linjc16/ctgov huggingface dataset:
Restylane Silk for Photoaged Thinned Hands

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands

Official Title
-----------------
Restylane Silk for Photoaged Thinned Hands

Conditions
-----------------
Photoaged Thinning of the Hands

Intervention / Treatment
-----------------
* Device: Restylane Silk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female volunteer Aged from 40-70 years on the day of screening No known medical conditions that may interfere with study participation Moderate to very severe Photoaged thinning of the hands based on the 5-point hand grading scale Willingness to not use any products on their hands for the duration of the study Read, understand, and sign informed consent forms Willingness to sign photography release form Willing and able to comply with all follow-up requirements Willingness to undergo Restylane Silk injections to one hand Exclusion Criteria: Any significant skin disease at treatment area Any medical condition which could interfere with the treatment Inability or unwillingness to follow the treatment schedule Inability or unwillingness to sign the informed consent History of poor wound healing History of keloid formation History of HIV, hepatitis, immuno-compromised Pregnant or lactating Previous use of deep chemical peels on the treatment area Previous injections of Restylane Silk to the hands Known hypersensitivity to Restylane Silk or any of its ingredients Previous laser or light based treatments to the treatment area 6 months prior to the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

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: Restylane Silk Treated Hand<br>The dorsal aspect of one hand will be injected with Restylane Silk. | Device: Restylane Silk<br> <br> |
| No Intervention: Control Hand<br>The dorsal aspect of the hand that is not treated will be used for baseline comparison. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale |  | Baseline, 1month, 3months, 6 months |
A Study of the Rate of Progression of Glaucoma During a Follow-up Period of Two Years

Study Overview
=================
Brief Summary
-----------------
This is an epidemiological, non-interventional, prospective study to collect data on glaucoma progression in a routine setting. Patients may receive treatment at the discretion of their physician per local standard of care.

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma in one or both eyes Exclusion Criteria: Participation in a glaucoma therapeutic clinical trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma<br>Patients with glaucoma | Other: Standard of Care<br>* Patients with glaucoma treated with standard of care at the discretion of the physician. There is no specific treatment required for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Visual Field |  | Baseline, 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Intraocular Pressure (IOP) |  | Baseline, 24 Months |
Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients

Study Overview
=================
Brief Summary
-----------------
The investigators are studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.

Official Title
-----------------
Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients ≥ 75 Years of Age and Their Caregivers (CKD-EDU Study) - A Pilot Study

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Behavioral: CKD-EDU
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥75 years old Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 25 ml/min) Patient's nephrologist is enrolled in the study and has seen that nephrologist at least once Speaks English Have not attended a dialysis education class or met with the dialysis education coordinator. Have not made a dialysis decision Exclusion Criteria: Patient has already been seen by a palliative care clinician or is enrolled in hospice Is already on dialysis Hospitalized at the time of recruitment

Ages Eligible for Study
-----------------
Minimum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual care<br> | Other: usual care<br>* Nephrologist based usual care<br>|
| Experimental: CKD-EDU arm<br> | Behavioral: CKD-EDU<br>* Palliative Care based coaching intervention for support with dialysis-related decision making.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants receiving the intervention | We'll assess feasibility by determining the reach of the intervention | 24 months | 
| Acceptability of the intervention | We'll assess the acceptability of the CKD-PC intervention by qualitative interviews by reporting the percentage of patients with a favorable response to the intervention. | 24 months |
Prazosin for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The most likely outcome of smoking cessation attempts is relapse, underscoring the need to advance novel treatments. Preclinical research shows that the noradrenergic system is critical for modulating drug-seeking behavior and recent findings indicate that the α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement. Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An efficient method for screening novel smoking cessation medications is to integrate human laboratory paradigms in the context of brief, randomized trials of smoking cessation that include smokers motivated to quit. This study aims to provide an initial test of prazosin for smoking cessation by implementing a brief, randomized trial that will include both human laboratory and clinical phenotypes. This approach will allow an efficient but sensitive method for medication screening that maximizes clinical validity.

Official Title
-----------------
Prazosin as a Novel Treatment for Smoking Cessation

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Prazosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 10 cigarettes per day for past year Baseline Fagerstrom Test for Nicotine Dependence (FTND) score of greater than or equal to four Willing to engage in two practice quit attempts Willingness to forgo other medication based treatments during the trial Exclusion Criteria: Current illicit drug use Current treatment with psychiatric medications other than selective serotonin re-uptake inhibitors (SSRIs) Lifetime diagnosis of post-traumatic stress disorder (PTSD) Significant medical/neurological illness Baseline BP outside of normal range Current use of tobacco aids Current use of medications that could interact with prazosin Pregnancy or nursing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pills<br> | Drug: Placebo<br>* Placebo capsules, 3x daily<br>|
| Active Comparator: Prazosin pills<br> | Drug: Prazosin<br>* Prazosin medication, 3x daily dosing, up to 15mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term smoking cessation |  | 4 days |
Comparison of Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse effects associated with anesthesia

Official Title
-----------------
To Compare Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female paediatric patients In age range neonates to 15 years Planned for elective inguinal hernia repair Patients with uncomplicated hernia With ASA class I or II Exclusion Criteria: Patients undergoing emergency inguinal repair Patients with ASA class III,IV,V or VI Patients present with complicated hernia Patients with BMI above 40kg/m2 Patients with any allergy to anesthesia Patients with coagulopathy Patients with narcotic/opioid addiction

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Inj. Dexmedetomidine (precidex) 200/mcg/2ml given to participants in infusion form for 10 mins of surgery and maintenance dose given till the end of surgery | Drug: Dexmedetomidine<br>* Inj dexmedetomidine and inj midazolam given to 2 groups of participants and sedative effects of both drugs will be observed during surgery<br>|
| Active Comparator: Midazolam<br>Inj midazolam 0.5 mg/kg stat dose will be given to participants during surgery | Drug: Midazolam<br>* Midazolam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of sedation assessed through Ramsay Sedation Scale RSS |  | 6 months |
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.

Official Title
-----------------
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery: a Randomized, Controlled Trial.

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Biological: Platelet transfusion
* Biological: Fibrinogen concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children < 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass. Body weight < 10 kg. Expected CPB time > 90 minutes. Exclusion Criteria: Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases > normal interval for the patient´s age), gestational age < 34 weeks.

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelets<br>Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, a platelet transfusion. | Biological: Platelet transfusion<br>* Platelets (10 ml/kg body weight) is transfused.<br>|
| Experimental: Fibrinogen<br>Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, fibrinogen concentrate. | Biological: Fibrinogen concentrate<br>* Fibrinogen concentrate (300 mg/kg body weight) is administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HEPTEM-A10 | The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis. | 45 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of transfused packed red blood cells |  | up to first postoperative morning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary bypass, Bleeding, Coagulopathy, Heart surgery
Effects of 5-Aminolevulinic Acid on Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2 diabetes on medication.

Official Title
-----------------
A Randomized, Double-blind, Cross-over Study to Assess Efficacy of 5-Aminolevulinic Acid in Type 2 Diabetic Patients on Medication.

Conditions
-----------------
Type 2 Diabetes on Medication

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: 5-aminolevulinic acid phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients on medication HbA1c ≤ 9.0% (as JDS values, which is equivalent to HbA1c ≤ 9.4% as NGSP values) On stable treatment of diabetes for at least the last 3 months With permission to attend the clinical trial from the primary doctor Exclusion Criteria: On insulin therapy BMI ≤ 18 kg/m2 or ≥ 30 kg/m2 History of porphyria, hemochromatosis, or viral hepatitis Pregnant or nursing a child Heart disease Renal or hepatic dysfunction Participation in any clinical trial within 90 days of the commencement of the trial

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |
| Experimental: Supplement<br> | Dietary Supplement: 5-aminolevulinic acid phosphate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose level |  | Every 4 weeks (Overall 36 weeks) | 
| HbA1c level |  | Every 4 weeks (Overall 36 weeks) | 
| Glycoalbumin level |  | Every 4 weeks (Overall 36 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting insulin level |  | Every 4 weeks (Overall 36 weeks) | 
| 1,5-AG level |  | Every 4 weeks (Overall 36 weeks) | 
| Serum C-peptide level |  | Every 4 weeks (Overall 36 weeks) | 
| HOMA-R |  | Every 4 weeks (Overall 36 weeks) |
Longitudinal Study of Empathy Levels in Physiotherapy Students

Study Overview
=================
Brief Summary
-----------------
'Empathy' is a core term of occupations related to health sciences like physiotherapy. In physiotherapy education programs, empathy is necessary to have a successful cooperation with the clients. This study was planned to follow the changes of empathy levels in physiotherapy students of a four-year bachelor program and therefore enhance the curriculum related to the results. To the best of our knowledge, this research is the first longitudinal study about empathy levels of students in Turkey. Hypotheses: Empathy levels of the students increase year by year (1). Female students are more empathetic than male ones (2).

Detailed Description
-----------------
Totally 120 physiotherapy students at a non-governmental university in Istanbul participated in this study. The Turkish reworded student version of the Jefferson scale of physician empathy was used. Empathy scores were compared related to study years and gender. Empathy scores relevant to gender were compared using Mann-Whitney U test. The Kruskal-Wallis one-way analysis of variance was used for differences among the four study years.

Official Title
-----------------
A Four-Year Longitudinal Study of Empathy Levels in Undergraduate Physiotherapy Students

Conditions
-----------------
Longitudinal Study of Empathy Levels in Physiotherapy Students

Intervention / Treatment
-----------------
* Behavioral: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: attending the first through fourth year of physiotherapy department being willing to participate in the study Exclusion Criteria: do not continue in physiotherapy department

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 24 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 |
| --- | --- |
| physiotherapy students<br>Totally 120 physiotherapy students at a non-governmental university in Istanbul participated in this study. | Behavioral: survey<br>* The Turkish reworded student version of the Jefferson scale of physician empathy was used. Empathy scores were compared related to study years and gender.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empathy levels of the students | It was measured if the empathy levels of the students increase year by year | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empathy levels of female students | It was measured if female students are more empathetic than male ones | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
students, empathy, longitudinal studies
Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.

Official Title
-----------------
A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Betamethasone Microsphere (DE-102） Low Dose
* Drug: Betamethasone Microsphere (DE-102） High Dose
* Drug: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provided signed, written informed consent 20 years of age or older with diabetic macular edema Exclusion Criteria: Active proliferative diabetic retinopathies (PDR) in the study eye Uncontrolled diabetes mellitus and hypertension Known steroid-responder

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: 1<br> | Drug: Betamethasone Microsphere (DE-102） Low Dose<br> <br> |
| Experimental: 2<br> | Drug: Betamethasone Microsphere (DE-102） High Dose<br> <br> |
| Sham Comparator: 3<br> | Drug: Sham<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity(BCVA) | Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal thickness | Change in retinal thickness from baseline |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DME