linjc16/ctgov huggingface dataset:
Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
The primary goal is to build and test a previously developed and validated risk model and clinical decision support tool embedded within the electronic health record to improve risk stratification of emergency department (ED) patients with acute heart failure (AHF).

Detailed Description
-----------------
The study team will build an electronic health record-embedded clinical decision support tool using a recently developed risk prediction model that curates patient-specific data in real-time, accurately estimates short-term patient risk, and presents tailored clinical recommendations. This will be a regional implementation study in which the tool is turned on at 21 emergency departments (ED) across Kaiser Permanente Northern California (KPNC). The study team will validate risk predictions and study key clinical outcomes as part of this trial.

Official Title
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Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure: Building and Testing a Machine-learning Platform for Personalized, Accurate, Real-time Risk Prediction

Conditions
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Heart Failure

Intervention / Treatment
-----------------
* Other: Comprehensive ED heart failure management tool


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Adult (≥18y) KPNC members treated in the ED for presumed acute heart failure Exclusion Criteria: Children (<18y). Patients who left against medical advice or eloped prior to ED physician evaluation.

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

| Intervention/Treatment |
| --- |
|Other: Comprehensive ED heart failure management tool|The investigators plan a regional implementation of an electronic health record-based heart failure decision support tool across 21 EDs of Kaiser Permanente Northern California (KPNC).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with serious adverse events | Serious adverse events include mortality, cardiopulmonary resuscitation (CPR), intubation/ventilation, new end-stage renal disease (ESRD), balloon pump placement, or percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG) | 30 days from index ED visit | 
| Number of patients with all-cause mortality |  | 30 days from index ED visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency Department, Risk Prediction
A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This research will admit a wide range of data on the clinical study experience of metastatic prostate cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with metastatic prostate cancer.

Official Title
-----------------
Engagement Trends in Clinical Trials for Metastatic Prostate Cancer - A Journey Into Participation Patterns Among Individuals Affected by the Condition

Conditions
-----------------
Metastatic Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years of age Diagnosis of metastatic prostate cancer Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Enrolled in another research study Patients with psychiatric illness/social situations that would limit compliance with study requirements Inability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of patients who decide to participate in a metastatic prostate cancer clinical research |  | 3 months | 
| Rate of patients who remain in metastatic prostate cancer clinical research to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic prostate cancer
Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.

Official Title
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Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

Conditions
-----------------
Peripheral Neuropathy

Intervention / Treatment
-----------------
* Drug: Roflumilast
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients who will receive paclitaxel post-anthracycline therapy. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2. Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine < 1.5 mg/dl). Exclusion Criteria: Patients with signs and symptoms of clinical neuropathy at baseline. Patients with diabetes mellitus or alcoholic disease. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Drug: Roflumilast<br>* 0.5 mg once daily for treatment period<br>|
| Placebo Comparator: Control<br> | Drug: Placebo<br>* Placebo for treatment period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria | Number of patients reported neuropathy from paclitaxel | 8 weeks post intervention |
ASQ Scores of Transient Hypothyroxinemia of Prematurity

Study Overview
=================
Brief Summary
-----------------
• Transient hypothyroxinemia of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP).

Official Title
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Neurodevelopmental Outcome of the Infants With Transient Hypothyroxinemia of Prematurity in Newborn Intensive Care Unit

Conditions
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Transient Hypothyroxinemia of Prematurity, Neurodevelopmental Abnormality

Intervention / Treatment
-----------------
* Other: 'Ages and Stages Questionnaries' (ASQ)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn infants who were born at 28-36 gestational weeks Infants who were hospitalized in the neonatal intensive care unit Infants with transient hypothyroxinemia of prematurity Exclusion Criteria: Newborns with maternal thyroid disease, Severe intracranial issues, Chromosomal and congenital anomalies, Infants older than 36 gestational weeks

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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 |
| --- | --- |
| Case<br>Infants with THoP | Other: 'Ages and Stages Questionnaries' (ASQ)<br>* ''ASQ' is a screening tool for assessing the development of infants and preschoolers in the areas of communication, fine motor, gross motor, problem-solving and personal-social development, and 'ASQ:SE' is a screening tool for social-emotional development<br>* Other names: 'Ages and Stages Questionnaries: Social-Emotional' (ASQ:SE) Inventories;|
| Control<br>Healthy infants | Other: 'Ages and Stages Questionnaries' (ASQ)<br>* ''ASQ' is a screening tool for assessing the development of infants and preschoolers in the areas of communication, fine motor, gross motor, problem-solving and personal-social development, and 'ASQ:SE' is a screening tool for social-emotional development<br>* Other names: 'Ages and Stages Questionnaries: Social-Emotional' (ASQ:SE) Inventories;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Neurodevelopment | 'Ages And Stages Questionnaires' (ASQ) 'Ages And Stages Questionnaires: Social-Emotional' (ASQ:SE) Developmental Screening Tests evaluates the areas of communication, fine motor, gross motor, problem-solving and personal-social development. ASQ score differs 0-60 and results are interpreted in three group according to the gained points as normal, risky, and follow-up required. | 5 years |
Gut Recovery In Patients Following Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them..

Detailed Description
-----------------
Measure myoelectric signals with the G-Tech WPS and determine if a correlation exists between signal strength and the rate of gastrointestinal recovery following surgery. Determine the relationship between gastrointestinal myoelectrical signal strength and clinical markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.

Official Title
-----------------
Gut Recovery In Patients Following Surgery

Conditions
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Gastrointestinal Diseases, Ileus

Intervention / Treatment
-----------------
* Diagnostic Test: G-Tech Wireless Patch System (WPS)


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Willing and able to follow all study requirements Eighteen (18) years of age or older Subject is willing and able to follow all study requirements Subject will undergo a colectomy Exclusion Criteria: Subject is pregnant or suspects pregnancy Known allergy to medical grade adhesive

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: G-Tech Wireless Patch System (WPS)|Noninvasive monitoring of myoelectrical signals|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI Functional Recovery | Observe a correlation between signal strength and the rate of gastrointestinal recovery following surgery. | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Anticipated adverse events through hospitalization; Unanticipated adverse events (UADEs) through hospitalization | 30 days after surgery |
Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)

Study Overview
=================
Brief Summary
-----------------
All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.

Official Title
-----------------
Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study

Conditions
-----------------
Death, Liver Transplant; Complications, Cardiovascular Complication, Cardiovascular; Attack, Cardiovascular Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center Exclusion Criteria: Missing Informed Consent Form Missing Contact Informations for Follow up

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

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 |
| --- | --- | --- |
| Cardiovascular death | death due to cardiac causes (myocardial infraction and/or stroke) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months | 
| cardiovascular complication | fatal and non fatal myocardial infraction and/or stroke | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months |
Gynaecological Gender-affirming Surgeries

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth). The main question it aims to answer are: • What is the experienced effect of gynaecological gender-affirming surgeries Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.

Official Title
-----------------
Patient Reported Outcomes After Gynaecological Gender Surgeries

Conditions
-----------------
Gender Dysphoria

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: assigned female at birth scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy) Exclusion Criteria: age below 18 y/o surgery combined with other surgeries (e.g. urethroplasty, metoidioplasty)

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

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 |
| --- | --- | --- |
| Experienced effect on gender dysphoria | On a scale of -5 to +5 the experienced effect on gender dysphoria | 3& 9 months | 
| Experienced effect on gender dysphoria measured by GCLS | Comparison of GCLS score (gender congruence life satisfaction scale) pre-operatively and post-operatively | 9 & 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experienced effect on psychological well being | On a scale of -5 to +5 the experienced effect on psychological well being | 3 & 9 months | 
| Experienced effect on confidence | On a scale of -5 to +5 the experienced effect on confidence | 3& 9 months | 
| Experienced effect on sexual experience | On a scale of -5 to +5 the experienced effect on sexual experience | 3& 9 months | 
| Surgical satisfaction |  | 3& 9 months | 
| Impact of health on satisfaction of life | Comparison of Short Form Health Survey (SF12) pre- and postoperatively | 3 & 9 months | 
| Physical complaints post-operatively | physical complaints (bleeding, discharge, abdominal/pelvic pain, difficulty sitting, difficulty peeing, climacterial other complaints) | 3 & 9 months | 
| Recovery time postoperatively | Time to recovery of daily activities | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterectomy, colpectomy, vaginectomy, tubectomy, patient-reported outcome measure
Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 Months

Study Overview
=================
Brief Summary
-----------------
The current study aimed to translate and validate Urdu version of that module from PedsQL, to measure the quality of life outcomes for Pakistan and Urdu speaking people.

Detailed Description
-----------------
Data will be collected by PedQL Infants Scale Parent report A mix method approach will be applied Forward translation Backward translation Review of forward and backward translation The process of translation will be followed the guidelines in the translation manual. Translators will translate the PedsQL Inventory Infants Scale Parent Report independently from each other in Urdu language following the proper forward and backward translation procedure. Data Analysis Quality of life pediatric population will assess through Urdu translated version of PedsQL Inventory Infants Scale Parent report. Data will be analyzed through SPSS.

Official Title
-----------------
Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report Ages 1 to 12 Months

Conditions
-----------------
Infant Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of both genders included Parents of infant age 1 to 12 months were included. Exclusion Criteria: Parents suffering from psychological disorders Parents with severe behavior issue Parents who cannot understand Urdu

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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 |
| --- | --- | --- |
| Quality of Life of Infants age 1 to 12 months | Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health related quality of life of Infants
Atrial Fibrillation and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.

Detailed Description
-----------------
A total number of 50 patients with diabetes mellitus will undergo radiofrequency-guided catheter ablation for atrial fibrillation. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. The relationship between diabetes mellitus and individual atrial arrhythmia substrates as well as patients' outcome following catheter ablation will be analyzed.

Official Title
-----------------
Impact of Individual Atrial Arrhythmia Substrate on the Outcome Following Radiofrequency-Guided Catheter Ablation for Atrial Fibrillation in Patients With Diabetes Mellitus

Conditions
-----------------
Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing their 1st radiofrequency-guided catheter ablation for atrial fibrillation Diabetes mellitus Able to understand and willing to sign the Informed Consent Form. Age ≥18 years. Exclusion Criteria: Contraindication for DE-MRI with a full dose of gadolinium-based contrast agent. Previous left atrial ablation or surgical procedure Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception Mental or physical inability to take part in the study Morbid obesity (BMI > 35), or inability to be placed in MRI due to body mass.

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 |
| --- | --- | --- |
| atrial fibrillation recurrence | atrial fibrillation recurrence following catheter ablation | 12 months |