linjc16/ctgov huggingface dataset:
Development of Validated Bruise Scale in HNV

Study Overview
=================
Brief Summary
-----------------
Subjects will have a mechanically induced bruise photographed over a period of 11 days to record the healing process. Assessors will rate the bruises to develop a bruising scale.

Detailed Description
-----------------
Observational study. Healthy normal volunteers will come into the clinic and have a bruise induced. The bruised area will be photographed each day through Day 11. Images will be provided to the Validator Team to rate on a 0-5 scale of severity. The actual numbers of volunteers will be adjusted to ensure there are at least 15 images for each Grade. The clinical site will be provided photography equipment, and study staff will be trained on photography technique to standardize the image quality and resolution across the study. The Validator Team will review the images and categorize them in to Grades 0-5.

Official Title
-----------------
Development of a Bruise Scale in Healthy Normal Volunteers

Conditions
-----------------
Bruise, Contusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick skin type 1-3 BMI 25 kg/m2 Self described bruisers Intact skin in the target area, free of markings, blemishes and hair Exclusion Criteria: Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing Inability to forego application of topical products in the target area Hair removal by laser, wax or chemicals within one week prior to Day 1 Avoid tanning beds Active wound or infection in the target area History of keloids or hypertrophic scarring History of collagen or vascular disease History of organ transplant

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bruise Healing over time | Record bruise images over 11 days | 11 days |
Sit-to-stand With Feedback in SCI Patients

Study Overview
=================
Brief Summary
-----------------
Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI? Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week training?

Detailed Description
-----------------
To compare immediate effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI To compare 2 weeks effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI.

Official Title
-----------------
The Provision of External Feedback During Sit-to-stand in Ambulatory Patients With Spinal Cord Injury

Conditions
-----------------
Injuries, Spinal Cord

Intervention / Treatment
-----------------
* Other: feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory spinal cord injury patients Exclusion Criteria: Deformity of musculoskeletal system

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback<br>Subjects will be trained using the sit-to-stand weight-taking machine. Prior to the training, subjects sit in a standard sitting position. Then they will be instructed to take most of their body-weight onto the legs while they standing up where the light bars will be gradually lightened from the red, yellow and green zones according to the level of LLL. Then they stand up, hold a standing position for 3-5 seconds and sit-down with always maximize their body-weight onto their legs during performing the task in which the green zone will always be lightened. | Other: feedback<br>* Sit to stand training with external feedback<br>|
| Sham Comparator: No feedback<br>Subjects will be trained using the same instruction and protocol as the experimental group, but without the provision of external feedback. | Other: feedback<br>* Sit to stand training with external feedback<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10MWT | walking speed test | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
feedback
Long-Term Follow-up of Subjects Who Were Treated With ST-920

Study Overview
=================
Brief Summary
-----------------
Long-term follow-up of subjects who received ST-920 in a previous trial (ST-920-201) and completed at least 52 weeks post-infusion follow-up in their primary protocol. Enrolled subjects will be followed for a total of up to 5 years following ST-920 infusion.

Detailed Description
-----------------
Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with ST-920 in the clinical study ST-920-201. All subjects dosed in the study who completed at least 52 weeks post-infusion follow-up in their primary protocol will be offered to participate. Subjects who enroll will be monitored for a total of up to 5 years following ST-920 infusion.

Official Title
-----------------
Long-Term Follow-up of Fabry Disease Subjects Who Were Treated With ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy

Conditions
-----------------
Fabry Disease, Fabry Disease, Cardiac Variant

Intervention / Treatment
-----------------
* Biological: ST-920


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who received ST-920 therapy in a separate parent trial Subjects who have consented to participate in this LTFU study. Exclusion Criteria: -This study has no exclusion 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who received ST-920<br>Subjects who received ST-920 in a separate parent trial | Biological: ST-920<br>* No study drug is administered in this study. Subjects who received ST-920 in a separate parent trial will be evaluated in this trial for long-term safety.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate long-term safety of ST-920 | To evaluate long-term safety of ST-920 by assessment of incidence and severity of adverse events (AEs) | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry Disease, Gene Therapy, ST-920, Rare, Genetic, DNA, Sangamo, Long Term
RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma

Study Overview
=================
Brief Summary
-----------------
The investigators proposed to compare a modified Prolonged Exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of PTSD.

Official Title
-----------------
RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma

Conditions
-----------------
Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Behavioral: modified Prolonged Exposure
* Behavioral: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive motor vehicle crash (MVC), industrial accident, and physical assault trauma survivors (i.e. victims of gunshot wounds, stab wounds), ages 18-75, to include both men and women, without evidence of serious cognitive impairment, admitted to the trauma surgery service at Froedtert Hospital beginning at the start of the funding period will be considered for recruitment. Exclusion Criteria: Individuals who: have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury, have self-inflicted injury, are more than 2 weeks post-trauma, do not meet the DSM-5 definition of a traumatic stressor for PTSD, screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis), are non-English speaking, are not medically stable, cannot identify a support person to attend a session with them do not score a 2 or more on the 5-item PTSD subscale of the 9-item screen.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified Prolonged Exposure<br> | Behavioral: modified Prolonged Exposure<br> <br> |
| Active Comparator: Treatment as usual<br> | Behavioral: Treatment as usual<br>* May include consult to health psychology and any follow-up deemed appropriate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale | Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms. | Three months post-trauma |
Treatment of Sodium Retention in Liver Cirrhosis With Dexamethasone

Study Overview
=================
Brief Summary
-----------------
Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented.

Official Title
-----------------
Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with established liver cirrhosis (biopsy or biochemically) hepatorenal syndrome type 1 or 2 (with a serum creatinin >175 umol/l) age between 18 and 75 no bacterial infection no cardiovascular or extrahepatic disease (end of life) no structural kidney disease no hepatocellular carcinoma Exclusion Criteria: age under 15 or over 75 treatment with corticosteroids (dexamethasone included) bacterial infection cardiovascular or extrahepatic disease (end of life) structural kidney disease (indicated by hematuria, proteinuria) hepatocellular carcinoma mental disability

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br> | Drug: Dexamethasone<br>* Daily administration of 2 mg of dexamethasone for 4 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Daily administration of 2 mg of placebo for 4 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily sodium excretion of sodium in the urine |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily potassium excretion |  | 4 days | 
| weight reduction |  | 4 days | 
| Reduction of doses of diuretics |  | 4 days | 
| Reduction of ascites |  | 4 days | 
| Reduction of cortisol excretion in the urine |  | 4 days | 
| Reduction of cortisol levels in the urine |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexamethasone, Sodium
COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

Study Overview
=================
Brief Summary
-----------------
COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.

Official Title
-----------------
COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Convalescent plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU With or without ventilatory assistance Treated or not with hydroxychloroquine 200 mg. every 12 hours Indistinct sex Older than 18 years Signed informed consent Exclusion Criteria: Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab. Patients with severe kidney failure who require replacement therapy.

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: Convalescent Plasma<br>200 ml of convalescent plasma, single dose. | Biological: Convalescent plasma<br>* Convalescent plasma obtained by aphaeresis from recovered patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung injury | PaO2/FiO2 relation | 7 days | 
| Overall survival | Patients survival after therapy | 15-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions to plasma | Determine the incidence of side effects from plasma administration | 7 days |
Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations

Study Overview
=================
Brief Summary
-----------------
An aberrometer measures visual aberrations by mapping how light rays travel through the eye and by providing maps using colored gradients to represent the magnitude of refractive errors of the eye. The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology), Zywave (Bausch & Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc). In particular, the investigators propose to focus on the ability of these devices to display the higher order visual aberrations and to compare the quality of outputs from these 4 devices in normal healthy subjects.

Official Title
-----------------
Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations

Conditions
-----------------
Normal Individuals With Visual Aberrations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female, at least 18 years of age no ocular abnormality other than refractive error patient in generally good & stable overall health has not worn contact lenses (hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 3 days) prior to the study exam corneal topography must be normal, as judged by the investigator topical anesthesia and mydriatics must be tolerated patient must be able to fixate steadily ability to understand and provide informed consent to participate in this study Exclusion Criteria: history of ocular surgery history of ocular trauma, infection, disease, or abnormality other than refractive error myopia or hyperopia > 7.0 D, astigmatism >3.0 D uncorrectable visual acuity below 20/20 abnormal corneal topography pattern including, but not limited to keratoconus, forme fruste keratoconus, or corneal warpage pupil sizes below 6.0 mm under mydriasis iris problems including, but not limited to, coloboma and previous iris surgery ocular media problems, corneal, lens and/or vitreous opacities including, but not limited to cataract ocular movement abnormalities including, but not limited to, strabismus or nystagmus phenol red thread test (Zone Quick-Menicon Ltd) less than 9 mm/15 seconds pregnancy and lactation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
GABA-glutamate Interactions and Psychosis

Study Overview
=================
Brief Summary
-----------------
This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by ERPs (event-related potentials) in healthy volunteers.

Official Title
-----------------
Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction

Conditions
-----------------
Cognitive Dysfunction

Intervention / Treatment
-----------------
* Drug: iomazenil
* Drug: iomazenil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Ages of 21-45 years from all ethnic backgrounds. Male or female. Written informed consent. Exclusion criteria: DSM-IV diagnosis for a psychotic, depressive or anxiety disorder. A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox). History of abnormal EEG. History of severe allergies or multiple adverse drug reactions. Any medication that could interfere with either the safety of the study and/or the outcome measures. Any other conditions which in the opinion of the investigator would preclude participation in the study. History of major psychiatric disorder in first degree relatives. Current substance abuse/dependency determined by urine toxicology. Treatment with medications with CNS effects. Treatment with benzodiazepines within one week prior to testing. Current treatment with medications with psychotropic effects. Education < 10th grade. IQ < 70, MR. Non-English speaking.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Active iomazenil and ketamine | Drug: iomazenil<br>* Given as IV infusion<br>|
| Placebo Comparator: 2<br>placebo iomazenil and ketamine | Drug: iomazenil<br>* saline IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P300 as an ERP measure |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMN (Mismatch Negativity) |  | prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GABA, glutamate, NMDA, P300, MMN
Effects of Stimulus Validity on Speech Recognition

Study Overview
=================
Brief Summary
-----------------
The effects of talker variability will be investigated with four groups of listeners (young normal-hearing; old normal-hearing; young hearing-impaired; old hearing-impaired). Experimental conditions will include between-talker differences, speaking rate, lexical difficult and semantic/linguistic context. A preliminary experiment will evaluate the relative merit of adaptive vs fixed-level methods of stimulus presentation.

Official Title
-----------------
Effects of Stimulus Validity on Speech Recognition

Conditions
-----------------
Hearing Impaired

Intervention / Treatment
-----------------
* Behavioral: Talker variability


Participation Criteria
=================
Eligibility Criteria
-----------------
Hearing impaired

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Talker variability|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
-----------------
Hearing loss, speech recognition