linjc16/ctgov huggingface dataset:
18611 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY 987517


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing; Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA Form (Health Insurance Portability and Accountability Act). An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY 987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY 987517<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application (Formulation number V26-160)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

Study Overview
=================
Brief Summary
-----------------
We hypothesise that the addition of glutamine supplementation to both parenteral nutrition and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.

Official Title
-----------------
Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.

Conditions
-----------------
Surgical Infants Requiring Total Parenteral Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Isonitrogenous Vaminolact
* Drug: Dipeptiven (L-glutamine- Lalanine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who have undergone surgical procedures for congenital anomalies or Intestinal inflammation who require total parenteral nutrition. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Dipeptiven (L-glutamine- Lalanine) | Drug: Dipeptiven (L-glutamine- Lalanine)<br>* 0.6g/kg/day<br>|
| Placebo Comparator: 2<br>Isonitrogenous Vaminolact | Dietary Supplement: Isonitrogenous Vaminolact<br>* Isonitrogenous Vaminolact<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of microbial invasion |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parenteral nutrition, Infants, Dipeotiven, Microbial invasion
Fever During Labour

Study Overview
=================
Brief Summary
-----------------
Pilot study to assess fever during labour.

Detailed Description
-----------------
200 parturients will be monitored for fever during labour using rectal thermometer. Repeated measurements 1/hr during the first 6 hours will allow us to find patients developing fever. Fever = rectal temp >38 Celsius twice within 60 min or 39 degrees Celsius measured once . After birth, blood samples are assessed for infection. Use of Antibiotics and other medication is Recorded. Subgroup analyses based on suspected causes of fever during birth.

Official Title
-----------------
Fever During Labour

Conditions
-----------------
Fever; Due to Heat, Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Temperature measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, planned vaginal birth, able to give consent Exclusion Criteria: do not speak Danish or English, unable to cooperate to rectal temperature measurements,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Temperature measurement|The 'intervention' is repeated rectal temperature measurements|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever | Fever = rectal temp >38 Celsius twice within 60 minutes or 39 degrees Celsius measured once | during labour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP | infection marker | 24 hours | 
| Leucocytosis | infection marker | 24 hours | 
| bacterial growth blood | infection marker | 1 week | 
| bacterial growth placenta blood | infection marker | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fever, epidural, birth, labour
Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.

Study Overview
=================
Brief Summary
-----------------
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain

Conditions
-----------------
no Conditions

Intervention / Treatment
-----------------
* Procedure: Epidural Prolotherapy
* Procedure: Epidural Steroid


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings. Evidence of low back pain base upon one or more of the following: i. Lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on VAS. ii. Has received at lest 2 types of ancillary treatment (i.e. physical therapy, oral analgesia, acupuncture, etc.) Men or women age greater than or equal to 18 years. No significant alcohol use (7 or fewer drinks per week). Patient has a history of at least 2 failed epidural CS injections. EXCLUSION CRITERIA Treatment risk factors including one or more of the following: i. Unstable or symptomatic cardiac complaints ii. Unstable or symptomatic respiratory complaints iii. Unable to reliably comprehend the protocol or reliably record data Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment. History of Malignancy Any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease, polyneuropathy) or psychosocial condition that in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Steroid<br>80mg depo-medrol 9mL 1% lidocaine | Procedure: Epidural Prolotherapy<br>* caudal injection of 10mL 5% dextrose<br>|
| Active Comparator: Epidural Prolotherapy<br>10ml of 5% generic dextrose | Procedure: Epidural Steroid<br>* caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief as measured by VAS pain scale. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the frequency and amount of opioid use. |  | 1 year | 
| Disability score as determined by Oswstery questionnaire. |  | 1 year |
Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to investigate how the brain responds to a procedure known as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a behavioral task. Research suggest that this procedure leads to improvement in brain and behavioral measures of inhibitory control (controlling impulses) in healthy control participants. The investigators want to explore whether the same improvement will be seen in kids with ADHD.

Official Title
-----------------
Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder

Conditions
-----------------
ADHD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ADHD Parent informed consent and child assent Exclusion Criteria: Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis Type 1 (NF1), tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology History of fainting spells of unknown or undetermined etiology that might constitute seizures History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) History of head injury resulting in prolonged loss of consciousness Substance abuse or dependence within the past six months Chronic treatment with prescription medications that decrease cortical seizure threshold that the patient is unable to withhold from taking during study visits Damaged skin on the scalp (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Stop-Signal Task |  | Immediately following tDCS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention Deficit Hyperactivity Disorder (ADHD)
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Pressure Support Ventilation (PSV), Neurally Adjusted Ventilatory Assist (NAVA) and Controlled by Patient

Study Overview
=================
Brief Summary
-----------------
The investigators' aim is to study the effect of pressure support ventilation versus neurally adjusted assist (NAVA) and controlled by patient in mechanically ventilated ALI/ARDS subjects.

Detailed Description
-----------------
In this study, PSV is compared with NAVA and assisted mechanically ventilation controlled by patient through a button. Inclusion criteria are: assisted mechanically ventilated ALI/ARDS patients.

Official Title
-----------------
Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients: PSV, NAVA and Controlled by Patient

Conditions
-----------------
ALI/ARDS Patients

Intervention / Treatment
-----------------
* Procedure: PSV
* Procedure: NAVA
* Procedure: patient-controlled


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALI/ARDS patients Exclusion Criteria: Haemodynamic instability Barotrauma COPD

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: 1<br>ALI/ARDS patients evaluated the effect of PSV, NAVA and assisted controlled mechanical ventilation by patient through a button | Procedure: PSV<br>* Pressure Support Ventilation<br>Procedure: NAVA<br>* Neurally Adjusted Ventilatory Assist<br>Procedure: patient-controlled<br>* assisted controlled MV through a button<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory mechanics work of breathing,end expiratory lung volume, gas exchange, dead space, patient's comfort level |  | 30 minutes |
Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Drug: quetiapine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours Exclusion Criteria: Female patients who are pregnant or breastfeeding active delirium Received other anti-psychotic drug before attend the study severe bradycardia alcohol intoxication No written consent from the legal representatives Being ill with renal or hepatic failure

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: quetiapine<br>quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. | Drug: quetiapine<br>* patient body weight <50kg : quetiapine 12.5mg patient body weight >=50kg : quetiapine 25mg quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. The study medicine(quetiapine) was provided as liquid form (medicine was pulverized and melted in 10cc water).<br>|
| Placebo Comparator: placebo<br>The placebo is made of 100mg of corn starch which is melted in 10cc water. | Drug: placebo<br>* The placebo is made of 100mg of corn starch which is melted in 10cc water.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of delirium within 14 days after admitting to ICU (Rate) |  | 14 days after admitting to intensive care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of delirium occurring within 14 days after admitting to ICU (Days) |  | 14 days after admitting to ICU | 
| Length of stay in ICU and hospital (Days) |  | up to 24 weeks | 
| 60 days in hospital mortality (Rate) |  | 60 days after admitting to ICU | 
| Duration of mechanical ventilation in ICU (Days) |  | 14days after admitting to intensive care unit |
Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery

Study Overview
=================
Brief Summary
-----------------
Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.

Official Title
-----------------
Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery

Conditions
-----------------
Retinal Detachment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute rhegmatogenous retinal detachment, fovea detached, able to signe Exclusion Criteria: Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on

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 |
| --- | --- | --- |
| Retinal shift | Measured on fundus autofluorescence | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Best Corrected Visual Acuity | 6 and 24 months | 
| Metamorphopsia | M-Chart | 6 and 24 months | 
| Aniseikonia | New Aniseikonia Test | 6 and 24 months | 
| Stereopsis | Titmus Test | 6 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal shift, Aniseikonia, Metamorphopsia, Autofluorescence
Impact of Abdominal Incompetence on Urinary Incontinence After Prostatectomy (PROSTABDO)

Study Overview
=================
Brief Summary
-----------------
the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.

Official Title
-----------------
Impact de l'incompétence Abdominale Sur l'Icontinence Urinaire Post Prostatectomie

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: evaluation of deep abdominal wall before surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy Exclusion Criteria: neurological patology with bladder impact (SCI, parkinson disease, multiple sclerosis....) urinary incontinence before surgery surgery for abdominal wallhernia

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

Sexes Eligible for Study
-----------------
Male

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

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 |
| --- | --- |
| Other: patient before Robotic-assisted Radical Prostatectomy<br>evaluation of deep abdominal wall before surgery : cough test + ulstrasonography of transversus abdominis | Diagnostic Test: evaluation of deep abdominal wall before surgery<br>* : cough test (L guillarme) + ulstrasonography of transversus abdominis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of incontinence after surgery (1 year) | mesured with pad test on 3 days | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of incontinence after 3 month | mesured with pad test on 3 days | 3 month | 
| amount of incontinence after 6 month | mesured with pad test on 3 days | 6 month | 
| quality of life after 3 month | Short-Form (SF-36) Health Survey | 3 month | 
| quality of life after6 month | Short-Form (SF-36) Health Survey | 6 month | 
| quality of life after 12 month | Short-Form (SF-36) Health Survey | 12 month | 
| quality of incontinence after 12 month | mesured with urinary symptom profil score | 12 month |