/kg/day for 5 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of G3139 |  | 6-day period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 30 days post last dose of study medication |
Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

Detailed Description
-----------------
Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF) increasingly added to other drugs in the treatment of colorectal cancer. Bev is typically used in combination with other chemotherapeutic agents such as oxaliplatin, irinotecan, leucovorin and 5-fluorouracil (5-FU) for treatment of patients with CRLM. The objective of this study was to assess the impact of neoadjuvant bevacizumab on clinical outcome after hepatectomy of colorectal liver metastases (CRLM). Patients, who underwent liver resection due to colorectal liver metastases after neoadjuvant chemotherapy, operated between 2005 and 2007 will be evaluated retrospectively. The patients will be distributed in two groups, either with or without bevacicumab. Outcome parameters are mortality, complications, hospital stay and ICU stay. To increase the power of the study the total number of patients will be increased by adding patients from other centers. Results will be adjusted for the propensity of developing complications.

Official Title
-----------------
Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study

Conditions
-----------------
Colorectal Liver Metastases

Intervention / Treatment
-----------------
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with neoadjuvant chemotherapy prior to liver resection Exclusion Criteria: Patients without neoadjuvant chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| with bevacizumab<br>Neoadjuvant chemotherapy with bevacizumab | Drug: bevacizumab<br>* Neoadjuvant chemotherapy with bevacizumab<br>|
| without Bevacizumab<br>Neoadjuvant chemotherapy without Bevacizumab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complications |  | postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specific complications such as liver insufficiency, length of hospital stay |  | postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoadjuvant chemotherapy, bevacizumab
The Valid of GFR in Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
Study was cancel due to principle investigator had been resigned

Detailed Description
-----------------
Study was cancel due to principle investigator had been resigned

Official Title
-----------------
The Validation of Calculated Equations of GFR in Thai Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 16 Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 120 Years

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

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

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
-----------------
GFR CKD
Bevacizumab and Photodynamic Therapy in Neovascular Age Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if of combination therapy of intravitreal bevacizumab 4 days after the application of photodynamic therapy could improve the visual outcomes of patients with neovascular age related macular degeneration.

Detailed Description
-----------------
The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD 4 days after photodynamic therapy with verteporfin

Official Title
-----------------
Effects of Intravitreal Injection of Bevacizumab in Combination With Verteporfin Photodynamic Therapy

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: bevacizumab intravitreal injection
* Procedure: verteporfin photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 55 years old neovascular Age related acular degeneration subfoveolar neovascular membrane best corrected visual acuity better than 20/200 snellen (1.0 logMAR) Exclusion Criteria: Previously treated eyes glaucoma diabetes mellitus uncontrolled hypertension coronary artery disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bevacizumab intravitreal injection|nan|
|Procedure: verteporfin photodynamic therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity improvement at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal thickness improvement at 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular degeneration, antibodies, angiogenesis inhibitor
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).

Official Title
-----------------
A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 2-Way Crossover Bioequivalence Study To Compare The Bosutinib Clinical Tablet And Clinical Capsule And To Investigate Food Effect On Bosutinib Commercial Formulation in Healthy Subjects

Conditions
-----------------
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Intervention / Treatment
-----------------
* Drug: Bosutinib
* Drug: Bosutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests. Exclusion Criteria: Pregnant or nursing women or women of childbearing potential.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: Bosutinib<br>* 5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition<br>* Other names: SKI-606, PF-05208763;|
| Experimental: Cohort 2<br> | Drug: Bosutinib<br>* 4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition<br>* Other names: SKI-606, PF-05208763;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Cmax for bosutinib. |  | 96 hr post dose in each period | 
| AUCt for bosutinib. |  | 96 hr post dose in each period | 
| Plasma AUCinf for bosutinib. |  | 96 hr post dose in each period | 
| AUClast for bosutinib. |  | 96 hr post dose in each period | 
| Tmax for bosutinib. |  | 96 hr post dose in each period | 
| t½ for bosutinib. |  | 96 hr post dose in each period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bosutinib, Bioequivalence and Food Effect Studies
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy

Study Overview
=================
Brief Summary
-----------------
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.

Official Title
-----------------
An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral® in Cardiac Transplant Recipients With Established Allograft Vasculopathy

Conditions
-----------------
Graft Rejection

Intervention / Treatment
-----------------
* Drug: everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography. Patient must be on statins at study entry. Patient who is more than 12 months post-transplant. Exclusion Criteria: Patient with a serum creatinine value >2.0 mg/dL. Patient with a biopsy-proven acute rejection episode (>= ISHLT 3A) within 6 months prior to study entry. Patient who had received any investigational drug within 4 weeks prior to study entry.

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: everolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events at 3 and 6 months. |  |  | 
| Patient survival at 3 and 6 months. |  |  | 
| Treated acute rejection at 3 and 6 months. |  |  | 
| Admission to the hospital at 3 and 6 months. |  |  | 
| Premature study treatment discontinuation at 3 and 6 months. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transplant, heart, adult, everolimus, allograft rejection
Energy Metabolism in Branched-chain Organic Acidemias

Study Overview
=================
Brief Summary
-----------------
Energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias.

Detailed Description
-----------------
Children and adults with branched-chain organic acidemias and matched healthy humans underwent deep metabolic phenotyping using non-invasive magnetic resonance spectroscopy, oral glucose tolerance tests and measurements of leucocyte respirometry in order to assess changes in energy metabolism and insulin sensitivity.

Official Title
-----------------
Non-invasive Measurement of Energy Metabolism in Patients With Primary and Secondary Mitochondrial Diseases

Conditions
-----------------
Energy Metabolism, Metabolic Syndrome, Insulin Resistance

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known branched-chain organic acidemia diagnosed by enzymatic or genetic test age>5 years Exclusion Criteria: acute inflammatory conditions with fever, cold symptoms, gastro-intestinal infection within the last 24 hours contraindications for an oral glucose tolerance test such as fasting blood glucose >126 mg/dl, severe chronic gastrointestinal conditions, allergy against black currant contraindications for magnetic resonance tomography (MRT) such as claustrophobia, metallic implants which are not MRT compatible

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| Patients<br>Patients with propionic acidemia, isovaleric acidemia, methylmalonic acidemia | Other: No intervention<br>* No intervention, observational study with metabolic characterisation<br>|
| Controls<br>Healthy humans | Other: No intervention<br>* No intervention, observational study with metabolic characterisation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic and skeletal muscle energy metabolism | Hepatic and skeletal muscle energy metabolism assessed by magnetic resonance spectroscopy | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Insulin sensitivity measured from oral glucose tolerance test | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Organic acidemias, Mitochondria, Oxidative stress, Fatty liver, Dyslipidemia