linjc16/ctgov huggingface dataset:
The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress

Study Overview
=================
Brief Summary
-----------------
Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. It can be not easy to distinguish this in the first hours. This study aimed to investigate the place of the lung ultrasonography score in the prognosis of these patients.

Official Title
-----------------
The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress

Conditions
-----------------
Respiratory Distress Syndrome, Lung Ultrasonography Score

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having symptoms of respiratory distress that begin soon after birth, > 34 gestational age, >1900 gr birth weight, Family consent Exclusion Criteria: Congenital anomaly Chromosomal anomaly Hydrops fetalis Congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Minutes
Maximum Age: 120 Minutes

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 |
| --- | --- | --- |
| Enrollment of a targeted number of patients |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory distress syndrome, Lung ultrasonography, Newborn
PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.

Study Overview
=================
Brief Summary
-----------------
Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study. The validation in larger groups of patients, and the comparison between the different clinical syndromes included in the spectrum, will allow the diagnostic and prognostic potential of the tracer to be evaluated, with important consequences for the clinical management of patients. In particular, the tracer could play a central role in the clinical management of patients with neurodegenerative diseases and cognitive impairment. Numerous pharmacological trials are currently underway, worldwide, for the validation of anti-amyloid drugs. In the future we could think about early monitoring with imaging of the effectiveness of the treatment. T he FDG PET technique can be of great help in obtaining relationships between radiation damage to the brain and possibly neurological and neuropsychological deficits associates.

Official Title
-----------------
PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Diagnostic Test: PET/CT with 11C-PiB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's diagnosis according to the diagnostic criteria in use. Exclusion Criteria: current or previous treatments with neuroactive drugs; pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET/CT with 11C-PiB|Subjects considered suitable will undergo a clinical and neuropsychological evaluation and a PET/CT study with intravenous administration of 11C-PIB.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/CT with 11C-PiB to characterize amyloid protein deposits in patients with neurodegenerative diseases. | Comparative evaluation of the accumulation of amyloid protein in the various neurodegenerative conditions included with attention to the specificity of the tracer as an element of differential diagnosis. | 2 years |
Impact of Health Literacy on Chronic Non-specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This prospective cohort study aims to assess the impact of health literacy on the quality of life in patients with chronic non-specific low back pain.

Detailed Description
-----------------
This prospective cohort study will enroll patients with chronic non-specific low back pain. Patients will be assessed using Turkey Health Literacy Scale-32, Short Form-36 Health Survey, and Oswestry Disability Index. The correlation between health literacy and quality of life will be assessed with statistical tests.

Official Title
-----------------
The Impact of Health Literacy on Quality of Life in Patients With Chronic Non-specific Low Back Pain: A Prospective Cohort Study

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Survey form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Chronic non-specific low back pain Exclusion Criteria: Acute low back pain Radicular pain Spinal stenosis

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic non-specific low back pain<br>Patients with chronic non-specific low back pain. | Other: Survey form<br>* Patients will be asked to fill a survey form that consists of socio-demographic information, Turkish Health Literacy Scale -32, Short Form-36 Health Survey and Oswestry Disability Index.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between health literacy and quality of life | Using the statistical analysis, this trial will assess the correlation between health literacy and quality of life. The Turkey Health Literacy Scale-32 results and Short Form-36 Health Survey results will be tested for possible correlation. Also, oswestry disability index and Turkey Health Literacy Scale-32 will also be tested for a possible correlation. | 1 day |
Verification of the Correct Insertion of a Central Venous Catheter

Study Overview
=================
Brief Summary
-----------------
The investigators propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.

Official Title
-----------------
Verification of the Correct Insertion of a Supradiaphragmatic Central Venous Catheter by a Single Echocardiographic Plane

Conditions
-----------------
Catheter Related Complication

Intervention / Treatment
-----------------
* Device: Insertion of central venous catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age in whom a decision is made to place a supradiaphragmatic central venous catheter. Patients who agree to participate in the study Exclusion Criteria: Patients with devices that may interfere with the ultrasound images. Patients with poor ultrasound window Patients with superior vena cava syndrome

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CVC location with Rx<br>After placement of the CVC we will perform the X-ray and subsequent verification of the correct location. Simultaneously, a stopwatch will be started to calculate the time interval until the interpretation of the X-ray by the anesthesiologist. | Device: Insertion of central venous catheter<br>* Central venous catheter verified by ultrasound and then verified by radiography.<br>|
| Active Comparator: CVC location with echocardiography<br>Cardiac ultrasound will be performed to visualize the correct position of the CVC tip, and the time until the interpretation of the ultrasound results will also be monitored. | Device: Insertion of central venous catheter<br>* Central venous catheter verified by ultrasound and then verified by radiography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence of malposition of central venous catheter | Incidence of malposition measured by echocardiography and chest radiography in confirming the correct positioning of the tip of the supradiaphragmatic central venous catheter. Moreover, this check can be performed in a shorter time interval. | Through study completion, an average of 1 year |
Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France

Study Overview
=================
Brief Summary
-----------------
Gynaecological check-ups for women are recommended in France. However, some groups of the population are affected by a lack or absence of medical surveillance. In France, there are one million people with an intellectual disability, including 50,000 with Down syndrome. Although this disability causes numerous physical and psychological deficits, no gynaecological consequences have yet been demonstrated. Regular gynaecological check-ups are therefore necessary, according to French recommendations. However, several studies have shown that women with mental illness receive less or no gynaecological care.

Detailed Description
-----------------
The aim is to describe the gynaecological follow-up of women with Down syndrom in France.

Official Title
-----------------
Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with Down's syndrome, aged between 18 and 30, whether or not they are being followed up in a medical facility, who agree to take part in the study. Exclusion Criteria: women with a disability other than Down's syndrome Not agreeing to take part in the study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women with Down syndrome aged 18 to 30<br>women aged 18 to 30 with Down syndrome, whether or not they were receiving medical care, who agreed to take part in the study. | Other: Data collection<br>* Data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gynaecological follow-up | Presence or not of gynaecological follow-up | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gynaecological follow-up, down syndrome, women
HCV Microfluidic Diagnostics

Study Overview
=================
Brief Summary
-----------------
Hepatitis C diagnostic devices have been developed at the University of Hull to detect and quantify the Hepatitis C virus in patients' plasma and serum samples. This study aims to test the new point-of-care devices that are designed to be low cost and user-friendly. Excess, stored, HCV patients' plasma, serum and blood samples will be supplied by the Virology laboratory (Hull University Teaching Hospital's Trust; HUTH). These samples were taken and analysed as part of patients' clinical monitoring, and are stored prior to disposal in the Virology laboratory. The proposed study will use the samples in a fully anonymised manner.

Official Title
-----------------
Development of Point-of-care and Wearable Sensors for Hepatitis C Diagnostics

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood sample taken Exclusion Criteria: None

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 |
| --- | --- |
| Test<br>Hep C positive | |
| Control<br>Hep C negative | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity | Paper microfluidic test | 30 min |
Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.

Official Title
-----------------
Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Other: Outpatient
* Other: Hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Diagnosed with amyotrophic lateral sclerosis Indication for start of non-invasive mechanical ventilation Exclusion Criteria: No informed consent Does not understand Danish or English Indication for invasive mechanical ventilation No morning baseline PCO2 Hospitalization

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Outpatient<br>Outpatient initiation of non-invasive mechanical ventilation | Other: Outpatient<br>* Outpatient Initiation of noninvasive mechanical ventilation<br>|
| Placebo Comparator: Hospitalization<br>Initiation of non-invasive mechanical ventilation during hospitalization | Other: Hospitalization<br>* Initiation of non-invasive mechanical ventilation during hospitalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of non-invasive mechanical ventilation | Use of non-invasive mechanical ventilation in minutes per day | The 83th to the 90th day after initiation of non-invasive mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the treatment | Patient satisfaction with the non-invasive mechanical ventilation (verbal-rating-score 1-5) | Measured at the 3 months follow-up visit | 
| Patient satisfaction with the proces in relation to the start of the treatment | Patient satisfaction with the proces in relation to the start of non-invasive mechanical ventilation (verbal-rating-score 1-5) | Measured at the 3 months follow-up visit |
Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.

Official Title
-----------------
Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Conditions
-----------------
Non-hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: CD38-SADA:177Lu-DOTA Complex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial. Exclusion Criteria: Primary central nervous system lymphoma or known central nervous system involvement with lymphoma Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA >40% lymphoma bone marrow involvement

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: CD38-SADA:177Lu-DOTA Complex<br> | Drug: CD38-SADA:177Lu-DOTA Complex<br>* The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A) |  | 4 weeks | 
| Occurrence of dose limiting toxicities during the DLT evaluation period (Part B) |  | 4 weeks |
Diagnostic POCUS of Patellar Tendinopathy in Female Athletes

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this study is to determine the clinical effectiveness of point-of-care diagnostic ultrasound in the assessment of patellar tendon pathologies

Detailed Description
-----------------
Participants will receive information about the study and informed consent will be provided. Participants will voluntarily agree to be a participant in the study. Participants will sign the informed consent, and complete the POCUS demographic information sheet, if they qualify then they will have both of their patellar tendons examined through the use of the Butterfly IQ diagnostic ultrasound. Following the examination, they will complete the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Knee Injury and Osteoarthritis Outcome Patellofemoral subscale (KOOS-PF) and then complete the study.

Official Title
-----------------
Diagnostic Point of Care Ultrasound of Patellar Tendon in Female Collegiate Athletes

Conditions
-----------------
Patellofemoral Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-25 yr. old female student-athletes who participate in jump-centric activities Exclusion Criteria: anyone who does not fit the inclusion criteria (18-25 yr old female student-athletes who participate in jump-centric activities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: female collegiate jumping athletes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jumping<br>Female jumping collegiate athletes | Diagnostic Test: POCUS<br>* Point of Care Ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of patellar tendons in jumping athletes | % of participants with hyperechoic or hypoechoic changes | 2 years | 
| KOOS | % of participants with hyperechoic or hypoechoic changes in relation to the Knee Injury and Osteoarthritis Scores | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POCUS