linjc16/ctgov huggingface dataset:
Clinical Evaluation of Insect Repellent and Insecticide Treated Nets in Lao PDR

Study Overview
=================
Brief Summary
-----------------
Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia. Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas. This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).

Official Title
-----------------
Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR

Conditions
-----------------
Malaria, Dengue, Japanese Encephalitis

Intervention / Treatment
-----------------
* Drug: 20% deet insect repellent
* Drug: placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: working in agriculture available for monthly follow-up Exclusion Criteria: allergy to repellent pregnant / breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20% deet insect repellent<br>experimental intervention | Drug: 20% deet insect repellent<br>* skin-applied repellent lotion<br>|
| Placebo Comparator: lotion without repellent active<br> | Drug: placebo control<br>* Identical base formulation of lotion but without any deet active<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in malaria incidence |  | monthly over 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Japanese Encephalitis and / or Dengue infections |  | After 7 months intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mosquito, repellent, vector control, malaria
RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy

Study Overview
=================
Brief Summary
-----------------
Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness. To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.

Official Title
-----------------
RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged between 6 and 18 years Receiving an MRI for lesional drug-resistant epilepsy Affiliated or beneficiary of a social security plan Whose parents or guardians have received information about the study and have given their express consent to participate in the study Exclusion Criteria: Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding women) History of intracranial surgery MRI performed under general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Resting-state functional MRI (r-fMRI)<br>The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional fMRI-r sequence, called resting state, and performed before injection of gadoline contrast. A neuropsychological evaluation is performed as part of the 6 months prior to the procedure. These data will be used as a basis for the evaluation of language visual and language recovery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy. | The variables measured with functional MRI will correspond to topological parameters of functional connectivity measured locally at the level of the lesion: the degree, the clustering coefficient and path length. Surgical success will be evaluated by a score of 1 on the modified Engel classification at one year after surgery. | One year |
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria

Study Overview
=================
Brief Summary
-----------------
No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4 parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is administered to the child. At this moment, quinine sulphate pellets are developed. These pellets enable an adequate dosing according to the body weight. 56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body weight.

Official Title
-----------------
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Administration of quinine sulphate taste-masked pellets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malaria (falciparium malaria, uncomplicated) Informed consent Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of quinine sulphate taste-masked pellets|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clocktime when child has had no fever for minimal 48h (< 37,5°C) |  |  | 
| Parasitemy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of quinine at day 4 between first and second administration |  |  |
Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine presence of central adrenal insufficiency in children with Prader Willi Syndrome using low dose (1 mcg) ACTH stimulation test compared to results of overnight metyrapone test.

Official Title
-----------------
Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome

Conditions
-----------------
Prader Willi Syndrome, Adrenal Insufficiency

Intervention / Treatment
-----------------
* Other: Low dose (1 mcg) ACTH stimulation test
* Other: Overnight metyrapone test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with Prader Willi Syndrome ages 2 years and older Exclusion Criteria: Individuals who are ill at the time of study Individuals who are pregnant at the time of study Individuals who it is deemed unsafe to stop taking medications known to affect the results of they study (hydrocortisone, phenytoin, estrogen, acetaminophen, oral anti-diabetic agents).

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assessment of Central Adrenal Insufficiency<br>Patients will undergo low dose ACTH stimulation test followed by overnight metyrapone test to assess for central adrenal insufficiency. | Other: Low dose (1 mcg) ACTH stimulation test<br>* Subjects will have baseline cortisol and ACTH drawn followed by administration of 1 mcg/m2 (max 1 mcg) of cortrosyn. Blood will be drawn at 20 and 40 minutes post cortrosyn for peak cortisol assessment of central adrenal insufficiency.<br>Other: Overnight metyrapone test<br>* Subjects will receive metyrapone 30 mg/kg (max 3 grams) by mouth at midnight. Blood will be drawn at 0800 AM the following morning for ACTH, cortisol and 11 deoxycortisol for assessment of central adrenal insufficiency.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of central adrenal insufficiency using low dose (1 mcg) ACTH stimulation test |  | 40 minutes | 
| Prescence of central adrenal insufficiency using overnight metyrapone test |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine peak cortisol value on low dose (1 mcg) ACTH stimulation test that can accurately predict central adrenal insufficiency based on overnight metyrapone test with good sensitivity and specificity. |  | 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metyrapone, ACTH stimulation test
SepsisFLAGS ( FLuidAndGender)

Study Overview
=================
Brief Summary
-----------------
In this single-center study the investigators will analyze gender differences among patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. About 11 000 patients will be included. Patient data including fluid therapy will be drawn from the electronic medical record; Take Care and Clinisoft. In the logistic regression analysis, the investigators will adjust for age, gender, comorbidities, vital signs, preliminary focus of infection, level of care and renal replacement therapy. The aim is to analyze gender differences in fluid treatment and the response to fluid treatment and if the treatment is associated with differences in mortality.

Official Title
-----------------
Fluid Treatment and the Impact of Gender in a Septic Population

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the emergency department with suspected sepsis (defined by blood culture taken and intravenous sepsis-antibiotics prescribed within 48 hours) and fulfilling sepsis-3 definition of sepsis (sequential organ failure assesment score of 2 or more) Exclusion Criteria: Patients transferred from other hospitals or treatment clinics.

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 |
| --- | --- |
| Female gender<br> | |
| Male gender<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender differences in fluid treatment | Millilitres of fluid given per kilogram of patient weight (ml/kg). | Fluid therapy during the first six hours (adherence to sepsis bundles) and the first five days after admission. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between amount of fluid and mortality | Analyze the whole cohort and female/ male gender as subgroups | In-Hospital Mortality, 30- and 90-days mortality | 
| Type of fluids | Type according to Anatomical, Therapeutic and Chemical Classification System | First five days after admission. | 
| Association between fluid therapy and levels of lactat | Analyze the whole cohort and female/ male gender as subgroups | First five days efter admission | 
| Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs | Analyze the whole cohort and female/ male gender as subgroups | First five days efter admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid Therapy, Gender difference
A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert

Study Overview
=================
Brief Summary
-----------------
To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP

Conditions
-----------------
Open Angle Glaucoma and Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Ophthalmic Insert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year Have provided written informed consent, approved by the appropriate Institutional Review Board Exclusion Criteria: Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis) Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy) Missed more than 2 visits during participation in the OTX-16-002 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Ophthalmic Insert<br>* Travoprost, 0.32 mg<br>* Other names: OTX-TP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Related Adverse Events (Safety and Tolerability) |  | 12 months |
MRI-changes in Morphometry and Cerebro Spinale Fluid (CSF) Flow in Spinal Cord Disorders

Study Overview
=================
Brief Summary
-----------------
Understanding the onset and progression of spinal cord disorders is an important aim in clinical neurology. An early diagnosis with consequent therapy might prevent the progression of disability. Therefore, we aim to determine structural and dynamic changes in the microstructure of the spinal cord and CSF, and to explore the relationships between the MRI parameters, clinical disability, and electrophysiology. In some patients that undergo decompressive surgery CSF pressure will be measured invasive perioperative for 24h to find out if functional limitations and structural changes correlate with the spinal pressure and the spinal perfusion when the spinal cord is damaged.

Conditions
-----------------
Spinal Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cervical injury Informed consent Age 18-80 CSM Exclusion Criteria: No other neurologic disorder and psychiatric disorder Seizure MRI incompatibility Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CSM<br> | |
| Patients with spinal injury (SCI)<br> | |
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphometric changes and changes in cerebro spinal fluid (CSF) flow and spinal cord movement in patients and control subjects will be correlated to functional deficits and neurophysiological data (regression model analysis). |  | Each patient will undergo a MRI scan, clinical and electrophysiological examinations at baseline, after 6 months and after 1, 2, 3, 4, and 5 years. Controls will undergo 1 MRI scan and some scan of retest analysis | 
| Assessment of CSF pressure dynamics in the perioperative setting |  | Perioperative for 24hours |
Repeated Insult Patch Test of Personal Lubricants

Study Overview
=================
Brief Summary
-----------------
Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.

Conditions
-----------------
Edema, Erythema

Intervention / Treatment
-----------------
* Device: Experimental: Novel lubricant Miami Fragrance
* Device: Experimental: Novel lubricant Miami no Fragrance
* Device: KY Liquid lubricant
* Device: Astroglide Gel lubricant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In general good health Free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema Complete a medical screening procedure Read, understand, and sign an informed consent agreement Exclusion Criteria: Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation Are receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results Have psoriasis and/or active atopic dermatitis/eczema. Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Repeat Insult Patch Test<br>Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back. | Device: Experimental: Novel lubricant Miami Fragrance<br> <br> Device: Experimental: Novel lubricant Miami no Fragrance<br> <br> Device: KY Liquid lubricant<br> <br> Device: Astroglide Gel lubricant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability |  | 24, 48, and 72 hours after patch application |