linjc16/ctgov huggingface dataset:
Trial of Supported Employment Versus USES Supported Employment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of USES, a strengths-based enhancement to supported employment (SE), as compared to supported employment alone.

Detailed Description
-----------------
The objective of this study is to test the effectiveness of supported employment plus Using Strengths in Employment Services (USES), an enhancement to supported employment that seeks to identify and increase the use of personal strengths, as compared to supported employment alone, for veterans with severe mental illness and/or substance abuse disorders. We hypothesize that rates of competitive employment will be greater in the experimental group than the control group. We also expect that individuals in the USES group will have greater job tenure, and will show greater improvements in recovery measures such as empowerment, self-efficacy and self-esteem.

Official Title
-----------------
A Randomized Trial of Supported Employment Versus USES Enhanced Supported Employment in Veterans With Serious Mental Illness

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: Supported Employment
* Behavioral: Using Strengths in Employment System (USES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veteran Unemployed Referred by clinician to SE services Able to provide informed consent

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Supported Employment|nan|
|Behavioral: Using Strengths in Employment System (USES)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| job tenure (cumulative throughout course of study) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| empowerment |  |  | 
| self-efficacy |  |  | 
| self-esteem |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Vocational, Virtues, Employment, supported, veterans, Mentally Ill Persons
Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.

Study Overview
=================
Brief Summary
-----------------
The trial aims to investigate the effect of supplementation with hyaluronic acid, alpha-lipoic acid, magnesium, vitamin D and vitamin B6 in progesterone-treated pregnant women with risk factors for abortion.

Official Title
-----------------
Supplementation With Hyaluronic Acid, Alpha-lipoic Acid, Magnesium, and Vitamin D and B6 in Patients at Risk of Abortion Treated With Progesterone: a Pilot Study.

Conditions
-----------------
Pregnancy, High Risk

Intervention / Treatment
-----------------
* Dietary Supplement: HA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures) Exclusion Criteria: Other pregnancy-related conditions Diabetes or hypertension Concomitant pharmacological therapies (anticoagulant or antihypertensive) Use of tocolytic drugs two months prior to enrollment Association with hypoglycemic drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Women with risk factors for abortion, treated with progesterone | |
| Experimental: study group<br>Women with risk factors for abortion, treated with progesterone and a dietary supplement containing hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6 | Dietary Supplement: HA<br>* hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of the abortion rate | rate of abortion | 1 day (single time-point before week 20 of gestation) |
Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D

Study Overview
=================
Brief Summary
-----------------
Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor. The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.

Official Title
-----------------
Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D

Conditions
-----------------
Hepatitis D, Chronic

Intervention / Treatment
-----------------
* Drug: Pegylated interferon alfa
* Drug: Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of anti-HDV in serum Presence of quantifiable HDV RNA in serum Elevated ALT > ULN Exclusion Criteria: Decompensated liver disease Patients with ALT levels greater than 10 times ULN (400 U/L) Pregnancy or inability to practice adequate contraception. Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease. Systemic immunosuppressive therapy Evidence of another form of liver disease in addition to viral hepatitis Active substance abuse, such as alcohol or injection drugs Hepatocellular carcinoma Concurrent hepatitis C infection or HIV coinfection Diagnosis of malignancy in the five years Concurrent usage of statins Concurrent use of any other drug known to inhibit NTCP Inability to understand or sign informed consent

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pegylated interferon<br>Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks | Drug: Pegylated interferon alfa<br>* Pegylated interferon alfa<br>|
| Experimental: Pegylated interferon with ezetimibe<br>Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks | Drug: Pegylated interferon alfa<br>* Pegylated interferon alfa<br>Drug: Ezetimibe<br>* Ezetimibe<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDV RNA quantitative measurements of >2 logs from baseline |  | 24 weeks of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis D, Ezetimibe, Pegylated interferon
Intrawound Administration of Vancomycin in TKA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.

Official Title
-----------------
Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Intrawound administration of vancomycin after closure of the arthrotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 50 and 80 Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis Exclusion Criteria: Diminished mental capacity Vancomycin allergy Chronic kidney disease stage III and stage IV

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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: Intrawound Administration of Vancomycin<br>After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 20ml of normal saline was injected directly into the joint. | Procedure: Intrawound administration of vancomycin after closure of the arthrotomy<br>* After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.<br>|
| Experimental: Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)<br>After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint. | Procedure: Intrawound administration of vancomycin after closure of the arthrotomy<br>* After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-articular vancomycin concentration |  | 2 hours, 8 hours and 24 hours postoperatively | 
| Serum vancomycin concentration |  | 2 hours, 8 hours and 24 hours postoperatively | 
| Renal function | blood urea nitrogen (BUN), creatinine (Cr), GFR | Postoperative Day 1 and Day 3 | 
| Blood loss |  | Postoperative Day 3 |
Y402H Comlement Factor H Polymorphism and Age-Related Macular Degeneration in the Austrian Population

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to show a higher expression of the Y402H polymorphism in the complement factor H in patients with AMD compared to healthy individuals. Additionaly a correlation between a subsided infection with chlamydia and patients with AMD and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma level shall give more hints into the pathomechanism of AMD.

Official Title
-----------------
Y402H Comlement Factor H Polymorphism and Age-Related Macular Degeneration in the Austrian Population

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: drawing blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: man and women over 18 years old Filled out informed consentBereitschaft zur Teilnahme Diagnosis of non-exudative/ exudative age related macular dgeneneration Exclusion Criteria: inherited retinal diseases other aquired retinal/ macular missing informed consent

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: drawing blood|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| higher expression of the Y402H polymorphism in the complement factor H in patients with AMD compared to healthy individuals |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a correlation between a subsided infection with chlamydia and patients with AMD and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma level shall give more hints into the pathomechanism of AMD |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age-related macular degeneration, genetics
Detailed Evaluation of Microchimerism

Study Overview
=================
Brief Summary
-----------------
Individuals who experience traumatic injury often require blood transfusion. In some individuals who receive blood after an injury, white blood cells from a person who donated blood may remain in the body for years, a condition known as microchimerism. This study is designed to examine a group of people who are known to have long-term microchimerism and, through analysis of their blood, determine whether there is evidence that the microchimerism involves blood stem cells that can become any type of blood cell (red blood cells, white blood cells, or platelets) and that might be a permanent part of the body.

Detailed Description
-----------------
Transfusion-associated microchimerism, the persistence of donor white blood cells months or years after transfusion in the recipient, has been observed in approximately 10-15% of transfused trauma patients. Previous studies suggest that the microchimeric cells include multiple immunophenotypes of leukocytes (CD4+, CD8+, CD15+, and CD19+) and that they can persist for decades, features suggestive of hematopoietic engraftment. In this study, ten subjects known to have long-term microchimerism will undergo either leukapheresis (a blood filtering procedure) or collection of a 500 mL whole blood sample (the amount of a standard blood donation). These samples will then be analyzed to determine whether the microchimeric (donor) cells include hematopoietic stem cells (CD34+) and precursor cells in the red blood cell, white blood cell, and platelet lineages.

Official Title
-----------------
Evaluation to Determine Whether Transfusion-associated Microchimerism Involves Engraftment With Hematopoietic Progenitor Cells

Conditions
-----------------
Chimerism, Blood Transfusion, Wounds and Injuries, Hematopoiesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Demonstrated long-term microchimerism following transfusion for traumatic injury Exclusion Criteria: Prior bone marrow or solid organ transplantation Pregnancy Blood transfusion within the past 12 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transfused microchimeric subject<br>Former trauma patient who underwent blood transfusion and has recent evidence of long-term transfusion-associated microchimerism | |

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
-----------------
Transfusion-associated microchimerism, Injuries, Leukocytes
Optimal Treatment of Miscarriage

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.

Official Title
-----------------
Which is the Optimal Treatment for Miscarriage With a Gestational ac in the Uterus and Which Factors Can Predict if the Treatment Will be Successful?

Conditions
-----------------
Abortion, Spontaneous

Intervention / Treatment
-----------------
* Drug: misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nonviable intrauterine pregnancy with retained gestational sac in the uterus the embryo if visible 5 to 35 mm without a heart beat vaginal bleeding circulatory stable hemoglobin at least 80 g/L Exclusion Criteria: contraindications against misoprostol

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

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

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

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: Misoprostol 800 micrograms intravaginally<br> | Drug: misoprostol<br>* 800 micrograms intravaginally ONCE<br>|
| No Intervention: expectant managment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete miscarriage |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete miscarriage |  | 17 days, 24 days, 31 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abortion, Spontaneous, Randomized Controlled Trial
Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.

Official Title
-----------------
Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia

Conditions
-----------------
Exercise Therapy, Pain

Intervention / Treatment
-----------------
* Behavioral: Physical exercise
* Behavioral: Active comparator: low intensive exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with Fibromyalgia, interested in exercise twice a week Exclusion Criteria: Other severe diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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 |
| --- | --- |
| Experimental: A. High intensive exercise<br>High intensive exercise | Behavioral: Physical exercise<br>* Supervised walks with poles twice a week at moderate-high intensity<br>|
| Active Comparator: B. Low-intensive exercise<br>Low-to-moderate intensive supervised walks | Behavioral: Active comparator: low intensive exercise<br>* Supervised walks once a week at low-intensity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute Walk Test | Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented. | 15 weeks | 
| Change of Pain Level From Baseline. | Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain. | 15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Physical activity, Function, Pain, Exercise, Inflammation
Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
This study deals with the possible molecular mechanisms that underlie the etiology of bipolar disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous digitalis-like compounds (DLC) in the depressive state of this disease. The possibility, however, that they are also involved in the manic phase of the disease was never addressed. The results of this study may have significant implications for the treatment of BD by DLC derivatives.

Detailed Description
-----------------
Depressive symptoms are the hallmark major depressive disorder, dysthymia and bipolar depression within the context of bipolar disorder (BD). They share clinical characteristics including depressed mood, anhedonia, and low energy and require medical treatment. The Na+, K+-ATPase is a major transporter in the plasma membrane which has an important role in regulating cell volume, cytoplasmic pH and Ca++ levels. Digitalis-like compounds (DLC); steroids identified as normal constituents of human brain, plasma and other tissues, exclusively interact with the Na+, K+-ATPase and induce numerous biological effects. We raised the hypothesis that Na+, K+-ATPase/DLC system is involved in BD based on studies from ours and other laboratories, which tested the involvement of this system in the depressive state of BD. The possibility that the interaction of DLC with the Na+, K+-ATPase is involved in the manic state of BD was scarcely investigated. To address this issue we intend to determine circulating DLC levels in patients with BD at different states of the disease;

Official Title
-----------------
Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder

Conditions
-----------------
BIPOLAR DISORDER

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BIPOLAR DISORDER PATIENTS Exclusion Criteria: NONE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Na+, K+-ATPase/DLC system in BD<br>Bipolar patients in the various phases of the disease. | |

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
-----------------
BIPOLAR, MANIA, DEPRESSION