linjc16/ctgov huggingface dataset:
ASPIRE (Aub-haS2 Plus bIomaRkErs)

Study Overview
=================
Brief Summary
-----------------
ASPIRE is a prospective, multicenter, observational study that will assess the performance of AUB-HAS2 to predict the occurrence of major adverse cardiovascular events 30-days after a non-cardiac surgery and the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac procedures.

Detailed Description
-----------------
Primary objectives: Primary objective of the validation arm: to analyze the accuracy of the AUB-HAS2 index in predicting the occurrence of myocardial infarction, stroke and death within 30 days after non-cardiac surgeries. Primary objective biomarker arm: to analyze the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac surgeries. Secondary objectives: To analyze the potentially preventable factors related to adverse outcomes after non-cardiac surgeries in order to offer subsidies for more assertive guidelines regarding the implementation of perioperative protection strategies. Compare the performance of these scores with others that have already been validated (ACP and Lee - see Annex A).

Official Title
-----------------
Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk

Conditions
-----------------
Perioperative Medicine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 40 years, in the preoperative period of non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively. Exclusion Criteria: Refusal to sign the informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS | COMPOSITE OF DEATH, MYOCARDIAL INFARCTION AND STROKE | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RATE OF MYOCARDIAL INJURY |  | 30 days |
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.

Study Overview
=================
Brief Summary
-----------------
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States

Official Title
-----------------
Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Palbociclib
* Drug: Aromatase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019 HR+/HER2- molecular subtype at diagnosis Initiated 1L systemic therapy with palbociclib + AI or AI alone Exclusion Criteria: Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Palbociclib + AI<br>Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare | Drug: Palbociclib<br>* Palbociclib with an aromatase inhibitor therapy<br>* Other names: Ibrance;Drug: Aromatase Inhibitor<br>* Aromatase Inhibitor Therapy<br>* Other names: letrozole, anastrozole, exemestane;|
| AI alone<br>Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy | Drug: Aromatase Inhibitor<br>* Aromatase Inhibitor Therapy<br>* Other names: letrozole, anastrozole, exemestane;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | From 1 February 2015 through 31 December 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast neoplasm, Hormone receptor-positive Human epidermal growth factor receptor 2 negative (HR+,HER2-), palbociclib, Metastatic, Medicare, SEER-Medicare
Mavacamten Pregnancy Surveillance Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.

Official Title
-----------------
Mavacamten Pregnancy Surveillance Program

Conditions
-----------------
Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related

Intervention / Treatment
-----------------
* Drug: Mavacamten


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first) At least 15 years of age or older at the time of enrollment Informed consent or institutional review board/ethics committee-approved waiver of informed consent Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Pregnant or breastfeeding women exposed to mavacamten | Drug: Mavacamten<br>* Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcomes | (1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications | Up to 10 months | 
| Fetal/neonatal/infant outcomes | Number of fetal/neonatal/infants in utero, at birth, and through the first year of life with major and minor congenital malformations, small for gestational age, premature delivery, and post-natal growth and development deficiency | Up to 12 months post pregnancy outcome |
Hearing Screener Study

Study Overview
=================
Brief Summary
-----------------
The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We will perform an in-office speech hearing test and compare the thresholds with those measured from the iPad at a distance of 1ft with a sound pressure level (SPL) (dBA) meter

Official Title
-----------------
Linus Health Hearing Screening Clinical Study

Conditions
-----------------
Hearing Screener

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants must be (1) Those with a range of hearing ability but not deaf; (2) 55+ years old; (3) able to use an iPad and Apple Pencil; (4) as close to their normal hearing conditions as possible: if they wear hearing aids normally they should have them during the assessment; if not, they should not wear them; (5) able to provide written informed consent in the Institutional Review Board-approved informed consent form; (6) willing and able to comply with all study procedures as outlined in the informed consent; and (7) fluent in English. Exclusion Criteria: Exclusion criteria include (1) individuals who are not able to understand or willing to comply with the directions for the administration of neuropsychological tests; (2) the presence of a major psychiatric upset such as bipolar disorder; (3) present with major medical problems such as cancer or epilepsy. Study staff will review potential participants who do not have dementia and can be approached about the study.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- | --- |
| Hearing Thresholds | The objective is to compare the Linus Health Hearing Screener (LHHS) to established hearing screening methods performed by a hearing specialist. We aim to perform an in-office hearing test and compare the thresholds with those measured from the iPad at a distance of 11ft with an SPL (dBA) meter. Comparing hearing test results between the LHHS and the results of a lab grade audiogram. | 1 Year |
The Relationship Between Self-disclosure, Perceived Social Support and Reproductive Concerns

Study Overview
=================
Brief Summary
-----------------
Participants were recruited from oncology units in two hospitals in Shanxi, China using a convenience sampling.Data were collected using a self-report questionnaire consisting of demographic and disease-related characteristics, and instruments measuring self-disclosure, social support and reproductive concerns.

Official Title
-----------------
How Self-disclosure Influences Reproductive Concerns Among Young Male Cancer Patients? The Mediating Role of Perceived Social Support

Conditions
-----------------
Survivors of Young Male Cancer Survivors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : ① male; ② Age 18-40 years old; ③ Diagnosed with cancer for 1 year or more; ④ Know the disease; ⑤ Clear mind, able to understand and cooperate with the investigation; ⑥ Sign informed consent to participate in the study voluntarily. Exclusion criteria: ① There were serious primary diseases of liver, kidney, hematopoietic, and serious organ failure; ② He has a history of mental illness, personality disorder, cognitive impairment, and organic brain disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Participants characteristics | Demographic and disease related characteristics included age, marital status, fertility status, payment method of medical expenses, primary caregiver, family history, treatment method, fertility intention, etc. | once | 
| self-disclosure | Distress Disclosure Index (DDI) was used to evaluated the level of self-disclosure of young male cancer patients | once | 
| perceived social support | the Perceived Social Support Scale (PSSS) was used to evaluate the level of perceived social support of young male cancer patients which includes 3 dimensions which are named by friend support, family support and other support, with a total of 12 items. | once | 
| reproductive concerns | the Reproductive concerns after cancer scale-male（RCAC-M） was used to evaluata the level of reproductive concerns in young male cancer survivors. | once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reproductive concerns, young male cancer survivors, self-disclosure, perceived social support
Preoperative Nutritional Status and Postoperative Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies. The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients undergoing major abdominal surgery.

Official Title
-----------------
Prognostic Significance of Preoperative Nutritional Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Major Abdominal Surgery

Conditions
-----------------
Postoperative Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥ 65 years intra-abdominal procedures including gastric, colorectal, pancreatic, prostate, and urinary bladder surgeries, as well as abdominal exploration. surgery duration lasting longer than 2 hours. Exclusion Criteria: patients with an American Society of Anesthesiologists (ASA) physical status V. those with concurrent cardiac or renal surgeries. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis). those did not have sufficient data required for nutritional evaluation or AKI evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative acute kidney injury | In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery. | Within 7 days after surgery |
Telenursing Through Short Messaging Service: It's Effect on Lipid Lowering Medication Adherence Outcomes

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of telenursing through SMS (Short Messaging Service) on lipid-lowering medication adherence outcomes.

Official Title
-----------------
Telenursing Through Short Messaging Service: It's Effect on Lipid Lowering Medication Adherence Outcomes

Conditions
-----------------
Telenursing Lipid Lowering Medication Adherence

Intervention / Treatment
-----------------
* Other: SMS reminder massages about adherence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic Exclusion Criteria: not on medication

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be offered to participate. Willing patients will be randomly assigned to one of two groups: Two arms study design: first arm (control group)won't receive intervention while the second arm (intervention group) will receive telenursing intervention through SMS; Is a text messages will be sent to the intervention group comprised of a reminder on when, how to take lipid lowering medication, benefits, and adverse effect of not taken the drug as prescribed for three months duration. Follow-up SMS (Short Messaging Service) will be sent two times per week.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>will not receive the intervention | |
| Experimental: Study group<br>will receive the intervention | Other: SMS reminder massages about adherence<br>* SMS three-times per week reminding the patient about adherence to prescribed medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate | percentage of pills taken per months | three months |
Lung Ultrasound in Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
prospective assessment of lung ultrasound score in children with different severities of bronchiolitis

Official Title
-----------------
Studio Osservazionale, Prospettico, Multicentrico, No-profit Sull' utilità Dell' ECOgrafia Pleuro-polmonare Nella Gestione Delle BRONchioliti Nella Popolazione Pediatrica di età ≤12 Mesi - ECO-BRON

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Diagnostic Test: lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with bronchiolitis Exclusion Criteria: children with bronchiolitis and comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 0 Months
Maximum Age: 12 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bronchiolitis<br>children with bronchiolitis | Diagnostic Test: lung ultrasound<br>* lung ultrasound score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung ultrasound score predict bronchiolitis severity | lung ultrasound score predict bronchiolitis severity | 1 year |
Legacy of the Special Olympics World Games Berlin 2023

Study Overview
=================
Brief Summary
-----------------
This research aims to evaluate the impact of the project 170 Nations - 170 Inclusive Communities of the Special Olympics World Games 2023 (SOWG 23) on sustain inclusive structures for people with intellectual disabilities (ID). The research utilizes a quasi-experimental research design and a qualitative research design and will synthesize qualitative and quantitative data to display successful and non-successful interventions for more inclusive communities. The research will target 56 host communities of SOWG 23 and 56 non-host communities, interviewing 200 people with ID and a minimum of 400 key stakeholders, as well as conducting qualitative interviews and focus groups.

Official Title
-----------------
Legacy of the Special Olympics World Games Berlin 2023

Conditions
-----------------
Inclusion, Social

Intervention / Treatment
-----------------
* Behavioral: Inclusive events


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: legal age 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?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants living in Host Towns<br>Participants live in Host Towns, where a delegation of athletes are hosted for one week. Furthermore, Host Town coordinator organize several inclusive events. | Behavioral: Inclusive events<br>* Inclusive events such as inclusive sport festivals, citizen festivals or working groups at school are organized<br>|
| No Intervention: Participants not living in Host Towns<br>Participants where no delegeation of athletes are hosted and no inclusive events are organized by Host Town coordinator. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ATTID-Questionnaire | Attitudes toward people with intellectual disabilities will be measured via the ATTID-questionnaire. It measures three dimensions of attitudes : emotional, cognitive and behavioral. The questionnaire was validated for German language. Moren Information on https://chaireditc.uqam.ca/attid-en/ | Change from baseline (T1) attitudes toward people with intellectual disability (ATTID-Questionnaire) at 3-4 month (T2) and 8-9 month (T3) |
Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
the aim is to measure the level of adherence of knee osteoartheritis patients to a Carefully curated program that follows the American College of Rheumatology/Arthritis (ACR) recommendation guidelines and investigate the factor that might affect the patient's adherence to the prescribed protocol.

Official Title
-----------------
Impact Of Health Education Program on Adherence to Treatment in Egyptian Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as having knee osteoarthritis according to the American College of Rheumatology criteria Exclusion Criteria: Patients with a A history of knee trauma or injury patients suffering from any other rheumatological diseases (e.g., Rheumatoid Arthritis) severe comorbidities, severe cardiovascular disease, heart failure, gastrointestinal bleeding risk, and chronic kidney disease.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intervention group<br> | Behavioral: health education<br>* adherence to treatment<br>* Other names: exercise and diet plan;|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved patient pain | measured by visual analog scale | 3 months | 
| improved patients function | measured by Western Ontario and McMaster University Osteoarthritis Index contains 5 items that address the following person-level activities: walking, stair climbing, sitting, lying down, and standing | 3 MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee, Adherence, Patient education, Guidelines