linjc16/ctgov huggingface dataset:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Heart Disease

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of congestive heart failure and angina

Detailed Description
-----------------
This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of congestive heart failure and angina. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Heart Disease

Conditions
-----------------
Congestive Heart Failure, Angina

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Congestive Heart Failure or Angina Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group (AlloRx)<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, stem cell treatment, Angina
Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction. Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand. This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis.

Official Title
-----------------
Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome

Conditions
-----------------
Amyloidosis Cardiac, Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: DPD Scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above sixty years of age previously operated for idiopathic carpal tunnel syndrome within the Region of Central Denmark (Region Midtjylland) the last five years. Informed written and verbal consent Exclusion Criteria: Operation by different indication such as Fracture Ganglion Tumors Osteophytes Rheumatoid Arthritis Persistent medial artery Metabolic causes Alcoholism Hyperthyroidism Myxedema Hereditary Cardiac Amyloidosis Known WT ATTR AL Amyloidosis Myelomatosis MGUS and Morbus Waldenström

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Suspicion of cardiac amyloidosis<br>Patients who display signs of cardiac amyloidosis will be referred for further diagnosis. | Diagnostic Test: DPD Scintigraphy<br>* Confirms/Refutes diagnosis of cardiac amyloidosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cardiac amyloidosis. | The prevalence of cardiac amyloidosis among patients previously operated for ipiopathic carpal tunnel syndrome. | Through study completion, an average of 2 years. |
Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

Study Overview
=================
Brief Summary
-----------------
Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.

Official Title
-----------------
Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction

Conditions
-----------------
Gastric Outlet Obstruction Due to Malignancy

Intervention / Treatment
-----------------
* Procedure: placement of double bare stent
* Device: DoubleBare stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant gastric outlet obstruction Symptoms compatible with gastric outlet obstruction An inoperable condition because of extent of disease or patient's conditions Exclusion Criteria: History of enteral stent placement, undergone gastric surgery. Additional small bowel stenosis distal to gastric outlet obstruction. Refuse to be enrolled to study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DoubleBare stent<br>Placement of double bare stent | Procedure: placement of double bare stent<br> <br> Device: DoubleBare stent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patency rate at 8 weeks after placement. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical and clinical success rates |  | up to 8 weeks | 
| re-stenosis rate |  | 8 weeks | 
| migration rate |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stent, gastric outlet obstruction, restenosis
Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day. (Arixtra is a trademark of the GlaxoSmithKline group of companies.)

Official Title
-----------------
Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

Conditions
-----------------
Ataxia

Intervention / Treatment
-----------------
* Drug: Fondaparinux sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute pulmonary thromboembolism or acute deep venous thrombosis Fondaparinux injection must be prescribed for the first time Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with VTE treated with fondaparinux<br>Patients with VTE treated with fondaparinux | Drug: Fondaparinux sodium<br>* For patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reaction |  | 3 months | 
| Number of patients with any serious adverse event |  | 3 months | 
| Number of patients with any hemorrhagic adverse event |  | 3 months | 
| Presence or absence of reoccurrence of VTE |  | 3 months |
Atorvastatin Versus Simvastatin In The Prevention Of Coronary Heart Disease (CHD) In Patients With Known CHD

Study Overview
=================
Brief Summary
-----------------
To investigate whether a long-term strategy to lower LDL cholesterol with atorvastatin as much as possible will improve prognosis in CHD patients compared with a strategy reflecting current best clinical practice with simvastatin.

Official Title
-----------------
Atorvastatin Compared With Simvastatin In The Prevention of CHD Morbidity And Mortality In Patients With CHD

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: atorvastatin
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous myocardial infarction Exclusion Criteria: Women who are breast feeding or are pregnant

Ages Eligible for Study
-----------------
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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atorvastatin|nan|
|Drug: simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to of a major coronary event: 1) non-fatal acute myocardial infarction 2) coronary death 3) resuscitated cardiac arrest |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Time to any CHD event, 2) Time to Hospitalization with primary diagnosis of CHF, 3) Time to Cerbrovascular Event, 4) Time to PAD, 5) Time to any CV event and 6) All Cause Mortality |  |  |
CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

Study Overview
=================
Brief Summary
-----------------
This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).

Official Title
-----------------
CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

Conditions
-----------------
Sacroiliitis

Intervention / Treatment
-----------------
* Device: SImmetry Sacroiliac Joint Fusion System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have a SImmetry device implanted. Patient is willing to comply with study procedures and provide informed consent. Exclusion Criteria: Patient is physically unable to return to the clinic for CT imaging.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SImmetry Sacroiliac Joint Fusion System|Minimally invasive surgery for implantation of the SImmetry System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SI Joint Fusion (CT evidence of SI joint fusion) | CT evidence of SI joint fusion evaluated by a core laboratory | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SI Joint Pain (CT evidence of SI joint fusion) | evaluated by a core laboratory | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sacroiliac joint, Simmetry, SI joint fusion, SI joint pain, SI joint, SI joint treatment, SI joint disease
Fluid Oriented Therapy During Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
In this before and after study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.

Official Title
-----------------
Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery

Conditions
-----------------
Goal Directed Therapy

Intervention / Treatment
-----------------
* Device: FloTrac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 patients Exclusion Criteria: Severe Caridiac Disease Renal Failure

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>patients before 2014, in which fluids were administered without FloTrac monitoring | |
| Active Comparator: case group<br>patients after 2014, after management of fluid therapy has been guided by FloTrac parameters as a standard clinical practice (NICE protocol) | Device: FloTrac<br>* Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  | up to 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization |  | an average of 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
[G09.330.380]
Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial where patients undergoing surgical treatment for urogenital cancers will be randomized in a two arms study: surgical treatment + antibiotics OR surgical treatment + placebo.

Official Title
-----------------
Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Conditions
-----------------
Microbial Disease

Intervention / Treatment
-----------------
* Drug: Tigecycline 50 MG
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy verified diagnosis of urological cancer, localized disease Exclusion Criteria: Hospitalization within three months of surgery Antibiotics within three months of surgery Infectious disease, including UTI's within three months of surgery History of cancers of the genitourinary tract Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical treatment + antibiotics<br>Use antibiotic | Drug: Tigecycline 50 MG<br>* Local instillation of drug directly to the tumour tissue<br>* Other names: Tigecycline;|
| Placebo Comparator: surgical treatment + placebo<br>Use placebo | Other: Placebo<br>* Local instillation of sterile water directly to the tumour tissue<br>* Other names: Sterile water;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate after surgical treatment of tumour | recurrence rate after surgical treatment of tumour | 5 years after treatment |
Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter

Study Overview
=================
Brief Summary
-----------------
In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery.

Official Title
-----------------
Comparison of the Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter in Patients Undergoing Middle Ear Surgery

Conditions
-----------------
Optic Nerve Sheath Diameter

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound examination of the optic nerve sheath diameter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing middle ear surgery Exclusion Criteria: History of cerebrovascular diseases Increased intracranial pressure History of ophthalmic surgery or diseases

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sevoflurane group<br>Anesthesia is maintained with sevoflurane during the surgery. | Diagnostic Test: Ultrasound examination of the optic nerve sheath diameter<br>* The optic nerve sheath diameter is examined using ultrasonography.<br>|
| Propofol group<br>Anesthesia is maintained with total venous anesthesia using propofol during the surgery. | Diagnostic Test: Ultrasound examination of the optic nerve sheath diameter<br>* The optic nerve sheath diameter is examined using ultrasonography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the optic nerve sheath diameter | The optic nerve sheath of each eye is observed using ultrasound, and the optic nerve sheath diameter is assessed after induction of anesthesia and at the end of surgery. | At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic nerve sheath diameter at each time point | The optic nerve sheath of each eye is observed using ultrasound, and the optic nerve sheath diameter is assessed after induction of anesthesia and at the end of surgery. | At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery | 
| Nausea and vomiting | Presence and severity of nausea and vomiting is assessed. | At 1 hour after surgery |
The Establishment of the Early Intervention Program for Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Schizophrenia is a severe mental illness, which has a prodromal phase of 1-2 years prior to the onset of the illness. During the prodromal phase, patients might show maladaptation and/or poor social functioning. However, these early symptom of schizophrenia might be overlooked by patients and their families. At that period, patients might strive to improve their social interactions and social functioning. However, the efforts might further create their stress level on everyday life, which can actually accelerate the illness onset of schizophrenia. In other words, the efforts would worsen the pathophysiologic changes in the brain, which can result in the positive symptoms of schizophrenia. Previous researches found that the critical period for treatment of schizophrenia is the early phase of illness onset, especially the first two or three years. Delay treatment would worsen the illness. To this extent, early treatment would bring to a better prognosis as well as minimize the costs of individuals, families and society. In other words, early interventions not only can prevent relapse, it also can benefit patients' psychosocial adjustments. However, researches found that the average duration of untreated psychosis is 25.2 months in Taiwan, which indicates the phenomena of delay treatment and this trend might result in missing the critical treatment period. This is a two years study aiming to establish an early intervention program for patients with schizophrenia. In the first year, it aims to understand the phenomena of psychiatric care services utilization for patients with schizophrenia, special emphasis will be on the delay treatment and pluralistic health seeking process. In the second year, it aims to establish an early intervention program. The results of this research would contribute to in-service trainings, service providing, and policy making of psychiatric services.

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with schizophrenia capable to express in Chinese willing to cooperate with Exclusion Criteria: patients with schizophrenia but not willing to cooperate with

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |