linjc16/ctgov huggingface dataset:
Post-Marketing Safety Study in Japan of Shock and Anaphylaxis After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons in at High Risk of Severe COVID-19

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.

Detailed Description
-----------------
Data collected from the JDMC Claims Database between May 2021 to November 2021.

Official Title
-----------------
Cohort Survey on Shock and Anaphylaxis in Persons With Underlying Diseases Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information

Conditions
-----------------
SARS-CoV-2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases. Data period for confirmation of presence/absence of underlying disease is May 2021 to November 2021. Exclusion Criteria: Underlying diseases that were determined undetectable by the pre-screening of JMDC Participants who did not consent to the questionnaire.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants received 2 doses of mRNA-1273 vaccine approximately 4 weeks apart. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2 |  | Up to 2 days post vaccination after either the first or second vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1 |  | Up to 2 days post vaccination | 
| Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2 |  | Up to 2 days post vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Allopurinol and Quality of Life in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the impact of allopurinol on patients' related quality of life.

Detailed Description
-----------------
Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers

Official Title
-----------------
the Impact of Allopurinol of HRQOL in Cirrhotic Patients

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

Intervention / Treatment
-----------------
* Drug: Allopurinol Tablet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cirrhosis adult both sex Exclusion Criteria: renal insufficiency

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* placebo once daily<br>|
| Active Comparator: allopurinol<br> | Drug: Allopurinol Tablet<br>* allopurinol300mg once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic liver disease questionnaire | effect on Chronic liver disease questionnaire score | 6 months |
Brain Representation of Acquisition in Humans of Motor-Sensory Skills

Study Overview
=================
Brief Summary
-----------------
Interactions between the perceptual and motor systems are fundamental to the performance of complex motor tasks and are at the heart of the fine motor control required for the production of complex sounds such as speech production or playing a musical instrument. In such situations, the brain must learn to generate relevant motor commands to a sound-producing system with fixed physical characteristics, such as the vocal tract or a musical instrument. No study has yet been able to directly test the dynamic aspect of this sensorimotor learning in an acoustic production task with fine motor control. The Adolphe de Rothschild Foundation Hospital takes care of patients requiring awake surgery. During these procedures, a direct cortical recording, called electro-corticography, is performed in order to better delineate the tumor or epileptogenic resection area. Reference recordings are made in healthy areas at a distance from the lesion site making it possible to record normal brain activity. In this case, we would propose to the patient to use a tool similar to the theremin (a musical instrument the size of a golf ball whose displacement in space modulates the frequency and the harmonics of a sound). The patient should therefore learn in order to create relevant motor patterns.

Official Title
-----------------
Brain Representation of Acquisition in Humans of Motor-Sensory Skills

Conditions
-----------------
Epilepsy, Cerebral Tumor

Intervention / Treatment
-----------------
* Other: use of a theremin-type musical instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Benefiting from an intracranial brain recording during a programmed surgery in awake condition. Exclusion Criteria: Patient with complete deafness Patient with a disorder or impairment that does not allow him/her to perform the experimental task according to the investigator's judgment

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

| Intervention/Treatment |
| --- |
|Other: use of a theremin-type musical instrument|The patient will perform the task of reproducing sounds by manipulating an object. The settings of the object will be changed and the patient will have to reproduce the sounds a second time by manipulating the object.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracranial electroencephalography recording | intracranial electroencephalography recording | Day 0 |
Comparison of Mini Squat and Endurance Training in Improving Quality of Life in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Interventional type of study in which one group of participants will be given mini squats training and other endurance training to improve the quality of life of knee osteoarthritis patients.

Detailed Description
-----------------
Interventional type of study in which one group of participants will be given mini squats training and other endurance training to improve the quality of life of knee osteoarthritis patients. 3 sessions per week for 4 weeks along with interferential therapy

Official Title
-----------------
Comparison of Mini Squat and Endurance Training in Improving Quality of Life in Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Mini Squats Training
* Other: Endurance Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both gender grade 2-3 OA No Comorbidity of serious type Exclusion Criteria: Pain greater than 8 on PNS DM HTN Neurological conditions

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Interventional Model Description: Single blind Randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Mini Squats at a rate of ten squats at minimum range around 10-15 degrees at start along with Interferential Therapy for 10 minutes. | Other: Mini Squats Training<br>* Mini Squats at a rate of ten squats at minimum range around 10-15 degrees at start along with Interferential Therapy for 10 minutes.<br>|
| Active Comparator: Group B<br>Endurance training by the use of medium resistance therapeutic band at start along with Interferential Therapy for 10 minutes. | Other: Endurance Training<br>* Endurance training by the use of medium resistance therapeutic band at start along with Interferential Therapy for 10 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PNS | PAin Numeric ascale with 0 means no pain and 10 means worst pain ever | 4 weeks | 
| SF-36 Quality of Life | Lower value means low QoL and higher value means better QoL | 4 weeks |
Occupational Exposures Among Firefighters

Study Overview
=================
Brief Summary
-----------------
This study aims to understand the effect of occupational exposures, including PFAS exposures, among firefighters.

Official Title
-----------------
Effect of Occupational Exposures on Cancer Pathophysiology Among Firefighters

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: PFAS / heavy metal testing, exposures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older; any gender Currently (or previously) employed as a firefighter, full-time or part-time, participating in Vincere's First Responder Cancer Screening Program Willing to provide a blood, urine, and/or tissue sample Able to provide informed consent to participate in the study (A small group of non-firefighters will be enrolled to act as a comparison group)

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Firefighters<br> | Other: PFAS / heavy metal testing, exposures<br>* PFAS / heavy metal concentrations, exposure survey<br>|
| Non-Firefighters<br> | Other: PFAS / heavy metal testing, exposures<br>* PFAS / heavy metal concentrations, exposure survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposures associated with elevated PFAS |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer rates |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Occupational exposure
Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
To determine sleep disturbance in different types of multiple sclerosis. To asses the effect of sleep disturbance on quality of life in patients with multiple sclerosis. Correlation between sleep disturbance in different types of multiple sclerosis.

Detailed Description
-----------------
Multiple sclerosis(MS) is a neurodegenerative disease of the central nervous system that commonly affects young adults. The disease is characterized by neurological symptoms that may lead to long-term physical disability. Patients with MS have many other problems associated with their disease, as obstructive sleep apnea (OSA) that characterized by obstructions of the respiratory tract throughout the night leadind to wake up the patients many times to achieve the right muscle tone and receive adequate oxygenation. Most patients with MS complain from poor sleep.It may be due to pain, fatigue, depression and immunotherapy that have been considered as potential factors, which could have role in sleep disturbances among MS patients.Restless leg syndrome (RLS) may trigger sleep disorders, especially insomnia, in patients with MS. Patients with sleep disorders may complain excessive daytime sleepiness, impaired concentration, altered mood, and fatigue. they are at risk to develop other problems,as vascular diseases, obesity, and diabetes, which further threaten long-term health.So patients with MS have lower quality of life(QoL) than healthy ones. Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire is the most common and standardized disease-specific questionnaire that based on the generic SF-36 QoL instrument.

Official Title
-----------------
Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Conditions
-----------------
Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients fulfill the criteria of case definition of multiple sclerosis. Gender: both sexes are included. Willingness to participate in the study and to be subjected to the disease-related examinations and assessments. Willing and able to provide informed consent. Exclusion Criteria: Patients unable to give informed consent. Patients with history of psychiatric disorders or collagen disease such as Behcet's disease or other neurological or medical disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of different types of sleep disorders in patients with multiple sclerosis | Identification of different types of sleep disorders in patients with multiple sclerosis using different scales | Baseline |
C-Reactive Protein/Albumin Ratio and Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Objective: Acne vulgaris, an inflammatory disease, was investigated in this study with the claim that C-reactive protein (CRP) / albumin ratio and some hematological parameter ratios have the potential to be used as inflammatory markers to monitor disease severity and prognosis. Methods: A descriptive cross-sectional study was conducted with two groups of patients aged 18-65 years, 61 patients diagnosed with acne vulgaris and 35 healthy control patients, and routine hemogram and biochemical parameters were compared. The Global Acne Severity Index was used to determine the severity of acne vulgaris.

Official Title
-----------------
Relationships Between Disease Severity and The C-Reactive Protein/Albumin Ratio and Various Hematological Parameters in Patients With Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Diagnostic Test: Biochemical blood analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne vulgaris patients diagnosed by a dermatologist Healthy participants without acne 18-40 years of age Voluntary participation Exclusion Criteria: Aged below18 or above 40 years Not voluntarily participated patents Pregnants, breast milked mothers, emergency situations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Acne group<br>Acne Vulgaris Diagnosed Patients | Diagnostic Test: Biochemical blood analysis<br>* Serum CRP and albumin levels<br>|
| Control group<br>Healthy participants | Diagnostic Test: Biochemical blood analysis<br>* Serum CRP and albumin levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP/albumin ratio | Statistical difference between groups | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of CRP/albumin ratio as a Biomarker | New detection of CRP/albumin ratio as a new biomarker in the Acne patients | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne vulgaris, CRP albumin ratio
Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The rationale of this study is to determine if an association exists between WT1 expression and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem cell transplantation. In particular, we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients.

Detailed Description
-----------------
This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant. The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria. For each patient a total of 24 ml of bone marrow was collected at day +60 post transplant, whereas the same quantity of bone marrow was collected from healthy donor during bone marrow harvest procedure.

Official Title
-----------------
Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation

Conditions
-----------------
Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Diagnosis of acute myeloid leukemia Patients received allogeneic stem cell transplantation Signed informed consent to storage and use biological samples for research scope Signed informed consent to privacy Exclusion Criteria: Patients who had received a previous stem cell transplant Hematological disease other than acute myeloid leukemia Patient not studied for WT1 level at day +60 after transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- | --- |
| we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients |  | day 60 after transplant |
Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.

Official Title
-----------------
Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study

Conditions
-----------------
Carotid Stenosis

Intervention / Treatment
-----------------
* Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years old Carotid stenosis diagnosis with indication to perform carotid endarterectomy informed consent form signing Exclusion Criteria: age <18 years old recurrent intraocular inflammation retinal disease optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images unstable fixation spheric refractive error > +/- 6 D spheric and/or +/- 3 D cylinder history of prior ocular surgery refusal of signing informed consent form

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study population<br> | Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram<br>* Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional retinal changes | To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy | 1 week and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vascular density changes | To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy | 1 week and 3 months |