linjc16/ctgov huggingface dataset:
Using Duke Activity Status Index (DASI) to Select Optimal Cardiac Stress Tests

Study Overview
=================
Brief Summary
-----------------
Cardiac stress testing with functional nuclear imaging is an invaluable technique in the diagnostic and prognostic evaluation of patients with known or suspected ischemic heart disease. Selection of the appropriate type of nuclear stress test: exercise stress Myocardial Perfusion Imaging (MPI) versus pharmacologic stress MPI is crucial for not only diagnostic accuracy and prognostic evaluation, but also for sound clinical decisions and resource utilization. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be a valid measurement of functional capacity. The investigators hypothesized that the DASI may be the screening tool that evaluates functional capacity and guides selection of the optimal stress MPI study.

Official Title
-----------------
Clinical Role of the Duke Activity Status Index in the Selection of the Optimal Type of Stress Myocardial Perfusion Imaging Study in Patients With Known or Suspected Ischemic Heart Disease

Conditions
-----------------
Ischemic Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Exclusion Criteria: None

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic Heart Disease, Duke Activity Status Index, Stress Myocardial Perfusion Imaging
Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report

Study Overview
=================
Brief Summary
-----------------
in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.

Official Title
-----------------
Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: sacral neuromodulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age, 18-70 Pain localized to the pelvic and perineal region The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer The intensity of pain assessed by VAS (visual analogue pain scale) > 7 Importantly, the included participants should gain > 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root Exclusion Criteria: Coagulopathy Infection at site of maneuver Abnormal Psychological behavior that interfere with integrity of obtained data

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sacral neuromodulation<br>Sacral neuromodulation group, will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation | Device: sacral neuromodulation<br>* Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation<br>|
| No Intervention: medical therapy<br>this group will be treated with sustained release morphine tablets for pain control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of intensity of pain | The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain | The outcome will be measured at day 15 postoperatively. |
YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

Study Overview
=================
Brief Summary
-----------------
The YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program provides patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials with YONDELIS (trabectedin), access to this investigational treatment.

Detailed Description
-----------------
The single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that he/she fulfills all eligibility criteria. The patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. Safety will be evaluated and serious adverse events will be reported. Disease assessments will occur according to institutional practice.

Official Title
-----------------
YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Drug: Trabectedin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. 18 years-of-age or older. Unresectable, advanced or metastatic, histologically proven soft tissue sarcoma. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or better. Hematologic variables: Hemoglobin ≥9 g/dL ANC ≥1,500/μL Platelet count ≥100,000/μL Serum creatinine ≤ upper limit of normal (ULN) Hepatic function variables: Total bilirubin ≤ ULN Total alkaline phosphatase ≤ ULN, or if > ULN, then alkaline phosphatase liver fraction or 5'-nucleotidase must be ≤ ULN. AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be ≤ 2.5xULN Albumin ≥2.5 g/dL Exclusion Criteria: Pregnant or breast-feeding women, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository. Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent Active viral hepatitis or chronic liver disease Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias Active infection

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trabectedin|Trabectedin i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Outcome of Female Non-gastric Gastrointestinal Stromal Tumor

Study Overview
=================
Brief Summary
-----------------
To elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors.

Detailed Description
-----------------
Gastrointestinal stromal tumor (GIST) are mesenchymal tumors arising from gastrointestinal tract, mesentery, or omentum. They took up about 3% of gastrointestinal malignancies. Although rarely, the clinical presentation of non-gastric GIST might mimick ovarian cancer, and would be managed by gynecologists. Therefore, retrospective review of female non-gastric GIST cases will be performed to investigate the clinical outcome of non-gastric GIST. The result of this study might be used as an important reference for gynecologists.

Official Title
-----------------
Far Eastern Memorial Hospital

Conditions
-----------------
Gastrointestinal Stromal Tumor

Intervention / Treatment
-----------------
* Procedure: Tumor excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 20 years of women. non-gastric gastrointestinal stromal tumor Exclusion Criteria: Those without pathological report or surgical record.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tumor excision|Excision of GIST|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The date of surgery to the date of death or last follow-up | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | The date of surgery to the date of recurrence or last follow-up | 20 years |
Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement

Study Overview
=================
Brief Summary
-----------------
The effectiveness of physical therapy for treatment of anterior disc displacement without reduction of temporomandibular disorders has not been well defined. This study compared the treatment method with conservative splint therapy. Fifty two subjects were assigned at random to either of two treatment groups: one is a splint treatment group, and the other is a joint mobilization self exercise group. Each treatment was evaluated using four outcome variables: (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities. All outcome variables were significantly improved after eight-week of treatment in the exercise group. Meanwhile, the splint treatment improved three variables, other than mouth opening with pain; however, the degree of improvement was less than that seen in the exercise group. This result demonstrates that the joint mobilization self exercise improves jaw function and relieves pain as compared to the splint treatment.

Conditions
-----------------
Herniated Disk, Temporomandibular Disorders

Intervention / Treatment
-----------------
* Behavioral: splint and joint mobilization self exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) male or female over 18 years old; (2) with mouth opening pain on the TMJ affected side; (3) over two weeks after the onset of ADDwoR; (4) with maximum mouth opening of less than 40 mm; and (5) MRI-confirmed ADDwoR. The Exclusion Criteria: (1) unwilling or unable to receive splint and/or exercise therapy; (2) with systemic bone or joint disease, (3) regular medication such as analgesics, anti-anxiety drugs, antidepressants and psychotropics; and (4) missing teeth and/or a removable denture but having a fixed partial denture restoration over one year.

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: splint<br> | Behavioral: splint and joint mobilization self exercise<br> <br> |
| Active Comparator: joint mobilization self exercise<br> | Behavioral: splint and joint mobilization self exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities |  | 0, 4 and 8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior disc displacement without reduction of temporomandibular disorders
Host Immune Response to Clostridium Difficile Infection (ICD)

Study Overview
=================
Brief Summary
-----------------
Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.

Official Title
-----------------
Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response

Conditions
-----------------
Diarrhea Due to Clostridium Difficile

Intervention / Treatment
-----------------
* Biological: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized Suffering from diarrhea related to C. difficile Confirmed diagnosis of CDI Informed consent by the patient Affiliated to the social security regime Exclusion Criteria: Out-patient No confirmed diagnosis of CDI Decline of participation Patient not affiliated to the social security regime

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clostridium difficile infection<br> | Biological: Blood sampling<br>* Blood samples of 10 mL will be performed every 2 days from the first symptoms of CDI and until clinical recovery and/or hospital discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune response rate |  | up to 60 days after diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clostridium difficile, recurrence, relapse, antibodies, immune response, prognosis
Sex Hormones and Pericardial Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
In this study, our aim is to show the relation between sex hormones and PAT and to confirm whether PAT is associated with coronary artery calcification (CAC) in different testosterone levels in the males.

Official Title
-----------------
Do Endogenous Sex Hormones Affect Pericardial Adipose Tissue Volume of Males in The Multi-Ethnic Study of Atherosclerosis (MESA)?

Conditions
-----------------
Pericardial Adipose Tissue and Sex Hormones

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3213 males African American Caucasian Asian (largely Chinese) and Hispanic adults aged 45-84 years and free of known cardiovascular disease at baseline (2000-2002) Exclusion Criteria: Patients with known coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 84 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3161 men (45-84 years old)<br>3161 men without known coronary artery disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation ship between pericardial adipose tissue and sex hormones in males | Total testosterone and sex hormone binding globulin levels were related with pericardial adipose tissue | years |
Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).

Official Title
-----------------
Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)

Conditions
-----------------
Endothelial Dysfunction, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Glimepiride/metformin
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders At least 18 years old Type 2 diabetes mellitus diagnosis Signed Informed Consent Exclusion Criteria: History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases Pregnancy or lactation History of abuse and/or substance dependence within 6 months preceding the survey. History of glimepiride or metformin allergy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glimepiride/metformin<br> | Drug: Glimepiride/metformin<br>* 4/1000 mg tablets once a day foe eight weeks<br>* Other names: GLIMETAL;|
| Active Comparator: Metformin<br> | Drug: Metformin<br>* 1000 mg tablets once daily for eight weeks<br>* Other names: PREDIAL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDVI | endothelial-dependent vasodilation index | 8 weeks | 
| MFR | myocardial flow reserve | 8 weeks | 
| %ΔMBF | percentage of the change between rest and CPT | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose |  | 8 weeks | 
| Glycated hemoglobin |  | 8 weeks | 
| Adverse effects |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelial dysfunction, Diabetes mellitus, glimepiride, metformin
Length of Tumour Feeding Artery After Colon Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The quality of colon cancer surgery is highly debated these years since the mortality of the disease is not declining markedly. Surgery is the main treatment of colon cancer and during surgery it is very important for the surgeon to remove the tumour and all potential ways of tumour spread. As colon cancer first of all spreads to the nearby lymph nodes lying along the tumour feeding artery the surgeon aims to cut the vessel as central as possible. This means that all of the tumour feeding artery should have been removed after surgery. In this study the investigators want to measure the length of the tumour feeding artery after surgery as a quality control of the surgery. The investigators hypothesize that the artery will be shorter than 5 mm. The investigators wish to CT scan all patients two days after colon cancer surgery and afterwards measure then length of the artery on the images. This study will not inflict with the normal routine for patient information and treatment.

Official Title
-----------------
Length of Tumour Feeding Artery After Colon Cancer Surgery

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: Patients with primary colon cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary colon cancer Exclusion Criteria: Kidney failure, allergy to contrast, pregnancy

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 |
| --- | --- |
| Quality of colon cancer surgery<br>Patients with primary colon cancer | Other: Patients with primary colon cancer<br>* CT scan two days after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan after colon cancer surgery. The length of the tumour feeding artery will be measured on the images. | Patients will have an extra CT scan two days after surgery. | 6 to 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon cancer, Quality of surgery, Length of tumour feeding artery