linjc16/ctgov huggingface dataset:
Evaluation Of Linezolid Pk Profile In Burns Patients

Study Overview
=================
Brief Summary
-----------------
Evaluation of linezolid pk profile in burns patients

Official Title
-----------------
An Open Label Parallel Group Study To Investigate The Pharmacokinetics Of Intravenous Linezolid, An Oxazolidinone, Administered To Healthy Volunteers And Patients With Major Thermal Injuries

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with a Body Mass Index (BMI) < 30 kg/m&#178;. For patient with major thermal injuries, the weight will be collected before the burn ; Patients with major thermal injuries >40% body area including 3rd degree burns with full thickness burns ; Patients hospitalized for at least 10 days since their thermal injury occurred ; Exclusion Criteria: Contra-indications to use linezolid as mentioned in the SmPC (Summarized Product Characteristics) : hypersensitivity to linezolid use or to any of its components, non-controlled hypertension, phaeochromocytoma, carcinoid syndrome, hyperthyroidism, bipolar disorders, schizoaffective disorders, acute confused state of mind, pregnancy, and breastfeeding ; Drugs metabolised by monoamine oxydase (MAO) should be evaluated for potential drug-to-drug interaction; Subject treated by: selective serotonin reuptake inhibitors (Prozac&#174;, Effexor&#174;, Ixel&#174; &#133;), tricyclic antidepressant (Anafranil&#174;, Sinequan&#174;, Surmontil&#174;, Tofranil&#174;), 5HT1 receptor agonists (triptan) direct or indirect sympathomimetic (including adrenergic bronchodilator, pseudoephedrine and phenylpropylamine), vasopressor (adrenaline and noradrenaline), dopaminergic drugs (dopamine, dobutamine), phenetidine or buspirone should be evaluated for potential drug-to-drug interaction;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare pharmacokinetic parameters of a single dose 1-hour intravenous linezolid (Zyvox) at 600 mg in patients with major thermal injuries (>40% body area) and in healthy volunteers |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare tolerability and safety of a single dose of 600mg IV linezolid administered in patients with major thermal injuries (>40% body area) and in healthy volunteers. |  |  |
Intraocular Pressure (IOP) and Isometric Exercise

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate changes in intraocular pressure measured continuously during isometric exercise.

Official Title
-----------------
Changes in Intraocular Pressure and Pulsatile Ocular Blood Flow Measured Continuously During Isometric Exercise

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Behavioral: isometric exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young, healthy subjects Exclusion Criteria: Known ocular diseases Previous ocular trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1: Healthy subjects | Behavioral: isometric exercise<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
-----------------
Isometric exercise, intraocular pressure, Physiological changes in intraocular pressure during isometric exercise
Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients

Study Overview
=================
Brief Summary
-----------------
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients

Official Title
-----------------
Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients

Conditions
-----------------
Pain, Opioid Tolerance, Analgesia Tolerance

Intervention / Treatment
-----------------
* Drug: Dextromethorphan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients above 2 years, admitted in PICU On Morphine or Fentanyl infusions for more than 48 hours Exclusion Criteria: Patients under 2 years of age Patients with anticipated PICU length of stay less than 3 days. Patients shall be excluded if Morphine or Fentanyl infusions not continued for the minimum duration of 72 hours after enrollment Patients develops hemodynamic instability Patients with Hepatic failure Withdrawal request by parent(s)/guardian/family

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dextromethorphan, opioid analgisia, efficacy<br> | Drug: Dextromethorphan<br>* The study medicines shall be administered via tube.<br>|
| Placebo Comparator: Placebo,opioid analgesia, efficacy<br> | Drug: Placebo<br>* The study medicines shall be administered via tube.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients | Control of pain | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients | Duration of ventilation in both groups | two years | 
| Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients | Length of Hospital Stay in two groups | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morphine, Dextromethorphan, Fentanyl, Opioid, analgesia, Efficacy
Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Single-centre, Open-label, Crossover, Controlled, Randomized Study to Investigate the Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters in 30 Healthy Female Volunteers Over 3 Treatment Cycles

Conditions
-----------------
Pregnancy, Unplanned

Intervention / Treatment
-----------------
* Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
* Drug: SH D01155E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female volunteers Exclusion Criteria: Pregnancy or lactation Any condition that might interfere with the outcome as all contraindications for OC use.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)<br>* per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo<br>|
| Active Comparator: Arm 2<br> | Drug: SH D01155E<br>* per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover |  | Baseline, Cycle 3 of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II). |  | Baseline, Cycle 3 of each treatment period | 
| Adverse events |  | 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention of unintended pregnancies
A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed Description
-----------------
Purpose: Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination. Phase II: Determine the complete remission rate (CR+CRp)

Official Title
-----------------
An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Conditions
-----------------
Leukemia, Myeloid

Intervention / Treatment
-----------------
* Drug: Zosuquidar
* Drug: gemtuzumab ozogamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morphologic evidence of acute myeloid leukemia in first relapse. Phase I: 18 years or older, Phase II: 50 years or older Exclusion Criteria: Prior treatment with zosuquidar Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents History of stem cell transplant

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zosuquidar|nan|
|Drug: gemtuzumab ozogamicin|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
-----------------
Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, gemtuzumab ozogamicin (GO)
2019-nCoV Outbreak and Cardiovascular Diseases

Study Overview
=================
Brief Summary
-----------------
Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.

Detailed Description
-----------------
This survey aims to assess whether the public anxiety from a novel coronavirus (2019-nCoV) outbreak increases cardiovascular disease risk in China. Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.

Official Title
-----------------
Impact of a Novel Coronavirus (2019-nCoV) Outbreak on Public Anxiety and Cardiovascular Disease Risk in China

Conditions
-----------------
Cardiovascular Death; Major Adverse Cardiovascular Events

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients visiting emergency department. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| After outbreak<br> | |
| Past 3 months<br> | |
| Last year<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Death |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events |  | 3 months | 
| Times From symptom onset to hospital arrival |  | 3 months | 
| Anxiety |  | 3 months |
Clinical Evaluation of Daptomycin Bone Penetration

Study Overview
=================
Brief Summary
-----------------
Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these infections is difficult because of the need of prolonged duration of antimicrobial agents in combination with surgical procedure. Moreover, in recent years, a growing resistance pattern to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently, there is an urgent need for new drugs with high bone penetration for the treatment of those infections. The investigators hypothesized that daptomycin allow to achieve high concentrations in bone compartments.

Official Title
-----------------
Clinical Evaluation of Daptomycin Bone Penetration

Conditions
-----------------
Bone and Joint Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient under treatment with daptomycin for more than 3 days with dosage at 6 mg/kg Patient undergoing imperative surgery with bone withdrawal Signed, and dated informed consent as defined by the Institutional Review Board Male and female patients older than 18 years of age Patients with social insurance Patient with information on previous mandatory medical examination Exclusion criteria : Patient with no treatment by daptomycin or with a dosage < 6mg/kg or with less than 3 doses of daptomycine Patient with no need for surgery Patient younger than 18 years of age Pregnant and nursing women Patient refusal for inclusion Patients with deprived liberty Inability to complete the informed consent process because of problems with mental capacity

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 |
| --- | --- | --- |
| Patients' percentage of which the intra-osseous daptomycin concentration is ≥ 8 times MIC (if available) or ≥ 8 times critical concentration (if Bacteriological documentation is unavailable) |  | 5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Daptomycin, Bone disease,infectious, Osteomyelitis, Diabetic foot, Staphylococcus aureus
Swallowing Sound in Preterm Infant Evaluation of Feeding Maturation

Study Overview
=================
Brief Summary
-----------------
Our objective was to evaluate maturation of sucking and swallowing in preterm infants using a non-invasive method: assessment of swallowing sounds. Findings in healthy term infants were used as reference values.

Detailed Description
-----------------
Successful transition to full oral feeding in preterm infants is important for safe discharge from hospital and for facilitating the mother-infant bond. Preterm infants were evaluated weekly for sucking and swallowing performance (i.e., feeding performance) from the time they began oral feeding (frequency 1-2 oral feedings/day) until they reached independent oral feeding (frequency 8 oral feedings/day) at postmenstrual 38-40 weeks. For the term infants, we evaluated a single oral feeding during the first week of life. The exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis. Each swallowing-sound recording was 2 minutes long and was captured in a quiet environment by the same investigator. The feeding parameters generated from the recordings were as follows: total number of swallows (S), total number of rhythmic swallows (RS), total number of resting intervals (RI), average time between resting intervals (ATRI), average time between swallows (ATS), average time between rhythmic swallows (ATRS), maximum number of rythymic swallows (MRS), and volume of milk ingested (VM) during the 2-minute evaluation.

Official Title
-----------------
Swallow Maturation in Preterm and Term Infants

Conditions
-----------------
Other Preterm Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants (< 37 gestational weeks) and term infants (>=37 gestational weeks) Exclusion Criteria: - The exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis.

Ages Eligible for Study
-----------------
Minimum Age: 26 Weeks
Maximum Age: 40 Weeks

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| swallow count | Mean MRS (mean±SD;17±7) for the preterm group reached the reference value at postmenstrual 38-40 weeks. | Participants will be followed up until postmenstrual 38-40 weeks, an expected avarage of 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maturation, preterm infants, sucking and swallowing
Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral Modafinil.

Detailed Description
-----------------
The primary aims of this experiment are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).

Official Title
-----------------
Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normotensive good physical and mental health body mass index between 18 and 30 if female, using an acceptable method of contraception and are not pregnant able to give voluntary informed consent Exclusion Criteria: Please contact site for further details

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular |  |  | 
| Subjective symptoms/Mood Effects |  |  |