linjc16/ctgov huggingface dataset:
Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators investigated the clinical impacts of preoperative nutritional status on mortality in patients undergoing valvular heart surgery. Preoperative nutritional status was evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score. The primary outcome was the association between preoperative nutritional status evaluated by PNI, GNRI, and CONUT score and postoperative mortality. The predictive discrimination ability for mortality between PNI, GNRI, and CONUT were compared. Risk factors for mortality were identified.

Official Title
-----------------
Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery

Conditions
-----------------
Patients Undergoing Valvular Heart Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent valvular heart surgery from January 2013 to February 2018 Exclusion Criteria: Patients younger than 18 years Patients undergoing combined congenital heart surgery Patients undergoing transcatheter valve replacement

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| postoperative mortality according to peroperative nutritional status | The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated. | 1 year after surgery | 
| postoperative mortality according to peroperative nutritional status | The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated. | 2 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive discrimination ability for mortality between PNI, GNRI, and CONUT | The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared. | 1 year after surgery | 
| predictive discrimination ability for mortality between PNI, GNRI, and CONUT | The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared. | 2 year after surgery |
Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation

Study Overview
=================
Brief Summary
-----------------
surgical site infiltration using ketamine versus Bupivacaine for analgesia in post-operative Appendectomy operation by Ketamine versus Bupivacaine

Official Title
-----------------
Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation

Conditions
-----------------
Appendicitis Acute

Intervention / Treatment
-----------------
* Drug: Ketamine Versus Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 adult patients with ASA physical physical status class 1 and class 2 undergoing uncomplicated appendectomy under general anesthesia Exclusion Criteria: Patient refusal drug abuse Patient with neurological, psychiatirc or neuromuscular disease chronic pain on medicine known allergy to the study medicine Infection at the site of infiltration

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group of Ketamine injection<br>Ketamine infiltration for post operative analgesia | Drug: Ketamine Versus Bupivacaine<br>* Drugs Ketamine versus Bupivacaine<br>|
| Experimental: Group of Bupivacaine injection<br>Bupivacaine infiltration for post operative analgesia | Drug: Ketamine Versus Bupivacaine<br>* Drugs Ketamine versus Bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison study between Ketamine and Bupivacaine for post operative analgesia | Analgesia for post -operative Appendectomy operation | one year |
Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

Study Overview
=================
Brief Summary
-----------------
Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers

Official Title
-----------------
Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

Conditions
-----------------
Contact Lens Wearers With Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: cyclosporine ophthalmic emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: contact lens wearer clinical diagnosis of dry eye syndrome Exclusion Criteria: -

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

| Intervention/Treatment |
| --- |
|Drug: cyclosporine ophthalmic emulsion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular exams and questionnaires at baseline and at 3 months will determine |  |  | 
| the effect of cyclosporine on dry eye syndrome. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased contact lens wearing time due to a decrease in severity |  |  | 
| of dry eye symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cyclosporine, dry eye syndrome, contact lens
Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

Study Overview
=================
Brief Summary
-----------------
Study to determine if men from around the world prefer sildenafil to tadalafil.

Official Title
-----------------
Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: tadalafil
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be of legal age according to your country. Must have had a history of erectile dysfunction for at least 3 months. Must currently and have been using sildenafil for the last six weeks. Agree to not use any other ED treatment during the study. Anticipate the same female sexual partner for the study. Exclusion Criteria: History of other primary sexual disorder Treatment with nitrates Have a penile implant or clinically significant penile deformity History of certain heart problems Do not meet certain lab value reference ranges

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Currently prescribed dosage of sildenafil is continued until wash-out period. | Drug: sildenafil<br>* Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.<br>|
| Active Comparator: 2<br>20 mg tadalafil given after one week sildenafil wash-out period. | Drug: tadalafil<br>* 20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.<br>* Other names: IC351;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. |  | 26 weeks |
Kyphotic Measure Using Distance From the Wall

Study Overview
=================
Brief Summary
-----------------
Are the KypDisT and conventional C7WD are practical, valid, reliable, and effectiveness of the tools to discriminate the functional ability impairments relating to kyphosis when compare with gold standard (Cobb's method), and compare among physical therapy, VHS and caregiver?

Detailed Description
-----------------
To further develop an innovation to measure kyphosis using distance from the wall, a Kyphosis wall distance tool (KypDisT). investigate validity of the measurements in terms of 2.1 Concurrent validity of conventional C7WD and KypDisT as compared to a gold standard (Cobb's method). 2.2 Discriminative ability of conventional C7WD and KypDisT on functional abilities in elderly with different severity of kyphosis. To investigate the reliability of the measurements in terms of 3.1 Test-retest reliability of conventional C7WD and KypDisT. 3.2 Reliability of conventional C7WD and KypDisT comparing among physical therapy, VHS and caregiver. To explore the distance to indicate risk of spinal fracture to indicate a risk of spinal fracture.

Official Title
-----------------
Kyphotic Measure Using Distance From the Wall: Reliability, Validity and Distance From the Wall to Indicate Risk for Spinal Fracture

Conditions
-----------------
Kyphosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Community-dwelling elderly with different degrees of kyphosis, Aged at least 60 years Body mass index between 18.5-29.9 kg/m2 OWD >0 cm. Exclusion Criteria: Present signs and symptoms that may affect participation in the study, i.e. unstable medical condition, pain or inflammation in the joints of the lower extremity (pain scale > 5), having sequelae of neurological deficits Unable to understand and follow a simple command used in the study.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Kyphosis group<br>Subjects are community-dwelling elderly with different degrees of kyphosis, aged at least 60 years with a body mass index between 18.5-29.9 kg/m2 and OWD >0 cm. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KMD | Kyphosis assessments using distance from the wall | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10MWT | walking speed | 1 day | 
| FTSST | Lower limb muscle strength | 1 day | 
| TUGT | Balance control | 1 day | 
| 6MinWT | Walking endurance | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kyphosis, Kyphosis wall distance, elderly
Prevention of Seasonal Affective Disorder

Study Overview
=================
Brief Summary
-----------------
This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).

Official Title
-----------------
A 7 Month, Multicenter, Randomized, Double-blind, Placebo-controlled Comparison of 150-300mg/Day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase

Conditions
-----------------
Seasonal Affective Disorder

Intervention / Treatment
-----------------
* Drug: Extended-release bupropion hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern. Exclusion Criteria: Patient has a current or past history of seizure disorder or brain injury. Patient has a history or current diagnosis of anorexia nervosa or bulimia. Patient has recurrent summer depression more frequently than winter depression. Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders. Patient has initiated psychotherapy within the last 3 months.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extended-release bupropion hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HAMD-24 and -17 total score. Change in pain score. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seasonal depression winter blues winter depression
Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis.

Official Title
-----------------
Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation

Conditions
-----------------
Atrial Fibrillation, Stroke, Transient Ischemic Attack, Bleeding, Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing aortic valve bioprosthesis implantation Exclusion Criteria: mechanical heart valves in any position

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke |  | 10 years | 
| Mortality |  | 10 years | 
| atrial fibrillation |  | 10 years | 
| major bleeding |  | 10 years |
Antihyperlipidemic Effects of Oyster Mushrooms

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to evaluate the short-term safety and potential efficacy of oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected patients who are taking Kaletra, a protease inhibitor (PI) that is commonly used in highly active antiretroviral therapy (HAART).

Detailed Description
-----------------
This is a single-arm, open-label, 8-week proof of concept pilot study in 20 subjects to determine if there are detectable lipid-lowering effects of oyster mushrooms in patients with HIV and hyperlipidemia who are taking Kaletra (a ritonavir-containing HAART regimen). The study will also assess whether the concurrent administration of oyster mushrooms and such regimens is safe, and investigate the mechanism of action whereby oyster mushrooms may exert their antihyperlipidemic effect.

Official Title
-----------------
Antihyperlipidemic Effects of Oyster Mushrooms

Conditions
-----------------
HIV Infections, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: oyster mushroom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Documented HIV infection (positive ELISA and Western Blot or measurable plasma HIV RNA). Taking Kaletra (ritonavir/lopinavir), a ritonavir-containing antiretroviral therapy, for at least 12 weeks Elevated non-HDL cholesterol >= 160 mg/dl as defined by the National Cholesterol Education Program guidelines (within 30 days of enrollment) AST or ALT <2.5 times the upper limit of normal (ULN) within 30 days of study entry. Exclusion criteria: Currently receiving antihyperlipidemic treatment (e.g., statins, fibrates, bile sequestrants, niacin) Pregnancy or breastfeeding Documented history of myopathy or myalgias on HMG-CoA reductase inhibitors Documented history of rhabdomyolysis Documented diagnosis of diabetes mellitus Any condition that, in the judgment of the investigator, precludes successful participation in the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oyster mushroom|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Highly active antiretroviral therapy (HAART), Ritonavir, Oyster mushrooms, Non-HDL cholesterol, Complementary Therapies, Treatment Experienced
Effect of a Single Colecalciferol Dose on Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after 90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease glucose level, since there is an association between hypovitaminosis D and increased insulin resistance.

Official Title
-----------------
Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial

Conditions
-----------------
Insulin Resistance, Glucose Intolerance

Intervention / Treatment
-----------------
* Drug: Colecalciferol (Vitamin D3) 300.000 UI
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasten Blood Glucose > 100 mg/dL and < 126 mg/dL Age > 18 years Exclusion Criteria: Diabetes Mellitus Use of metformin Vitamin D Use Hypercalcemia Chronic Hepatitis HIV

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br> | Drug: Colecalciferol (Vitamin D3) 300.000 UI<br>* Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo Capsule, Single Dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Level |  | Baseline and day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Calcium Level |  | Baseline and day 90 | 
| HOMA-R |  | Baseline and day 90 |