linjc16/ctgov huggingface dataset:
The Influences of Caffeine on Heart Rate Variability of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods.

Official Title
-----------------
The Influences of Caffeine on HRV of Preterm Infants

Conditions
-----------------
Autonomic Nervous System

Intervention / Treatment
-----------------
* Drug: Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants born before 34 weeks gestation Exclusion Criteria: sepsis congenital malformations

Ages Eligible for Study
-----------------
Minimum Age: 25 Weeks
Maximum Age: 34 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caffeine<br>caffeine will be given according to clinical judgment | Drug: Caffeine<br>* Caffeine will be given according to departmental protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Heart rate, SD, SDNN, HF, LF, VLF, TP | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autonomic nervous system
Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.

Conditions
-----------------
Meningeal Carcinomatosis

Intervention / Treatment
-----------------
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 14 or more a history of solid tumor a new clinical neurological signs and symptoms a typical CT(Computerized Tomography,CT) or MRI(Magnetic Resonance Imaging,MRI) imaging findings tumor cells in cerebrospinal fluid Exclusion Criteria: KPS score <60 the tumor patients with organ failure bacteria, fungi or viral meningitis

Ages Eligible for Study
-----------------
Minimum Age: 14 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: The small dose of group<br>The dose of methotrexate is 10 mg | Drug: methotrexate<br>* The quantity of methotrexate is different in the two groups.<br>* Other names: Intrathecal chemotherapy;|
| Active Comparator: The high dose of group<br>The dose of methotrexate is 15 mg | Drug: methotrexate<br>* The quantity of methotrexate is different in the two groups.<br>* Other names: Intrathecal chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse reactions | In accordance with the standard of CTCAE, an assessment will be assessed every month | one year | 
| KPS score | In accordance with the standard of KPS(Karnofsky Performance Status,KPS) score, an assessment will be assessed every month | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrathecal chemotherapy
A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

Study Overview
=================
Brief Summary
-----------------
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Official Title
-----------------
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: montelukast
* Drug: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female between and including the ages of 2 and 5 years Patient was treated with steroids for an asthma episode in the last 3 months Patient was admitted to the hospital or emergency room in the last 3 months Patient is able to chew a tablet Exclusion Criteria: Patient has been in a research study in the past 4 weeks Patient has visited the emergency room for an asthma episode in the past week Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug | Drug: montelukast<br>* One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks<br>* Other names: SINGULAIR ®;|
| Placebo Comparator: 2<br>Pbo | Drug: placebo (unspecified)<br>* Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma episodes in 2 - 5 year old children |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of treatments and duration of asthma episodes |  | at 12 months |
Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The study investigated the use and efficacy of the seeds of African bush mango (Irvingia gabonensis)to control body weight, blood lipids and hormones in overweight and obese people.

Detailed Description
-----------------
To assess the effects of seeds of Irvingia gabonensis on body weight, fasting blood glucose, plasma total and LDL cholesterol in 102 overweight and obese participants. The study was a 10 week randomized, double blind, placebo controlled design. participants were randomly divided into 2 groups of 51 participants each. Group 1 was the placebo group, while Group 2 was the active group. Each group received 2 daily doses of 125 mg (before meals) of either placebo or Irvingia gabonensis. Weight as well as fasting blood was taken at baseline and at 4, 8 and 10 weeks. No major detary changes or exercises were suggested during the study period.

Official Title
-----------------
The Efficacy of Irvingia Gabonensis (Bush Mango) in the Management of Overweight, Obesity and Metabolic Syndrome in Cameroon.

Conditions
-----------------
Metabolic Syndrome, Obesity, Dyslipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: IGOB131


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>26 Exclusion Criteria: Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Compare active to placebo | Dietary Supplement: IGOB131<br>* Comparison of 250 mg per day of Irvingia gabonensis to placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood lipids and hormone levels |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, Antiobesity, Metabolic syndrome, Leptin
A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).

Official Title
-----------------
A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Drug: Chloral Hydrate
* Drug: Dexmedetomidine
* Other: Oral placebo
* Other: Intranasal placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic. Exclusion Criteria: Patients younger than 6 months or older than 8 years Previously failed sedation Weight greater than 25 kg Weight less than 5 kg BMI above 30 Diagnosis of ADHD Any patient deemed inappropriate for nurse administered sedation Patients with any cardiac disease Obstructive sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 8 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Oral Chloral and intranasal placebo | Drug: Chloral Hydrate<br>* Oral chloral hydrate 50 mg/kg<br>Other: Intranasal placebo<br>* Intranasal saline administered<br>|
| Experimental: Arm 2<br>oral placebo and intranasal dexmedetomidine | Drug: Dexmedetomidine<br>* Intranasal dexmedetomidine 3 mcg/kg<br>Other: Oral placebo<br>* Oral saline administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Study | Time from medication administration to study completion. | 60-180 minutes |
Nanovectors to Prevent Placental Passage of Tocolytic Agents

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.

Detailed Description
-----------------
This is a prospective observational study. Subjects will undergo a biopsy from the middle of the upper margin of the uterine incision measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean section after delivery of the baby. Once the tissue is obtained, the site will be closed using sutures similar to the usual closure of the uterus at cesarean section. This biopsy will be taken to the laboratory to test whether the nanovector will increase or decrease contractions in the uterus. Once this test is finished, the tissue will be frozen and test for the absence or presence of the nanovector within the tissue.

Official Title
-----------------
Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent

Conditions
-----------------
Preterm Labor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women undergoing elective cesarean section who are greater than 37 weeks Exclusion Criteria: Known infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cesarean section<br>Women with cesarean section | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine contractions | Uterine biopsies obtained from subjects will be placed in a specimen chamber that measures uterine contractility. Mean contractile intensity will be determined before and after exposure to oxytocin, indomethacin, liposomes and liposome indomethacin. | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indomethacin, Nanovectors, Uterine contractions
Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the etiologic of stroke. However, the techniques usually used provide only static evaluation (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be used to review the supraaortic vessels. This MRA offers the following advantages: short acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic arteries), 3D spatial resolution and high temporal resolution. These qualities are even more optimal with a high magnetic field (3T). The high temporal resolution is interesting because it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of vascular filling and to assess the vascular supply of the infarcted territory. This sequence is classified as a 4D MRA.

Official Title
-----------------
Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients

Conditions
-----------------
Stroke, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over 18 years Eligibility for intravenous thrombolytic treatment (National Institute of Neurological Disorders and Stroke criteria) Permanent ischemic stroke confirm with encephalic MRI (Magnetic Resonance Imaging) Patient able of accepting protocol information Patient who received information about the protocol and had not expressed its opposition to participate Exclusion Criteria: Pacemaker Surgical ferromagnetic clips Cochlear implants Intraocular metallic foreign body Iron implants or objects likely to concentrate the Radio Frequency field Claustrophobia Known intolerance to contrast media (DOTAREM) Pregnant women (Beta Human Chorionic gonadotrophin performed for biological assessment of thrombolysis) Patient with severe kidney with Glomerular Filtration rate < 30 ml/min Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

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 |
| --- | --- | --- |
| Images quality for each cervical and intracranial arteries |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of carotid stenosis with NASCET classification |  | 6 months | 
| Study of dynamic vascular consequences of carotid stenosis |  | 6 months |
Anesthetic Efficacy of Intrauterine Lidocaine for Removal of a Lost Intrauterine Device

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a lost intrauterine device (IUD). Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a lost IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using Friedman's test with Bonferroni correction, Student's t test, and 2.

Conditions
-----------------
Lost IUD

Intervention / Treatment
-----------------
* Drug: Lidocaine (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing a minor gynecologic procedure for removal of a lost IUD. Exclusion Criteria: women with a history of cervical stenosis, known allergy to lidocaine, pregnancy, acute cervicitis
Sexes Eligible for Study
-----------------
Female

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lidocaine (drug)|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
-----------------
Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a lost IUD
A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery.

Study Overview
=================
Brief Summary
-----------------
The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.

Official Title
-----------------
Compliance and Efficacy in the Use of PICOPREP for Bowel Cleansing

Conditions
-----------------
Bowel Cleanliness

Intervention / Treatment
-----------------
* Drug: sodium picosulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery Exclusion Criteria: Patients in which prescription of PICOPREP® is contraindicated
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PICOPREP®<br> | Drug: sodium picosulphate<br>* Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.<br>* Other names: PICOPREP®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of use PICOPREP in everyday practice |  | Day 0 - 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction and compliance after bowel cleansing |  | Days 0-2 | 
| Participants with adverse events reported by frequency and severity |  | Days 1-2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopy, colonoscopy, preparation for surgery
Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients

Study Overview
=================
Brief Summary
-----------------
This is an evaluation of the use of silver impregnated catheters in burn patients to reduce catheter colonisation compared to the standard central venous catheter without antiseptic activity.

Official Title
-----------------
Study on the Infection Risk of Long Dwell Period Catheters in High Risk ICU Patients

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

Intervention / Treatment
-----------------
* Device: Placement of a silver impregnated central venous catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn patient Placement of a new trilumen central venous catheter
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Placement of a silver impregnated central venous catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of colonisation of the central venous catheter at the moment of removal |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a catheter related blood stream infection during the presence of the catheter |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonisation of the catheter