linjc16/ctgov huggingface dataset:
Deep Learning Based Early Warning Score in Rapid Response Team Activation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and clinical usefulness of the Deep learning based Early Warning Score (DEWS).

Detailed Description
-----------------
SPTTS is the representative trigger tracking system. In addition to the conventional SPTTS, DEWS will be calculated at each time point by the previously developed algorithm. SPTTS and DEWS will be shown simulataneously on the screening board. The rapid response team performs the rescue activity as before, using both SPTTS and DEWS simultaneously. The alarm threshold setting of DEWS will be changed to 70 points, 75 points, and 80 points every month. The primary and secondary outcomes will be evaluated to compare SPTTS and DEWS (based on each threshold).

Official Title
-----------------
Comparison of Deep Learning Based Early Warning Score and Conventional Screening System in Rapid Response Team Activation in General Ward Patients

Conditions
-----------------
Hospital Rapid Response Team, Hospital Medical Emergency Team

Intervention / Treatment
-----------------
* Diagnostic Test: Deep Learning Based Early Warning Score (DEWS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to general ward and monitored by in-hospital rapid response system Exclusion Criteria: patients admitted to pediatric ward patients in emergency room, intensive care unit, and operating room

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Deep Learning Based Early Warning Score (DEWS)|DEWS use 4 vital signs (systolic blood pressure, HR, respiratory rate, and body temperature) to predict in-hospital cardiac arrest. Deep-learning approach facilitates learning the relationship between the vital signs and cardiac arrest to achieve the high sensitivity and low false-alarm rate of the track-and-trigger system (TTS).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital cardiac arrest | Compare the predictability of in-hospital cardiac arrest between DEWS and SPTTS. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alarm coincidence | Evaluate the alarm coincidence between DEWS and SPTTS. | 3 month | 
| Total alarm count. | Compare the total alarm count between DEWS and SPTTS. | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep learning based early warning score, rapid response team, in-hospital cardiac arrest
Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies

Study Overview
=================
Brief Summary
-----------------
Compound HP802-247 comprises two topical sprays, administered sequentially right after another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface. HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg ulcers. The present study will enroll up to five patients who are suffering venous leg ulcers, have failed a prolonged course of standard wound therapy and one or more advanced technologies, but who would not qualify for the Phase 2 study.

Official Title
-----------------
TRIAL OF COMPASSIONATE USE OF HP802-247 TO TREAT VENOUS LEG ULCERS IN SUBJECTS WHO HAVE FAILED MULTIPLE OTHER HEALING TECHNOLOGIES

Conditions
-----------------
Venous Leg Ulcer

Intervention / Treatment
-----------------
* Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic (duration greater than six months) open wound that has been diagnosed as a venous leg ulcer on the basis of consultation with a vascular surgeon and/or venous ultrasound evaluation Patient has been under continuous care at the Overlook Hospital Wound Healing Program for at least four months for treatment of the study lesion(s) Total study wound surface area greater than or equal to 12 cm2, but less than 48 cm2 Wounds must have failed to heal despite the patient's compliance with elevation, compression and regular debridement, as well as at least one advanced wound therapy (for example, bioengineered dressing such as Oasis® or MatriStem®, low-frequency ultrasound, or cultured skin substitute (Apligraf®, Dermagraft®) Patient has no reasonable likelihood of healing with additional attempts to treat with FDA-approved products and treatments Exclusion Criteria: Patients eligible to participate in a Healthpoint sponsored clinical study of HP802-247 trial (IND 13,900) Patients who have been previously treated with HP802-247 Women of child-bearing potential Patients who are allergic to any of the components of HP802-247
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly HP802247 treatment<br> | Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247<br>* Weekly spray with HP802-247<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete wound closure during the treatment period |  | 24 weeks |
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.

Official Title
-----------------
Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Conditions
-----------------
Severe Head Trauma

Intervention / Treatment
-----------------
* Drug: AbelaDrug200
* Drug: mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis TBI GCS 4-8 Age 16-70 Exclusion Criteria: Multiple trauma resulting in shock Bilateral absent pupil response Time from injury > 6 hours Brain tumor or mass effect secondary to hemorrhage or brain surgery Pregnancy Confounding condition or injury Spinal cord injury Sustained high blood pressure or arterial oxygen saturation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Control: Standard treatment for severe head trauma including mannitol | Drug: mannitol<br>* mannitol plus standard treatment<br>|
| Experimental: 2<br>Study drug plus standard treatment | Drug: AbelaDrug200<br>* IV 200 ml 28%drug in D5W every six hours, 10 min. duration, until ICP < 20 mmHg, then IV 100 ml same schedule for 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in intracranial pressure |  | 24 hours, 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 3 months | 
| Glasgow Outcome Scale |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TBI, closed head injury, severe head trauma, traumatic brain injury
Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch.

Detailed Description
-----------------
To improve the quality of the surgery of the pouch created in CU and FAP patients, the following information will be collected: Patients Characteristics, Operative Data, Postoperative Outcome and Functional Postoperative Recovery.

Official Title
-----------------
KOPOF Registry (Patients Characteristics, Operative Data, Postoperative Outcome, Functional Postoperative Recovery ) of Patients in Which a Pouch Has Been Created Due to Colitis Ulcerosa (CU) or Familial Adenomatous Polyposis(FAP)

Conditions
-----------------
Colitis,Ulcerative, Adenomatous Polyposis Coli, Reservoir, Ileoanal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA Exclusion Criteria: No
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colitis Ulcerosa<br>Colitis Ulcerosa With creation of IPAA | |
| Familial Adenomatous Polyposis<br>Familial Adenomatous Polyposis with creation of IPAA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of postoperatieve recovery | STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU | 1 YEAR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry, Colitis Ulcerosa (CU), Familial Adenomatous Polyposis(FAP), IPAA
Registry for Proton Beam Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
The goal is to collect information on each patient treated with proton beam radiation therapy.

Official Title
-----------------
Registry for Proton Beam Radiation Therapy

Conditions
-----------------
Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Any patient receiving proton beam therapy is eligible for enrollment to this registry (regardless of diagnosis, age, other concurrent therapies, etc.) provided s/he consents to participate.
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 |
| --- | --- | --- |
| Treatment-specific data for all patients receiving proton beam radiation therapy | Treatment-specific data collection record for all patients receiving proton beam radiation therapy | 10 years |
Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing basis.

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > or = 18 years of age Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF Exclusion Criteria: Hypersensitivity to Esbriet (pirfenidone) Concomitant use of fluvoxamine Severe hepatic impairment or end-stage liver disease Severe renal impairment or end-stage renal disease requiring dialysis

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 |
| --- | --- |
| Overall study<br>Specific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study. | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Observed Predicted Forced Vital Capacity |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone) |  | Up to 4 years | 
| Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF) |  | Up to 4 years | 
| Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL) |  | Up to 4 years | 
| Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH) |  | Up to 4 years | 
| Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D) |  | Up to 4 years | 
| Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ) |  | Up to 4 years | 
| Progression-Free Survival (PFS) |  | Up to 4 years | 
| Proportion of Patients Taking Full Dose of Esbriet (pirfenidone) |  | Up to 4 years |
Video Stylet vs. Flexible Bronchoscopy for C-Spine

Study Overview
=================
Brief Summary
-----------------
Comparison of cervical spine movement during intubation with the C-MAC Video Stylet to Flexible Bronchoscopy

Detailed Description
-----------------
Elective surgical patients who require intubation will be randomised to one of 2 groups: C-MAC Video Stylet Flexible Bronchoscopy During intubation, fluoroscopy will be recorded for later analysis to determine the amount of cervical spine movement during the intubation process. The intubation will also be timed to determine the duration of the intubation process.

Official Title
-----------------
Comparison of Video Stylet to Flexible Bronchoscopy for Intubation of Patients With Potential Cervical Spine Injury

Conditions
-----------------
Intubation;Difficult, Intubation Complication

Intervention / Treatment
-----------------
* Device: C-MAC VS
* Device: Flexible Bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective Surgery requiring oral intubation undergoing elective non-cardiac surgery American Society of Anesthesiologists physical status 1-3 age 18-80 years Exclusion Criteria: gastro-esophageal reflux disease body mass index > 35 kg/m2 possibility of pregnancy previous neck surgery unstable C-spine known or predicted difficult airway.

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
Interventional Model Description: Parallel randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-Mac VS<br>Intubation using the C-MAC Video Stylet | Device: C-MAC VS<br>* C-MAC Video Stylet<br>|
| Active Comparator: FB<br>Intubation using the Flexible Bronchoscope | Device: Flexible Bronchoscopy<br>* Flexible Bronchoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation | Duration of Intubation | Concurrent, during the intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Spine Movement | Degrees of C-Spine Movement as measured via Fluoroscope | Concurrent, during the intubation | 
| Sore Throat | Sore Throat rated as none, mild, moderate, or Severe | 24-48 hours post-op. | 
| Vocal Changes | Vocal Changes rated as none, mild, moderate, or Severe | 24-48 hours post-op. | 
| Ease of Intubation | Duration of Intubation, scored on a 100 mm VAS | Concurrent, during the intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical spine injury
Ultrasound Guided Port-A-Cath Isertion in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Port-A-Cath is a totally implanted central venous access system and one of the most frequently used systems for administration of chemotherapies in oncological patients . The currently used techniques for placement of totally implantable venous access devices involve the open insertion by cut down technique, or percutaneous puncture of the central vein either by anatomical landmarks or image guided approach by using ultrasound guidance which is increasingly being preferred over the traditional anatomical landmark due to its low complication rate and high technical success rate; as this technique enables the direct visualization of needle entrance and advancement into the target vein

Official Title
-----------------
Effectiveness of Ultrasound Guidance for Port-A-Cath Insertion in Cancer Patients

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Port-A-Cath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer patients Indicated for receiving long term chemotherapy Accepted coagulation profile. Exclusion Criteria: Severe uncorrectable coagulopathy. Prior incidence of central vein thrombosis. Patients with active infection.
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: Port-a-cath<br>Ultrasound guided Port-a-cath insertion | Device: Port-A-Cath<br>* Totally implanted central venous access device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications | Early complications associated with Ultrasound guided Port-a-cath insertion periprocedural and within 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late complications | complications associated with Ultrasound guided Port-a-cath insertion after 24 hours | Up to 100 months |
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control

Official Title
-----------------
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: SPARC Placebo
* Drug: SPARC1310 I
* Drug: SPARC1310 II
* Drug: SPARC1310 III


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis Participants able to understand and willing to sign the informed consent form Exclusion Criteria: Anotomical deviations of the nasal septum that significantly impair ventilation or airflow Pregnant or nursing women Positive serology for infectious disease (Hepatitis B or C, HIV) at screening Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: SPARC Placebo<br> | Drug: SPARC Placebo<br>* Placebo<br>|
| Experimental: SPARC1310 I<br> | Drug: SPARC1310 I<br>* SPARC1310 I<br>|
| Experimental: SPARC1310 II<br> | Drug: SPARC1310 II<br>* SPARC1310 II<br>|
| Experimental: SPARC1310 III<br> | Drug: SPARC1310 III<br>* SPARC1310 III<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Nasal Symptom Score From Baseline to Day 14. | The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity. | Baseline to Day 14 |