linjc16/ctgov huggingface dataset:
Post-Marketing Safety Study in Japan in Participants With High Risk of Severe Exacerbation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess the adverse events in the acute phase observed after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation specified in COVID-19.

Detailed Description
-----------------
Data collected from the JDMC Claims Database between August 2020 to November 2021.

Official Title
-----------------
Cohort Survey on Acute Phase Safety 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 have underlying diseases. Data period for confirmation of presence/absence of underlying disease is August 2020 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 Solicited Acute Adverse Events |  | Up to 8 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
A Study of Plant-based Diet on Postprandial Sleepiness

Study Overview
=================
Brief Summary
-----------------
This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.

Official Title
-----------------
Effect of Plant-based Diet on Postprandial Sleepiness

Conditions
-----------------
Drowsiness

Intervention / Treatment
-----------------
* Behavioral: Plant-based diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Sleepiness after eating lunch. ESS score ≥3 for answering the question about these two situations: 'sitting quietly after lunch without alcohol' and 'lying down to rest in the afternoon when circumstances permit'. Exclusion Criteria Diabetes. Pregnancy or lactation. Current use of a vegan/plant-based diet BMI ≤ 22. Iron deficiency. Vitamin B12 deficiency.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant-based diet<br>Subjects will receive a handbook on plant-based diet including recipe recommendations. They will follow a strict plant-based diet for 21 day. | Behavioral: Plant-based diet<br>* 21 day diet that excludes any form of meat and other animal products, including dairy products.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postprandial sleepiness | Measured by Epworth Sleepiness Questionnaire before and after a plant-based diet. The Epworth sleepiness scale (ESS) is an 8 item questionnaire that measures daytime sleepiness in participants. Possible scores range from 0-24, with higher scores indicating a higher average sleep propensity in daily life, and a worse outcome. | Baseline, 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postprandial Sleepiness
Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics

Study Overview
=================
Brief Summary
-----------------
The management of kidneys with poor function less than 10% has been the subject of debate for more than a decade. Some authors have recommended nephrectomy while others favor renal salvage (pyeloplasty). the investigators reported their experience of lap assisted pyeloplasty in poorly functioning kidneys in the pediatric age group, concerning on the benefits of a minimally invasive method for repair of UPJO, in comparison with open approach.

Official Title
-----------------
Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics

Conditions
-----------------
Uretro-pelvic Junction Obstruction, Poorly Function Kidney

Intervention / Treatment
-----------------
* Procedure: Dismembered Pyeloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hydronephrosis diagnosed as UPJO Antero-Posterior pelvic diameter more than 20 mm renal function equal or less than 10%, corrected by laparoscopic assisted or open pyeloplasty Exclusion Criteria: Patients with ureteral dilatation (VUR), renal function more than 10%, acquired and recurrent cases

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 14 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 |
| --- | --- |
| GroupA<br>Laparoscopic assisted dismembered pyeloplasty in poorly function kidney | Procedure: Dismembered Pyeloplasty<br>* dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.<br>|
| Group B<br>Open dismembered pyeloplasty in poorly function kidney | Procedure: Dismembered Pyeloplasty<br>* dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | Split renal function by Renal scan (DTPA) % | 12 months post-operative | 
| Measurments A-P renal pelvis diameter | ultrasound measuerment of renal pelvis diameter by mm | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | operative time by minutes | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UPJO, Poorly function kidney, Laparoscopic assissted pyeloplasty, Open pyeloplasty, Pediatrics
Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm

Study Overview
=================
Brief Summary
-----------------
Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.

Official Title
-----------------
Prospective Measurement of Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Device: Research Prototype Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo cardiac catheterization with cardiac output measurement and Fick Planned to undergo general anesthesia for cardiac catheterization standard of care Parent/Guardian able to provide informed consent Exclusion Criteria: Not planned for standard of care general anesthesia for cardiac catheterization

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

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

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

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: Research Prototype Monitor<br> | Device: Research Prototype Monitor<br>* Continuous vital sign is collected via a research prototype monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a non-invasive monitoring device | Feasibility of a non-invasive monitoring device that can accurately measure cardiac output in patients with congenital heart disease as determined by percent error compared to catheter-measured cardiac output. | From device placement to removal, up to 12 hours |
Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration. Participants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. A follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.

Official Title
-----------------
Interventional Study of Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration, Nonexudative Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Device: Active microcurrent therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged at least 50 years with dry AMD in at least one eye Exclusion Criteria: Eye diseases other than dry AMD Implanted electrical devices Seizure disorders

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Active microcurrent therapy<br> | Device: Active microcurrent therapy<br>* Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean logMAR BCVA | Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of improved, stable or worsened BCVA | Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open | Week 1 |
Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.

Official Title
-----------------
Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

Conditions
-----------------
Pharmacokinetics, Area Under Curve, Tacrolimus, Immunosuppressive Agents, Mycophenolic Acid

Intervention / Treatment
-----------------
* Other: venipuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant patients using tacrolimus and/or mycophenolic acid Age between 0 and 18 years Indication for an AUC measurement - judgement of clinician Exclusion Criteria: Incapacitated patients No informed consent Not proficient in the Dutch language

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum 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: venipuncture|An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bias | Mean prediction error | 1 year | 
| Precision | Root mean squared error | 1 year |
Correlation Between Missing Posterior Teeth and Vertical Dimension Measurements With Temporomandibular Joint Disorders in a Sample of Adult Egyptian Subjects

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about the correlation between missing posterior teeth and vertical dimension cephalometric measurements with temporomandibular disorders in a sample of adult Egyptian subjects in. The main questions it aims to answer are: Is there a correlation between missing posterior teeth and temporomandibular disorders? Is there a correlation between vertical dimension cephalometric measurements and temporomandibular disorders? Participants will be asked for the following:- to give their phone numbers & it will be collected through the orthodontic department patient's database ensuring complete confidentiality. to fill Personal data chart (name, age, date of birth, mobile number, address). to receive Clinical examination to determine number of missing teeth. to receive Clinical examination to diagnose TMD using the DC/TMD. to do Lateral cephalometric radiograph to measure the vertical dimension.

Official Title
-----------------
Correlation Between Missing Posterior Teeth and Vertical Dimension Cephalometric Measurements With Temporomandibular Disorders in a Sample of Adult Egyptian Subjects: A Cross-Sectional Study

Conditions
-----------------
Correlation Between Missing Posterior Teeth and Vertical Dimension Cephalometric Measurements With Temporomandibular Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with 2 or more missing posterior teeth seeking treatment at the faculty. Age: 16-49 years. Exclusion Criteria: - Patients who refuse to participate in the study. Patients younger than 16 years. Subjects who received previous TMD treatment. Subjects suffering from systemic conditions which may affect the functioning of TMJ, for example, rheumatoid arthritis, scleroderma, and septic arthritis. Subjects with a history of trauma to the maxillofacial area. Subjects with a previous history of maxillofacial surgery. Subjects with a history of malignancy or current malignancy of the maxillofacial area.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 49 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: imaging|clinical examination to see missing posterior teeth & vertical measurements by lateral cephalometric x-ray|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| temporomandibular disorder | will see the Correlation Between Missing Posterior Teeth and Vertical Dimension cephalometric measurements with Temporomandibular Disorders | 3 months |
Effectiveness of McKenzie and Trochanteric Belt With CT Therapy to Reduce Pain and Dysfunction of SI Joint

Study Overview
=================
Brief Summary
-----------------
To determine the effectiveness of McKenzie exercises and trochanteric belt with conventional physical therapy to reduce pain and dysfunction of Sacroiliac joint (SIJ) in pregnant women

Detailed Description
-----------------
to findout the effectiveness of exercises in pregnant women

Official Title
-----------------
Effectiveness of McKenzie Exercises and Trochanteric Belt With Conventional Physical Therapy to Reduce Pain and Dysfunction of SI Joint in Pregnant Women

Conditions
-----------------
Sacroiliac Joint Dysfunction

Intervention / Treatment
-----------------
* Behavioral: McKenzie exercise
* Diagnostic Test: Trochanteric belt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant patients with sacroiliac joint pain are included and participant patients with age group 18- to 35 low back pain due to sacroiliac joint who suffer from sever pain during sitting and during positioning change when stand from sitting position are included Exclusion Criteria: Patients with age group of below 18 years and above 35 years Patients with disease of coagulopathy systemic infection skin infection over sacroiliac joint patients with history of allergies to injected medications. Patients with psoriasis inflammatory bowel disease peripheral arthritis Women with UTI complications are excluded. Women with respiratory issues are also excluded

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: McKenzie exercise<br> | Behavioral: McKenzie exercise<br>* routine simple McKenzie exercise<br>|
| Other: Trochanteric belt<br> | Diagnostic Test: Trochanteric belt<br>* Trochanteric belt with conventional physical therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feature of Visual analogue scale to check pain and feature PSFS to check Movement of joints | Pre and Post interventions using VAS, PDFS | 6 Months |
Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients

Study Overview
=================
Brief Summary
-----------------
This research aims to investigate potential variations in the success rate and occurrence of complications during nasogastric tube insertion between Difficult and Easy Airway Patients.

Detailed Description
-----------------
Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study. Two groups will be formed, the easy airway group and the difficult airway group. The main aim is to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion. Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim. At the end of the study, determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.

Official Title
-----------------
Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients

Conditions
-----------------
Intubation; Difficult or Failed

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study. - Exclusion Criteria: Patients under 18 year-old Patients who do not require nasogastric tube insertion Patients with anatomical changes in the head and neck region Patients without an informed consent form

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Nasogastric Tube Insertion in Difficult and Easy Airway Patients | The main aim was to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications in Difficult and Easy Airway Patients | Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim | 5 minutes | 
| Airway parameters and failure of nasogastric tube insertion | Determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal. | 10 minutes |