linjc16/ctgov huggingface dataset:
Pulse Oximetry Accuracy by Skin Color

Study Overview
=================
Brief Summary
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This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean squared to evaluate device performance.

Detailed Description
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This is a prospective, non-randomized, non-blinded comparative study. There will be no changes to the anesthetic or surgical plan to accommodate this study. Patients undergoing anesthesia will be induced per their anesthetic team. Following endotracheal intubation, the patient will be placed on air (FiO2 21%) at 4 liters per minute fresh gas flow. After a minimum of 3 minutes has elapsed, the anesthesia team will obtain an arterial blood sample of approximately 1 mL. This can be obtained from an arterial line if one is planned for the procedure or already in place by accessing the line per standard procedure. If an arterial line is not placed, the arterial sample will be obtained by percutaneous arterial puncture using ultrasound guidance and a 25-gauge blood gas syringe. The patient's SpO2 will be noted using a pulse oximetry probe placed on the right index finger when the arterial sample is drawn, along with the date/time of sample acquisition. Once the sample is drawn, the patient's anesthetic and surgery will proceed as per his anesthesia team. The arterial sample will be immediately delivered to the Nationwide Children's Hospital laboratory for simultaneous ABG and ABG-CoOx analysis to obtain SaO2S and SaO2C, respectively.

Official Title
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Pulse Oximetry Accuracy by Skin Color

Conditions
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Surgery

Intervention / Treatment
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* Diagnostic Test: Arterial blood gas with co-oximetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 2-9 years undergoing general anesthesia with or without arterial line placement. Exclusion Criteria: Patients with cyanotic congenital heart disease. Patients with bleeding disorders. Patients taking blood thinners.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 9 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Arterial blood gas with co-oximetry|1 mL blood sample for ABG-CoOx analysis to obtain co-oximetry measured arterial oxygen saturation (SaO2C) and standard ABG derived arterial oxygen saturation (SaO2S).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Pulse Oximetry | Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations measured by arterial blood gas with co-oximetry (ABG-CoOx). | Baseline |
Pre-calculation for Frequency Lowering With Hearing Devices

Study Overview
=================
Brief Summary
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Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.

Official Title
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Pre-calculation for Frequency Lowering With Hearing Devices

Conditions
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Frequency Lowering

Intervention / Treatment
-----------------
* Other: Frequency lowering intervention
* Other: Frequency lowering reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experienced hearing aid user (minimum use duration 1 year) Adult (minimum age: 18 years), Experience with frequency lowering, Hearing thresholds with N5-N7, S1, S2, S3 hearing loss Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz) , Sensorineural hearing loss, Air Conduction - bone conduction gap <= 10 dB, Written and spoken German, Ability to understand instruction, Ability to describe listening experiences, Ability to attend to the appointments, Ability to fill in a questionnaire conscientiously Healthy outer ear (without previous surgical procedures) Hearing loss within the fitting ranges of the investigational product, Informed consent as documented by signature. Exclusion Criteria: Clinical contraindications deformity of the ear (closed ear canal or absence of pinna), Not willing to wear the hearing aid, Fluctuating hearing that could influence the results, Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product, Limited mobility and not in the position to attend all appoint-ments, Limited ability to describe listening impressions/experiences and the use of the hearing aid, Inability to produce a reliable hearing test result, Massively limited dexterity, Known psychological problems, Known central hearing disorders.

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: Hearing impaired group<br>The hearing impaired group will compare the reference condition with the intervention condition. | Other: Frequency lowering intervention<br>* Modified parametrization of the current frequency lowering parametrization.<br>* Other names: Intervention condition;Other: Frequency lowering reference<br>* Current frequency lowering parametrization<br>* Other names: Reference condition;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization. |  | 6 weeks |
Textbook Outcome in Adrenal Neoplasms

Study Overview
=================
Brief Summary
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BACKGROUND: Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an ideal surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for adrenal neoplasms. MATERIAL AND METHODS: Retrospective study of all patients undergoing scheduled adrenal neoplasms surgery at a Spanish university hospital from September January 2010 to December 2022. Emergency surgeries were excluded. The variables included in the definition of TO were: R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days. The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled adrenal neoplasms resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators compare the group of patients who achieve a TO result with the group of patients who do not. A univariable and multivariable analysis will be carry out in order to indentified the variables associated with TO.

Official Title
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A Novel Study, Textbook Outcome in Adrenal Neoplasms: Observational Study in a Endocrine Surgical Unit.

Conditions
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Outcome Assessment, Adrenal Neoplasm

Intervention / Treatment
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* Procedure: Adrenalectomy


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective adrenal resection were eligible for the study Exclusion Criteria: Age under 18 years Emergency surgery Resections of other organs in the same surgery.

Ages Eligible for Study
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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 |
| --- | --- |
| Yes Textbook Outcome<br>Patients undergoing scheduled adrenal neoplasm surgery with a R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days | Procedure: Adrenalectomy<br>* Scheduled adrenal surgery<br>|
| No Textbook outcome<br>Patients undergoing scheduled colon cancer surgery without any of the following items: R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days | Procedure: Adrenalectomy<br>* Scheduled adrenal surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Textbook Outcome | Analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled adrenal resection. Number of Participants with R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay (<P75), no readmissions, and no mortality in the first 30 days | January 2010 to December 2022 |
MAP THE SMA: a Machine-learning Based Algorithm to Predict THErapeutic Response in Spinal Muscular Atrophy

Study Overview
=================
Brief Summary
-----------------
Spinal Muscular Atrophy (SMA) is caused by the homozygous loss of the Survival Motor Neuron (SMN) 1 gene, which leads to degeneration of spinal alpha-motor neurons and muscle atrophy. Three treatments have been approved for SMA but the available data show interpatient variability in therapy response and, to date, individual factors such as age or SMN2 copies,cannot fully explain this variance. The aim of this project is: collect clinical data and patient-reported outcome measures (PROM) from patients treated with nusinersen, risdiplam, onasemnogene abeparvovec, identify novel biomarkers and RNA molecular signature profiling, develop a predictive algorithm using artificial intelligence (AI) methodologies based on machine learning (ML), able to integrate clinical outcomes, patients' characteristics, and specific biomarkers. This effort will help to better stratify the SMA patients and to predict their therapeutic outcome, thus to address patients towards personalized therapies.

Official Title
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MAP THE SMA: a Machine-learning Based Algorithm to Predict THErapeutic Response in Spinal Muscular Atrophy

Conditions
-----------------
Spinal Muscular Atrophy

Intervention / Treatment
-----------------
* Drug: disease modifying treatments


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: confirmed genetic diagnosis of SMA (5q) clinical phenotype of type I or II or III; able to provide (patient/caregiver) written informed consent Exclusion Criteria: None
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 treated with nusinersen<br> | Drug: disease modifying treatments<br>* Patients will be enrolled if exposed to nusinersen, risdiplam, onasemnogene abeparvovec<br>|
| Patients treated with risdiplam<br> | Drug: disease modifying treatments<br>* Patients will be enrolled if exposed to nusinersen, risdiplam, onasemnogene abeparvovec<br>|
| Patients treated with onasemnogene abeparvovec<br> | Drug: disease modifying treatments<br>* Patients will be enrolled if exposed to nusinersen, risdiplam, onasemnogene abeparvovec<br>|
| Patients naive from disease modifying treatments<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect clinical data and patient-reported outcome measures (PROM) from patients treated with nusinersen, risdiplam, onasemnogene abeparvovec |  | 30 months | 
| Identify novel biomarkers and RNA molecular signature profiling |  | 30 months | 
| Develop a predictive algorithm using artificial intelligence (AI) methodologies based on machine learning (ML), able to integrate clinical outcomes, patients' characteristics, and specific biomarkers |  | 24 months |
Patients Derived Organoids in Ovarian Cancer

Study Overview
=================
Brief Summary
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Among cancer models, patients derived organoids (PDOs) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response. For these reasons, it has been designed a study to assess the feasibility of PDOs immune cells co-culture in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, PDOs could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.

Official Title
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Patients Derived Organoids (PDOs) Immune Cells Co-culture in Ovarian Cancer: the Role of TUmoR microEnvironment.

Conditions
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Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer; Histologic diagnoses of epithelial ovarian cancer at frozen section Age >18 and years; Estimated life expectancy of at least 4 weeks; Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) < 2 Exclusion Criteria: Non-serous histology at frozen section; Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- |
| Other: Interventional<br> | Procedure: Blood sample<br>* Patients will be enrolled starting right after Ethics Committee approval. Samples will be taken during surgery that will take place in the operating rooms of oncological gynecology.<br>* Other names: Tumor Biopsy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model. | To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model, organoids, aimed at obtaining information on the genomic and molecular characteristics of tumor cells and cells belonging to the immune system specific to each individual ovarian cancer patient and to study their interaction. | 24 months |
Different Dietary Patterns

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.

Official Title
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Different Dietary Patterns: Investigations in Healthy Participants

Conditions
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Diet, Healthy, Endotoxemia

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: BMI between 18.5 kg/m² und 24.9 kg/m² Exclusion Criteria: Chronic inflammatory diseases Metabolic diseases Viral or bacterial infections in the last 3 weeks Allergic reactions in the last 3 weeks Intake of anti-inflammatory drugs Malignant diseases Pregnancy and lactation Smoking Alcohol consumption > 10 g/d for women and > 20 g/d for men Drug consumption Vegetarian or vegan diet Food intolerances

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary pattern 1<br>Participants receive a standardized diet following the recommendation of DACH nutrition societies. | Other: Dietary intervention<br>* Participants receive diets following different dietary patterns for 1 week.<br>|
| Experimental: Dietary pattern 2<br>Participants receive a standardized diet following the recommendation of DACH nutrition societies. | Other: Dietary intervention<br>* Participants receive diets following different dietary patterns for 1 week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in parameters of intestinal barrier function | Changes in TLR ligand serum levels | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in parameters of immune response | Changes in concentration of Interleukin-6 in cell culture supernatant of stimulated immune cells | 1 week | 
| Changes in blood lipid levels | Changes in triglyceride, cholesterol levels [mg/dl] | 1 week | 
| Changes in cognitive skills | Assessment of cognitive processes using computer-based psychological tasks (Stroop effect; calculation of differences in response times to incongruent vs. congruent word-color associations) | 1 week |
Improvement of Hyperglycemia/Diabetes in Patients to Improve Safety

Study Overview
=================
Brief Summary
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The goal of this project is to bring together staff and clinicians from Northwestern University/Northwestern Medical Group/Northwestern Memorial Hospital as well as patients and caregivers to assess and redesign the identification and management of hyperglycemia and diabetes during and in transitions of care. There will be 3 different groups for the study: a group of providers [Group 1], a group of patients/caregivers and laypersons [Group 2], and a stakeholder group [Group 3]. Participants will be asked to provide input on potential interventions for a future clinical trial.

Official Title
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Improvement of Hyperglycemia/Diabetes in Patients to Improve Safety

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Interviews


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Provider Group: Multidisciplinary clinical team (including but not limited to inpatient endocrine nurse practitioners, nurse coordinators, diabetes educators, outpatient nurses, attending physicians, and pharmacists) Patient, Caregiver and Layperson Group: Patients must have had hyperglycemia or diabetes at Northwestern Memorial Hospital in the last 5 years. Stakeholder Group: Involved in the specific care delivery of diabetes Exclusion Criteria: Provider Group: None Patient, Caregiver, and Layperson Group: Patients will be excluded if they did not have diabetes or had hyperglycemia. Stakeholder Group: 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

| Intervention/Treatment |
| --- |
|Other: Interviews|Interviews|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Results from Interviews | Participants will be asked to provide their thoughts on potential interventions for a future clinical trial. | Up to one year |
Multicenter Retrospective Observational Study of Acute Myocarditis in Korea

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators analyze the clinical characteristics and prognosis of patients with acute myocarditis in South Korea

Detailed Description
-----------------
Acute myocarditis refers to a condition in which inflammatory cells infiltrate the heart muscle due to various causes. Until now, there is no clear treatment method for myocarditis itself, and when myocardial function deteriorates or arrhythmia occurs due to myocarditis, it is common to wait for natural recovery while performing general supportive treatment for heart failure. Through this study, the investigators analyze the factors contributing to the long-term prognosis, myocardial recovery rate, and clinical course of myocarditis. And, the investigators plan to establish an appropriate treatment strategy necessary to increase the survival rate of patients with myocarditis.

Official Title
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Multicenter Retrospective Observational Study to Investigate the Characteristics and Prognosis of Patients With Acute Myocarditis in Korea

Conditions
-----------------
Myocarditis Acute

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Typical myocarditis symptom and sign, such as fever, chest pain, chest discomfort or shortness of breath, accompanied by elevated myocardial enzymes The above condition is satisfied and additional information is obtained through imaging such as cardiac MRI or cardiac biopsy Exclusion Criteria: ● Coronary artery disease
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 |
| --- | --- | --- |
| Rate of In hospital mortality | In hospital death by any cause | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality | Death by any cause during follow-up | through study completion, an average of 1 year | 
| Requirement of cardiac replacement therapy | Left ventricular assist device insertion or heart transplantation during follow-up | through study completion, an average of 1 year | 
| Rates of Re-hospitalization due to any cause | Re-hospitalization due to any cause during follow-up | through study completion, an average of 1 year |