linjc16/ctgov huggingface dataset:
Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)

Study Overview
=================
Brief Summary
-----------------
Evaluate the long-term safety of amifampridine phosphate in the symptomatic relief of antibody positive MuSK-MG.

Official Title
-----------------
Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis

Conditions
-----------------
Myasthenia Gravis, MuSK

Intervention / Treatment
-----------------
* Drug: Amifampridine Phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in the MSK-002 study Exclusion Criteria: Epilepsy and currently on medication Clinically significant abnormalities in ECG, in the opinion of the Investigator

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: amifampridine phosphate<br>tablets equivalent to 10mg amifampridine, 3 to 4 times per day | Drug: Amifampridine Phosphate<br>* tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Evaluate the long-term safety and tolerability amifampridine phosphate through the number of patients with treatment-emergent adverse events mapped to the Medical Dictionary for Regulatory Activities (MedDRA) SOCs and PTs. [ Time Frame: over 21 monts ] Descriptive statistics will be used to summarize study data. | over 21 months |
Evaluation of Clinical Airway Assessments With a Gray Zone Approach

Study Overview
=================
Brief Summary
-----------------
Failure of advanced airway security has been reported that it could lead lethal complication such as brain hypoxic damage. There have been controversial reports for the airway assessment tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity of pre-existing airway assessment tests and scoring system using a gray zone approach in patients undergoing general anesthesia required endotracheal intubation.

Detailed Description
-----------------
POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)

Official Title
-----------------
Evaluation of Clinical Airway Assessments for Predicting Difficult Laryngoscopy Using a Gray Zone Approach

Conditions
-----------------
Difficult Laryngoscopy

Intervention / Treatment
-----------------
* Other: Measurements of parameters related with physical examinations for difficult airway prediction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 80 years old patients undergoing general anesthesia for any operation. Exclusion Criteria: previous difficult airway history upper airway obstruction disease congenital disorders that are known to relate with difficult airway neurologic symptom associated with neck extension emergent operation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
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 |
| --- | --- |
| Preoperative airway examination<br>patients undergoing general anesthesia for any surgery | Other: Measurements of parameters related with physical examinations for difficult airway prediction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of glottic opening (POGO) | POGO image will be captured using attachable fiberoptic scope. | During laryngoscopy manipulation for endotracheal intubation (average 3min after muscle relaxant is delivered) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical examinations, Percentage of glottic opening(POGO)
Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
This study involves the collection ocular lens tissue from individuals with Down syndrome and age-matched controls at the time of cataract surgery.

Detailed Description
-----------------
Individuals with Down syndrome have an increased rate of cataract. The reason for this increase is unclear. Normally, once cataracts become a significant impairment, an ophthalmologist will determine when cataract surgery should be performed. When this surgery is performed, cataractous tissues are cut out and discarded with medical waste. In this study, these tissue will be collected and protein analysis performed to determine what changes in different proteins are found in Down syndrome lenses as compared to normal cataractous lenses.

Official Title
-----------------
Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome

Conditions
-----------------
Cataract, Down Syndrome

Intervention / Treatment
-----------------
* Procedure: cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing cataract surgery for lens extraction. Exclusion Criteria: Known genetic cause other than Down syndrome causing cataract.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- |
| Down syndrome<br>Individuals with Down syndrome undergoing cataract surgery. | Procedure: cataract surgery<br>* tissue collection.<br>|
| Control<br>Age-matched controls undergoing cataract surgery. | Procedure: cataract surgery<br>* tissue collection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in protein composition | western blot analysis of proteins from cataractous tissue | one week after collection of tissue |
Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori (H. pylori), a bacteria transmitted from human to human through upper digestive tract as well as fecal-oral transmission, had infected more than half of people around the world. However, the quantity of H. pylori in oral cavity and its influence on oral microbiota remains to be unclear. The aim of the present study was to examine the effects of H. pylori infection as well as its eradication on oral microbiota.

Official Title
-----------------
Analysis of the Impact of Helicobacter Pylori Infection and Eradication on Salivary Microbiome in Adults by 16S Pyrosequencing

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Amoxicillin
* Drug: Bismuth Potassium Citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with non-ulcer functional dyspepsia or peptic ulcer disease Ability and willingness to participate in the study and to sign and give informed consent Received both endoscopy and 13C urea breath test (13C-UBT) before enrolled Exclusion Criteria: Less than 18 years old With previous gastric surgery Major systemic diseases Pregnancy or lactation Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion The use of antibiotics or PPI within 2 months before the study The presence of dental carious or any untreated cavitated carious lesions and oral abscesses

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bismuth Plus triple Therapy<br>Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Amoxicillin<br>* Antibiotics for H. pylori eradication<br>* Other names: Metronidazole;Drug: Bismuth Potassium Citrate<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of saliva microbiota after eradication | Two months after completion of therapy, saliva microbiota was assessed by 16S rDNA Pyrosequencing. | Two months after completion of therapy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
helicobacter pylori, saliva microbiota
Use of Complementary and Alternative Medicine Among Older Mexican Americans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine complementary and alternative medicine use among older Mexican Americans and to determine how this use influences physical, functional, and mental health.

Detailed Description
-----------------
Alternative medicine has received increasing attention from both the scientific and public communities. While the majority of current alternative medicine use is the result of interest in replacing or augmenting formal medical treatments, several cultures have long-standing traditions of herbal medicine use, particularly among older, more traditional members. Research in this area has been limited primarily to small-scale studies that identify herbal remedies popular in specific cultures. This study observes older Mexican Americans because a substantial proportion of this population continue to utilize traditional herbal remedies in their everyday life.

Official Title
-----------------
Complementary Alternative Medicine

Conditions
-----------------
Arthritis, Diabetes Mellitus, Fractures, Hypertension, Depression, Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mexican American Exclusion Criteria: Unable to complete survey questionnaire

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Mexican Americans, Complementary Therapies
SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.

Official Title
-----------------
Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency

Conditions
-----------------
Status Epilepticus

Intervention / Treatment
-----------------
* Device: Transcranial Direct Current Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of super refractory status epilepticus admitted to the intensive care unit identifiable epileptogenic focus on EEG Exclusion Criteria: contraindications to scalp EEG lice scabies other hair/skin infection scalp psoriasis hypersensitivity other severe dermatological condition previous adverse reaction to collodion vagal nerve stimulator implantable cardioverter defibrillator cardiac pacemaker

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: Transcranial Direct Current Stimulation<br> | Device: Transcranial Direct Current Stimulation<br>* Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Epileptiform Activity, Per Patient-based | EEG epileptiform activity as defined in units of spikes per second for a given patient. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation. | Up to 3 hours per EEG recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Epileptiform Activity, Per-session Based | EEG epileptiform activity as defined in units of spikes per second for a given stimulation session. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation. | Up to 3 hours per EEG recording |
FLuid Responsiveness Prediction Using EXtra Systoles

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload. Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids

Official Title
-----------------
FLuid Responsiveness Prediction Using EXtra Systoles

Conditions
-----------------
Coronary Artery Bypass Graft

Intervention / Treatment
-----------------
* Other: fluid challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring elective CABG or OPCAB surgery Patient's age ≥ 18 years Exclusion Criteria: Patient refusal Pregnancy EF < 35% End stage kidney failure (defined by the need for haemodialysis) Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Other: fluid challenge<br> | Other: fluid challenge<br>* At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid challenge response in stroke volume | To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume | during operation |
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions(DDI) Among Osteoarthritis Patients

Study Overview
=================
Brief Summary
-----------------
Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one other prescription drug metabolized via the CYP450 system were evaluated for an incident drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic drug-drug interaction (DDI).

Official Title
-----------------
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Osteoarthritis Patients Taking Opioid Analgesics and Associated Economic Outcomes

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retrospective database analysis in osteoarthritis patients
Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study

Study Overview
=================
Brief Summary
-----------------
Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study

Official Title
-----------------
Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study Multicentric Study

Conditions
-----------------
Covid 19, BCG Vaccination

Intervention / Treatment
-----------------
* Diagnostic Test: Test PCR
* Genetic: TDR
* Other: Clinical Examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 (+), inpatient or outpatient, confirmed by PCR test COVID-19 (-) confirmed by PCR test having been in contact with COVID-19 (+) Exclusion Criteria: COVID(+) and COVID(-) diagnosed by other tests than PCR COVID-19 (-) Not having been in contact with COVID19(+)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| COVID (+)<br>Patients COVID19(+) confirmed by PCR | Diagnostic Test: Test PCR<br>* Viral load (COVID+) testing by PCR<br>Genetic: TDR<br>* IDR and blood sampling for testing DNA Cheque<br>Other: Clinical Examination<br>* COVID 19 symptoms and Physical Examination<br>|
| COVID (-)<br>Patients COVID19 (-) who had been in contact with COVID-19 (+) confirmed by PCR | Diagnostic Test: Test PCR<br>* Viral load (COVID+) testing by PCR<br>Genetic: TDR<br>* IDR and blood sampling for testing DNA Cheque<br>Other: Clinical Examination<br>* COVID 19 symptoms and Physical Examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences related to epidemiological demographic characteristics | Identify differences related to epidemiological demographic characteristics and the profile of COVID(+) vs. the profile of COVID(-) patients who have been in contact with COVID(+) Vaccination History Questionnaire Medical and Surgical History Questionnaire Clinical Examination TDR and blood sampling for DNA Checks | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid 19, BCG Vaccination
Meibomian Gland Dysfunction (MGD) and Tear Cytokines After Cataract Surgery According to Preoperative Meibomian Gland Status

Study Overview
=================
Brief Summary
-----------------
To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular surface parameters after cataract surgery according to the preoperative MGD grade.

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males or non-pregnant females aged between 55 to 80 years-old. Exclusion Criteria: had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease, as well as patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| inflammatory tear cytokine concentration | comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay | 1 month after cataract surgery | 
| ocular surface staining |  | 1 month after cataract surgery | 
| tear film break-up time, |  | 1 month after cataract surgery | 
| conjunctival injection, |  | 1 month after cataract surgery | 
| Schirmer's test I |  | 1 month after cataract surgery | 
| ocular surface disease index |  | 1 month after cataract surgery |