linjc16/ctgov huggingface dataset:
Plan for Testing Fingerstick Bloods on Magellan Systems

Study Overview
=================
Brief Summary
-----------------
This study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II instrument in development.

Official Title
-----------------
Plan for Testing Fingerstick Bloods on Magellan Systems

Conditions
-----------------
Lead Poisoning

Intervention / Treatment
-----------------
* Device: Lead testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects who consent to a capillary blood collection Exclusion Criteria: Patients are not currently taking chelating agents, e.g., penicillamine, succimer
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 |
| --- | --- |
| Adult<br>Patients aged 18+ years | Device: Lead testing<br>* Fingerstick<br>|
| Children 7 - 17<br>Patients aged 7 - 17 years | Device: Lead testing<br>* Fingerstick<br>|
| Children <7<br>Patients aged under 7 years | Device: Lead testing<br>* Fingerstick<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead poisoning | >10ug/dL lead in whole blood is considered lead poisoning These measurements will be taken to compare the fingerstick data collected in the field with data received through reference method | 1 day |
Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters

Study Overview
=================
Brief Summary
-----------------
Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?

Official Title
-----------------
Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters

Conditions
-----------------
Neovascular

Intervention / Treatment
-----------------
* Procedure: laser photocoagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: untreated Proliferative diabetic retinopathy Exclusion Criteria: Previous photocoagulation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: photocoagulation<br>Laser photocoagulation | Procedure: laser photocoagulation<br>* Laser photocoagulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stabilization of proliferative diabetic retinopathy |  | 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic retinopathy, Diabetic macular edema, Panretinal photocoagulation
Impact of COVID 19 on Psoriasis Patients

Study Overview
=================
Brief Summary
-----------------
The main objective of this work is to investigate the effect of COVID-19 pandemic on psoriasis patients. This work is designed as a cross-sectional survey based on a questionnaire directed to Egyptian psoriasis patients.

Official Title
-----------------
COVID 19 Impact on Psoriasis Patients, a Hospital Based Study

Conditions
-----------------
The Impact of COVID19 on Psoriasis Patients

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psoriaisis patients Exclusion Criteria: Children

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaire to assess the impact of COVID 19 on psoriasis patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | To assess the effect of COVID 19 on psoriasis disease, treatment, follow up, vaccine | 2-4 weeks |
Incidence of HANA Conditions in HIV-infected Individuals

Study Overview
=================
Brief Summary
-----------------
With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy. But at the same time, HIV-associated non-AIDS (HANA) conditions are becoming more important in their clinical management. It is currently uncertain whether patients started on different anti-retroviral regimens will have different incidence of HANA conditions. This study aims to evaluate the incidence of various HANA conditions in a cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating anti-retroviral treatment. The incidence of various HANA conditions will be evaluated for those receiving INSTI versus other non-INSTI-based regimens. The HANA conditions evaluated will include 1. Hypertension 2. Diabetes and insulin resistance 3. Dyslipidemia 4. Lipodystrophy 5. Metabolic syndrome 6. Osteopenia and osteoporosis 7. Vitamin D deficiency 8. Renal impairment and kidney tubular dysfunction and 9. Liver fibrosis. Patients will be assessed prior to initiation of anti-retroviral therapy, and 48 weeks and 96 weeks after initiation of treatment. The incidence of development of each HANA condition will be determined and compared between those initiated different anti-retroviral regimens.

Official Title
-----------------
A Prospective Longitudinal Cohort Study to Determine the Incidence of HIV-associated Non-AIDS Conditions in Newly Diagnosed HIV-infected Individuals Initiating Integrase Inhibitor-based and Other Anti-retroviral Regimens

Conditions
-----------------
Liver Fibroses, HIV, Metabolic Syndrome, Osteopenia, Osteoporosis, Vitamin D Deficiency, Renal Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed HIV infection by HIV antibody or RNA test Age ≥40 years old Anti-retroviral treatment naïve Agree to initiate anti-retroviral therapy (ART) as determined by in-charge HIV physician Exclusion Criteria: Pregnancy Unable to give informed consent

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 |
| --- | --- | --- |
| HANA incidence | The incidence rates of HANA conditions which will be assessed. | 96 weeks |
Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery

Study Overview
=================
Brief Summary
-----------------
Exploring the reorganization (plasticity) of neuroanatomic networks associated with language and memory in patients with left (or dominant hemisphere) temporal lobe epilepsy using functional MRI (fMRI)

Detailed Description
-----------------
The purpose of this study is to explore the reorganization of neuroanatomic networks associated with language and memory in adult patients with temporal lobe epilepsy (ELT). By using functional MRI, patients will be examined before and after surgery. Cerebral plasticity, defined in terms of intrinsic variables such as the topography of the activated regions, will be explored according to some extrinsic factors such as the age at onset of crises (before or after 5-6 years), whether or not Hippocampal sclerosis, hemispheric predominance of language (left or right).

Official Title
-----------------
Cartography of Functional and Epileptic Cerebral Areas by Functional MRI and Electroencephalography in Epileptic Patients Before and After Surgery

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

Intervention / Treatment
-----------------
* Other: functional MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epileptic patients medical exam before inclusion social security affiliation Pharmaco-resistant epilepsy Exclusion Criteria: MRI contraindication pregnant women breastfeeding mothers person under tutorship

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Interventional Model Description: 2 arms : epileptic patient and healthy volonteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epileptic patients<br>2 functional MRI (pre and post resective surgery) with memory and language tasks | Other: functional MRI<br> <br> |
| Other: Healthy volunteers<br>1 functional MRI with memory and language tasks | Other: functional MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuronal reorganization exploration in language and memory area thanks to functionnal MRI | fMRI exam before and after resection surgery of epileptogenic area: assess (plasticity) of neuroanatomic networks associated with language and memory - examined before and after surgery | one hour for each exam |
Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative Thrombotic Thrombocytopenic Purpura (TTP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.

Official Title
-----------------
Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative TTP

Conditions
-----------------
Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac surgery with or without (OPCAB) the use of extracorporeal circulation patient agrees Exclusion Criteria: no agreement known TTP in medical history

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 |
| --- | --- |
| with extracorporeal circulation<br>Patients undergoing cardiac surgery with the use of an extracorporeal circulation | |
| without extracorporeal circulation<br>Patients undergoing cardiac surgery without the use of extracorporeal circulation (OPCAB) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADAMTS13-Activity over time |  | during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADAMTS13-Antibody over time |  | during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery | 
| Change in Platelet count over time |  | during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery | 
| time duration of extracorporeal circulation during surgery |  | during surgery | 
| Amount of intraoperative given fluid replacement |  | during surgery | 
| Amount of given blood products (red blood cells) |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, adamts13, TTP, extracorporeal circulation, Heart-Lung Machine
Virtual Reality Hypnosis for Chronic Pain Reduction

Study Overview
=================
Brief Summary
-----------------
We would like to determine how well hypnosis works when induced through virtual reality medium for patients who have suffered a major burn injury in the past two years and suffer from chronic pain. These patients are coming back to the outpatient burn and plastic clinic at Harborview Medical Center for routine follow-up. We think that patients will find VR-Hypnosis interesting, and it will help them relax and feel less pain.

Official Title
-----------------
Virtual Reality Hypnosis for Chronic Pain Reduction

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

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality Hypnosis for chronic pain
* Behavioral: Virtual Reality Distraction for Chronic Pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 13 - 75 years Able to complete subjective evaluations of pain English-speaking Able to communicate orally Exclusion Criteria: Age less than 13 years or greater than 75 years Incapable of indicating subjective evaluation of pain Non-English-speaking (Virtual Reality Hypnosis only available in English) Demonstrating delirium, psychosis, or Organic Brain Disorder Unable to communicate verbally Significant developmental disability Extreme susceptibility to motion sickness Significant head/or neck injury Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Hypnosis<br>Virtual Reality Hypnosis for chronic pain | Behavioral: Virtual Reality Hypnosis for chronic pain<br>* At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Hypnosis. After VRH, the will again answer Pain and anxiety questionnaires.<br>|
| Experimental: Virtual Reality Distraction<br>Virtual Reality Distraction for Chronic Pain | Behavioral: Virtual Reality Distraction for Chronic Pain<br>* At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Distraction. After VRD, the will again answer Pain and anxiety questionnaires.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and anxiety | The subjects will answer questions regarding pain and anxiety at the time of their clinic visit, before and after experiencing virtual reality. Then the subject will be followed for up to one month. | pre and post VR and then up to one month |
Isocyanate Dermal Exposures in Autobody Shops

Study Overview
=================
Brief Summary
-----------------
To characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI) in the auto body industry.

Detailed Description
-----------------
BACKGROUND: Isocyanates account for the highest number of reported cases of occupational asthma in the United States and developed countries. Prevention, however is limited by inadequate knowledge of isocyanate routes of exposure, exposure patterns, mechanisms of sensitization and other causal factors. The Survey of Painters and Repairers of Auto Bodies by Yale (SPRAY), a five-year cross-sectional epidemiologic survey of painters and repairers of autobodies at Yale was therefore initiated to address these questions. At the outset of Spray, it was not known how frequent skin contact among the painters might be. Moreover, there is new and exciting data from animal studies demonstrating that dermal rather than respiratory contact may be crucial to immune sensitization leading to asthma. Little is known, so far, about dermal exposure in autobody shops and its modifiers, especially the effectiveness of personal protective equipment (PPE) in preventing workers from skin contamination by isocyanates. DESIGN NARRATIVE: The study was ancillary to the SPRAY study and was integrated into it. The overall design was a cross-sectional investigation of 20 shops with 120 workers. This would allow a better understanding of the complex basis for asthma risk in these workers, and better recommendations to autobody shops and workers on protective measures for isocyanate dermal exposures. Specific aims included: 1) Qualitatively and quantitatively assessing surface and skin contamination of HDI; 2) Identifying modifiers that affected surface and skin contamination, and specifically evaluating the effectiveness of personal protective equipment in protecting the skin from isocyanate contamination; 3) Exploring the relationships of dermal exposure with airborne exposure, biomarkers of systemic absorption and skin sensitization, and asthma-developing risk. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.

Detailed Description
-----------------
This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.

Official Title
-----------------
A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: azelaic acid pre-foam formulation
* Drug: Vehicle pre-foam formulation
* Drug: Water
* Drug: Sodium lauryl sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers male ore female subjects aged 18 - 65 years ability to understand and fulfill the study requirements Exclusion Criteria: affected skin in designated test area pregnancy or lactation not willing to comply with study requirements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Topical application of verum (azelaic acid pre-foam formulation) on the skin | Drug: azelaic acid pre-foam formulation<br> <br> |
| Placebo Comparator: Vehicle<br>Topical application of vehicle formulation (same as verum but without active drug substance) on the skin | Drug: Vehicle pre-foam formulation<br> <br> |
| Placebo Comparator: Negative control<br>Topical application of distilled water (negative control) on the skin | Drug: Water<br> <br> |
| Active Comparator: Positive control<br>Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin | Drug: Sodium lauryl sulfate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| irritancy rating scale | skin reaction as well as superficial layer effects will be scored according to standardized scales | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermal irritative potential
Health Outcomes and Costs (HOC) in Lung Cancer (LC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the costs, health-related quality of life and preference values from lung cancer patients assisted in a Brazilian public health care unit.

Detailed Description
-----------------
The costs will be assessed by micro-costing approach. All procedures involved in lung cancer at diagnosis, staging, treatment and best supportive care will be assessed. The health-related quality of life will be assessed by EORTC-QLQ-C30, EQ-5D and EORTC-QLQ-LC13 in all different stages of lung cancer. An utility measure will be considered. The preference values will be assessed via discrete choice experiment. Two scenarios will be designed and the lung cancer patients will be asked about the preferences.

Official Title
-----------------
Health Outcomes and Costs (HOC) in Brazilian Public Health Care System - The HOC Study in Lung Cancer

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lung cancer disease Able to understand the overall concept of study and sign the written informed consent Exclusion Criteria: Illiterate Visible cognitive impaired Non-primary lung tumor

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 |
| --- | --- | --- |
| Direct costs | Direct costs related to each procedure involved on lung cancer | one year | 
| HRQoL |  | up to 30 days after the procedure | 
| Preference values | Evaluate preference values in hypothetic scenarios | cross sectional |