linjc16/ctgov huggingface dataset:
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.

Official Title
-----------------
A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses

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

Intervention / Treatment
-----------------
* Drug: AZD2516
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old. Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2 Exclusion Criteria: History of previous or ongoing psychiatric disease. Abnormalities in ECG that may interfere with interpretation of data.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD2516<br> | Drug: AZD2516<br>* Solution administered once orally<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Solution administered only once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables |  | From first to last visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2516 by assessment of non-serious adverse events |  | Collected from start of residential period until last visit. | 
| Determine the single ascending dose pharmacokinetics of AZD2516 |  | PK sampling taken at defined timepoints during residential period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple dosing study,, safety
Mechanisms of Anaphylaxis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore different mechanisms for anaphylaxis and find novel biomarkers for this hypersensitivity syndrome. The study participants are patients with anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion reactions. The investigators will also include a group of healthy controls.

Official Title
-----------------
Mechanisms of Anaphylaxis

Conditions
-----------------
Anaphylaxis, Allergy, Transfusion Reaction, Febrile Transfusion Reaction

Intervention / Treatment
-----------------
* Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to the specific cohort: Diagnosis of anaphylaxis Mild allergic reaction Febrile transfusion reaction Healthy, no known allergic disease Exclusion Criteria: Suspicion or diagnosed sepsis Children

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 120 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 |
| --- | --- |
| Anaphylaxis<br> | Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)<br>* Analysis of biomarkers and basophil activation test<br>|
| Febrile transfusion reactions<br> | Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)<br>* Analysis of biomarkers and basophil activation test<br>|
| Mild allergic reactions<br> | Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)<br>* Analysis of biomarkers and basophil activation test<br>|
| Healthy controls<br> | Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)<br>* Analysis of biomarkers and basophil activation test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome | Immunological/nonimmunological mechanism | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet activating factor, Basophil activation test, Anaphylatoxins
The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.

Study Overview
=================
Brief Summary
-----------------
Androgenetic alopecia is the most common type of hair loss in men, and affects approximately 50 percent of Caucasian men by age 50. The condition is characterized by the progressive loss of terminal hairs on the scalp in a characteristic distribution. The anterior scalp, mid scalp, temporal scalp, and vertex of the scalp are typical sites of involvement. Male balding and male pattern hair loss are additional terms used to refer to this condition. The aim of this study is to investigate the effect of microneedling in androgenic alopecia

Official Title
-----------------
The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.

Conditions
-----------------
Dermatologic Disease

Intervention / Treatment
-----------------
* Device: accupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - androgenic alopecia patients Exclusion Criteria: infection, immune disorder, other dermatosis in treating areas

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

| Intervention/Treatment |
| --- |
|Device: accupuncture|accupuncture|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hair regrowth(7-point rating scale (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).) | hair regrowth(7-point rating scale (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased).) | 12weeks |
A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection

Study Overview
=================
Brief Summary
-----------------
A new enzymatic assay was developed by NMD Diagnostics for rapid diagnosis of Enteroviral CNS infection. This study will compare this assay to RT-PCR, by testing human CSF samples taken from children at the ER who are undergoing a spinal tap due to suspicion of meningitis.

Detailed Description
-----------------
MND's new enzymatic assay is based on the detection of a specific viral enzyme through the detection of its enzymatic reaction. The detection of a specific enzymatic reaction is indicative to the presence of the specific virus in a biological specimen. This study will compare this diagnostic assay to RT-PCR for diagnosis of enteroviral infection in cerebrospinal fluid. CSF samples will be taken from children undergoing a spinal tap at the pediatric ER due to a suspicion of meningitis. A total of 100 samples will be collected, from children 0-16 years old who's parents agreed on participation in the study. A comparison of the enzymatic assay to RT-PCR as well as calibration and validation of the new assay will be done with the harvested samples, for a rapid and accurate identification of Enterovirus in human cerebrospinal fluid.

Official Title
-----------------
A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection

Conditions
-----------------
Viral Meningitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any child undergoing a spinal tap parents agreed on participation Exclusion Criteria: refusal to participate in the study

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| pediatric ER<br>any child undergoing a spinal tap due to suspected meningitis | |

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
-----------------
enterovirus, aseptic meningitis, real time PCR, diagnostics
AR Ruler to Improve Safety and Clinical Workflow During PICC Placement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the utility of an augmented reality virtual ruler during placement of peripherally inserted central catheters.

Detailed Description
-----------------
After being informed about the study, patients who give consent will have their peripheral inserted central catheter placed by a physician wearing mixed reality smart glasses. The mixed reality smart glasses will have an application that allows the physician to measure distances with their hands. This application will be used to measure the appropriate length for which to trim the central catheter.

Official Title
-----------------
Augmented Reality Ruler to Improve Safety and Clinical Workflow During Placement of Peripherally Inserted Central Catheters

Conditions
-----------------
Insertion of Peripherally Inserted Central Catheter

Intervention / Treatment
-----------------
* Other: Augmented reality virtual ruler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for a non-emergent peripherally inserted central catheter placement in Interventional Radiology Over 18 years Exclusion Criteria: Undergoing an emergent peripherally inserted central catheter placement Younger than 18 years old

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented reality virtual ruler<br>Patient's in this arm will have their physician use an augmented reality virtual ruler to measure catheter length during catheter placement. | Other: Augmented reality virtual ruler<br>* Use of augmented reality virtual ruler to measure catheter length<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with appropriate catheter tip location | Catheter tip location will be evaluated by the treating physician on x-ray | End of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose | Total radiation dose of the procedure will be captured from the fluoroscopy machine | End of procedure | 
| Procedure time | Procedure time to complete catheter placement will be captured from the radiology information system. | End of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheters, Augmented Reality, Radiology, Interventional
Influence of Postoperative Rehabilitation and Pre- and Postoperative Physical Activity in Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of patients. This strategy targets multiple elements (20 items) to support pre-, intra- and postoperative patients. This reduces the pain and the different organ dysfunction induced by surgical stress significantly decreasing length of hospital stay, postoperative morbidity and costs. Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies have analyzed the influence of preoperative exercise on postoperative rehabilitation.

Conditions
-----------------
Abdominal Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria non-cancerous and cancerous pathology signed Consent Every patient operated on a scheduled or emergency abdominal surgery Exclusion criteria inability to give informed about information minor Patient

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 |
| --- | --- | --- |
| quality of life questionnaire |  | before and after the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early rehabilitation, abdominal surgery, ERAS
The Influence of Covid-19 on the Audio-vestibular System

Study Overview
=================
Brief Summary
-----------------
the study's porpuse is to examine whether Covid-19 causese a reduction in sensorineural hearing and vestibular function in recovered pateints - compared to healthy controls. Both study groups will undergo audiometry, tympanometry, Video Head Impulse testing, Subjective Visual Vertigo testing and Video-Nystamography. Previous audiometry results will also be aquired.

Official Title
-----------------
The Influence of Covid-19 on the Audio-vestibular System

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Audio-Vestibular evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-80 performed audiometry testing in the last two years Exclusion Criteria: known inner ear dysfunction - Sudden sensorineural hearing loss; autoimmune disease (Cogan's syndrom, SLE, ect.), familial/genetic sensorineural hearing loss, excessive noise exposure. knowm conductive hearing loss (Air-bone gap>10dB) prior ear surgery chronic tympanic membrane perforation.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Recovered Covid-19 patients<br>Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG. | Diagnostic Test: Audio-Vestibular evaluation<br>* Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.<br>|
| Other: Healthy Control<br>Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG. | Diagnostic Test: Audio-Vestibular evaluation<br>* Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensoneural hearing level - PTA | PTA at each frequency will be compared between new and baseline audiogram for each group. Afterwhich - the average PTA decreament would be compared betwenn both groups - contrl and recovered COVID-19 patients | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vestibular function | vestibular function will be compared netween the two groups after VHIT, SVV and VNG testing | through study completion, an average of 1 year |
Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients

Study Overview
=================
Brief Summary
-----------------
This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.

Detailed Description
-----------------
Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease

Conditions
-----------------
Anemia, Sickle Cell, Pneumonia

Intervention / Treatment
-----------------
* Drug: Arginine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia) Acute chest syndrome with the following: New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following: Fever Cough, tachypnea, retractions, rales, or wheezing Chest pain Exclusion criteria: Inability to take or tolerate oral medications Hepatic dysfunction (SGPT greater than 2 times normal) Renal dysfunction (creatinine greater than 2 times normal) Mental status or neurological changes Allergy to arginine History of priapism Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Arginine hydrochloride|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
-----------------
Nitric Oxide, Administration, Oral
Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics

Study Overview
=================
Brief Summary
-----------------
In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. How obesity affects asthma is not fully understood. This research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways. Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens. This research study includes optional genetic and bronchoscopy substudies.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 to 70 years of age If asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid Never smoked or limited smoking history Exclusion Criteria: Current upper respiratory illness (other than asthma) Illegal drug use within past month Consumption of more than 6 alcoholic drinks per week Active, pronounced rhinitis or sinusitis Pregnancy Currently taking oral steroids or steroid injection over the past month Asthma exacerbation over the past month Certain medical illnesses

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Asthmatics | Other: No intervention<br>* no intervention<br>|
| 2<br>Healthy volunteers (without asthma) | Other: No intervention<br>* no intervention<br>|

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
-----------------
asthma, inhaled corticosteroids