linjc16/ctgov huggingface dataset:
Urinary KIM-1 After Vancomycin or Linezolid Administration

Study Overview
=================
Brief Summary
-----------------
Acute renal injury is a common complication of critical illness. Drug induced renal insult compounds the degree of injury in many patients, and a great deal of research has focused on prevention of this complication. Traditional biomarkers of renal injury like serum creatinine and blood urea nitrogen content fail to consistently predict harm among patients at risk. Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.

Detailed Description
-----------------
see above

Official Title
-----------------
Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours. Eligible patients are already prescribed intravenous vancomycin or linezolid per their primary care providers as a standard of care and dosed in manner that is consistent with current institutional practices. Receipt of these antibiotics is not investigational. Exclusion Criteria: Exclusion criteria will include patients who have stage 3or greater Chronic Kidney Disease or who have acute kidney injury prior to the start of intravenous vancomycin therapy, patients that only receive one dose of IV vancomycin or linezolid in total, as well as patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2). Additionally, patients will be excluded if they are to receive more than 1 concurrent nephrotoxic medication within the prior 72 hours, have received intravenous contrast within 120 hours before randomization, exhibit baseline hematuria, or baseline proteinuria. A list of concurrent nephrotoxins that would exclude patients from the study is provided in Appendix C. Age Range: ≥18 years of age, if age > 90 will report as > 90 years

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 |
| --- | --- |
| Vancomycin<br>Vancomycin | |
| Linezolid<br>Linezolid | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary KIM-1 concentrations | Urinary KIM-1 concentrations will be compared between patients receiving vancomycin and linezolid | Urinary levels from day -1 to day +5, clinical outcomes and variables followed for duration of hospitalization |
Physiotherapy and Therapeutic Exercise Program in Graft-versus-host Disease (GvHD)

Study Overview
=================
Brief Summary
-----------------
Range of motion, antropometric measurements, quality of life questionnaire and 2 minutes walk test will be implemented as an initial assessment. Physical exercise program will take 2 sessions a week for six months, and several follow-ups: before, during and after treatment.

Official Title
-----------------
Effects of a Physical Therapy and Therapeutic Exercise Program in Graft-versus-host Disease (GVHD)

Conditions
-----------------
GVHD,Acute, GVHD, Chronic

Intervention / Treatment
-----------------
* Other: Physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allogenic Transplantation patients with Graft versus host disease Exclusion Criteria: Cognitive impairment Physical limitation from other pathologies
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Graft versus host disease Group<br> | Other: Physical exercise<br>* An adapted physical exercise protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF36 Questionnaire | Quality of life | baseline and post-intervention (24 weeks) | 
| 2 minutes walk test | walking for 2 minutes without rest | baseline and post-intervention (24 weeks) | 
| Hands strength | Dynamometer | baseline and post-intervention (24 weeks) | 
| Active range of motion | P-ROM. Active ROM will be compared with standard pictures (1-4 points for lower limb and 1-7 points for upper limb) | baseline and post-intervention (24 weeks) |
Study of the Laboratory-based Evaluation of the Degrees of Activity of Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint osteoarthritis.

Detailed Description
-----------------
Osteoarthritis (OA) is a chronic progressive disease, characterized by degradation of joint cartilage, synovial inflammation and joint dysfunction. This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint OA. Samples of synovial fluid (SF) from the patients with the OA (ICD-10 codes: M15, M16 and M17) will be assessed for T-cell subsets, msast cells, fibroblast-like synoviocytes (FLS) and macrophage-like synoviocytes (MLS) by flow cytometry. Subpopulations of blood T-cells involved in the inflammation will also be assayed. Standard clinical investigation will be performed and the results will be used to estimate the laboratory criteria or degrees of activity of medium and large joint OA.

Official Title
-----------------
Study of the Laboratory-based Evaluation of the Degrees of Activity of Medium and Large Joint Osteoarthritis

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medium and large joint active osteoarthritis Exclusion Criteria: refuse of patient to participate in the trial; acute infectious diseases; pregnancy/lactation; intercurrent severe chronic diseases; HIV, Hepatites B/C; active tuberculosis; alcohol use disorder/drug addiction; malignant neoplasms/leukemia.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with osteoarthritis<br>Patients with medium and large joint osteoarthritis | |
| Control group<br>Control group of healthy persons | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of osteoarthritis | The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of medium and large joint osteoarthritis | 2 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Flow cytometry, Synovial fluid
The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.

Study Overview
=================
Brief Summary
-----------------
Post-operative tissue oedema is one of the main causes of failure of hypospadias repair. Severe oedema may disrupt the suture line, invite infection and result in repair failure. Thus, we suggested that local injection of corticosteroids in just below coronal sulcus into dartos and buck's fascia may limit this oedema thus improving the outcome of hypospadias repair.

Detailed Description
-----------------
This is a prospective comparative trial : comparing the use of local steroids injection to reduce tissue edema after hypospadias and to preserve the final cosmesis after tissue repair. The patients will be divided into 2 groups(each group 20 patients): one group will be injected steroids just after hypospadias surgery while the other will not. The short and long term outcomes between both groups will be compared.

Official Title
-----------------
Prospective Comparative Trial to Assess the Role of Local Long Acting Steroid Injection After Hypospadias Surgery in Decreasing Complications and Preserving Better Cosmesis

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Drug: steroid betamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypospadias Patient Recurrent Cases 6 months or more Distal, and mid penile hypospadias Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: comparative prospective clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid injection<br>Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site. | Drug: steroid betamethasone<br>* The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Tissue edema |  | 3 days, 5 days, 10 days, 2 weeks | 
| Infection Rate |  | 3 days, 5 days, 10 days, 2 weeks | 
| Fistula rate |  | 2 weeks | 
| Final cosmesis | The shape of the glans penis and surrounding tissue | 3 days, 5 days, 10 days, 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypospadias, edema, failure, fistula, steroids
A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

Study Overview
=================
Brief Summary
-----------------
This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

Detailed Description
-----------------
Malignant hypertension is the most severe form of high blood pressure, fatal if left untreated. It has not disappeared, with an increasing incidence. Patients with the disease, mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of cardiovascular and renal events at 4 years). Despite these facts, scientific research on the subject remains limited. The definitions and diagnostic criteria have not changed since 1929, and the therapeutic recommendations remain empirical. This first prospective and multicentric registry will increase and modernize the knowledge of the disease. From these data, diagnostic and therapeutic recommendations based on solid scientific evidence could be developed. The investigators want to first recruit 500 patients and define their prognosis at 5 years. The impact of the patient's phenotype, type and number of target organs affected will be studied. A modern definition, adapted to these results, could be proposed. The epidemiology of the disease, the care pathways, the target organ disorders and the management carried out in the centers will be described in detail.

Official Title
-----------------
A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

Conditions
-----------------
Malignant Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant hypertension according to the classic definition (Severe hypertension, above 180/110 associated with severe hypertensive retinopathy) Severe hypertension (above 180/110) associated with acute damage of 3 target organ due to high blood pressure Exclusion Criteria: Age < 18 years old Patients who cannot freely give their consent, or patients who refuse to participate Dialysis

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 |
| --- | --- | --- |
| prognosis | 5-year prognosis for patients with malignant hypertension | 5 years |
Congenital Heart Defects and NIRS

Study Overview
=================
Brief Summary
-----------------
Congenital Heart Defects and NIRS

Detailed Description
-----------------
Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.

Official Title
-----------------
Tissue Oxygenation in Newborns With Congenital Heart Defects

Conditions
-----------------
Heart Defects, Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography. Exclusion Criteria: The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 4 Weeks

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 |
| --- | --- |
| CHD<br>Newborns with structural congenital heart defects. The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD. | |
| Healthy controls<br>The control group comprised of healthy matched newborns without a diagnosed CHD. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rSO2 | regional tissue oxygenation assessed by NIRS | RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
congenital heart defects, near-infrared spectroscopy, newborn, tissue oxygenation
Evaluation Study: Obsessive-compulsive Disorders in Childhood and Young Adulthood

Study Overview
=================
Brief Summary
-----------------
Obsessive-compulsive disorders are very damaging illnesses that can already manifest in childhood and adolescence. With an average prevalence from 1 - 3%, they are one of the most frequently diagnosed psychiatric illness in these age groups. With the further use of data, the treatment success can be significantly improved; causal variables/predictors can be recognized, understood and taken carefully into account. The anticipated incremental knowledge will ultimately help children and young people with obsessive-compulsive disorders to receive faster and more effective treatment.

Official Title
-----------------
Evaluation Study: Obsessive-compulsive Disorders in Childhood and Young Adulthood

Conditions
-----------------
Obsessive-compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and young people from 8-18 years of age who fulfill the international classification of diseases tenth edition (ICD-10) , obsessive-compulsive disorder handled in our clinic. Good German language speaking skills IQ > 75 All study participants or their legal representative have given written permission for their experiences to be documented in the study. Exclusion Criteria: Schizophrenia-related disorders (psychoses) Missing data Data sets without confirmed diagnosis Purely consultaive patient interview (no therapy intervention prescribed)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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 |
| --- | --- | --- |
| Symptoms severity of obsessive and compulsive symptoms in children and adolescents | The clinician report questionnaire (BY-BOCS) contains 19 items designed to assess severity of obsessive and compulsive symptoms in children and adolescents.The test uses a four point scale to rate the severity of their obsessive compulsive behaviors. Higher score means a worse outcome. | 24 months |
Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: SK-0403


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment-naive subjects diagnosed with type 2 diabetes mellitus Stable diet program for at least 8 weeks Criteria for HbA1c are met Exclusion Criteria: Type 1 diabetes Patients treated with other antidiabetic drugs or Insulin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SK-0403|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Death Following Congenital Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate the patterns of death following congenital heart surgery.

Detailed Description
-----------------
With the improvements in instrumentation, surgical technique, and critical care, the overall mortality following congenital heart surgery has become extremely low. Also, with the introduction of extracorporeal support (ECMO), especially in the emergency setting, acute deaths are extremely rare. The majority of post-operative deaths seem to be the result of a prolonged hospitalization with a progressive decline to multi-system organ failure. The primary aim of the study is to elucidate the patterns of death following congenital heart surgery. The secondary aims of the study are to discover patterns and consistencies among the deaths and to discover points of potential intervention to reduce surgical mortality. The study will be conducted through a retrospective chart review of approximately 40 patients.

Official Title
-----------------
Death Following Congenital Heart Surgery

Conditions
-----------------
Congenital Heart Surgery, Congenital Heart Defects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the congenital surgery database Post-operative surgical mortality Deaths within 30 days of surgery Deaths prior to ever leaving the hospital
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Death after heart surgery, surgical mortality, post-operative mortality, pediatric health, cardiac
Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

Study Overview
=================
Brief Summary
-----------------
To investigate the changes in MRI-derived markers of joint inflammation and destruction and in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid arthritis patients treated with Enbrel and Enbrel+methotrexate.

Official Title
-----------------
A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

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

Intervention / Treatment
-----------------
* Drug: Methotrexate plus ENBREL or ENBREL alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In the case of contra-indications for MRI, the patient may participate in the remaining part of the project. Exclusion Criteria: N/A

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

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

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: Methotrexate plus ENBREL or ENBREL alone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy and safety of substituting ENBREL versus adding ENBREL to Methotrexate in patients with active Rheumatoid Arthritis despite adequate Methotrexate therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of combination therapy with ENBREL plus Methotrexate versus ENBREL alone on health-related quality of life measures. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis