linjc16/ctgov huggingface dataset:
Prophylactic PRP in Moderate NPDR

Study Overview
=================
Brief Summary
-----------------
Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR) provided careful follow-up can be maintained,. When retinopathy is more severe, scatter photocoagulation should be considered and should not be delayed if the eye has reached the high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal, good as it is, is not what ophthalmic practice has to deal with in communities of low-resource settings, where patients often seek medical advice due to visual complaints from the complications of PDR without being diagnosed in the non-proliferative stage or high risk PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic lockdown.

Official Title
-----------------
The Case for Selective Prophylactic Pan-retinal Photocoagulation in Moderate Non-Proliferative Diabetic Retinopathy in Ophthalmic Practice in Low- Resource Settings

Conditions
-----------------
Diabetes, Eye Diseases, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: PRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate NPDR at high risk which includ: Patients with PDR in the other eye Patients whose Glycosylated Haemoglobin (HbA1c) more than 8 %. Patients with early cataract Patients on regular renal dialysis or with impaired renal function Patients with restricted mobility because of neurological or orthopedic conditions Patients dependent on others, including old age. Women in rural areas, who are dependent on the accompaniment of a male relative. Exclusion Criteria: Any patient who or whose relatives confirmed their attendance for regular follow-up according to the planned schedules after being informed of the possible complications which could happen if he or she did not attend. Patients with clinically significant macular edema (CSME).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PRP|Single session prophylactic early Pan-retinal Photocoagulation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA |  | 3 months |
Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases.

Official Title
-----------------
Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells

Conditions
-----------------
Red Blood Cell, Peripheral Blood Mononuclear Cell, Endothelial NO-synthase

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Patients: stable coronary artery disease with accordingly endothelial dysfunction Exclusion Criteria: acute inflammation (CRP>0,5 mg/dl, leucocyte >11000/dl) malignant diseases acute or terminated kidney disease relevant heart failure (NYHA III-IV)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>100 healthy volunteers in age of 20-75 years | |
| Patients<br>100 patients with stable coronary artery disease and accordingly endothelial dysfunction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood examination | Following parameters will be examined: Blood count (red cells, white cells, platelets, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), mean platelet volume (MPV) ) Creatinin Urea Glucose Glycated hemoglobin (HbA1c) Cholesterol Triglyceride C-reactive Protein Apolipoprotein | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein expression | Determination with western blot | baseline | 
| Asymmetric dimethylarginine (ADMA) and Cytokine | Determination with enzyme-linked immunosorbent assay (ELISA). | baseline | 
| Microparticles | Determination with ELISA and flow cytometry | baseline | 
| Immunocytochemistry |  | baseline | 
| Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN) | Determination with reductive chemiluminescence | baseline | 
| Nitric oxid and reactive oxygen species | Determination with fluorescence coloring in flow cytometry and fluorescence microscopy | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelial NO-synthase, red blood cell, erythrocytes, Peripheral Blood Mononuclear Cell, cardiovascular disease
Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder

Study Overview
=================
Brief Summary
-----------------
In 2017, structured physical exercise with high intensity was implemented as a part of the treatment program at St. Olav Hospital Clinic of Substance Use and Addiction Medicine. The objective of this study is to examine whether implementing structured physical exercise in the treatment program has implications for patients' physical and mental health and quality of life after completing a 3 month residential treatment program. The results of this study will benefit substance use disorder patients in the future, and may have an impact on further implementation of physical exercise in addiction treatment clinics both nationally and internationally.

Official Title
-----------------
Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder: Implications for Abstinence, Quality of Life, Physical- and Mental Health

Conditions
-----------------
Substance-Related Disorders, Drug Abuse, Drug Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being an inpatient at the clinic Exclusion Criteria: -

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 |
| --- | --- |
| Exercise group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical health | Change in oxygen uptake | 18 months | 
| Physical health | Change in maximum leg strength | 18 months | 
| Mental health | assessed by a in-house developed questionnaire, which is composed of 4 parts: Severity of Dependence 5-items (each of the five items is scored on a 4-point scale (0-3). Total score is the sum of the 5-item ratings. The higher the score the higher the level of dependence); Circumstances, Motivation, Readiness, and Suitability instrument (Five items measured on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (totally agree). High scores indicate increased intrinsic motivation); Quality-of-Life rating five items recorded on a five-point Likert scale: 1 (very poor) - 5 (very good). The raw scores are transformed to a decimal scale, ranging from 0.1 worst score to 0.9 best score); Hopkins Symptom Checklist (HSCL-10): Ten items recorded on a four-point Likert scale: (1) not at all - (4) extremely. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise therapy, Exercise physiology
Effects of Mucoprotective Product on Xerostomia

Study Overview
=================
Brief Summary
-----------------
In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.

Official Title
-----------------
Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients

Conditions
-----------------
Xerostomia

Intervention / Treatment
-----------------
* Other: XER2020


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be at least 18 years of age. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer The patient must understand and consent in writing to the procedure. Exclusion Criteria: Do not meet the criterion for dry mouth regarding saliva secretion threshold values. Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene Patients who are unable or unwilling to cooperate with study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XER2020<br>mucoprotective product | Other: XER2020<br>* mucoprotective product<br>|
| Active Comparator: Saliva Natura<br>salivary substitute | Other: XER2020<br>* mucoprotective product<br>|
| Placebo Comparator: XER2020 placebo<br> | Other: XER2020<br>* mucoprotective product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHIP questionaire health impact profile | Effect on oral health quality will be assessed after each treatment period | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
xerostomia, saliva, mucoprotection, oral health
Xenon Inhalation for Treatment of Posttraumatic Stress Disorder

Study Overview
=================
Brief Summary
-----------------
This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Combination Product: NBTX-001 Xenon Inhaler
* Combination Product: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria and a Clinician Administered PTSD Scale [CAPS-5] total severity score of >30). Male and female patients between the ages of 18 and 85 years. Exclusion Criteria: History of schizophrenia, bipolar and other psychotic disorders. Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function. Currently undergoing PTSD-targeted psychotherapy. Currently undergoing exposure-based psychotherapy for any condition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: NBTX-001<br> | Combination Product: NBTX-001 Xenon Inhaler<br>* The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.<br>|
| Placebo Comparator: Placebo<br> | Combination Product: Placebo<br>* The placebo medical gas consists of 30% oxygen and 70% nitrogen.The dose of placebo medical gas is 10 L by volume.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS-5 | Change in CAPS-5 score | Baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCL-5 | Change in PCL-5 score | Baseline to Week 6 |
Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia

Study Overview
=================
Brief Summary
-----------------
Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points: • ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority was not considered possible. . It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.

Official Title
-----------------
A Single Blind, Multi-centre, Randomised Multinational Phase III Study to Compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients With Essential Thrombocythaemia

Conditions
-----------------
Essential Thrombocythaemia

Intervention / Treatment
-----------------
* Drug: Anagrelide
* Drug: Hydroxyurea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of essential thrombocythaemia with high-risk profile. Exclusion Criteria: previous treatment with cytoreductive drugs or Anagrelide pregnant women or women in childbearing age with inadequate contraception patients with contraindications for study drugs due to anaphylactoid reactions to either active or non-active ingredients known lactose intolerance cardiovascular diseases grade III-IV (Toxicity Criteria of the South West Oncology Group, 1992) - with a negative benefit/risk ratio severe renal disease (Creatinin Clearance < 30 ml/min) severe liver disease (AST or ALT > 5-times normal) coexisting, malignant, systemic diseases

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anagrelide<br> | Drug: Anagrelide<br> <br> |
| Active Comparator: Hydroxyurea<br> | Drug: Hydroxyurea<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and woodsmoke air pollution indoors and to improve subclinical indicators of microvascular function, systemic inflammation, and oxidative stress among healthy adult participants.

Detailed Description
-----------------
The investigators will use portable HEPA filters in a single-blind randomized crossover design. Each participant's home will be monitored for two consecutive seven-day periods, during which time two HEPA units (one in the bedroom and one in the main living room) will be operated indoors. During one 7-day period the HEPA filters will be operated normally, and during the other period the HEPA unit will be operated without the internal filter in place (i.e., placebo filtration), thus blinding participants to the filters' status. The order of filtration or non-filtration will be random. At the end of each 7-day period microvascular function will be assessed, blood will be collected for assessment of systemic inflammatory markers, and urine will be collected for assessment of oxidative stress markers.

Official Title
-----------------
Assessing the Impact of Wood Stove Interventions on Air Quality

Conditions
-----------------
Endothelial Function, Oxidative Stress, Systemic Inflammation

Intervention / Treatment
-----------------
* Device: HEPA filter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years or older Non-smoking household Lives in study region (Smithers or Telkwa British Columbia) Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Indoor air HEPA filtration<br>HEPA filters operating in the participant's bedroom and living room. | Device: HEPA filter<br> <br> * Other names: Honeywell model 18150;|
| No Intervention: Control<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive hyperemia index |  | After 1 week of air filtration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein |  | After 1 week of filtration |
Functional Microarray Augmentation of Skin Treatment With Lidocaine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.

Detailed Description
-----------------
The study's primary goal is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided by lidocaine gel 4% (LG4). A secondary goal is to determine whether the depth of anesthesia is enhanced.

Official Title
-----------------
Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)

Conditions
-----------------
Pain Perception, Phlebotomy

Intervention / Treatment
-----------------
* Drug: 4% lidocaine gel application with sham microneedle device
* Drug: Microneedle-facilitated lidocaine application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age at least 18 years, must provide voluntary consent, weight at least 50 kg, no allergies to lidocaine, no skin disease, inflammation, or infection at the venipuncture sites to be tested Exclusion Criteria: cannot have any major dermatologic disease history, known liver abnormalities, women who are currently breastfeeding

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>Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement. | Drug: 4% lidocaine gel application with sham microneedle device<br>* Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).<br>* Other names: 4% Lidocaine gel with sham-functional microarray (FMA);|
| Experimental: Microneedle<br>Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement. | Drug: Microneedle-facilitated lidocaine application<br>* Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device<br>* Other names: 4% lidocaine gel with functional microarray;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venipuncture pain levels |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undesirable side effects |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venipuncture, phlebotomy, pain perception