linjc16/ctgov huggingface dataset:
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.

Official Title
-----------------
A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: HFA-BDP
* Drug: Fluticasone
* Drug: Seretide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory, non-smoking asthmatics with FEV1 les than 80% predicted RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication. Informed consent and ability to perform exhaled nitric oxide assessment. Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in. Exclusion Criteria: Recent respiratory infection or oral steroid use. Pregnancy or lactation. Known or suspected contra-indication to any of the IMP's. CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fine particle steroid inhaler<br>HFA-BDP plus Fluticasone/Salmeterol Combination | Drug: HFA-BDP<br>* HFA-BDP (Qvar) 100ug 2puff b.i.d<br>Drug: Seretide<br>* Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d<br>|
| Active Comparator: Coarse Particle Inhaler<br>FP plus Fluticasone/Salmeterol combination | Drug: Fluticasone<br>* Fluticasone propionate Accuhaler 250ug b.i.d.<br>Drug: Seretide<br>* Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar nitric oxide |  | 16 weeks |
Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus)

Study Overview
=================
Brief Summary
-----------------
The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.

Official Title
-----------------
REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial

Conditions
-----------------
Coronavirus

Intervention / Treatment
-----------------
* Device: SensiumVitals wearable sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or over. Able to provide written consent. Exclusion Criteria: Any participants that withdraw their consent. A skin condition/reaction preventing wearing the wearable sensor. The presence of a permanent pacemaker or cardiac defibrillator. Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team. Inability to cooperate or communicate with the research team.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SensiumVitals wearable sensor|A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deterioration resulting in healthcare review | Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation | Deterioration resulting in hospitalisation | 1 year | 
| Participant anxiety | General Anxiety Disorder (GAD-7) questionnaire (responses noted on Likert scales); min score 0 and max score 21. Higher score associated with greater anxiety | 1 year | 
| Participant depression | Patient Health Questionnaire (PHQ-9) questionnaire (responses noted on Likert scales); min score 0 and max score 27. Higher score associated with greater depression. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronavirus, remote monitoring, deterioration, escalation
Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home

Study Overview
=================
Brief Summary
-----------------
Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication. In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.

Official Title
-----------------
Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: Neuroelectrics Enobio 8(R)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Known diagnosis of Epilepsy Expected to experience seizures during the period of the study as determined by the PI. Able to meet with the Sponsor representative at home Exclusion Criteria: Trauma/broken skin on forehead. Patient can not follow or comply with instructions Patients who are unable to independently provide an informed consent Patients with major psychiatric co-morbidities Patients with psychogenic non-epileptic seizures

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neuroelectrics Enobio 8(R)|Monitoring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful data collection during hospitalization | Continuous recording from wearable sensors of physiologic signals during hospitalization in the video EEG unit | 12 hours daily for up to 5 days | 
| Successful data collection during at home monitoring | Continuous recording from wearable sensors of physiologic signals during at home monitoring | 12 hours daily for up to 14 days |
The Correlation Between CITED2 and Collateral Circulation in Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Evaluating the collateral circulation of acute ischemic stroke (AIS) mainly depends on the imaging examination. At present, there is no effective and sensitive biomarker for collateral circulation. Thus, the research objective was to evaluate the predicting role of the CBP/P300-interacting transactivator with Glu/Asp-rich C-terminal domain 2 Ratio (CITED2) from peripheral blood mononuclear cells in the collateral circulation of AIS. We classified the AIS patients into two groups (the good collateral group and the poor collateral group) by DWI-ASPECTS score. The western blot was applied to test the protein expression of vascular endothelial growth factor (VEGF) and CITED2. Then, we collected other clinical data. Binary logistic regression analysis between collateral circulation and clinical data was performed. Finally, Receiver operating characteristic (ROC) curve analysis was used to explore the predictive value of the CITED2.

Official Title
-----------------
The Impact of CITED2 on Collateral Circulation and Early Neurological Functional Outcome for Ischemic Stroke by Critically Regulating HIF-1α-VEGF Pathway

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Other: non-applicable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the first-time onset or previous stroke with mRS score ≤1, and the onset time less than 3 days without intravenous thrombolysis or endovascular therapy ; age range of 18 to 80 years old; patients with a clinical diagnosis of acute ischemic stroke; ④ NIHSS score ≥4; ⑤ patients volunteer to participate in this study and signed a written informed consent Exclusion Criteria: ①the patients with AIS combined with other diseases that may affect the CITED2 and VEGF expression, such as acute myocardial infarction, peripheral artery occlusion disease and congenital heart defect; the patients exhibited serious heart, live or kidney diseases; ③disturbance of consciousness or mental illness; ④ patients with tumor; ⑤ pregnant and lactating patients.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the good collateral group<br> | Other: non-applicable<br>* non-applicable<br>|
| the poor collateral group<br> | Other: non-applicable<br>* non-applicable<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CITED2 | western blot | within 24 hours after hospitalization | 
| VEGF | western blot | within 24 hours after hospitalization |
Treatment of Distal Radius Buckle Fractures

Study Overview
=================
Brief Summary
-----------------
This study determines if patients with buckle fractures of the distal radius and/or ulna treated with supportive care only demonstrate non-inferior outcomes in regard to pain control during healing, functional outcome at the wrist joint, and parental satisfaction, when compared with patients treated with the standard treatment regimen of 3-4 weeks in a short arm cast.

Official Title
-----------------
Supportive Care Versus Casting for Distal Forearm Buckle Fractures in Children; A Randomized Controlled Trial

Conditions
-----------------
Fracture Treatment

Intervention / Treatment
-----------------
* Other: Supportive Care
* Procedure: Cast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age 1-17 with buckle fractures of the distal radius and/or ulna. - Exclusion Criteria: Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care<br>No casting or splinting, supportive care only by parents | Other: Supportive Care<br> <br> |
| Active Comparator: Cast<br>Casting for 4 weeks | Procedure: Cast<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 4-6 weeks |
Fear of Recurrence and Stopping Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.

Detailed Description
-----------------
The intervention will be delivered through telemedicine to reduce the patient-related barriers to treatment including cost, transportation, and being able to maintain appointments while managing the side effects of treatment. The intervention will provide the patient with skills to reduce distress associated with ceasing treatment of a checkpoint inhibitor through the development evidence-based psychological and behavioral strategies that are tailored to the patients' preferences.

Official Title
-----------------
Distress Associated With Stopping Immunotherapy of Cancer Patients

Conditions
-----------------
Cognitive Behavioral Therapy

Intervention / Treatment
-----------------
* Behavioral: cognitive behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21 years and older Fluent in English Diagnosis of cancer and history of treatment with immunotherapy Exclusion Criteria: Active suicidal ideation, delusions or hallucinations

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will receive treatment and be evaluated pre- and post-treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cessation of treatment<br>If the patient is randomized to this arm, they will be asked to stop their immunotherapy | Behavioral: cognitive behavioral therapy<br>* Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce fear of recurrence | Change by 50% | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve quality of life | Change of quality of life by 5 points | 3 months | 
| Reduction of anxiety | Change of anxiety by 2 points | 3 months | 
| Depressive symptoms | Change by 25% | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fear of recurrence, Quality of life, Depression, Anxiety
22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the upper gastrointestinal tract.

Official Title
-----------------
Endoscopic Ultrasound Guided Biopsy of Subepithelial Tumors of the Upper Gastrointestinal Tract Using the 22-G-Procore Needle

Conditions
-----------------
Subepithelial Tumors of the Upper Gastrointestinal Tract

Intervention / Treatment
-----------------
* Device: 22-G Procore Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age 18 years and older All patients with subepithelial tumors of the upper GI tract (maximum size: 3 cm) Exclusion Criteria: Unable to obtain informed consent ASA class 4 or 5 known pregnancy contraindication endoscopy contraindication for taking biopsies

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 22-G Procore Needle<br> | Device: 22-G Procore Needle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic yield | Number of patients with adequate tissue sample (which allows definitive diagnosis) | 6 months |
A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to ensure the quality of the COPD treatment in primary care by implementing planned follow-up visits, where the disease condition is evaluated and optimised in accordance with the national COPD recommendations. If relevant the general practitioner (GP) will refer patients to COPD rehabilitation conducted by relevant municipality rehabilitation teams. Secondarily the purpose is to improve collaboration and communication between the local hospital pulmonologist, GPs and the municipality rehabilitation team

Official Title
-----------------
A Project Ensuring Quality and Cooperation in the Chronic Obstructive Pulmonary Disease (COPD) Treatment

Conditions
-----------------
COPD, Chronic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD diagnose, verified by spirometry Having given informed consent Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- | --- |
| Control visits at General practitioners |  | 6-12 months | 
| Lung function measured by spirometry |  | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnoea on MRC scale |  | 6-12 months | 
| Smoking status |  | 6-12 months | 
| Rehabilitation completed in the municipality rehabilitation team |  | 6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality assurance, rehabilitation, chronic care model, COPD
Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

Study Overview
=================
Brief Summary
-----------------
In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage. Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.

Official Title
-----------------
Acetylcystein Vid Stapedotomi

Conditions
-----------------
Otosclerosis

Intervention / Treatment
-----------------
* Drug: Acetylcysteine
* Drug: Placebo (NaCl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otosclerosis where surgery is planned Air / bone gap larger than 20 dB Normal middle ear status Exclusion Criteria: Hypersensitivity to acetylcysteine Deafness on the other ear Stapedotomy previously performed on the ear Pregnancy Asthma

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Acetylcysteine<br>* 150 mg / kg body weight. Drug is dissolved in NaCl to a final volume of 300 mL. This volume is infused starting one hour prior to surgery, and continued 1 hour after the end of surgery.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo (NaCl)<br>* 300 mL 0.9% NaCl<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing thresholds |  | one year |