linjc16/ctgov huggingface dataset:
New Topographic Classification of Knee Bone Marrow Lesions

Study Overview
=================
Brief Summary
-----------------
the investigator are studying a new topographic classification of bone marrow lesion in the knee and validating it.

Official Title
-----------------
Validation of a New Topographic Classification of Bone Marrow Lesions of the Knee

Conditions
-----------------
Knee Bone Marrow Lesions

Intervention / Treatment
-----------------
* Diagnostic Test: mri


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 with mri with lesion consent given Exclusion Criteria: under mri previous surgery tumors no consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| a<br> | Diagnostic Test: mri<br>* knee mri<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The researchers will calculate the prevalence of BMLs in knee MRI and calculate the intra-observer and inter-observer reliability of the new classification proposed. | This study proposes a topographic classification for knee BMLs consisting in 5 different types of lesions. the classification proposed will be validated by 3 independent researchers. | The lesions will be evaluated on knee MRI performed in the period between January 2017 to December 2018 |
NASH in Subjects With Different Classes of Obesity

Study Overview
=================
Brief Summary
-----------------
It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.

Detailed Description
-----------------
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common cause of chronic liver disease due to an increase in the prevalence of obesity. The development of NASH leads to an increase in morbidity and mortality. Since patients with obesity are at an increased risk of NASH, the aim of this trial is to assess the prevalence of NASH in this class of patients.

Official Title
-----------------
Prevalence of NASH in Subjects With Different Classes of Obesity

Conditions
-----------------
NAFLD, NASH - Nonalcoholic Steatohepatitis, Obesity, Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: Liver biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 19 and 69 years Exclusion Criteria: Pregnancy Active cancer End stage renal failure End stage liver failure Being unable to understand and sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 69 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 |
| --- | --- |
| Patients with obesity<br>Subjects with different classes of obesity | Procedure: Liver biopsy<br>* Biopsy of the liver to assess for Non-alcoholic steatohepatitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of NASH | Prevalence of NASH in a cohort of patients with different classes of obesity | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of lipid profile | Assessment of triglycerides, total cholesterol, LDL and HDL cholesterol | 6 months | 
| Assessment of glycemic profile | Assessment of fasting glucose | 6 months | 
| Assessment of glycated hemoglobin | Assessment of glycated hemoglobin | 6 months | 
| Assessment of liver enzymes | Assessment of AST, ALT, GGT | 6 months | 
| Assessment of insulin | Assessment of fasting insulin | 6 months | 
| Assessment of metabolic profile | Assessment of HOMA-IR index | 6 months |
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.

Official Title
-----------------
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian

Conditions
-----------------
Ovarian Epithelial Cancer

Intervention / Treatment
-----------------
* Drug: Olaparib
* Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum At least 1 previous line of chemotherapy Measurable disease Patients have a normal organ and bone marrow function measured within 28 days of randomization WHO 0-2 Exclusion Criteria: Primary platinum-refractory disease Known hypersensitivity to olaparib Resting ECG with QTc > 470 msec Concomitant use of known potent CYP3A4 inhibitors Symptomatic uncontrolled brain metastases Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olaparib<br>olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles | Drug: Olaparib<br> <br> * Other names: Lynparza;|
| Active Comparator: Chemotherapy<br>physician's choice chemotherapy | Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly<br>* physician's choice chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Objective Response |  | 1 year after end inclusion |
YM598 in Patients With Rising PSA After Initial Therapy for Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: YM598


Participation Criteria
=================

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

Sexes Eligible for Study
-----------------
Male

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: YM598|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.

Detailed Description
-----------------
Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.

Official Title
-----------------
A Prospective, Open-label, Single-arm, Multinational, Multi-centre, Flexible-dose, Extension Study of the SCoP 99824 With Sertindole for Patients Suffering From Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Sertindole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the previous SCoP study, 99824 Still fulfils the EU SPC requirements for Sertindole Exclusion Criteria: Withdrawn before the end of the SCoP study, 99824 Become homeless Participation in another clinical trial at the same time Unlikely to comply with the clinical study protocol or is unsuitable for any reason

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: Sertindole<br> | Drug: Sertindole<br>* Flexible dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All serious adverse events reported; visits scheduled every 3 months |  | Every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Sertindole, Safety study
Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies

Study Overview
=================
Brief Summary
-----------------
In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.

Detailed Description
-----------------
Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.

Official Title
-----------------
A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.

Conditions
-----------------
Disease-free Survival

Intervention / Treatment
-----------------
* Drug: MBF-RIC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55-65 patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors. patients with AML in remission, or MDS in any stage, or CMML in any stage inform consent provided Exclusion Criteria: patients with abnormal liver (>3N), renal (1.5N) or cardiac function patients with active infection

Ages Eligible for Study
-----------------
Minimum Age: 55 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: MBF-RIC<br>Patients with MBF-RIC as conditioning regimen | Drug: MBF-RIC<br>* Reduced intensity conditioning regimen with fludarabine, busulfan and melphalan<br>* Other names: MBF100;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | survival without disease relapse or progression | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | survival | 2 year | 
| GVHD and relapse free survival | survival without graft failure, without relapse, without III-IV aGVHD and without mod/sev cGVHD. | 2 year | 
| Non-relapse mortality | Death without disease progression or relapse | 2 year | 
| Relapse | disease progression or relapse | 2 year |
Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.

Official Title
-----------------
Occurrence of Anti-drug Antibody and Change of Drug Level for 1 Year After CT-P13 Therapy and Their Impact on Clinical Outcomes in Moderate to Severe Inflammatory Bowel Disease (OACIS Study)

Conditions
-----------------
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Crohn's disease or ulcerative colitis Exclusion Criteria: Tuberculosis infection Allergy to CT-P13

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| Crohn's disease<br>Patients with moderate to severe Crohn's disease who need to get a biosimilar CT-P13 | |
| Ulcerative colitis<br>Patients with moderate to severe ulcerative colitis who need to get a biosimilar CT-P13 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of anti-drug antibody to CT-P13 |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of drug trough concentration |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory bowel disease, biosimilar, anti-drug antibody, trough drug concentration
Zinc Absorption From Biofortified Rice

Study Overview
=================
Brief Summary
-----------------
One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.

Official Title
-----------------
Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Zinc biofortified rice
* Other: Rice extrinsically fortified with zinc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of 18 to 45 years old Body Mass Index in the range of 19 to 25 No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study Exclusion Criteria: Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement) Long-term medication during the whole study (except for contraceptives) Pregnancy Lactation Intention to become pregnant during the course of the study Lack of safe contraception Consumption of mineral and vitamin supplements within 2 weeks prior to 1st - Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc biofortified rice<br> | Other: Zinc biofortified rice<br>* 1.12 mg zinc per meal<br>|
| Active Comparator: Rice extrinsically fortified with zinc<br> | Other: Rice extrinsically fortified with zinc<br>* 1.12 mg zinc per meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional absorption of zinc | Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry. | 33 days |
Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.

Detailed Description
-----------------
Lung transplant recipients are at high risk for lung rejection and lung infection after transplant. This is diagnosed by performing lung bronchoscopies and lung biopsies. These procedures carry an increased risk for complications and are costly. This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.

Official Title
-----------------
Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients

Conditions
-----------------
Post-Lung Transplantation Bronchiectasis

Intervention / Treatment
-----------------
* Diagnostic Test: Lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 yrs) who had undergone single/double/heart-lung transplant Asymptomatic Normal spirometry defined as a FEV1 without significant drop from baseline (significant drop = >10% decrease from baseline) Clear chest radiograph over allograft Exclusion Criteria: Patients who are unable to consent for the procedure Patients with subcutaneous emphysema or other technical challenges that could interfere with satisfactory image acquisition- as deemed by the operator.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: There is only 1 group of participants being monitored. Every patient will follow the same study procedures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving Ultrasound<br>Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops. | Diagnostic Test: Lung ultrasound<br>* The lung ultrasound will be performed by a trained pulmonologist by gently pressing a probe to various areas of your chest. This is a non-invasive procedure and you should not feel any pain. The ultrasound will take less than 10 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish predictive value of lung ultrasound | Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy | Month 0 to month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post lung transplant, Lung bronchoscopy, Lung biopsy, Lung rejection
Use of a Hypertension Tool to Manage Blood Pressure in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to develop, validate, and implement a tool to help manager hypertension in patients on hemodialysis.

Official Title
-----------------
Development, Validation, and Implementation of a Clinical Decision Tool for Blood Pressure Management in Patients on Hemodialysis

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Hypertension tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Receiving in-centre HD for at least 3 months Considered hypertensive based on a median intradialytic blood pressure ≥ 140/90 mmgHG Exclusion Criteria: Are unable to provide informed consent Are deemed medically unstable by the primary physician
Sexes Eligible for Study
-----------------
All

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation group<br>This group will have the hypertension tool implemented on them. | Other: Hypertension tool<br>* An algorithm developed by staff at UHN to help manage hypertension in hemodialysis patients.<br>|
| No Intervention: Control group<br>This group will not have the tool implemented. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 3 months |