linjc16/ctgov huggingface dataset:
A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones

Study Overview
=================
Brief Summary
-----------------
Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

Official Title
-----------------
A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Drug: Alfuzosin (Xatral)
* Drug: Placebo Alfuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan stone radiopaque on KUB, distal to the sacro-iliac joint patient suitable for discharge from ER patient willing to return for follow-up on a weekly basis for maximum 4 visits Exclusion Criteria: more than one ureteral calculi radiolucent stones or cystine stones prior ipsilateral calculus or ureteral surgery congenital anomalies of the ureter patients presents with an absolute indication for intervention allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP <90 mmHg) patient currently taking an alpha-blocker hepatic insufficiency pregnancy

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Alfuzosin (Xatral)<br>* 10 mg PO once a day<br>|
| Placebo Comparator: B<br> | Drug: Placebo Alfuzosin<br>* 10 mg PO once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be Cox proportional hazards survival analysis of stone passage over time |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates |  | 4 weeks |
Benefit of SeptiFast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis

Study Overview
=================
Brief Summary
-----------------
A SpetiFast multiplex PCR kit has recently been placed on the market witch can evidence the DNA of 90% of micro-organisms (bacteria and fungus) implicated in sepsis. However, the clinical impact of being able to detect the DNA of these various agents is unknown. We propose to assess the benefit to patient care of the SeptiFast multiples PCR by answering three questions : 1/in patients with septic immunosuppression, does this kit evidence etiologic agents not revealed by classical methods? 2/Does the use of PCR results permit different diagnostic hypotheses to be considered? 3/Does having the SeptiFast results entail changes to the therapeutic plan?

Detailed Description
-----------------
This study has double purpose : To compare the results obtained from the SeptiFast system with the results from classical microbiological sampling, in particular hemoculture, for immunosuppressed patients presenting sepsis. To perform a blind assessment of the benefit of septiFast care of these patients.

Official Title
-----------------
Benefit of Septifast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis

Conditions
-----------------
Hematologic Diseases, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with onco-hematologic or cancerous pathology, or hematologic disease with chemotherapy and/or radiotherapy and/or some other immunosuppressant treatment in progress presenting an infection requiring hospitalisation and meeting the following criteria: Sepsis (at least one of the following signs): Fever > 38.2°C or hypothermia < 36°C FO120 min PA<120 mmHg (or 50 mmHg reduction in base numbers) Respiratory F > 30/min Confusion Hyperleucocytosis (>12 G/l) or leucopenia (<4 G/l) C-Reactive protein > 40 With or without organ dysfunction as defined by : Hypoxia (PaO2/FiO2<300mmHg) Oliguria (urine deficiency<0.5 ml/kg/h in probed patient) Creatinine > 200umol/l INR>1.5 or TCA>2 X control in the absence of anticoagulant treatment Platelets < 100 G/l Bilirubin > 35 umol/l Lactatemia > 2 mmol/l Arterial hypotension (PAS<90mmHg, or PAM<70mmHg or reduction of more than 40 mmHG if known hypertension) Exclusion Criteria: Minor patient Pregnancy A patient cannot be included again within 15 days of his/her preceding inclusion
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
-----------------
sepsis, immunosuppressed, multiplex PCR, diagnosis, therapeutic
The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine if the colour of sweets (candy) effects taste.

Detailed Description
-----------------
The purpose of this trial is to increase children's awareness of randomised controlled trials and gain insights into the best way to conduct a fair comparison. Everyday children are faced with health claims, some reliable and some not so reliable. The purpose of the SMARTY trial is to help children critically assess and develop a critical eye when it comes to information they encounter every day, in particular when it comes to their health. The SMARTY trial is a pragmatic, two group, parallel, randomised trial.

Official Title
-----------------
The SMARTY Trial: Evaluating the Effects of Colour of Candy on Perceptions of Taste. A Randomised Trial

Conditions
-----------------
Education

Intervention / Treatment
-----------------
* Other: Smartie© sweet/candy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parental/guardian consent obtained Exclusion Criteria: unable or unwilling to ingest intervention. medical conditions which prohibit ingestion of intervention (ie allergy, intolerance etc)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Participants will be randomised to eat an orange coloured smartie© | Other: Smartie© sweet/candy<br>* one chocolate sweet/ chocolate candy<br>|
| Active Comparator: Control Group<br>Participants will be randomised to eat a pink coloured smartie © | Other: Smartie© sweet/candy<br>* one chocolate sweet/ chocolate candy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste | Participants will be asked to indicate on visual scale how much they like the taste of the smartie© they ate using the 'single-item sleep quality scale (SQS)' . The SQS is a self-administered visual analogue scale on which respondents rate the overall quality of sleep over a 7-day recall period on a likert type scaling option from 0 to 10, according to the following five categories: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent . | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Education, Randomised trial, Children, SMARTY
An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: MT-3995 Low
* Drug: MT-3995 Middle
* Drug: MT-3995 High


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent for participation before the completion of MT-3995-J05 Study Completion of MT-3995-J05 study Exclusion Criteria: UACR of ≥300 mg/g Cr with an increase of ≥30% in MT-3995-J05 Study Symptomatic and clinically significant hypotension QT prolongation or torsades de pointes New York Heart Association (NYHA) Class III or IV heart failure Patients who are judged to be unsuitable for participation based on their safety profile in MT-3995-J05 Study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-3995 Low<br> | Drug: MT-3995 Low<br> <br> |
| Experimental: MT-3995 Middle<br> | Drug: MT-3995 Middle<br> <br> |
| Experimental: MT-3995 High<br> | Drug: MT-3995 High<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | From baseline to 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Urine Albumin to Creatinine Ratio (UACR) |  | baseline and Week 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Nephropathy
NAG-excretion During Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.

Detailed Description
-----------------
The standard biomarker of AKI, serum creatinine, has poor specificity and sensitivity in the early phases of renal injury. Since the therapeutic window is likely to be in the earlier stages before renal injury is manifest, there is a need for novel diagnostic methods. In the recent years, several new biomarkers of kidney injury have been introduced. To date, none has proven outstanding regarding precision in early detection of AKI. NAG (N-acetyl-b-D-glucosaminidase) is a lysosomal enzyme with high molecular weight. Due to its size, NAG does not normally pass the glomerulus apparatus, but urine levels are elevated after tubulus damage. NAG excretion in urine is seen in AKI after cardiac surgery, exposure to nephrotoxic agents and after renal transplantation. However, its role in clinical decision-making is yet to be established. We aim to study the excretion pattern of urinary NAG during and after cardiac surgery with cardiopulmonary bypass. Association with perioperative variables will be explored.

Official Title
-----------------
Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Procedure: cardiopulmonary bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Expected cardiopulmonary bypass time exceeding 60 minutes Elective surgery Exclusion Criteria: End-stage kidney disease with dialysis Ongoing treatment with nephrotoxic antibiotic agent

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 |
| --- |
|Procedure: cardiopulmonary bypass|Routine use of cardiopulmonary bypass as needed during cardiac surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary NAG secretion | Secretion pattern of NAG | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of AKI (acute kidney injury) according to AKIN criteria | Development of AKI (acute kidney injury) according to AKIN criteria | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary bypass
Uptake and Biodistribution of 18F-fluorocholine in Histiocytic Disorders by PET Imaging and Biopsy Measurement

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to discover how 18F-cholineFCH distributes in the body, and see if it can distinguish active histiocytes (tumor) from inflammatory (non- tumor) cells. This tracer has the potential to give the investigators' team more information when trying to identify the tumor cells that are most important to collect with biopsy. In addition, the study will measure levels of 18F-cholineFCH in the biopsy tissue.

Official Title
-----------------
Pilot Study to Determine Uptake and Biodistribution of 18F-fluorocholine in Histiocytic Disorders by PET Imaging and Biopsy Measurement

Conditions
-----------------
Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Histiocytic Disorders

Intervention / Treatment
-----------------
* Radiation: F-choline PET Scan
* Device: FDG-PET
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Suspected but pathologically unconfirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder on the basis of clinical diagnosis, radiologic features, or findings from prior biopsies Or Confirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder and requiring additional diagnostic imaging and biopsy to determine mutational status in order to determine therapeutic options. Exclusion Criteria: Inability to undergo or cooperate with PET/CT scan (e.g., claustrophobia) Pregnant or nursing female

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 |
| --- | --- |
| PET Imaging<br>This study will enroll patients who have a clinical diagnosis of a systemic histiocytic disorder, and who are scheduled to undergo confirmatory biopsies of the systemic lesions, that were identified by standard imaging modalities. | Radiation: F-choline PET Scan<br> <br> Device: FDG-PET<br> <br> Procedure: biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients who successfully undergo paired biopsies | The overall histiocyte content will be described in each patient for each paired biopsy: there will be one biopsy that has high 18F-FCH F-choline uptake and one biopsy that has low 18F-FCH F-choline uptake. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
18F-fluorocholine, Pet imaging, Biopsy, 15-268
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia

Study Overview
=================
Brief Summary
-----------------
The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.

Official Title
-----------------
A Phase II Randomized Study to Verify the Papaldo's Hypothesis : the Effectiveness of a Reduced Dosing of G-CSF in Chemotherapy-treated Patients With a Low to Moderate Risk of Febrile Neutropenia

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: GCSF administration on days 8 and 12 after chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant Exclusion Criteria: Eligibility to receive reimbursed GCSF
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subcutaneous GCSF 5 µg/kg days 8 and 12<br>Prophylactic administration of GCSF on days 8 and 12 following chemotherapy | Drug: GCSF administration on days 8 and 12 after chemotherapy<br> <br> |
| No Intervention: No intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU) |  | At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for unplanned hospitalization | Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration | At the beginning of second chemotherapy cycle, no more than 30 days after randomization | 
| Complicated febrile neutropenic episode | A complicated febrile neutropenic episode is defined as a febrile neutropenic episode (see above) that does not resolve without the occurrence of serious medical complication as defined in Klasterky J et al; JCO 2000 : 3038-3051 | At the beginning of the second chemotherapy cycle, no more than 30 days after randomization | 
| Mortality any cause |  | 30 days from randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy, Breast cancer, Prophylaxis, GCSF
Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment

Study Overview
=================
Brief Summary
-----------------
To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.

Official Title
-----------------
Le20: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment

Conditions
-----------------
Lymphoma, Non-Hodgkin, Lymphomas: Non-Hodgkin, Lymphomas: Non-Hodgkin Cutaneous Lymphoma, Lymphomas: Non-Hodgkin Diffuse Large B-Cell, Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell, Lymphomas: Non-Hodgkin Mantle Cell, Lymphomas: Non-Hodgkin Marginal Zone, Lymphomas: Non-Hodgkin Peripheral T-Cell, Lymphomas: Non-Hodgkin Waldenstr Macroglobulinemia

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: Epratuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|
|Drug: Epratuzumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the molecular and cell biology of the tumor cells in lymphoma. |  | 6 months |