linjc16/ctgov huggingface dataset:
Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY

Study Overview
=================
Brief Summary
-----------------
This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.

Detailed Description
-----------------
This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.

Official Title
-----------------
Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY

Conditions
-----------------
Cardiac Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years old and able to provide informed consent Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order Exclusion Criteria: Cardiac implantable device (pacemaker or ICD) Contact precautions or isolation Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)

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 |
| --- | --- | --- |
| Connectivity | Successful patch application by nursing, and transmission of cardiac waveform data to gateway and then to offline secure server | 48 hours | 
| Continuity | Loss of cardiac waveform signal from patch compared with traditional telemetry monitor. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement for cardiac arrhythmia detection (post hoc, offline) | Analysis of cardiac arrhythmia detections on patch compared with traditional telemetry for agreement, concordance and discordance. | 48 hours | 
| Body temperature (post hoc, offline) | Body temperature recorded by patch compared with nursing documentation in a post hoc analysis. Data from patch will not be assessed for patient care in real time. | 48 hours | 
| Cardiac waveform (post hoc, offline) | Pre-specified analysis of cardiac waveform characteristics in association with pre-specified clinical events such as deployment of emergency response team. | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemetry, Patch Monitor, Alarm Fatigue
APOL1 Gene Variants in African American Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Aim 1: Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans Aim 2: Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease Aim 3: Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.

Official Title
-----------------
Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms

Conditions
-----------------
Transplant;Failure,Kidney, Kidney Disease, Kidney Failure, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Aim 1: Inclusion Criteria: self-reported African American 18 years or older kidney transplant within 12 years Aim 2: Inclusion Criteria for patients with recurrent disease: self-reported African American 18 years or older kidney transplant within 12 years recurrent or de novo glomerular disease on allograft kidney biopsy Inclusion Criteria for control group: self-reported African American 18 years or older kidney transplant within 12 years end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy Exclusion Criteria for control group: clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine >2) Aim 3: Inclusion Criteria: self-reported African American 18 years or older scheduled living kidney transplant

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 |
| --- | --- |
| 2 APOL1 genotypes<br>African American transplant recipients with homozygous APOL1 gene variants | |
| 0 or 1 APOL1 genotypes<br>African American transplant recipients without homozygous APOL1 gene variants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allograft survival |  | year 1, 3, 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allograft function as measured by serum creatinine |  | creatinine levels at year-1, year-3 and year-5 |
Study of the Effect of Vagus Nerve Stimulation on Human Brown Adipose Tissue Activity

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.

Official Title
-----------------
Brown Adipose Tissue After Vagus Nerve Stimulation

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Enabling and disabling VNS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects treated with VNS for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) ≤ 28 kg/m2. Exclusion Criteria: Body Mass Index > 28 kg/m2 Daily epileptic insults. Subjects that need 'Rapid Cycling' VNS to control their frequency of epileptic insults. Psychological unstable subjects (as judged by the treating neurologist). subjects with mental retardation (as judged by the treating neurologist). subjects with severe behaviour disorders (as judged by the treating neurologist). Pregnant subjects. Subjects that previously underwent high dose radiation for diagnostic or therapeutic purposes (radiotherapy, high frequency CT-scans). The use of the following medication is an exclusion criterium; ß-blockers, Ketogenic diet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br> | Other: Enabling and disabling VNS<br>* No intervention<br>* Other names: VNS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| human brown adipose tissue activity |  | baseline and 2 weeks after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human brown adipose tissue activity, obesity, energy metabolism, adaptive thermogenesis
The Effect of Pressure-controlled Ventilation on the Respiratory Complication in Patients Undergoing Laparoscopic Colectomy Compared With Volume-controlled Ventilation

Study Overview
=================
Brief Summary
-----------------
Postoperative pulmonary complications following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative pulmonary complications.

Conditions
-----------------
Postoperative Respiratory Complication

Intervention / Treatment
-----------------
* Procedure: volume controlled ventilation
* Procedure: pressure controlled ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status classification patients scheduled for laparoscopic colectomy Exclusion Criteria: severe cardiopulmonary disease patients who cannot understand Korean

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: volume controlled ventilation<br>volume controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight) | Procedure: volume controlled ventilation<br> <br> |
| Active Comparator: pressure controlled ventilation<br>pressure controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight) | Procedure: pressure controlled ventilation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak airway pressure in patients receiving pressure controlled ventilation and volume controlled ventilation |  | 40 minutes after pneumoperitoneum |
Filter Initial & Long Term Evaluation After Placement and Retrieval Registry

Study Overview
=================
Brief Summary
-----------------
A prospective data registry for all patients who undergo IVC (Inferior Vena Cava) filter placement or retrieval at Stanford. Potential enrollees will already be undergoing the procedure. If patients are willing, they will be prospectively enrolled prior to the procedure. As part of the study, chart and clinical data reviews will be used to track patient progress and response to the treatment.

Detailed Description
-----------------
Patient clinical data will be used in a clinical registry. Before a patient is to undergo their initial procedure for filter placement/retrieval, we will approach them for consent to participate in the study. If patients consent, we will follow clinical data from the procedure, and perform prospective follow-up over time to track clinical response and effects of the placement or removal procedure. Various real-world protocols involving advanced filter removal (including laser-assisted filter removal) will be investigated by conducting registry-based clinical trials. Participants will only be enrolled if they will be undergoing an IVC (Inferior Vena Cava) filter placement/retrieval procedure.

Official Title
-----------------
FILTER - Filter Initial & Long Term Evaluation After Placement and Retrieval (Including Laser-Assisted Retrieval) Prospective Registry

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Procedure: IVC Filter Placement or Retrieval


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are adults, 18 years old or older Participants will be undergoing a procedure to have an IVC filter placed or removed 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 |
| --- | --- |
| IVC Filter Placement or Removal<br>Patients undergoing IVC filter placement and/or IVC filter removal at Stanford Medical Center. | Procedure: IVC Filter Placement or Retrieval<br>* An IVC Filter will be placed or removed using endovascular techniques.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Deep rTMS in Parkinson Disease Pain Syndromes

Study Overview
=================
Brief Summary
-----------------
Pain is the most prevalent non-motor symptom in Parkinson disease, and the motor improvement not always is related to the pain improvement with the medication treatment. By this, we are testing a non-invasive method called transcranial magnetic stimulation as an alternative to treat pain related to Parkinson disease. This technique can lead to either inhibitory or excitatory effects in brain circuits depending on stimulation parameters, and is known to provide analgesic effects.

Official Title
-----------------
Deep rTMS in Parkinson Disease Pain Syndromes

Conditions
-----------------
Pain, Parkinson Disease

Intervention / Treatment
-----------------
* Device: deep rTMS
* Device: placebo deep rTMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson disease Signed term of informed consent Parkinsson disease related pain Exclusion Criteria: Trauma of Skull, epilepsy don't treated Use of medications decrease the seizure threshold Patients in use of drugs, how cocaine and alcohol neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure) Pregnant or lacting women Moderate or severe cognitive impairment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: deep rTMS-active doble coil<br>patients undergoing of deep rTMS real with doble coil | Device: deep rTMS<br> <br> |
| Sham Comparator: deep rTMS-sham<br>patients undergoing to placebo deep rTMS | Device: placebo deep rTMS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline of Pain | assessing by Visual Analog Scale for Pain (VAS). This scale range from 0 (no pain) to 10 (maximum pain), being considered an effective improvement in the patient's pain when the pain decreases at least in 30% from the basal score. | base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep repetitive transcranial magnetic stimulation, chronic pain, parkinson, treatment, non-motor symptom
Acoustical Properties of Speech as Indicators of Suicidal Risk

Study Overview
=================
Brief Summary
-----------------
This project is focused on acoustical, sound, analysis of speech in order to identify vocal characteristics of speech that are associated with suicidality. Speech samples will be collected from four populations with different mental health status: suicidal, ideational suicidal, depressed and those in remission from depression, (the control group). Speech of subjects will be recorded during routine diagnostic interview sessions. The speech samples will be acoustically analyzed via digital computer algorithms. The acoustical differences among those groups will be determined based on the statistical analysis.

Official Title
-----------------
Acoustical Properties of Speech as Indicators of Suicidal Risk

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age Range: 25 to 65 years of age Participants must be depressed or be in remission from depression (have a history of depression) Exclusion Criteria: speech impediment intoxication at time of interview

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, suicide, voice
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus (RESET Real Life)

Study Overview
=================
Brief Summary
-----------------
Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting. Identification of early indicators for therapy success Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms Representative set of safety data in a broad patient spectrum Measurement of tinnitus burden (TBF-12 Questionnaire) Generation of longterm compliance data

Official Title
-----------------
Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a Real Life Patient Population With Chronic Tonal Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: ANM T30 CR®-System


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: symptomatic subjective tonal chronical (> 3 months) tinnitus <60dB hearing loss men and women ≥18 years old Main Exclusion Criteria: serious neurologic psychiatric or internistic disease objective tinnitus Morbus Menière craniomandibular triggered tinnitus

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: standard<br>Standard treatment with the ANM T30 CR®-System | Device: ANM T30 CR®-System<br>* Stimulation for 4-6h/day for a time of 1 year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of TBF-12 Score or CGI Score | Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS loudness and annoyance (0-100) |  | 0.5, 1, 2, 3, 6, 9, 12 months | 
| Tinnitus-freedom |  | 3,6,9,12 months | 
| Compliance | Questioning if the specified application was kept. | 0.5,1,3,6,9,12 months | 
| Alteration of tinnitus | Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System. | 0.5,1,2,3,6,9,12 months | 
| Audiogram for hearing loss change |  | 3,12 months | 
| TBF-12 |  | 3,6,9,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acoustic CR®-neuromodulation, ANM T30 CR®-System
Validation of a Universal Cataract Intelligence Platform

Study Overview
=================
Brief Summary
-----------------
This study established and validated a universal artificial intelligence (AI) platform for collaborative management of cataracts involving multi-level clinical scenarios and explored an AI-based medical referral pattern to improve collaborative efficiency and resource coverage.The datasets were labeled using a three-step strategy: (1) categorize slit lamp photographs into four separate capture modes; (2) diagnose each photograph as a normal lens, cataract or a postoperative eye; and (3) based on etiology and severity, further classify each diagnosed photograph for a management strategy of referral or follow-up. A deep residual convolutional neural network (CS-ResCNN) was used for the image classification task. Moreover, we integrated the cataract AI agent with a real-world multi-level referral pattern involving self-monitoring at home, primary healthcare, and specialized hospital services.

Official Title
-----------------
Validation of the Utility of a Universal Cataract Intelligence Platform

Conditions
-----------------
Artificial Intelligence, Cataract

Intervention / Treatment
-----------------
* Device: Cataract AI agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the primary healthcare center. Exclusion Criteria: The patients who cannot cooperate with the examinations.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Intelligence<br>A universal diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of cataract. | Device: Cataract AI agent<br>* An artificial intelligence to make comprehensive evaluation and treatment decision of different types of cataracts.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the cataract AI agent | AUC: area under the receiver operating curve; accuracy (ACC) = (TP + TN) / (TP + TN + FP + FN); sensitivity (SEN) = TP / (TP + FN); specificity (SPE) = TN / (TN + FP); TP = true positive; TN = true negative; FP = false positive; FN = false negative. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Artificial Intelligence, Medical Referral Pattern