linjc16/ctgov huggingface dataset:
Relationship Between EBV and PTLD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD.

Detailed Description
-----------------
The relationship between Epstein-Barr virus and lymphoproliferative disease has been established, particularly in the immuno-suppressed patient. Over the past several years a quantitative EBV PCR lab test has been established. Unfortunately, the significance of an elevated test remains unclear. The relationship of a particular EBV PCR value and the risk of developing PTLD is unknown. The primary aims will be to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD. The study will be conducted through a retrospective chart review of approximately 160 patients and we will look at postoperative data including Quantitative EBV PCR results, the presence / absence of PTLD and the treatment of PTLD and results of EBV PCR with treatment.

Official Title
-----------------
Relationship Between Quantitative Epstein-Bar Viral(EBV) Titres and Post-Transplant Lymphoproliferative Disease

Conditions
-----------------
Pediatric Heart Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergone pediatric heart transplant followed by pediatric heart transplant program Exclusion Criteria: -
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
-----------------
Epstein-Barr virus, pediatric health, cardiac, heart transplant, lymphoproliferative disease, post-transplant, pediatric transplant
High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
It has been reported that Baclofen is an appropriate tool in the therapeutic management of Gastroesophageal Reflux Disease. To objectify gastroesophageal reflux combined pH-metry/impedance monitoring was applied to patients with persistent reflux-associated symptoms despite PPI-therapy (40mg esomeprazole for 2 weeks). After provement of pathological findings in the test PPI-dosage was escalated to double standard-dosage for another for weeks. In case of persistent symptoms another ph-metry/impedance monitoring was performed. In case of pathological findings additional baclofen was administered to the therapeutic regime. After 3 months another ph-metry/impedance monitoring was performed. At the time point of the tests a questionnaire was completed. Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional baclofen in patients with persistent symptoms and objectified gastroesophageal reflux.

Conditions
-----------------
Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18-70 years informed consent patients with persistent reflux-associated symptoms despite PPI-therapy Exclusion Criteria: epilepsy synthetic liver diseases renal failure disability to understand informed consent

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?
-----------------
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
-----------------
gastroesophageal reflux disease, baclofen, impedance
Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)

Study Overview
=================
Brief Summary
-----------------
anxiety disorder is one of the major public health problems worldwide. 25% of people experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as the most prevalent anxiety disorder. Saffron has previously approved as an effective adjuvant therapy in depression and might alleviate GAD symptoms.Since up to the best of our knowledge no human studies have assessed the therapeutic effect of saffron as an adjuvant therapy in GAD patients, Therefore, this study is planned to evaluateThe effect of saffron (Crocus satious L.) in the treatment of mild to moderate generalized anxiety disorder:

Official Title
-----------------
The Effect of Saffron (Crocus Satious L.) in the Treatment of Mild to Moderate Generalized Anxiety Disorder: a Double Blind Randomized Controlled Trial

Conditions
-----------------
Patients With Mild to Moderate GAD

Intervention / Treatment
-----------------
* Dietary Supplement: Saffron
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who diagnosed with GAD according to DSM-V criteria, Hamilton score of 18-25 Exclusion Criteria: pregnancy and lactation receiving antipsychotic medications in a month prior to the recruitment suffered from other psychological disorders (e.g. bipolar disorder, schizophrenia, mood disorders), and drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: saffron<br>450 mg of saffron capsule once a day for 6 weeks | Dietary Supplement: Saffron<br>* 20 patients with mild to moderate GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders-IѴ (DSM-IѴ) who receive sertraline will randomly receive saffron (450 mg) as an add-on therapy on daily bases for 6 weeks. Hamilton Anxiety Rating Scale (HAM-A) will use to assess the effect of treatment.<br>|
| Placebo Comparator: placebo<br>placebo capsule once a day for 6 weeks | Dietary Supplement: placebo<br>* 20 patients with mild to moderate GAD who receive sertraline will receive placebo too<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton anxiety score |  | 6 weeks |
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes

Official Title
-----------------
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: metformin
* Drug: glicazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 3 months No previous treatment for diabetes HbA1c between 7.0-12.0% Body Mass Index (BMI) between 19.0-40.0 kg/m2 Exclusion Criteria: Type 1 diabetes Known unstable/untreated proliferative retinopathy Uncontrolled treated/untreated hypertension Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: repaglinide|nan|
|Drug: metformin|nan|
|Drug: glicazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 16 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose profiles |  |  | 
| Quality of life assessment |  |  | 
| Treatment satisfaction |  |  | 
| Hypoglycaemic events |  |  | 
| Adverse events |  |  |
Effect of AVACEN 100 on Brachial Artery Blood Flow and Heart Rate Variability

Study Overview
=================
Brief Summary
-----------------
Determine effect of AVACEN 100 on brachial artery blood flow and heart rate variability

Detailed Description
-----------------
Blood flow measured via ultrasound doppler. Heart rate variability measured via polar chest strap

Official Title
-----------------
Effect of AVACEN 100 on Brachial Artery Blood Flow and Heart Rate Variability

Conditions
-----------------
Blood Flow, Heart Rate Variability

Intervention / Treatment
-----------------
* Device: Heat
* Device: Vacuum
* Device: sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anyone within specified age Exclusion Criteria: anyone outside specified age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Thermoneutral<br>Neither heat nor vacuum applied to hand | Device: sham<br>* neither heat nor vacuum<br>|
| Experimental: Heat and Vacuum<br>Heat and vacuum applied to hand | Device: Heat<br>* Heat applied to hand<br>Device: Vacuum<br>* vacuum applied to hand<br>|
| Experimental: Heat only<br>Only heat applied to hand | Device: Heat<br>* Heat applied to hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brachial artery blood flow via ultrasound doppler |  | 10 min | 
| brachial artery blood flow via ultrasound doppler |  | 20 min | 
| brachial artery blood flow via ultrasound doppler |  | 30 min | 
| heart rate variability |  | 10 min | 
| heart rate variability |  | 20 min | 
| heart rate variability |  | 30 min |
Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to provide data and the guidelines for the use of IDRT SL in small wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of this product as a one stage procedure.

Official Title
-----------------
Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial

Conditions
-----------------
Traumatic Wound, Reconstruction Wound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological wounds included) Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted (even if the patient is not taking part in the study) with a Split Thickness Skin Graft in the same operating procedure Wound treated with only one layer of a maximum size 10cm*12.5cm Exclusion Criteria: Immunosuppressed patient Chronic wound (with no healing since 6 months) Addition of any substances (growth factor, stem cells,…) in the IDRT SL during the surgery Patient with a corticoid treatment with a daily dose greater than 5 mg Patients whose life expectancy is less than 12 months Patients whose mental health or health condition (Visual deficiency, Alzheimers…) would compromise completion of the self-evaluation questionnaires Patient with an hypersensitivity to bovine collagen, chondroitin Patient with clinical signs of infection (fever, pain, colour, swelling,…) and for whom the investigator diagnosed infection

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 |
| --- | --- | --- |
| Rate of graft take | the mean percentage of healing expected at Day 15 after the surgery | Day 15 after the surgery |
Hemoglobin Measured by MASIMO SpHb™ Device and Laboratory Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™ device and the Clinical Laboratory.

Official Title
-----------------
Comparison of the Hemoglobin Results Obtained With the Masimo SpHb™ Device and the Clinical Laboratory Measurement

Conditions
-----------------
Patients' Assessment

Intervention / Treatment
-----------------
* Biological: hemoglobin determination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: emergency unit patients, PACU (post-anaesthesia care unit) and ICU patients requiring an hemoglobin determination Exclusion Criteria: none

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 |
| --- | --- |
| hemoglobin determination<br>ICU and emergency unit patients | Biological: hemoglobin determination<br>* laboratory and non invasive hemoglobin determinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the Masimo Labs Pulse-Hemoglobin-Meter Monitor |  | End of the period of recruitment |
Infraclavicular Perineural Dexmedetomidine

Study Overview
=================
Brief Summary
-----------------
Infraclavicular block is one of the peripheral nerve block used in upper extremity surgery. Adjuvant agents are used in peripheral nerve blocks to increase the duration and block quality. We investigated that the effects of patient-controlled perineural dexmedetomidine application on postoperative analgesia.

Official Title
-----------------
Does Patient-Controlled Infraclavicular Perineural Dexmedetomidine Improve Postoperative Analgesia Deadline?

Conditions
-----------------
The Analgesic Effects

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be undergoing distal upper extremity surgery Be between 18-65 years to agree to participate in research Exclusion Criteria: allergy to dexmedetomidine AV block or bradycardia being serious cardiac - liver - kidney function disorders Being coagulopathy neuropathy in the upper extremity adrenoceptor agonists or antagonists use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: perineural bupivacaine<br>patient-controlled infraclavicular perineural bupivacaine (1% bupivacaine (marcaine), 5 ml bolus dose, infusion rate of 5 ml / h, lockout time 1 hour) | Drug: Bupivacaine<br>* patient- controlled infraclavicular perineural marcaine infusion<br>Drug: Dexmedetomidine<br>* patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion<br>|
| Experimental: perineural dexmedetomidine<br>patient-controlled infraclavicular perineural dexmedetomidine (1% bupivacaine + 200 mic / 100cc dexmedetomidine, 5 ml bolus dose, infusion rate of 5 ml / h, lockout time 1 hour) | Drug: Bupivacaine<br>* patient- controlled infraclavicular perineural marcaine infusion<br>Drug: Dexmedetomidine<br>* patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | Scores range from 0 [no pain] to 10 [worst possible pain | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  | 3 month | 
| The effect of dexmedetomidine to the Ramsey Sedation Scale |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perineural dexmedetomidine, infraclavicular perineural catheter, postoperative analgesia
Sleep, Fatigue, and Dexamethosone in Children With Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.

Detailed Description
-----------------
Approximately 134 children and adolescents will be enrolled. All children and adolescents will wear a wrist actigraph for two consecutive 5-day study periods. Children and adolescents will have blood drawn 2 times on Day 1 when they are on dexamethosone. Their parents will complete a sleep diary and fatigue questionnaire by telephone on Days 2 and 5 of both study periods.

Official Title
-----------------
Sleep, Fatigue, and Dexamethosone in Childhood Cancer

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: Dexamethosone


Participation Criteria
=================
Eligibility Criteria
-----------------
Children and adolescents with Leukemia, both genders

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 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: Study Cycle<br> | Drug: Dexamethosone<br>* 10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid<br>* Other names: Mestinon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue and sleep quality changes |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacogenetics with dextamethasone use |  | 5 days | 
| Pharmacokinetics with dextamethasone use |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Adverse Effect, Pediatric Cancer
Fixed Dose Heparin Study

Study Overview
=================
Brief Summary
-----------------
FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).

Detailed Description
-----------------
The general objective was to simplify and reduce the cost of treatment of acute venous thromboembolism (VTE).Specific objectives were to compare the efficacy, safety and cost effectiveness of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) when each is administered subcutaneously (sc), twice daily, in weight -adjusted, fixed doses; and to determine if the anticoagulant response (anti-Factor Xa heparin levels, APTT results) influence efficacy and safety of UFH and LMWH, independently of dose.

Official Title
-----------------
Fixed Dose Unfractionated Heparin for Initial Treatment of Venous Thromboembolism

Conditions
-----------------
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism

Intervention / Treatment
-----------------
* Drug: UFH 250 U/kg or LMWH 100 U/kg sc twice daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE) Exclusion Criteria: Contraindication to subcutaneous (sc) route of administration (eg:shock (evidence of poor peripheral perfusion), major surgery within 48 hours) Active Bleeding process Comorbid condition limiting expected survival to less than 3 months Current treatment with therapeutic dose of UFH, LMWH, danaparoid sodium, or a direct thrombin inhibitor for more than 48 hours Currently on long term warfarin or heparin therapy Allergy to heparin or history of heparin induced thrombocytopenia Currently pregnant Contraindication to contrast media (eg: allergy or creatinine >200 umol/L). Currently enrolled or will be enrolled in a competing study Geographically inaccessible for follow-up assessment

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: UFH 250 U/kg or LMWH 100 U/kg sc twice daily|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic Venous Thromboembolism |  |  | 
| Major Bleeding |  |  | 
| Death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aXa  6h after sc injection on 3rd day of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unfractionated Heparin, Low Molecular Weight Heparin, Venous Thromboembolism, APTT, Treatment