linjc16/ctgov huggingface dataset:
Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX

Official Title
-----------------
Multicentre, Randomised, Open Label Study Comparing a Scheduled Steroid Reduction Strategy Versus a Free Steroid Reduction Strategy (Physician's Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months

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

Intervention / Treatment
-----------------
* Drug: adalimumab (up to 9 months exposure)
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria Exclusion Criteria: Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast-feeding or considering becoming pregnant

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adalimumab (up to 9 months exposure)|nan|
|Drug: methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corticoid reduction and DAS 28 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes |  |  | 
| Clinical response indicators |  |  | 
| Safety parameters |  |  |
Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography

Study Overview
=================
Brief Summary
-----------------
RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Having an 2D-STE interchangeable parameter would allow accurate measurement of RV systolic function before, during and after cardiac surgery. However, to date, there are no data on the interchangeability of RV-LSF measurements performed in TTE and TEE. The aim of the study is to evaluate the interchangeability of TTE and TEE measurements of RV-LSF during cardiopulmonary bypass surgery.

Official Title
-----------------
Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room

Conditions
-----------------
Strains, Right Ventricle, Speckle Tracking, Cardiac Surgery

Intervention / Treatment
-----------------
* Other: transthoracic echocardiography (TTE)
* Other: transoesophageal echocardiography (TEE).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (>18 years) Patient hospitalized at the Amiens University Hospital for scheduled cardiac surgery under cardiopulmonary bypass. Information of the patient and collection of his non-opposition Exclusion Criteria: Patient with a contraindication to the realization of TEE (gastric or mediastinal pathology) Patient with poor echogenicity on TEE not allowing evaluation of 2D-STE parameters of the right ventricle Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE and/or TEE.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: transthoracic echocardiography (TTE)|In order to evaluate the interchangeability of RV-LSF, a TTE will be performed just after the placement of general anesthesia, when the patient is under mechanical ventilation|
|Other: transoesophageal echocardiography (TEE).|During cardiopulmonary bypass surgery patients is monitored by a TEE as recommended.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the RV-LSF (in %) between TTE and TEE | RV-LSF is : Right ventricular longitudinal shortening fraction. RV-LSF is an angle-independent and automatically calculated speckle-tracking parameter and reproducible parameter. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Right ventricle, speckle tracking, Strains, cardiac surgery
Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis

Study Overview
=================
Brief Summary
-----------------
Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial emotional impact on an individual, which is not necessarily related to the extent of skin disease. FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that chronic disease such as end stage renal disease with depressive symptoms have decreased cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms in patients with psoriasis.

Detailed Description
-----------------
10 Patients with psoriasis Evaluate PASI score Evaluate comorbidity with metabolic syndrome Body mass index(BMI) Checking blood pressure Checking blood sugar Smoking and drinking history Checking blood cholesterol level Risk factors of cardiovascular disease PET/CT for measuring the extent and site of psoriasis with inflammation

Official Title
-----------------
Phase 0 Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis

Conditions
-----------------
Psoriasis, Metabolic Syndrome, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of plaque type psoriasis at least 18 years old Exclusion Criteria: those who cannot understand questionnaire those who take antidepressant

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck depression inventory scoring and Korean Hamilton depression scale scoring |  | Day 0 and 28 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain glucose uptake using PET/CT |  | Day 0 and 28 weeks later |
Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low. This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome. This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.

Official Title
-----------------
Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy

Conditions
-----------------
Stage III Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Dose escalated, accelerated, hypofractionated radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion. Exclusion Criteria: Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus Greater than minimal, exudative, or cytologically positive pleural effusions ≥ 10% weight loss within the past month Prior invasive malignancy (with exceptions) Prior radiotherapy to the region of the study cancer Significant co-morbidities Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception Known allergic reactions to components of planned chemotherapy regimen

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Dose escalated, accelerated, hypofractionated radiotherapy|Intensity modulated radiotherapy with concurrent chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, locoregional control, disease free survival, toxicity |  | 2 years |
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)

Study Overview
=================
Brief Summary
-----------------
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.

Official Title
-----------------
Retrospective Study on Intrapatient VAriabiLity of the Hemoglobin Levels in Anemic CKD Patients in Predialysis (Stage 3-4) and Dialysis (Stage 5) Treated With MIRCERA® (RIVAL Study)

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Chronic kidney disease in predialysis (stage 3 and 4) and dialysis Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent Exclusion Criteria: Participation in an interventional clinical trial within the retrospective observation period Contraindications to Mircera administration as per label or judged by the investigator

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Hemoglobin Cycling | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Full Hemoglobin Cycles Per Participant | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks. | 9 months | 
| Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks. | 9 months |
Hepatic Histopathology in Urea Cycle Disorders

Study Overview
=================
Brief Summary
-----------------
This is a multi-site, retrospective chart review as well as a prospective study to evaluate histopathologic findings in liver samples from individuals with any UCD diagnosis. This study will be conducted at all Urea Cycle Disorders Consortium (UCDC) sites: Baylor College of Medicine in Houston, TX and Children's National Medical Center in Washington D.C.

Detailed Description
-----------------
Urea cycle disorders (UCDs) are among the most common inborn errors of liver metabolism. With early diagnosis and improved treatments, the survival of individuals with UCDs has improved, and this improved survival has led to unmasking of some long-term complications such as hepatic dysfunction and progressive fibrosis in a subset of patients. Hepatic complications in UCDs are quite variable and dependent upon the specific metabolic defect.

Official Title
-----------------
Hepatic Histopathology in Urea Cycle Disorders

Conditions
-----------------
Urea Cycle Disorder, Ornithine Transcarbamylase Deficiency, Citrullinemia 1, ARGI Deficiency, ASL Deficiency, Argininosuccinic Aciduria, ASS Deficiency, Hyperargininemia, Carbamyl Phosphate Synthetase Deficiency, NAGS Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary urea cycle disorder based on clinical suspicion confirmed by enzyme activity, DNA testing or metabolite analysis. History of liver transplantation and/or liver biopsy OR Planned liver transplantation and/or liver biopsy Exclusion Criteria: Unavailability of histopathology report from the liver biopsy or explant, or unavailability of liver tissue or slides from the biopsy or explant OR Anticipated inability to obtain pathology report, liver disease, tissue blocks, or pathology slides after liver biopsy or transplantation Known history of a secondary cause for liver disease such as chronic viral hepatitis, autoimmune liver disease, short gut, small bowel syndrome, alcohol liver disease, or TPN-related cholestatic disease
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 |
| --- | --- | --- |
| Hepatic fibrosis | Staging of fibrosis from histopathology report from the liver biopsy or explant | Day 1 | 
| Steatosis | Grade of steatosis from histopathology report from the liver biopsy or explant | Day 1 | 
| Hepatic glycogenosis | Presence and type of glycogenosis from histopathology report from the liver biopsy or explant | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplant, Liver disease, Liver biopsy, Histopathology
Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill

Study Overview
=================
Brief Summary
-----------------
In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome. Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.

Official Title
-----------------
Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Other: additional blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill patients requiring ICU admission for at least 48 hours Adults Exclusion Criteria: Chronic small bowel disease Chronic renal failure (clearance of creatinine < 50 mL/min) Pregnancy

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: additional blood sample|Two blood samples will be taken at ICU admission|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma citrulline concentration | biological assay | Up to 12 hours after admission in the unit | 
| plasma lipopolysaccharide concentration | biological assay | Up to 12 hours after admission in the unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plasma citrulline, lipopolysaccharide, critically ill, Hospitalization in an Intensive Care Unit
The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.

Official Title
-----------------
An 8 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Adding Montelukast Sodium 10 mg Per Day to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: montelukast sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Is 18 Years Old Note 1: Regulatory Requirements Necessitate The Following Criterion. It May Not Be Appropriate For Your Patients. Female Patients Of Childbearing Potential Should Be Informed Not To Become Pregnant During The Study By Using The Appropriate Contraceptive Methods (Oral Or Long-Acting Contraceptive Injections (Depo Provera), Intrauterine Device (Iud), Or Barrier Methods (E.G. Condom Or Diaphragm Plus Spermicide) Or To Be Abstinent (No Sexual Intercourse)) Beginning At Least 7 Days Before Visit 1 And Continuing At Least 14 Days After Visit 4 Or A Discontinuation Visit Note 2: For Alberta: Investigators Who Will Recruit In Private Office, No Patients Can Be Recruited In The Study Until Approval From The College Of Physicians And Surgeons Of Alberta Ethics Committee Is Obtained Exclusion Criteria: Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Montelukast | Drug: montelukast sodium<br>* Montelukast Tablet, 10 mg, 8 weeks, daily<br>* Other names: Singulair;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the percentage of patients with asthma who will be controlled after 8 weeks of treatment with montelukast used in combination with inhaled corticosteroids |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of montelukast |  | 8 weeks |
Proton Radiation Therapy for Pituitary Adenoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on pituitary tumors and analyze possible side effects.

Detailed Description
-----------------
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Official Title
-----------------
Clinical Outcomes Study of Proton Radiation Therapy for Pituitary Adenoma

Conditions
-----------------
Pituitary Adenoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven pituitary adenoma. Age 18 years or older. Status post biopsy, gross total resection (from initial surgery for recurrent disease) or subtotal resection. Good to moderate neurological function status Exclusion Criteria: *Previous radiation that would compromise the ability to deliver the prescribed treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Proton Radiation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze outcome data on tumor control. |  | When each patient has been followed for a minimum or 12 months and then again after 24 months to a maximum of 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze outcome data on normal tissue morbidity. |  | When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pituitary tumor, Outcomes, Proton radiation