linjc16/ctgov huggingface dataset:
Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes. Two postoperative transfusion strategies: Liberal - transfused when Hgb is <100g/L Restrictive - transfused when Hgb is <70g/L

Official Title
-----------------
Evaluation of a Liberal Versus Restrictive Blood Transfusion Strategy in Elderly Patients Following Coronary Bypass or Aortic Valve Surgery

Conditions
-----------------
Anemia, Coronary Artery Bypass Surgery

Intervention / Treatment
-----------------
* Procedure: Blood Transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >=70 years of age undergoing non-emergency coronary artery bypass surgery Initial postoperative hemoglobin level 70-90g/L Exclusion Criteria: Patients who are unable to provide informed consent in English Patients with preoperative hemoglobin concentrations <100g/L Patients who require emergency re-operation Patients with intraoperative or postoperative bleeding diathesis Patients with postoperative clinical instability (eg. low output state) Patients in whom insertion of an intra-aortic balloon pump is required

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberal Red cell transfusion arm<br>Transfusion if Hgb <100g/L | Procedure: Blood Transfusion<br>* Blood transfusion will be administered when the transfusion trigger is met.<br>|
| Active Comparator: Restrictive Red Cell transfusion<br>Transfusion if Hgb <70g/L | Procedure: Blood Transfusion<br>* Blood transfusion will be administered when the transfusion trigger is met.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance walked during 6 minute walk test at 5 weeks postop |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal failure, hospital length of stay, Quality of Life questionnaire |  | during hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative care, Cardiac Surgery, Blood Transfusion
Evaluation of New Histoprognostic Criteria in a Retrospective Study of Colon Cancers Operated at Amiens University Hospital

Study Overview
=================
Brief Summary
-----------------
Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the pathological results. Histoprognostic new factors have recently been published by several authors, but their validity is still debated.

Official Title
-----------------
Evaluation of New Histoprognostic Criteria in a Retrospective Study of Colon Cancers Operated at Amiens University Hospital

Conditions
-----------------
Colonic Neoplasms

Intervention / Treatment
-----------------
* Drug: Orcein staining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients operated on for colon adenocarcinoma between 2004 and 2009 at the University Hospital of Amiens Exclusion Criteria: Non-operated patients Patients operated on before 2004 or after 2009 Patients operated in another center The other histological types Vicinity of tumors invading the colon by contiguity Colic metastasis Patients whose blocks or blades were not found in the archives.

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 |
| --- |
|Drug: Orcein staining|Prognostic value of venous emboli detected by orcein staining|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 1 year |
Phase II Study of Calcitonin for Tumoral Calcinosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks. Ondansetron premedication and intravenous hydration are also administered. Patients are followed for disease progression and tumor recurrence.

Conditions
-----------------
Calcinosis

Intervention / Treatment
-----------------
* Drug: calcitonin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: calcitonin|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
-----------------
arthritis & connective tissue diseases, rare disease, tumoral calcinosis
Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital

Study Overview
=================
Brief Summary
-----------------
One centre follow-up study on safety and efficacy of treatment with rituximab among patients with RA during 4 year period. Basic data is collected for the national register of biologicals.

Detailed Description
-----------------
Data is collected on regular visits in the outpatient department. In collection national register forms have been used.

Official Title
-----------------
One Centre Follow-up Study on Safety and Efficacy

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

Intervention / Treatment
-----------------
* Drug: rituximab
* Drug: rituximab, observational study amon patients with active RA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active RA without response to earlier treatment Exclusion Criteria: contraindications to rituximab

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 |
| --- | --- |
| patients with active RA<br>drug, follow-up | Drug: rituximab<br>* rituximab two 1000 mg intravenous infusions separated by two weeks<br>Drug: rituximab, observational study amon patients with active RA<br>* two 1000 mg intravenous infusions separated by 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 ACR50 ACR70 response |  | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of clinical response |  | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, rituximab, therapy
Fluconazole Pharmacokinetics in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and evaluate the dose exposure relationship of current fluconazole dosing in infants who are receiving fluconazole for the prevention or treatment of systemic fungal infections.

Detailed Description
-----------------
Systemic fungal infections in neonates are associated with high morbidity and mortality. The increasing use of intravenous central catheters, parenteral nutrition, and antibiotics in neonatal intensive care units has contributed not only to improved survival but also to the increasing incidence of fungal sepsis particularly in preterm infants. Decreasing fungal colonization can decrease the risk of systemic fungal infection. Fluconazole is a potent antifungal agent in the triazole family. Fluconazole has been shown to reduce the risk of fungal colonization and systemic infection however we do not have sufficient pharmacokinetic information in neonates to support dosing guidelines. In this study, we will perform a population pharmacokinetic study in neonates receiving fluconazole as standard of care. Fluconazole levels will be measured using a liquid chromatography/tandem mass spectroscopy (LC/MS/MS) assay from very small quantities of blood appropriate for neonates. Pharmacokinetic data obtained in this study will support appropriate dosing of fluconazole in neonates and provide information regarding drug metabolism in neonates.

Official Title
-----------------
A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants

Conditions
-----------------
Fungal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant born >23 weeks gestational age with postnatal age <120 days Due to receive fluconazole therapy for clinical care Permission from attending neonatologist Informed consent of parent or legal guardian

Ages Eligible for Study
-----------------
Maximum Age: 119 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| gestational age<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop a population PK model of fluconazole drug disposition in premature infants who are receiving fluconazole for treatment or prophylaxis against systemic fungal infections. | PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fungal, Infection, sepsis, pharmacokinetics
Safety and Efficacy of APD356 in the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity. The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.

Detailed Description
-----------------
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Official Title
-----------------
A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: APD356


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive) Body Mass Index (BMI) of 30-45 Kg/m^2. Non-smoker No concomitant medications No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: APD356|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Changes in waist circumference, hip circumference and waist/hip ratio |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Loss, Serotonin, 5-HT2c, Satiety, Obesity, Appetite suppressant, Overweight
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.

Official Title
-----------------
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison

Conditions
-----------------
Lyme Neuroborreliosis

Intervention / Treatment
-----------------
* Drug: Ceftriaxone
* Drug: Doxycycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled: Intrathecal production of borrelia antibodies; White cell count in cerebrospinal fluid (CSF) > 5/mm3; Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval; Verified acrodermatitis chronica atrophicans. Exclusion Criteria: Allergy to the contents in the medication, or earlier type I reaction to penicillin. Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days Pregnancy or breastfeeding Age < 18 years

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Doxycycline | Drug: Doxycycline<br> <br> |
| Active Comparator: 2<br>cephtriaxone | Drug: Ceftriaxone<br> <br> |

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
-----------------
Neuroborreliosis
Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.

Official Title
-----------------
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Conditions
-----------------
Seizures, Epilepsy

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on the physical examination, medical history, or clinical labratory results duirng screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxcarbazepne or any other comparable or similar product.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, 7 day washout |
Simplification From Protease Inhibitors to Raltegravir

Study Overview
=================
Brief Summary
-----------------
A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).

Official Title
-----------------
Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Raltegravir (Use RAL as a simplification strategy)
* Drug: Raltegravir (Use RAL as a simplification strategy)
* Drug: Raltegravir (Use RAL as a simplification strategy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV1 sero-positive using standard diagnostic criteria Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry Exclusion Criteria: Pregnancy or breast feeding Prior use of Integrase inhibitors Alcohol or substance abuse if according to the investigator opinion would interfere with compliance UIse of investigational medications within 30 days before study entry or during the trial

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAL QD 800 mg/24 hs<br> | Drug: Raltegravir (Use RAL as a simplification strategy)<br>* RAL QD: RAL 800 mg/24 hs<br>|
| Active Comparator: RAL BID 400 mg/12 hs<br> | Drug: Raltegravir (Use RAL as a simplification strategy)<br>* RAL BID 400 mg/12 hs<br>|
| Experimental: RAL BID to QD<br> | Drug: Raltegravir (Use RAL as a simplification strategy)<br>* RAL BID to QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 gains, lipid profile, adverse events, |  | 24 weeks | 
| Drug resistance mutations |  | 24 weeks | 
| Raltegravir through plasma levels and correlation with virological failure |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Simplification from protease inhibitors to raltegravir, Treatment Experienced, HIV-1 Infections