linjc16/ctgov huggingface dataset:
Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.

Official Title
-----------------
A Phase 1, Randomized Single-blind (Subject-blind), Placebo Controlled Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese male and/or female subjects of non-childbearing potential. Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg. Exclusion Criteria: History of sensitivity to lorazepam or other benzodiazepines. Evidence or history of acute narrow-angle glaucoma or sleep apnea syndrome. Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorazepam<br> | Drug: Lorazepam<br>* A single intravenous administration of 2 mg lorazepam over 1 minute<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* A single intravenous administration of 0.9% saline over 1 minute<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs). | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Day 1 to Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Day 1 | 
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | Day1 to Day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy, lorazepam, intravenous, pharmacolinetics, Japanese
Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre

Study Overview
=================
Brief Summary
-----------------
Observational study about prevalence, predictors of sodium imbalance and prognostic significance.

Official Title
-----------------
Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre

Conditions
-----------------
Sodium Imbalance in Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult and paediatric patients with isolated head injury Exclusion Criteria: age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- |
| patients with sodium imbalance<br> | |
| patients without sodium imbalance<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports |  | first 10 days after admission in icu or discharge whichever is earlier | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predisposing factors for development of sodium imbalance in traumatic brain injury patients by logistic regression analysis of data |  | first 10 days after admission in icu or discharge whichever is earlier | 
| relationship between sodium imbalance and outcome in traumatic brain injury patients by assessing Glasgow outcome score telephonically |  | 1st and 3rd month after discharge |
Use of 852A in Metastatic Cutaneous Melanoma.

Study Overview
=================
Brief Summary
-----------------
Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.

Official Title
-----------------
Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.

Conditions
-----------------
Melanoma, Unresectable Metatstatic Cutaneous Melanoma

Intervention / Treatment
-----------------
* Drug: 852A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced melanoma not responding to 1st line chemotherapy Histological evidence of melanoma Measurable disease according to RECIST criteria ECOG performance status less than or equal to 2 Life expectancy 6 months or more Normal organ and bone marrow function as defined by hematological and serum chemistry limits Adequate contraception for females of childbearing potential Exclusion Criteria: Stage IV disease which has previously progressed during interferon treatment. Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes History of uncontrolled seizure disorders Uncontrolled coagulation disorders. History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months History of uncontrolled intercurrent or chronic illness Concurrent malignancies. Brain metastases. HIV positive. Prolonged QTc interval Uncontrolled intercurrent or chronic illnesses. Pregnant or lactating women

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 852A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess the safety of the dosage regiment over 12 weeks |  |  | 
| to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncology, Melanoma
Measuring Cardiovascular Stress in Patients on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
To determine if proprietary software that uses pulse-wave analysis to interpret the output of a conventional pulse-oximeter, can predict the onset of circulatory stress, before changes in blood pressure and pulse occur, in patients undergoing outpatient hemodialysis.

Official Title
-----------------
Measuring Cardiovascular Stress in Patients on Hemodialysis

Conditions
-----------------
Hemodialysis, Hypotension, Circulatory Stress, Photo-plethysmography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having regular outpatient dialysis treatments Patients who are willing and able to provide informed consent Exclusion Criteria: Patients who do not wish to participate Patients with contraindications to attachment of monitoring devices Patients with skin rash or hypersensitivity to the adhesive sensors

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 |
| --- | --- |
| chronic hemodialysis outpatients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| photoplethysmography | Pulse-wave analysis of an oximeter signal | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | measured continuously during treatment | 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, hypotension, circulatory stress, photo-plethysmography
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis

Study Overview
=================
Brief Summary
-----------------
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis

Detailed Description
-----------------
To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to severe scalp psoriasis.

Official Title
-----------------
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS Topical Product in Patients With Mild to Severe Scalp Psoriasis

Conditions
-----------------
Scalp Psoriasis

Intervention / Treatment
-----------------
* Drug: DSXS topical
* Drug: Vehicle topical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-lactating females 18 years of age and older. Exclusion Criteria: Females who are pregnant, lactating or likely to become pregnant during the study.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSXS topical<br>applied once daily for 28 days | Drug: DSXS topical<br>* topical treatment<br>* Other names: Active;|
| Placebo Comparator: Vehicle topical<br>applied once daily for 28 days | Drug: Vehicle topical<br>* topical treatment<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success | Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2 | Day 29 |
CentriMag Failure-to-Wean Post Approval Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.

Official Title
-----------------
CentriMag Failure-to-Wean Post-Approval Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CentriMag Circulatory Support System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject >18 years of age Subject or legal representative has signed Informed Consent Form (ICF) Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from Cardiopulmonary Bypass Exclusion Criteria: • Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB

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 |
| --- | --- |
| Treatment<br>Subjects who receive the CentriMag Circulatory Support System | Device: CentriMag Circulatory Support System<br>* The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to 30 days Post CentriMag support or to hospital discharge | The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer). | 30 days | 
| Survival to induction of anesthesia for surgery for transplant or a long-term system | The proportion of subjects who do not recover and are bridged to a transplant or long-term system | Approximately 30 days |
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

Study Overview
=================
Brief Summary
-----------------
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.

Official Title
-----------------
Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: P-3058


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 2 to 17 years Males and females Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis. Positive mycroscopy examination from the target nail at screening. Positive culture for dermatophyte from the target nail at screening. Exclusion Criteria: Patients with onychomycosis caused by yeasts or non-dermatophytes mould. Patients with nail psoriasis. Patients with nail changes due to eczema, lichen planus or alopecia areata. Patients with one-hand two-foot syndrome. Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it. Use of systemic antifungal drugs in the 6 months prior to screening visit. Use of topical nail antifungal drugs in the four weeks prior to screening visit.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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: P-3058<br> | Drug: P-3058<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tolerability | Local tolerability at all treated nails by means of the Severity Score for Skin Irritation | from week 4 up to maximum week 48 of treatment |
Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Study Overview
=================
Brief Summary
-----------------
Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.

Official Title
-----------------
Incidence of Invasive Aspergillosis in Allogeneic Stem Cell Transplantation Patients: an Italian Prospective Multicentre Study

Conditions
-----------------
Hematological Diseases, Invasive Aspergillosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 16 years Allogeneic HSCT for a haematological disease Written informed consent to the study Exclusion Criteria: Pediatric patients

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Allogeneic pts<br>Adult allogeneic HSCT recipients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of invasive aspergillosis |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical applicability of the EORTC/MSG criteria in a prospective multicenter trial |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allogeneic transplantation, Invasive aspergillosis
fMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers

Study Overview
=================
Brief Summary
-----------------
EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols, Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference between the groups in regard to their emotion regulation capability will be tested by fMRI with regard to amygdala activation following EEG-NF LMI as well as two stress challenge tests.

Official Title
-----------------
Longitudinal Study of the Effect of Neurofeedback Training on Soldiers Emotional Regulation Ability and Mental Resilience to Stress.

Conditions
-----------------
Stress, Depression

Intervention / Treatment
-----------------
* Device: EEG neurofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: soldiers in preliminary combat training Exclusion Criteria: known mental disorders or neuro-pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NF group<br>This group will train modulation of the amygdala EEG fingerprint by EEG neurofeedback. | Device: EEG neurofeedback<br> <br> |
| Sham Comparator: Sham NF<br>This group preform the same procedure as the NF group only reviving sham feedback | Device: EEG neurofeedback<br> <br> |
| Active Comparator: A\T NF<br>This group will train modulation of A\T ratio by EEG neurofeedback | Device: EEG neurofeedback<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at Amygdala modulation ability | The test group will show a grater improvment from baseline in amygdala modulation abilities as measured by real time fMRI | At baseline and after 6 month of neurofeeback training. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Emotion regulation ability | The test group will show grater improvement from baseline of emotion regulation abilities as measured by implicit and explicit test and by fMRI | At baseline and after 6 month of neurofeedback training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress and depression related symptoms