linjc16/ctgov huggingface dataset:
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS

Study Overview
=================
Brief Summary
-----------------
To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population

Official Title
-----------------
Neonatal and Pediatric Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1

Conditions
-----------------
Subjects With an Existing Intra-arterial Line

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or legal guardian is willing and able to sign informed consent prior to study initiation. Subject is able to participate for the duration of the evaluation. In most instances, the length of the study will not exceed twenty-four hours. Subject satisfies a specified sensor requirement (see Table 1). Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws. Subject is able to accommodate multiple sensors. Neonatal subjects up to 1 month of age or Pediatric subjects 1 month up to 18 years old. Exclusion Criteria: Subjects that have an existing health condition, in which the investigators determine that safe or accurate oximetry measures may not be obtained at the areas where the pulse oximetry sensor could be placed, will not be included in the study. For example, anyone with burns, abrasions or surface lesions on the contact areas would be excluded. Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare. Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors. Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals. Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- | --- |
| SpO2 Accuracy (percentage of blood oxygen saturation) |  | Planned duration of study was up to 12 months. Duration of subject participation: 1-24 hours |
IRT in Infants With Intestinal Perforation

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.

Detailed Description
-----------------
At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.

Official Title
-----------------
Immunoreactive Trypsinogen in Infants With Intestinal Perforation

Conditions
-----------------
Intestinal Perforation, Necrotizing Enterocolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Birth weight less than 1000 grams Admitted to investigative site within first 16 days of life. Exclusion Criteria: Evidence of Intestinal perforation in utero Suspected or confirmed custic fibrosis Abdominal wall defect or intestinal atresia Concomitant medical condition that may create an unacceptable risk.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 Days

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 |
| --- | --- |
| Premature infants<br>Weight less than 1000 grams, age 1 - 16 days. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if factors other than intestinal perforation affect serum IRT. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunoreactive Trypsinogen, Nectrotizing Enterocolitis, Premature Infants, Serial IRT
WGS Analysis of COVID-19 Positive Patients

Study Overview
=================
Brief Summary
-----------------
We aim to better understand the mode of action of COVID-19 in the context of its interaction with the host genome through whole-genome sequencing.

Official Title
-----------------
Whole-Genome Sequencing Analysis of COVID-19 Positive Patients

Conditions
-----------------
Coronavirus Infection, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability and acceptance to provide written informed consent and fluent in English. Men or women between 18-100+ years, inclusive. Willing to comply with study procedures. SARS-CoV-2 positive test result as confirmed by a RT-PCR assay with a sputum or nasopharyngeal sample (either done prior to or at the screening visit).

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Associations with severity and outcomes | Clinical associations with human and viral genetics | next 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, WGS, viral load, viral genome
Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to evaluate cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care.

Detailed Description
-----------------
This study will be performed on patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Official Title
-----------------
Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care

Conditions
-----------------
Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteering to participate in the research Being under surveillance in the coronary intensive care unit Exclusion Criteria: Presence of neurological disease that may affect the cognitive status Not being clinically stable Not to cooperate

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 |
| --- | --- |
| Study Group<br>Patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Performance Assessment | Functional status score for the intensive care unit (FSS-ICU) will be used. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Assessment | Cardiac symptom survey will be used. | 2 weeks | 
| Cognitive Status Assessment | The Montreal Cognitive Assessment (MoCA) will be used | 2 weeks | 
| Physical Activity Level | Physical activity level will be evaluated using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). | 2 weeks | 
| Fear of Movement | Fear of movement will be evaluated using the Fear of Activity in Patients with Coronary Artery Disease (Fact-CAD). | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care, coronary artery disease, kinesiophobia, physical activity level
Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment

Detailed Description
-----------------
The multicentric prospective trial is to evaluate the quality of life and psychological effects in patients with head and neck tumor treated by curative intent radiation therapy. The treatment consists in a conventionally fractionated Intensity Modulated Radiotherapy (IMRT) or until 2.2 Gy per fraction with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.

Official Title
-----------------
Quality of Life and Psychological Evaluation of Patients Affected by Head and Neck Cancer Treated With Curative Intent: Multicentric Prospective Study

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Radiation: Head and Neck patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) in non-metastatic staging; curative intent treatment (radiation therapy associated or not to chemotherapy; surgery associated or not to post-operative radiotherapy and chemotherapy); performance status < 2; age ≥ 18 years; good knowledge of italian language; written informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Head and Neck patients<br>Patients affected by squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) with no metastasis | Radiation: Head and Neck patients<br>* Treatment consists of Intensity Modulated Radiation Therapy (until 2.2 Gy) with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and psychological effetcs evaluated by patient reported outcome (PRO) |  | 18 months |
Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis

Study Overview
=================
Brief Summary
-----------------
The study aimed to evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis

Detailed Description
-----------------
application of new device to find a Solution for Nursing Challenge for caring patient Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis

Official Title
-----------------
A Mixed Methods Sequential Explanatory Study to Evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis

Conditions
-----------------
Post Dialysis Arterio-Venous Fistula Puncture Sites

Intervention / Treatment
-----------------
* Device: Moziak Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing hemodialysis therapy Both sex Exclusion Criteria: Less than 18 years old Patient has central vascular access

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: A Mixed Methods Sequential Explanatory Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moziak Device<br>Applying Moziak Device Compared to Standard Manual Compression | Device: Moziak Device<br>* Applying Moziak Device Compared to Standard Manual Compression<br>* Other names: Standard Manual Compression;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change the time of Haemostasis post dialysis | Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites | 3 months |
Temperature Measurement Using a Non Invasive Device

Study Overview
=================
Brief Summary
-----------------
Main study objectives: To compare the temperature measured using Medisim's thermometers to the temperature measured using mercury or equivalent reference thermometers. To develop more accurate algorithms for measuring on the forehead as well as behind the ear. To test the difference between various forehead measurement locations in order to allow more convenient measuring that is not depended on the exact location.

Conditions
-----------------
Body Temperature Measurement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients arriving to the emergency room A signed consent by the patient or the guardian. Exclusion Criteria: The medical staff decides that patient is not allowed to participate. The patient refuses to participate.
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
-----------------
Body temperature, Thermometers, Non invasive, Medisim's non invasive thermometers
Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

Study Overview
=================
Brief Summary
-----------------
To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.

Detailed Description
-----------------
This will be an observational cohort trial of the pregnancy of women who conceive in RMN trials, and of their resulting infants through the first 3 years of life. Study specific procedures will include a patient completed log of prescribed and over the counter medications taken during a normal pregnancy, a review of their pregnancy, delivery, and neonatal records, an exam of the infant within 60 days of birth by a dysmorphologist, and yearly review of infant medical records, growth charts, and a yearly parent administered developmental questionnaire (Ages and Stages) for the first three years of the infant's life.

Official Title
-----------------
Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive serum hCG within the context of a RMN trial; History of infertility meeting female subject entry criteria for a RMN trial; Informed consent. Exclusion Criteria: Unable to comply with the demands of the trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| 1<br>Infertile women who conceive spontaneously | |
| 2<br>Infertile women who conceive on various ovulation stimulation medications | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative risks of genetic abnormalities identified at birth and within the first 60 days of life |  | 2009 - 2016 | 
| The relative risk of structural anomalies |  | 2009 - 2016 | 
| The relative risk of cognitive differences |  | 2009 - 2016 | 
| The relative risk of perceived differences of neuro-developmental milestones |  | 2009 - 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of pregnancy complications, including pregnancy loss |  | 2009 - 2016 | 
| Rates of neonatal and infant medical disorders |  | 2009 - 2016 | 
| Rates of infant growth related to use of letrozole for stimulation of ovulation compared to other treatment modalities for ovulation stimulation, including compared to women who conceive spontaneously. |  | 2009 - 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Ovulation stimulation, Pregnancy
Evaluation of Hoarding Behaviour and Eating Disorders Among Holocaust Survivors and Their Descendants

Study Overview
=================
Brief Summary
-----------------
Hoarding is a common behavior among Holocaust survivors and is related to the traumatic events they have experienced, and we assume that storage behavior and eating disorders are related to future generations of Holocaust survivors.

Official Title
-----------------
Evaluation of Hoarding Behaviour and Eating Disorders Among Holocaust Survivors and Their Descendants

Conditions
-----------------
Hoarding Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Jewish Holocaust survivors living in Germany and Israel who have expressed their written and written consent to participate in monitoring and testing, and who are able to answer the research questionnaires. • Their direct offspring and their children (second and third generation) The control population - non-Jewish subjects who are not the descendants of Holocaust survivors living in Germany who have expressed their written and oral consent to participate in monitoring and testing and who are able to answer the research questionnaires and whose parents were not imprisoned in the camps second. Exclusion Criteria: (Participants who do not agree to participate (did not sign informed consent form Respondents who are unable to answer interviewer questions Non-Jewish subjects whose parents were in camps (ie prisoner camps, labor camps, etc.) during the second war.
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 |
| --- | --- |
| Group 1<br>At least 200 Jewish Holocaust survivors of the first generation living in Germany and Israel - an equal number in each country | |
| Group 2<br>The second generation, whose parents lived in Europe during the Second World War, now live in Germany (originating from Western and Eastern Europe) - at least 200 participants. | |
| Group 3<br>Third generation of Jewish Holocaust survivors who participated in the first phase, currently living in Germany and Israel - at least 200 participants including at least 100 subjects in each country. These are adults only. The research program does not include children and adolescents | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoarding | Questionnaire that will follow behaviour over generations | Three years |