linjc16/ctgov huggingface dataset:
Evaluation of HEMO2Life® for Kidney Graft Preservation (OXYOP): 4 Years Follow-up

Study Overview
=================
Brief Summary
-----------------
4 years follow-up of the oxyop study.

Detailed Description
-----------------
Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). We also analyzed some efficacy secondary end points using a paired analysis (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop4 aims to analyse 4 years results.

Official Title
-----------------
Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up

Conditions
-----------------
Transplant; Complication, Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed patients participating to the oxyop study Exclusion Criteria: patients refusing to participate

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 |
| --- | --- |
| interventional group<br>kidney graft preserved with M101 | |
| control group<br>kident graft preserved in standard condition (without M101) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR | estimated GFR (CKDEPI) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient survival | patient survival at last follow-up | 4 years | 
| graft survival | graft survival at last follow-up | 4 years | 
| rejection rate | biopsy proven rejection | 4 years | 
| infection rate | all infection episodes | 4 years | 
| hospitalization | number of hospitalization, hospital stay | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal transplantation, organ preservation, oxygen carrier
Impact of Moderate Alcohol Use on Hepatitis C Virus (HCV) Progression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of moderate alcohol intake on liver disease caused by HCV in terms of speed of progression as compared to those not drinking alcohol.

Official Title
-----------------
The Use of Validated Measures of Alcohol Intake to Measure the Impact of Moderate Alcohol Consumption on Hepatic Fibrogenesis in Individuals Infected With Hepatitis C

Conditions
-----------------
Hepatic Fibrogenesis, Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient with HCV who is not receiving or planning treatment but is receiving standard of care monitoring every 3 months and is either abstinent from alcohol or drinking only moderately Exclusion Criteria: HIV co-infection Treated within the past 6 months History (hx) of other liver disease Alcohol use greater than 30 g/day or history of binge drinking in the last year Decompensated liver disease

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 |
| --- | --- |
| Case<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison Between Symbicort® and Prednisolone in COPD

Study Overview
=================
Brief Summary
-----------------
To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

Official Title
-----------------
A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exacerbation, Followed by Twelve Weeks Open Follow up Period With Budesonide/Formoterol (Symbicort Forte Turbuhaler)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol
* Drug: Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic obstructive pulmonary disease and an acute exacerbation After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value. Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease Exclusion Criteria: Diagnosis/history of asthma Oxygen uptake (saturation) is <92% after the initial acute treatment A requirement for regular use of oxygen therapy Regular treatment with any inhaled steroid >1 000 µg/day at study entry Additional inclusion and exclusion criteria will be evaluated by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Drug: budesonide/formoterol|nan|
|Drug: Prednisolone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in one second (FEV1) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment failures |  |  | 
| Time to first exacerbation |  |  | 
| Number of patients developing an exacerbation |  |  | 
| Diary cards |  |  | 
| Quality of Life |  |  | 
| - Adverse Events (AEs) |  |  | 
| Serious Adverse Events (SAEs) and Discontinuations due to AEs |  |  | 
| Variables will be assessed before and over the 2+12 weeks treatment period |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T

Study Overview
=================
Brief Summary
-----------------
Radiation in combination with Provenge based immunotherapy may improve outcomes seen on imaging as well as immunologic monitoring. This study will assess the effect of radiation therapy to augment anti-tumor responses from immune therapy with Provenge.

Detailed Description
-----------------
It is common knowledge that the host can make anti-tumor immune responses, although often these are ineffective in causing tumor regression. Boosting these responses with immunotherapy is therefore an attractive, relatively benign adjunctive cancer treatment. Little is known in regards to how standard anti-cancer therapies like radiation therapy might interact with immunotherapy in a clinical setting. We are interested in knowing if the tumor cell death occasioned by radiation therapy might augment anti-tumor responses from the immune therapy, Provenge. The tentative assumption is that cell death following radiation therapy will stimulate anti-tumor immunity, which could provide a more permanent solution to curing cancer and discouraging tumors from spreading throughout the body. In order to find out if this assumption is correct, for patients undergoing radiation 28 days prior to Provenge, highly developed, laboratory analyses for tumor-specific immunity and imaging will be performed.

Official Title
-----------------
A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T

Conditions
-----------------
Castrate Refractory Metastatic Prostate Cancer (mCRPC)

Intervention / Treatment
-----------------
* Drug: Provenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be recruited from the population of patients who are castrate refractory metastatic prostate cancer (mCRPC) and have made the decision to be treated with radiation therapy to one or more metastatic sites of concern followed at least 28 days later by Provenge. Exclusion Criteria: The potential subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent Form.

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

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immune stimulation | The percentage of subjects who exhibit a two-fold increase in peripheral immune response at any post-treatment time point (6, 10, 14, 26, 39 and 52 weeks after the first infusion of sipuleucel-T) utilizing IFNγ ELISPOT response to PA2024. | At 52 Weeks post first injection of sipuleucel-T |
Blood Pressure Monitor Clinical Test (Cuff Range: 22 Cm-42cm)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 22 cm-42 cm.

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cuff circumference: 22cm-42cm

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 84 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 |
| --- | --- |
| blood pressure monitor<br>Cuff circumference:22cm-42cm | |
| stethoscopy<br>Cuff circumference: 22cm-42cm | |

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
-----------------
BP
Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?

Study Overview
=================
Brief Summary
-----------------
Blood vitamin D levels may be associated with COVID-19 disease severity, we aimed to find out whether blood 25-hydroxy vitamin D (25(OH)D) levels were correlated with COVID-19 disease severity or noy.

Detailed Description
-----------------
Purpose: Vitamin D a steroid hormone has profound effects on human immunity. Active vitamin D, 1,25(OH)2D acts as an immune system modulator, preventing excessive expression of inflammatory cytokines and increasing the 'oxidative burst' potential of macrophages. Epidemiological data has linked vitamin D deficiency to increased susceptibility to acute viral respiratory infections. There is evidence that some patients with severe COVID-19 experience a cytokine storm with production of large quantities of interleukins, specifically IL-1 and IL-6. Moreover it was hipotiesied that the sufficient vitamin D levels may help to decrease IL-6 levels like tocizulamab which is a potent blocking agent of the IL-6 receptor. In present trial we aimed to find out is there a relation between the disease and vitamin D levels in COVİD-19 patients. Material and Methods: To find out vitamin D levels and it's relation with the disease severity serum 25-hydroxy-vitamin D levels will be measured in nearly 100 confirmed COVİD-19 patients. Same patients will also be evaluated for vital signs, laboratory and pulmoner CT findings. Demographic and medical data will also be collected. Statically significant positive or negative results and the comparison of these findings will be presented. We think that revealing the vitamin- D levels and it's possible relation with disease severity may inspire new perspectives for future trials and treatments that spesifically focused on the novel corona virus disease.

Official Title
-----------------
Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin d


Participation Criteria
=================
Eligibility Criteria
-----------------
To find out vitamin D levels and it's relation with the disease severity serum 25-hydroxy-vitamin D levels will be measured in nearly 100 confirmed COVİD-19 patients. İntensive care unit patients will be exluded
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: vitamin d|vitamin D levels|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory measured vitamin D levels | serum 25-hydroxy-vitamin D levels | 45 day |
Smart-CKD/BP Study

Study Overview
=================
Brief Summary
-----------------
Through remote management and propaganda of intelligent mobile phone, the standard rate of blood pressure control and the change of renal function were observed.

Official Title
-----------------
Through Remote Management and Propaganda of Intelligent Mobile Phone, the Standard Rate of Blood Pressure Control and the Change of Renal Function Were Observed

Conditions
-----------------
CKD

Intervention / Treatment
-----------------
* Behavioral: WeChat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis in line with the 2012 international kidney disease: improving global outcomes (kidney disease improving global out-comes, KDIGO) of chronic kidney disease diagnosis standard of hypertension diagnosis, China Hypertension Prevention Guide 2010 diagnostic criteria; and will have the use of intelligent mobile phone, and a network connection; at the age of 18-70. Exclusion Criteria: GFR<15 ml/min or start replacement therapy; do not understand Chinese, do not understand Chinese; malignant tumor patients; have mental illness; there is consciousness disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Management Group<br> | Behavioral: WeChat<br>* Through remote management and propaganda of intelligent mobile phone, the standard rate of blood pressure control and the change of renal function were observed.<br>|
| Other: control group<br> | Behavioral: WeChat<br>* Through remote management and propaganda of intelligent mobile phone, the standard rate of blood pressure control and the change of renal function were observed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control rate of blood pressure control | Average blood pressure of each patient ,thenStatistics of the number of blood pressure control standards . | 1 year | 
| Drug compliance | Take medications according to the doctor's advice | 1 year |
Placenta Accreta Index Score in Placenta Accreta Spectrum

Study Overview
=================
Brief Summary
-----------------
role of placenta accreta index score in prediction of conservative surgery for placenta placenta accreta spectrum

Detailed Description
-----------------
in this study ,we will recruit 60 cases diagnosed placenta previa accreta by 2D ultrasound and Doppler then patients will have 3D Doppler to calculate placenta accreta index score according to agarawl et al criteria , patients will have cs accroding to our hospital protocol Al demerdash maternity hospital ,Ainshams university .Intraoperative findings will be noticed ,postoperative histopathological examination may br needed in cases of cs hystrectomy ,placenta accreta index score will be compared to intra and postoperative findings , patients will be followed up for two weeks after delivery for any postoperative complication

Official Title
-----------------
Role of Placenta Accreta Index in Predicting Conservative Surgery for Placenta Accreta Spectrum

Conditions
-----------------
Placenta Accreta, Third Trimester

Intervention / Treatment
-----------------
* Diagnostic Test: placenta accreta index score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Pregnant women above 28 weeks gestation by 1st trimesteric U/S,2nd trimesteric U/S or sure reliable dates; diagnosed as placenta previa by 2D ultrasound, Doppler on placental bed. Patients who have done one or more cesarean sections Exclusion Criteria: Patients who refuse to participate in our study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: placenta accreta index score|role of placenta accreta index score in prediction of conservative surgery for placenta placenta accreta spectrum|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of PAS index score in prediction of conservative surgery |  | 2022 to 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss |  | at delivery |
Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .

Official Title
-----------------
A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: CC-5013


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration. Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline. More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion. Women must not be pregnant or lactating No use of another experimental study drug within 30 dy\ays of baseline Understand and sign written informed consent Able to adhere to study visit schedule, understand and comply with other protocol requirements.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CC-5013|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Revimid, CC5013, CC-5013
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

Study Overview
=================
Brief Summary
-----------------
STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.

Conditions
-----------------
Growth Hormone Insensitivity Syndrome (GHIS), Laron Syndrome

Intervention / Treatment
-----------------
* Drug: rhIGF-I/rhIGFBP-3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of GHIS such as Laron syndrome, 2 - 18 years of age, Height less than or equal to -3SD for age, Pre-pubertal, defined as Tanner breast stage 1 or testis volume <4mL Exclusion Criteria: Children in puberty, Diagnosed malignancy, A diagnosis of diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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: rhIGF-I/rhIGFBP-3|nan|

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

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