linjc16/ctgov huggingface dataset:
Effects of H1-Antagonist on Cognition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.

Detailed Description
-----------------
The neurotransmitter histamine appears to be involved in human cognitive performance. However, the exact role is very unclear. The role it plays in memory performance is highly disputed, as animal studies show decreased performance when the H1-receptor is blocked in the central nervous system while such findings in humans is scarce. To clarify the role of histamine in human memory and different processes in cognition, the effects of an H1-antagonist (dexchlorpheniramine) on memory, alertness and sensory and motor processes are measured. The study will be conducted according to a within subject cross-over design using healthy volunteers.

Official Title
-----------------
Effects of H1-Antagonist on Stages of Human Information Processing

Conditions
-----------------
Cognition

Intervention / Treatment
-----------------
* Drug: dexchlorpheniramine, lorazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by a physician Exclusion Criteria: present or history of any neurological of psychiatric disease present or history of any substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy volunteers<br> | Drug: dexchlorpheniramine, lorazepam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P300 latency and LRP onset latency |  | 1.5 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Words recalled |  | 1.5 hours after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H1-antagonist, Event Related Potentials, Memory, Information processing, The effects of an H1 antagonist (dexchlorpheniramine) on human cognition
Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

Study Overview
=================
Brief Summary
-----------------
Surgery initiates a complex cascade of events involving the release of chemical compounds from nerve endings and damaged tissue which leads to an inflammatory and pain response. The purpose of this investigation is to measure various chemical mediators in the blood and cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients treated with a COX-2 inhibitor.

Detailed Description
-----------------
Surgery initiates a complex cascade of events involving the release of nociceptive compounds from nerve endings and damaged tissue which leads to an inflammatory and hyperalgesic response. COX-2 inhibitors are often used for treating pain. This is a double-blind randomized study in surgical patients receiving a spinal drain for surgical purposes. The hypothesis is that valdecoxib will reach therapeutic concentrations in CSF, and will decrease plasma and CSF concentrations of inflammatory mediators. Subjects will receive valdecoxib 40 mg or placebo approximately 1 hr prior to surgery. Serial blood and CSF samples will be obtained. Valdecoxib and cytokine concentrations will be measured.

Official Title
-----------------
Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization

Conditions
-----------------
Neurosurgery, Pain

Intervention / Treatment
-----------------
* Drug: valdecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery requiring lumbar drain placement Exclusion Criteria: Contraindication to COX-2 inhibitor (renal or hepatic insufficiency) Known adverse reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) Use of NSAID or COX-2 within 7 days prior to surgery

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrospinal fluid (CSF) valdecoxib concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma valdecoxib concentration |  |  | 
| CSF/plasma valdecoxib concentration ratio |  |  | 
| CSF and plasma cytokine concentrations |  |  | 
| Postoperative opioid consumption |  |  | 
| Pain visual analogue scale (VAS) scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurosurgery, COX-2, inflammation, pain
High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

Study Overview
=================
Brief Summary
-----------------
Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.

Official Title
-----------------
High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria

Conditions
-----------------
Urticaria

Intervention / Treatment
-----------------
* Drug: Vitamin D3 (High dose)
* Drug: Vitamin D3 (Low dose)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks Exclusion Criteria: Physical urticaria aquired or hereditary angioedema Calcium level > 10.3 mg/dl Glomerular filtration rate <50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: Vitamin D3 (Low dose)<br>Daily 600 unites of vitamin D + Cetirizine 10mg twice a day | Drug: Vitamin D3 (Low dose)<br>* Daily 600 unites vitamin D<br>* Other names: cholecalciferol;|
| Experimental: Vitamin D3 (High dose)<br>Daily 4000 unites vitamin D + Cetirizine 10mg twice a day | Drug: Vitamin D3 (High dose)<br>* Daily 4000 unites vitamin D<br>* Other names: cholecalciferol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urticaria symptom severity questionnaire after 1 week | Urticaria Symptom Severity ranging from 0 to 93 | 1 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urticaria symptom severity questionnaire after 6 week | Urticaria Symptom Severity ranging from 0 to 93 | 6 weeks | 
| Urticaria symptom severity questionnaire after 12 week | Urticaria Symptom Severity ranging from 0 to 93 | 12 weeks |
Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

Study Overview
=================
Brief Summary
-----------------
This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.

Official Title
-----------------
Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.

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

Intervention / Treatment
-----------------
* Drug: Seletracetam (ucb 44212)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65. Minimum body weight of 40 kg. Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months. Patients must be receiving 1 - 3 concomitant AEDs. Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method. Exclusion Criteria: Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted). Status epilepticus within 3 months of Visit 1. History of non-epileptic seizures. Patients on vigabatrin. Patients on felbamate, unless treatment has been continuous for ≥ 18 months. Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs. Ongoing psychiatric disease other than mild controlled disorders. Patients with a clinically significant organ dysfunction. Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients. Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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: Seletracetam (ucb 44212)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of seletracetam |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in seizure frequency |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial Onset, Primary Generalized Seizures, Seletracetam
Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg gentamicin achieved target concentrations in ICU patients with severe sepsis.

Official Title
-----------------
Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis

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

Intervention / Treatment
-----------------
* Drug: 30 mg/kg amikacin or 8 mg/kg gentamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patient with severe sepsis Treated with aminoglycosides Exclusion Criteria: Renal replacement therapy Allergy to aminoglycosides Confirmed and/or suspected to have myasthenia ICU-acquired neuromuscular disorder Under guardianship Prisoners The patient has already participated in the present protocol

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: The study population<br>ICU patients with severe sepsis treated with aminoglycosides were recruited. Intervention: 30 mg/kg amikacin or 8 mg/kg gentamicin | Drug: 30 mg/kg amikacin or 8 mg/kg gentamicin<br>* In order to improve the achievement of target peak concentrations, either 30 mg/kg amikacin or 8 mg/kg gentamicin was prescribed in ICU patients with severe sepsis. In combination with broad-spectrum antibiotics, according to the suspected pathogens and local clinical practice, 30 mg/kg amikacin or 8 mg/kg gentamicin was given (30 min intravenous infusion; the dosage ampoule was systematically emptied with a 5 ml flush). The peak serum concentration sampling occurred 30 minutes after the end of the infusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of target peak serum concentration of aminosides | Achievement of targeted peak serum concentration? | 30 minutes after the end of the infusion. |
Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life.

Official Title
-----------------
Individual Patient Expanded Access Investigation New Drug (IND) Application for Administration of Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Adipose-Derived Mesenchymal Stem Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is diagnosed with later stage of Alzheimer Disease with sever cognitive disability. All current anti-Alzheimer medicines cannot prevent disease progression and the patient's mental and physical ability persistently declined Patient's legal guardian and caregiver must voluntarily sign an approved written consent form after ample explanation of the proposed therapy. Exclusion Criteria: Current diagnosis of malignancy Renal/liver dysfunction: Exceed two times as normal subject Pregnant or nursing Received other trial drugs within 30 days after participation of this study Experienced major surgery or trauma in the last 14 days

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adipose-Derived Mesenchymal Stem Cells|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
-----------------
Autologous Adipose-derived Stem Cells (AdMSCs)
Sunlight Exposure and Vitamin D Status of Children of South Asian Ethnicity Living in the UK

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren of South Asian ethnicity in each season throughout the year.

Official Title
-----------------
Sunlight Exposure and Vitamin D Status of Children of South Asian Ethnicity Living in the UK

Conditions
-----------------
Healthy Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy schoolchildren aged 12-15 years Sun-reactive skin type V (naturally brown skin) South Asian ethnicity Male or female Exclusion Criteria: History of photosensitivity disorder Non-ambulant

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 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 |
| --- | --- |
| Healthy schoolchildren<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum concentration of 25-hydroxyvitamin D | Serum vitamin D will be assessed every 3 months over a period of 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sunlight exposure received | Exposure to sunlight over 7 consecutive days is measured using polysulphone badges with one badge for weekdays and a second badge for the weekend. Exposure is assessed every 3 months for 1 year. | 1 year | 
| Change in dietary intake of vitamin D | Intake of foods containing vitamin D is recorded for a one week period once every 3 months over a period of 1 year and the average daily intake determined. | 1 year |
COVID-19 and the Developement of Phobic Fears of Disease

Study Overview
=================
Brief Summary
-----------------
A lot of people suffer from phobias. Phobias concerning certain diseases are not rare. This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able to rise phobias in people and if those with preexisting phobias or fears were more likely to develop a phobia concerning COVID. It will look at different subtypes - physicians, medical staff, general public (not medically affiliated) and patients with psychiatric disorders.

Official Title
-----------------
COVID-19 and the Developement of Phobic Fears of Disease

Conditions
-----------------
COVID19

Intervention / Treatment
-----------------
* Other: Questionnaires for specific phobia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person gives written consent Persons between 18-90 years of age (men and women) No positive COVID infection known at time of first examination Exclusion Criteria: Dementia, Delirium (not able to give consent) Not fulfilling the inclusion criteria COVID infection known at first examination point

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Physicians<br>Questionnaires | Other: Questionnaires for specific phobia<br>* Questionnaires will be used.<br>|
| Medical staff<br>Questionnaires | Other: Questionnaires for specific phobia<br>* Questionnaires will be used.<br>|
| General public<br>Questionnaires | Other: Questionnaires for specific phobia<br>* Questionnaires will be used.<br>|
| Patients with psychiatric disorders<br>Questionnaires | Other: Questionnaires for specific phobia<br>* Questionnaires will be used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of phobias | Specific Phobia Questionnaire (SPQ): The SPQ consists of 43 items, each rated using a 5-point Likert scale on two dimensions: (1) level of fear, with scores ranging from 0 (no fear) to 4 (extreme fear) and (2) extent to which the fear interferes with one's daily life, with scores ranging from 0 (no interference) to 4 (extreme interference). The SPQ is scored by combining fear ratings of each Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) specific phobia type. Severity Measure for Specific Phobia-Adult: The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia. | 2 years |
ARIA to Predict Coronary Artery Disease in HIV-infected Individuals

Study Overview
=================
Brief Summary
-----------------
With effective anti-retroviral therapy, non-communicable diseases, such as cardiovascular diseases, have become the major cause of morbidity and mortality for people living with HIV. There is only limited data evaluating the burden and risk factors of cardiovascular disease in the Asian HIV-infected population. Accurate non-invasive tools for prediction of cardiovascular disease, particularly in Asian HIV-infected populations, are urgently needed. Recently, more detailed evaluation of the complex retinal vasculature has been made feasible with advances in digitalized retinal imaging techniques. This study aims 1. to determine the prevalence of coronary atherosclerosis and obstructive coronary artery disease HIV-infected individuals with one or more cardiovascular disease risk factors in Asia. 2. to determine the performance of automatic retinal image analysis (ARIA) in predicting the risk of coronary artery disease in HIV-infected individuals, as compared to traditional risk prediction tools. Patients will undergo a coronary CT angiogram, followed by an automatic retinal image analysis within 4 weeks post completion of CT angiogram.

Official Title
-----------------
Automatic Retinal Image Analysis (ARIA) to Predict Coronary Artery Disease in HIV-infected Individuals

Conditions
-----------------
Hiv, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive anti-HIV antibody Age 30 or above Presence of one or more risk factors for cardiovascular disease Exclusion Criteria: Presence of overt coronary artery disease Impaired renal function Allergy to intravenous contrast Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Coronary atherosclerosis defined as the presence of any plaque in one or more coronary artery segments |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of any CAC, Presence of significant CAC, Obstructive coronary artery disease |  | 1 year |