linjc16/ctgov huggingface dataset:
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant.

Detailed Description
-----------------
PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for PGD is often expensive, and it is the leading cause of death following lung transplantation. Many potential lung donors and recipients are considered unsuitable for lung transplantation because of concern for the development of PGD. Increased levels of chemicals that are involved in bleeding and clotting, including protein C, and certain markers of oxidant stress, which can cause damage to the body's cells and tissues, may increase a person's risk of developing complications following a lung transplant. The purpose of this study is to analyze blood samples to determine if elevated levels of certain chemicals may be associated with an increased risk of developing PGD after lung transplantation. This study will enroll individuals who are undergoing lung or heart and lung transplantation. Blood samples will be collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will also review participants' medical records. There will be no additional study visits.

Official Title
-----------------
Clinical Risk Factors for Primary Graft Dysfunction

Conditions
-----------------
Primary Graft Dysfunction, Lung Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing lung or combined heart and lung transplantation Exclusion Criteria: Undergoing combined organ transplantation other than heart and lung transplantation

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 68 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 |
| --- | --- | --- |
| Primary graft dysfunction, defined by the ISHLT criteria |  | Measured within 72 hours following transplantation |
Study Watch Atrial Fibrillation (AF) Detection Investigation

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.

Official Title
-----------------
Study Watch Atrial Fibrillation (AF) Detection Investigation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Study Watch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Able to read and speak English Able and willing to sign written Informed Consent Interest in participating in the study Subjects with a known history of AF (including persistent or paroxysmal AF) Without significant limitation in ability to participate in the study, in the opinion of the investigator. Exclusion Criteria: Currently in a paced rhythm Known severe allergy to nickel or metal jewelry Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies

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 |
| --- | --- |
| All Participants<br> | Device: Study Watch<br>* Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF) | Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm | At least 60 minutes | 
| PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data. | Number of AF events identified from FDA-cleared ECG Device | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF) | Predictive value estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm | At least 60 minutes | 
| Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population. | Qualitative listing of participant-reported feedback | 14 days |
Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)

Study Overview
=================
Brief Summary
-----------------
This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.

Detailed Description
-----------------
By comparing one group with active CSF shunting with another with non .

Official Title
-----------------
Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus

Conditions
-----------------
Normal Pressure Hydrocephalus

Intervention / Treatment
-----------------
* Procedure: Surgical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Normal pressure Hydrocephalus Exclusion Criteria: Alzheimer disease Vascular dementia

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open shunt<br>functioning shunt | Procedure: Surgical treatment<br>* Insertion of a functioning shunt<br>* Other names: Functioning shunt;|
| Active Comparator: closed shunt<br>NON FUNCTIONING SHUNT | Procedure: Surgical treatment<br>* Insertion of a functioning shunt<br>* Other names: Functioning shunt;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in walking speed |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved cognition or continence |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPH, Hydrocephalus, Shunt
Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.

Official Title
-----------------
A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study

Conditions
-----------------
Chronic Uveitis

Intervention / Treatment
-----------------
* Biological: Gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: either completed participation to one of the following: CL3-78989-002 open-label extension, or X052130/CL3-78989-005 double-masked period or open-label period, or X052131/CL3-78989-006 double-masked period or open-label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies Male or female, age ≥18 (or legal age of majority in the country) at selection. For subject with reproductive potential, a willingness to use highly effective contraceptive measures Exclusion Criteria: Meeting criteria for discontinuation of any of gevokizumab uveitis previous study. Infectious uveitis and masquerade syndrome History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient. Currently active infectious disease. Other protocol-defined inclusion/exclusion criteria may apply

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: gevokizumab<br> | Biological: Gevokizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints (adverse events, ...) |  | 108 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Behçet's disease uveitis
The Effect of HealthWear on Short-Term Weight Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of a computer tracking system and energy expenditure device on weight loss in adults.

Official Title
-----------------
The Effect of HealthWear on Short-Term Weight Loss

Conditions
-----------------
Weight Loss, Obesity

Intervention / Treatment
-----------------
* Behavioral: behavioral weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-55 years of age. Body mass index (BMI) between 25.0-39.9 kg/m2. Access to a computer, Internet access, and will demonstrate proficiency with using the Internet and Web-based software programs. Potential participants will be asked to provide the type of computer they have, the name of their internet service provider, and will have to demonstrate their ability to search the internet during their screening visit. Exclusion Criteria: Report losing >5% of current body weight in the previous 6 months. Report participating in a research project involving weight loss or physical activity in the previous 6 months. For women, report being pregnant during the previous 6 months, or planning on becoming pregnant over the following 3 months of the intervention. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. In addition, this will also be obtained as part of the signed medical clearance from the individual's personal physician.) Currently being treated for any medical condition that could impact body weight (i.e., diabetes mellitus, cancer, etc.). History of myocardial infarction, or a history of undergoing heart surgery such as bypass or angioplasty. Taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers). Taking medication that could affect metabolism and/or contribute to a change in body weight (e.g., synthroid). Being treated by a therapist for psychological issues or problems, taking pyschotropic medications, or receiving treatment with psychotropic medications within the previous 6 months. No exclusion criteria shall be based on race, ethnicity, or gender.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavioral weight loss|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fitness |  |  | 
| physical activity |  |  | 
| dietary intake |  |  | 
| mediators |  |  |
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Study Overview
=================
Brief Summary
-----------------
A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload. The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

Official Title
-----------------
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Conditions
-----------------
Transfusional Iron Overload

Intervention / Treatment
-----------------
* Drug: Deferasirox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox Exclusion Criteria: Pregnant or breast feeding patients Patients being considered by the investigator potentially unreliable and/or a history of non-compliance

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Deferasirox<br> <br> * Other names: ICL670;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment |  | at 3, 4, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver iron content measured by SQUID, at 3, 4, and 5 years |  | at 3, 4, 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transfusional iron overload, Deferasirox
Safety and Efficacy of Medications COVID-19

Study Overview
=================
Brief Summary
-----------------
We performed a quasi-experimental open-label pragmatic study alternating standard of care (SOC) and oral bedtime melatonin (OBM) at different high doses over 4 consecutive time periods enrolling all consecutive RT-PCR SARS-CoV-2 severe Covid-19 admissions.

Detailed Description
-----------------
The 4 successive study time periods spanned from March 2020 to April 2021 and included: 1) standard of care (SOC) (C1), 2) SOC + oral bedtime melatonin (OBM) (T1), 3) SOC (C2), and 4) SOC + OBM (T2). During T1, 3 consecutive subgroups received 50 mg, 100 mg and 200 mg OBM. During T2, 100 mg OBM was given. Melatonin was administered from ICU admission to hospital discharge or death. The main objectives were occurrence of predefined severe adverse events (SAEs), Sequential Organ Failure Assessment (SOFA) scores and day-30 (D30) and 90 (D90) mortality. Study subjects were followed for modified Rankin scale (mRS) at 30 days after the last OBM dose or hospital discharge.

Official Title
-----------------
Safety and Efficacy of Drugs Given Off-label for COVID-19

Conditions
-----------------
Severe Covid-19

Intervention / Treatment
-----------------
* Drug: Oral bedtime melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive RT-PCR for SARS-CoV-2 Exclusion Criteria: Anticipated death within 48 hours or paliative care
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: Sequential Assignment
Interventional Model Description: quasi-experimental
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of care management of severe Covid-19 patients | |
| Experimental: Oral bedtime melatonin<br>Standard of care with oral bedtime melatonin | Drug: Oral bedtime melatonin<br>* Different doses of oral bedtime melatonin<br>* Other names: Standard of care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe adverse events | predefined severe adverse events | From date of inclusion until date of hospital discharge or death | 
| Organ dysfunction | Sequential organ failure assessment score | On days 1, 4, 7, 14 and 30 since first dose of melatonin | 
| Mortality | From date of inclusión to date of day 30 and day 90 mortality | On days 30 and 90 since first dose of melatonin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of ICU and hospital stay | Date of inclusion until date of ICU and hospital discharge or death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mortality, Covid-19, Adverse events, Organ dysfunction
A Completed-cycle Local Audit of Patient Load in the SHO-led ENT Casualty Clinic

Study Overview
=================
Brief Summary
-----------------
ENT UK guidelines recommend booking no more than 6 patients during each 4-hour clinic session. Retrospectively, the investigators counted patients booked for each clinic on ourbooking system. The second cycle showed improved compliance with guidelines.

Detailed Description
-----------------
Background The investigators' centre runs a regular ENT casualty clinic, run by an SHO, for rapid assessment and treatment of simple, acute ENT cases. ENT UK guidelines from 2017 recommend that no more than 6 patients be booked for an SHO to see during a 4-hour clinic session. This study aims to assess whether this centre meets those guidelines. Method Data was retrospectively collected from MedWay, the centre's networked booking system. The number of patients booked for each ENT casualty clinic was counted over a period of two months. This was repeated two months after intervention to close the loop. Result In the first cycle, 2 out of 22 clinics (9%) were found to be compliant with guidelines. Our intervention was to inform clinic booking staff of the guidelines. In the second cycle, 20 of 24 clinics were compliant (83%). Discussion Anecdotally, prior to intervention, SHOs would often struggle to keep up with the casualty clinic caseload, and clinics would overrun. Clinic booking staff were not previously aware of ENT UK guidelines, and the number of clinic slots was set arbitrarily. This was easily and effectively resolved by educating staff. It can be learned that de facto management practice is not always based on guidelines or evidence; and highlights the importance of auditing all aspects of how organisations are run. Further quality improvement studies should focus on what happens to patients who can no longer be fit into existing casualty clinics.

Official Title
-----------------
A Completed-cycle Local Audit of Patient Load in the SHO-led ENT Casualty Clinic

Conditions
-----------------
ENT Disease

Intervention / Treatment
-----------------
* Other: Clerical policy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ENT casualty clinics with patients booked within the study time period Exclusion Criteria: All clinics that were not staffed by an SHO
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cycle 1<br>Counted number of patients booked into clinic. No individual patient data collected. | |
| Cycle 2<br>Counted number of patients booked into clinic. No individual patient data collected. | Other: Clerical policy<br>* Clerical policy introduction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospectively counted patients booked | Retrospectively counted patients booked | 2 months |