linjc16/ctgov huggingface dataset:
Improving Non-invasive Ventilation

Study Overview
=================
Brief Summary
-----------------
A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.

Official Title
-----------------
Improving Non Invasive Ventilation

Conditions
-----------------
Acute Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: Non-invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment with non-invasive ventilation informed consent Exclusion Criteria: refusal of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| NIV<br>All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data | Procedure: Non-invasive ventilation<br>* Non-invasive ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring NIV in a large university hospital. Incidence of NIV failure (including patient compliance) and NIV related complications. Imaging (chest ultrasound) in a subgroup of patients before and after receiving NIV. |  | Outcome measures will be assessed every day and participants will be followed for the duration of hospital stay, an expected average of 1 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIV, acute respiratory failure, hypoxia, hypercapnia, non-invasive ventilation, hospital ward
Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.

Official Title
-----------------
Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-Blind Controlled Trial

Conditions
-----------------
Video-assisted Thoracoscopic Surgery

Intervention / Treatment
-----------------
* Drug: Morphine
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA (American Society of Anesthesiologist) physical status I to III, Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals capable of using a patient-controlled analgesia (PCA) machine understanding the numeric rating scale (NRS) score for pain assessment. Exclusion Criteria: history of allergy to the study drugs bleeding disorder infection of the back refusing spinal anesthesia history of cerebrovascular disease using postoperative ventilator support were excluded

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 |
| --- | --- |
| Sham Comparator: Control<br>The skin will be injected with local anesthetic without spinal block | Other: control<br>* Patient receive only local infiltration without spinal analgesia<br>|
| Active Comparator: Spinal morphine<br>0.15 mg spinal morphine | Drug: Morphine<br>* spinal morphine 0.15 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total post-operative morphine requirement. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after surgery |  | 48 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, spinal morphine, video-assisted thoracoscopic surgery
Diabetes and Psoriasis

Study Overview
=================
Brief Summary
-----------------
Patients with psoriasis will be evaluated. The investigators will collect personal history, concomitant diseases and in particular the presence of type 2 diabetes mellitus, impaired fasting glucose and impaired glucose tollerance. The aim of the study will be to evaluate if there is a correlation among inflammation, insulin-resistance and psoriasis.

Official Title
-----------------
Diabetes and Psoriasis: Study on Prevalence, Role of Inflammation and Insulin-resistance

Conditions
-----------------
Diabetes, Psoriasis

Intervention / Treatment
-----------------
* Other: PASI and HOMA index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with psoriasis Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PASI and HOMA index|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of correlation between diabetes and psoriasis |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Psoriasis, Inflammation, Insulin-resistance
Influence of Posture and Gas Insufflation on Perioperative Lung Function

Study Overview
=================
Brief Summary
-----------------
Perioperative airway resistance and lung function are evaluated perioperatively in patients, who undergo surgical procedures in different postures and with or without gas insufflation into the peritoneal cavity.

Detailed Description
-----------------
Lung function, upper and lower airway resistance measurements are performed in patients in prone horizontal or head tilted down (40°) position. Half of the patients with head down position will have surgery in laparoscopic technique (including gas insufflation to achieve a pneumoperitoneum). Measurements are performed on the day prior to surgery, on the morning of surgery, 30 - 45 minutes, 2 hours, and 24 hours after extubation.

Official Title
-----------------
Influence of Posture, Anesthesia and Surgical Technique on Airway Resistance of the Upper and Lower Airway and Lung Function.

Conditions
-----------------
Pneumoperitoneum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years of age. Patients with normal lung function with respect to age, gender and weight. -Patients scheduled for Prostatectomies, robotic Prostatectomies, and open hemicolectomies. Exclusion Criteria: Patients younger than 18 years. Patients with pathological lung function. Patients with with major cardiac disease.

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 |
| --- | --- |
| head down, laparoscopic<br>20 patients with laparoscopic surgery (radical robotic prostatectomy) in head down position | |
| head down, open<br>20 patients undergoing opensurgery (open radical prostatectomy) in head down position. | |
| horizontal, open<br>20 patients undergoing open surgery in horizontal position (open hemicolectomy) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nasal airway resistance |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vital capacity, FEV1, airway resistance, perioperative changes in lung function
Long-term Extension Study of BEMA™ Fentanyl

Study Overview
=================
Brief Summary
-----------------
This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.

Detailed Description
-----------------
This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.

Official Title
-----------------
Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl

Conditions
-----------------
Respiratory Depression

Intervention / Treatment
-----------------
* Drug: BEMA Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously qualified for and participated in study FEN-202 for at least 2 weeks, wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and provide signed informed consent at screening prior to any study procedures. Exclusion Criteria: they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or there is evidence of improper use of the study drug.

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: BEMA Fentanyl<br>BEMA Fentanyl | Drug: BEMA Fentanyl<br>* buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily<br>* Other names: ONSOLIS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported. | Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pain, Ventilatory Response to Hypercapnia (VRH)
Safety Study of Abatacept in Sweden

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.

Official Title
-----------------
A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Sweden 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 |
| --- | --- |
| Patients initiating abatacept<br> | |
| Patients receiving other biologic disease-modifying drugs<br> | |
| Patients with early rheumatoid arthritis (RA)<br> | |
| Patients with prevalent RA identified by hospitalization<br> | |
| General population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalized infection |  | Every 6 months throughout the study | 
| Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer) |  | Every 6 months throughout the study | 
| Total mortality |  | Every 6 months throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autoimmune disorders (lupus, psoriasis, multiple sclerosis) |  | Every 6 months throughout the study |
Effect General and Regional Anesthesia on Glycocalyx

Study Overview
=================
Brief Summary
-----------------
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Detailed Description
-----------------
Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia. The aim of the study: Comparison of two anaesthesia techniques with respect to GCX. Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.

Official Title
-----------------
Effect General and Regional Anesthesia on Glycocalyx

Conditions
-----------------
Anesthesia, Glycocalyx, Perfused Boundary Region

Intervention / Treatment
-----------------
* Other: General anesthesia
* Other: Regional anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ASA 2-3 undergoing elective total knee replacement surgery Exclusion Criteria: None

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 |
| --- | --- |
| General anesthesia<br>Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia. | Other: General anesthesia<br>* General anesthesia<br>|
| Regional anesthesia<br>Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia. | Other: Regional anesthesia<br>* Regional anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perfused Boundary Region (PBR) | PBR is an indirect measure of glycocalyx thickness | Change from baseline PBR at 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, glycocalyx, perfused boundary region
Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.

Detailed Description
-----------------
LDL-C after 12 weeks of treatment Safety and tolerability Plasma levels of SLx-4090

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: SLx-4090
* Drug: SLx-4090
* Other: Placebo
* Drug: Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LDL-C > or = 100 mg/dL On stable statin therapy for at least 6 weeks Exclusion Criteria: Coronary heart disease or risk factors for CHD

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 |
| --- | --- |
| Experimental: 1<br>SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. | Drug: SLx-4090<br>* tablet<br>Drug: Statin<br>* Subjects were dosed with the statin prescribed specifically by their prescribing physician.<br>|
| Experimental: 2<br>SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. | Drug: SLx-4090<br>* tablet<br>Drug: Statin<br>* Subjects were dosed with the statin prescribed specifically by their prescribing physician.<br>|
| Other: 3<br>Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician. | Other: Placebo<br>* matching tablet<br>Drug: Statin<br>* Subjects were dosed with the statin prescribed specifically by their prescribing physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in LDL-C |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 12 weeks |
Identifying Methylation Biomarkers for Monitoring Bladder Tumors

Study Overview
=================
Brief Summary
-----------------
To investigate the methylation status of 4-6 genes in Urine and matching bladder tissue biopsies, in order to find methylation markers for use in a noninvasive test in monitoring patients with bladder tumors.

Official Title
-----------------
Using PCR Technology (Polymerase Chain Reaction Technology) for Monitoring Patients With Bladder Tumors - Optimizing Genanalyses for Clinical Use.

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: Identifying genes methylated in urine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bladder tumors and patients with benign urinary tract conditions with no clinical suspicion of bladder cancer. Exclusion Criteria: Patients with competing urinary and systemic diseases, pregnant and patients under 18 years of age.

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 |
| --- |
|Procedure: Identifying genes methylated in urine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Study Overview
=================
Brief Summary
-----------------
Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with frequent nosebleeds in the majority of cases. Several reports in the literature support the use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the study are to test if Tranexamic acid taken orally can improve anemia (lead to an increased hemoglobin level) reduce nosebleeds.

Official Title
-----------------
Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia

Conditions
-----------------
Hereditary Hemorrhagic Telangiectasia

Intervention / Treatment
-----------------
* Drug: Tranexamic acid first, than placebo
* Drug: First placebo, than Tranexamic acid.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated. Exclusion Criteria: pregnant, minor, had an increased risk of thrombotic events (history or signs of cerebrovascular events, cardiac arrhythmias, biochemically increased coagulation parameters), renal insufficiency, a history of massive hematuria or defects of color vision.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months. | Drug: Tranexamic acid first, than placebo<br>* For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.<br>|
| Experimental: Group II<br>First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily). | Drug: First placebo, than Tranexamic acid.<br>* First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hemoglobin level within the phases. |  | Beginning and end of each 3 months period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean epistaxis score (daily duration multiplied by mean subjective daily intensity) |  | Measured once a day during each 3 months period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hereditary hemorrhagic telangiectasia, Rendu-Osler-Weber syndrome, Epistaxis, Nosebleeds, Anemia, Tranexamic acid, Antifibrinolytics