linjc16/ctgov huggingface dataset:
Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.

Official Title
-----------------
Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis

Conditions
-----------------
Osteopenia, Complications of Heart-lung Transplant, Other Complications of Lung Transplant

Intervention / Treatment
-----------------
* Drug: zoledronic acid vs pamidronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reduced bone density as indicated by a bone density T score <-1.in either the lumbar spine or femoral neck have undergone or are on the waiting list for heart or lung transplantation are receiving adequate calcium and vitamin D therapy have provided written informed consent prior to participation in the trial Exclusion Criteria: untreated hypogonadism, hypothyroidism or hyperthyroidism acute or major organ rejection or intercurrent illness pregnancy or breastfeeding

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zoledronic acid vs pamidronate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of lumbar spine at 12 months as measured by DEXA. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of femoral neck at 12 months as measured by DEXA. |  |  |
MRI Perfusion Imaging at 3Tx Compared to Invasive FFR Measurements

Study Overview
=================
Brief Summary
-----------------
Coronary artery disease (CAD) has a great significance concerning prevalence and mortality in the western world. It is usually diagnosed by catheterization and coronary arteries are visually assessed by the examiner. Thus having a great spectrum of interobserver differences, especially when it comes to intermediate lesions. The gold standard to assess the haemodynamic significance is the measurement of the myocardial fractional flow reserve (FFR). The FAME-study (Tonino, De Bruyne et al. 2009) was able o show that additional FFR- measurements in patients with intermediate lesions could significantly reduce stent implementation and consequently mortality. However this method is not used in daily routine and is available only in a fraction of catheter labs worldwide. Taking this into account decision finding especially in intermediate lesions remains difficult. One major step to simplify the invasive approach concerning intermediate lesions would be to establish a non-invasive procedures which localizes the coronary vessel to intervene ahead catheterization. Do to steady technical development cardiac MRI has become a powerful tool which is able to determine myocardial vitality, perfusion and function. In particular the new generation of 3 Tesla multi transmit MR with its higher field strength and better spatial resolution seems to be able to show first pass myocardial perfusion more precise. With this new technology prefixed to cardiac catheterization clinical relevant information can be made accessible and thus reduce the number of unnecessary implemented stents.

Official Title
-----------------
MRI Perfusion Imaging at 3T With TX Parallel RF Technology to Identify Myocardial Ischemia Compared to Invasive FFR Measurements

Conditions
-----------------
Perfusion Imaging, MRI, Myocardial Fractional Flow Reserve, Myocardial Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intermediate lesion defined by myocardial fractional flow reserve measurement age > 18 years Exclusion Criteria: pregnancy contraindication with adenosin, contrast agents or MR-Scaning severe renal dysfunktion instable patient(e.g. acute myocardial infarction)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the plasma pharmacokinetic of rosiglitazone in healthy adult subjects.

Official Title
-----------------
A Phase 1, Single-Center, One-Sequence, Open-Label Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Drug: FG-4592


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males, 18 to 45 years Body weight ≥ 75 kg Good health Non-smoker Blood pressure not greater than 140/90 mm Hg Exclusion Criteria: Positive for any of the following: Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab) Blood donation or significant blood loss within 60 days prior to Day 1 Use of prescription and over the counter medications/herbal preparations is not allowed within 14 days prior to Day 1 and through treatment phase History or presence of alcoholism or drug abuse within 2 years prior to Day 1 Consumption of alcohol within 7 days prior to Day 1 or during treatment phase Positive urine drug/alcohol testing at screening or check-in visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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 |
| --- | --- |
| Experimental: FG-4592<br> | Drug: FG-4592<br>* FG-4592 on days 3,5,7,9 Rosiglitazone maleate on days 1 and 9<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma concentration of Rosiglitazone |  | Day 1- Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma concentration of Rosiglitazone metabolites |  | Day 3 - Day 11 |
A Study With Health Educational Material on Health Promotion in Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide educational material to promote screening for second primary cancer for the intervention group, or educational material to instruct appropriate use of dietary supplement for the control group.

Official Title
-----------------
A Randomized Controlled Trial on the Effect of Intervention With Health Educational Material on Knowledge, Attitude, and Behavior in Cancer Survivors

Conditions
-----------------
Stomach Cancer, Colon Cancer, Thyroid Cancer, Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Brochure of Secondary Cancer Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18, <80 Cancer survivors (pathologically confirmed) Finished primary treatment (surgery, radiotherapy, chemotherapy) >= 1 year from cancer diagnosis No evidence of recurrence, metastasis, and second primary cancer No evidence of hereditary cancer ECOG 0,1,2 Ability in reading Korean educational material Exclusion Criteria: ECOG 3,4 Disagree with the investigators study purpose

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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photonovella of Secondary Cancer Screening<br> | Behavioral: Brochure of Secondary Cancer Screening<br>* One kind of printed educational material<br>|
| Active Comparator: Photonovella of Dietary Suppelment of Cancer survivor<br> | Behavioral: Brochure of Secondary Cancer Screening<br>* One kind of printed educational material<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening behavior for second primary cancer |  | After 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge and attitudes of Secondary cancer screening and dietary supplement |  | In 2 weeks |
DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting

Study Overview
=================
Brief Summary
-----------------
The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Stent implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum legal age (18) Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines Patient has consented to participate and authorized in writing the collection and release of medical information Exclusion Criteria: Pregnancy Participating in another study that interferes with study endpoints Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated

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

| Intervention/Treatment |
| --- |
|Device: Stent implantation|Single arm, open label stent implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Success | The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location. | stent implantation until hospital discharge (average 1-3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital MACE (Major Adverse Cardiac Event) |  | stent implantation until hospital discharge (average 1-3 days) |
Single Dose of 9-cis-retinoic Acid in Hepatic Patients

Study Overview
=================
Brief Summary
-----------------
To test whether patients with hepatic insufficiency can tolerate one oral dose of 9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.

Official Title
-----------------
The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency

Conditions
-----------------
Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: 9-cis-retinoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have biopsy verified hepatic insufficiency Medically stable. Ultra sonic examination of lever within the past 3 months No pregnancy documented in women. use of anticonception during study and 1 month after Exclusion criteria: Odd blood counts and samples not related to hepatic disease encephalopathy (> grad II) concomitant treatment with pharmaca that is metabolized by CYP3A4 in the liver. Cardiac disease Kidney disease Epilepsia Stroke Esophagal bleeding Severe ascites HIV-positivity Psychiatric disorder Cancer pregnancy or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatic patients<br>patients with hepatic insufficiency | Drug: 9-cis-retinoic acid<br>* Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure<br>|
| Healthy Controls<br>Healthy adults | Drug: 9-cis-retinoic acid<br>* Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls | Analysis on samples | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolisation of 9-cis-retinoic acid, hepatic patients, investigation of urine and blood samples
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

Study Overview
=================
Brief Summary
-----------------
In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected trough vitreal and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.

Official Title
-----------------
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Conditions
-----------------
Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Intervention / Treatment
-----------------
* Drug: Avastin and Triamcinolone
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days) Exclusion criteria: Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy) Neurologic defect Abnormal ESR, CRP, any history of retina or vitreal surgery Severe corneal opacity which makes retina examination impossible
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 |
| --- | --- |
| Active Comparator: Avastin and Triamcinolone<br> | Drug: Avastin and Triamcinolone<br>* 1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal<br>|
| Placebo Comparator: Placebo<br> | Other: placebo<br>* 2mg placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Best corrected visual acuity(BCVA) | outcome method of measurement: Snellen chart | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Visual Field | Automated perimeter | 6 month |
Electrophysiological Recording for Patients Receiving Deep Brain Stimulation Electrode for Treatment-resistant Obsessive-compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to study live recordings from neuronal population of the human nucleus accumbens during the implantation of deep brain stimulation (DBS) electrodes for the treatment-resistant obsessive compulsive disorder (OCD). The central aim of this project is to determine if intra-operative electrophysiological data can confirm that the electrode is located in the nucleus accumbens. This confirmation could allow the placement of the DBS electrodes with a higher degree of precision. An additional aim of this project will be to study the activity of the neuronal population of the nucleus accumbens while a subject is presented with a task involving an unexpected reward. The investigators central hypothesis is that unexpected reward will be associated with increase firing and synchrony in the neuronal population. This will translate into recordable increase activity in the investigators region of interest and therefore confirm the proper placement of the electrode. This study enrolled 2 subjects, with 1 subject completing the protocol showing the feasibility of the experiment. There were electrophysiological variations with the task presented but no conclusion could be drawn given the small sample size.

Conditions
-----------------
Obsessive-compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment-resistant OCD Failure of psychotherapy Failure of pharmacotherapy Meets inclusion criteria for DBS implant in OCD Exclusion Criteria: Significant substance use disorder Significant personality disorder

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

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

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

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
-----------------
treatment resistant obsessive-compulsive disorder
Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

Study Overview
=================
Brief Summary
-----------------
The Optical Coherence Tomography is a minimally-invasive diagnostic tool in both the office and operating room settings can identify sources of airway obstruction and effective surgical interventions. The researcher can use Optical Coherence Tomography to image tissues of the aero-digestive tract during surgical endoscopy in to the nose, oral cavity, larynx and ear in an outpatient clinic setting.

Detailed Description
-----------------
The Optical Coherence Tomography imaging system has low power non-laser broad band infrared light shine onto laryngeal, esophageal, tracheal, oral, nasal and ear tissue and does not involve input of significant amounts of energy and no temperature rise occurs. The gradual development and acceptance of Optical Coherence Tomography as an imaging modality serves as an alternative to invasive tissue biopsy as a diagnostic measure. Imaging diagnosis, can implement and more convenient than tissue biopsy and can reduce procedural complications.

Official Title
-----------------
Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

Conditions
-----------------
Disorder of Upper Digestive Tract

Intervention / Treatment
-----------------
* Device: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female age from new born to all age Exclusion Criteria: subject who do not sign consent form

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Optical coherence tomography|Optical coherence tomography imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic tool |  | up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper Areo-Digestive tract