linjc16/ctgov huggingface dataset:
Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment

Study Overview
=================
Brief Summary
-----------------
This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.

Official Title
-----------------
Effects of 3D Printing Technology on Maternal Fetal Bonding Compared to 2D/3D Ultrasounds

Conditions
-----------------
Maternal-Fetal Relations

Intervention / Treatment
-----------------
* Other: 3D printed model
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women between19-45 years of age singleton pregnancy no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization normal fetal anatomic survey (fas) ultrasound fluent in English Exclusion Criteria: additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 3D ultrasound only or 3D ultrasound and printed model of fetal face
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D model<br>patient is given 3D printed model of her fetus's face | Other: 3D printed model<br>* Same as previously reported in arm descriptions<br>|
| Placebo Comparator: picture<br>patient is given a fetal picture only. | Other: Placebo<br>* nothing other than the ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Antenatal Attachment Scale (MAAS) | The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.) | 5 minutes |
Real-Life Study in Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in diabetic macular edema (DME) patients.

Detailed Description
-----------------
The study included patients who were being observed in the retina departments of 8 tertiary hospitals in the Northern Marmara Region of Turkey (Istanbul's Asian Side, Kocaeli, and Sakarya). The records of DME patients treated with an anti-VEGF agent between January 2015 and December 2018 were reviewed.

Official Title
-----------------
Real-World Outcomes of Anti-VEGF Treatment for Diabetic Macular Edema in Turkey: A Multicenter Retrospective Study, MARMASIA Study Group

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Other: Retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic macular edema treated with intravitreal anti-VEGF injection Having at least 4 or more annual examination visits Exclusion Criteria: Phacoemulsification surgery in the last 1 month PRFK / grid / focal / micropulse in the last 4 months Previous intraocular surgery (excluding PPV and phacoemulsification)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3-month follow-up<br> | Other: Retrospective study<br>* Retrospective study<br>|
| 6-month follow-up<br> | Other: Retrospective study<br>* Retrospective study<br>|
| 12-month follow-up<br> | Other: Retrospective study<br>* Retrospective study<br>|
| 24-month follow-up<br> | Other: Retrospective study<br>* Retrospective study<br>|
| 36-month follow-up<br> | Other: Retrospective study<br>* Retrospective study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visit and Intravitreal Injection Numbers | The primary outcomes were changes in best-corrected visual acuity and central macular thickness in the first year and frequency of visits and intravitreal anti-VEGF injections. | First year |
OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA

Study Overview
=================
Brief Summary
-----------------
In order to compare the effectiveness between Remdesivir and Favipiravir, an observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021

Detailed Description
-----------------
Coronavirus Disease 2019 (COVID-19) is an infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2). Antiviral therapies are considered to be one of the COVID-19 treatments. Remdesivir and favipiravir are the antivirals recommended by Indonesia's 3rd COVID-19 Management Guidelines. They have a similar mechanism to inhibit virus replication, specifically by inhibiting RNA-dependent RNA polymerase (RdRp) of the virus. Several studies reported that patients who received these antivirals had a lower duration of hospitalization. However, the effectiveness comparison of remdesivir and favipiravir remains unknown. An observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021 are collected by consecutive sampling technique, and this research was carried out at Gotong Royong Hospital Surabaya.

Official Title
-----------------
OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA

Conditions
-----------------
Duration of Hospitalization, Clinical Manifestation of COVID-19

Intervention / Treatment
-----------------
* Drug: Remdesivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (eighteen years old or above) with moderate to severe COVID-19 (categorized based on KEPUTUSAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR HK. 01. 07/MENKES/413/2020); Admitted to Gotong Royong Hospital Surabaya from January 2021 to August 2021; Received remdesivir OR favipiravir with minimal five days of treatment Not in pregnancy and lactating condition Exclusion Criteria: female patient with pregnancy and lactation patient whom was passed away or forced home during two-weeks observation period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 97 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remdesivir|The patients, based on their clinical condition, got remdesivir OR favipiravir at least five days of treatment. The WHO ordinal scale was used to assess patients' clinical progress in the first and second weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical manifestation | Oxygen needs, cough, dyspnea | 2 weeks since drug (remdesivir OR favipiravir) administration |
Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.

Detailed Description
-----------------
The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.

Official Title
-----------------
The CHOLEGAS Study: Multicentric Randomized, Double-blinded, Controlled Trial of Gastrectomy Plus Prophylactic Cholecystectomy Versus Gastrectomy Only, in Adults Submitted to Gastric Cancer Surgery With Curative Intent.

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing standard gastric surgery for cancer Exclusion Criteria: gallbladder disease

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: B<br>no cholecystectomy | |
| Experimental: A<br>cholecystectomy | Procedure: cholecystectomy<br>* prophylactic cholecystectomy during standard gastric surgery for cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced biliary complications |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved quality of life |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, surgery, prophylactic cholecystectomy
Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry

Study Overview
=================
Brief Summary
-----------------
The aim of the study is: to develop a comprehensive biochemical assay for detection of Pompe disease (glycogen storage disease type II), to be implemented in the Newborn screening program among the Israeli population.

Official Title
-----------------
Screening for Early Detection and Prevention of Pompe Disease in Israel Using Tandem Mass Spectrometry

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Other: Drawing blood spots from Newborns


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New born babies born during the study period Exclusion Criteria: Premature babies

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 7 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Drawing blood spots from Newborns|Dry blood spots would be taken for determination of Alpha Glucosidase activity using LC-MS-MS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the normal mean control value of Alpha glucosidase activity in Dry blood spots among Newborns in Israel |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pompe disease, Alpha glucosidase, Newborn screening, Tandem Mass Spectrometry (LC-MS-MS), The study aims:, To establish the control mean values of alpha glucosidase activity in Dry blood spots of Newborn babies from Israel., To include the alpha glucosidase assay in the newborn screening program in Israel
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
The intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia

Official Title
-----------------
A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects

Conditions
-----------------
Brittle Type I Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: ORMD 0801


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus Male or female aged 18-50 years inclusive Body weight between 50-100kg and BMI between 18 and 30 kg/m2 Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia No other medical problems Exclusion Criteria: History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug Positive pregnancy test or lactation Lack of family support Unwilling or unable to follow the study protocol Concurrent medical problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ORMD 0801|1 capsule ORMD 0801 3 times a day, before each meal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes |  | 15 days |
Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of Healthfinder

Study Overview
=================
Brief Summary
-----------------
Clinical preventive services (CPS) are fundamental to early disease detection and improvement of health outcomes but are often poorly understood and utilized by patients. Myhealthfinder is a web-based tool developed by the Office of Disease Prevention and Health Promotion (https://healthfinder.gov). This study tests the prescription of myhealthfinder to engage patients in CPS, improve patient-clinician communication and increase uptake of CPS.

Official Title
-----------------
Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of Healthfinder

Conditions
-----------------
Health Knowledge, Attitudes, Practice

Intervention / Treatment
-----------------
* Other: Healthfinder invitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled wellness appointment with primary care provider Exclusion Criteria: Inability to read English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Invitation to use healthfinder website | Other: Healthfinder invitation<br>* Invitation to use healthfinder (healthfinder.gov/myhealthfinder<br>|
| No Intervention: Control<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of clinical preventive services | Percent up-to-datedness on cancer screening (cervical, breast, colon, lung cancer); immunizations (influenza, pneumonia) and cardiovascular disease (hypercholesterolemia, diabetes). This will be calculated based on the number of recommended services as identified on the healthfinder website based on age/gender that each patient has received within the recommended time frame. | 3 months | 
| Change in communication and health knowledge | Patient survey asking about knowledge of recommended preventive services and communication with clinician; qualitative themes from audio-recordings of clinician-patient visit with subset of randomly selected patients | Immediately after the intervention |
Investigating Myocardial Remodelling in the Failing Human Heart

Study Overview
=================
Brief Summary
-----------------
Despite improvements in therapy, heart failure is a disease with high mortality and accelerating prevalence. To improve patient care, it is necessary to better understand the features and underlying mechanisms of myocardial remodeling; how it manifests in vivo and its underlying cellular and extracellular changes. The RELAX study will offer insight into myocardial remodeling, by comprehensively assessing function and structure of failing human hearts, and investigate its underlying cellular and extracellular changes.

Official Title
-----------------
Investigating Myocardial Remodelling in the Failing Human Heart

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for heart transplantation Willingness to participate in the present study and ability to understand and sign the written informed consent Exclusion Criteria: Patients under the age of 18.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain | Measurement of myocardial function by in-vivo methods. In-vivo myocardial function will be obtained by MRI and echocardiography. Measurements include LVEF and GLS. | 1 years | 
| MRI morphological parameters including LVEDV and LVESV. | Measurement of myocardial morphology by in-vivo methods including MRI and ultrasound. The expected outcome in regards to morphology is varying degrees of geometrical abnormalities. | 1 years | 
| Myocardial stiffness measured by MRI and ex-vivo methods. | Measurement of myocardial stiffness by in-vivo and ex-vivo methods. In-vivo myocardial stiffness will be measured by MRI. The expected outcome is varying degrees of stiffness in accordance with the underlying pathology as well as regionally in the heart. Ex-vivo methods include stiffness measurements by histology and protein analysis. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Heart transplantation, Heart failure, PET