linjc16/ctgov huggingface dataset:
Named Patient Program for Mitomycin for Pyelocalyceal Solution

Study Overview
=================
Brief Summary
-----------------
This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.

Conditions
-----------------
Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent, Urothelial Carcinoma, Urothelial Carcinoma Recurrent

Intervention / Treatment
-----------------
* Drug: Mitomycin for pyelocalyceal solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are suitable to receive JELMYTO and for whom there is reasonable expectation that JELMYTO may provide clinical benefit based on the medical judgment of their prescribing physician.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mitomycin for pyelocalyceal solution|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low-grade Upper Tract Urothelial Cancer, LG-UTUC, UGN-101, Mitomycin
Akershus Cardiac Examination (ACE) 1950 Study

Study Overview
=================
Brief Summary
-----------------
Akershus Cardiac Examination (ACE) 1950 Study is a large, observational, prospective, longitudinal, population-based cohort study. The overall aim is to establish an extensive cardio- and cerebrovascular age cohort of elderly subjects for various longitudinal long-term follow-up studies of cardiovascular and cerebrovascular disease.

Detailed Description
-----------------
Design: The Akershus Cardiac Examination (ACE) 1950 Study is a population-based, prospective, cerebro- and cardiovascular age-cohort study of all men and women born in 1950 in Akershus County, Norway. Time schedule: Study inclusion and baseline examinations took place in the period September 2012 - May 2015. Follow-up and sub-studies are ongoing. Current status: As per May 2018, follow-up and sub-studies are ongoing.

Official Title
-----------------
Akershus Cardiac Examination 1950 Study - a Cohort Study on Cardio- and Cerebrovascular Disease in 62-65-year-old Subjects

Conditions
-----------------
Atrial Fibrillation, Heart Failure, Mild Cognitive Impairment, Cardiovascular Diseases, Cerebrovascular Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident in Akershus County (as per October 2011, prior to study invitation) Born in the year of 1950 Ability to consent to participation

Ages Eligible for Study
-----------------
Minimum Age: 62 Years
Maximum Age: 65 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 |
| --- | --- |
| No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes related to CVD and CV-associated conditions |  | Maximum 35 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific CV endpoints; e.g. acute myocardial infarction, heart failure, atrial fibrillation, etc. |  | Maximum 35 years | 
| Specific CV-associated conditions, including renal, cerebrovascular, pulmonary, etc. |  | Maximum 35 years | 
| Specific clinical phenotypes; e.g. myocardial and arterial structure and function, lung function, etc. |  | Maximum 35 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular epidemiology, Prospective, observational cohort study, Biomarkers, Cardio- and cerebrovascular imaging
Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the amount of buprenorphine and its metabolites in blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers. Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the effect on the ability to concentrate and coordinate.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy 18-40 years able to follow the protocol able to provide informed consent Exclusion Criteria: Allergy to buprenorphine Mental illness Alcohol or drug abuse Chronic pain Daily use of analgesics Chronic medicinal treatment Treatment with corticosteroids Any use of medicine 48 hours before day of trial Smoker Blood donation within 3 months before day of trial Dementia Abnormal ECG Abnormal blood values: Serum creatinine > 100 umol/l Serum haemoglobin < 8 mmol/L LDH < 105 U/L or > 255 U/L ASAT > 45 U/L ALAT > 70 U/L PP < 0.9 INR or > 1.1 INR Alkaline phosphatase < 35 U/L or > 275 U/L K+ < 3,5 mmol/L or > 5,0 mmol/L Na + < 136 mmol/L or > 146 mmol/

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study

Study Overview
=================
Brief Summary
-----------------
Aortic atheroma has been correlated with traditional cardiac risk factors, coronary, carotid, renal and peripheral atherosclerosis, and is probably a manifestation of generalized atherosclerosis. Aortic atheroma has also been shown to be associated with atrial fibrillation, aortic valve sclerosis, and other calcification of the fibrous skeleton of the heart. None of the previous studies have looked at the noninvasive prediction of aortic atheroma using the history and physical signs of cardiovascular disease. This would be a time and cost-effective bedside diagnostic tool that would be useful prior to cardiac surgery, cardiac catheterization, and workup of ischemic stroke patients, especially when transesophageal echocardiogram (TEE) is being considered for diagnosis but cannot be obtained due to previously mentioned reasons. Although physical examination of peripheral vascular disease is non-specific, a combination of physical examination signs increases the probability of generalized atherosclerosis.

Official Title
-----------------
Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Procedure: transthoracic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients who are referred for transesophageal echocardiography (TEE) since the primary endpoint is diagnosis of aortic atheroma on TEE Exclusion Criteria: No exclusion after consent for TEE is obtained. Decision not to perform TEE at the discretion of treating physician

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| 1<br> | Procedure: transthoracic examination<br>* observational transthoracic examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify clinical predictors of aortic atheromatous disease and develop risk score to identify with reasonable accuracy the presence of any aortic atheromatous disease and severe atheromatous disease (grade 4 & 5). |  | 6 month. 1 year and 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the incremental value of physical exam signs to the history. |  | 6 month, 1 and 2 years | 
| Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications |  | 6 months, 1 and 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic atheroma
Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings. The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM. The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of continuous-flow left ventricular assist device heart failure patients.

Conditions
-----------------
Heart Failure.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure patients with HeartMate II (HM II) followed as outpatients at The Heart Centre at University Hospital of Copenhagen, Rigshospitalet. Age > 18 years. Heart failure in stable phase without the need for intravenous inotropic therapy. Ischemic or non-ischemic cardiomyopathy. Signed informed consent. Exclusion Criteria: Unstable patients with the need for intravenous inotropic therapy. Current hospitalization. Implantation of HM II less than one month ago.

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 |
| --- | --- |
| CF-LVAD pump speed.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary capillary wedge pressure in mmHg. |  | On trial day. |
Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.

Official Title
-----------------
A Study to Assess the Safety and Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: WC3055
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of LUTS for ≥6 months secondary to BPH Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening Exclusion Criteria: -

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

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

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: WC3055-01F<br>WC3055 12.5 mg tablet once daily for 12 weeks | Drug: WC3055<br>* 12.5, 25, 50 or 75 mg dose<br>|
| Experimental: WC3055-02F<br>WC3055 25 mg tablet once daily for 12 weeks | Drug: WC3055<br>* 12.5, 25, 50 or 75 mg dose<br>|
| Experimental: WC3055-03F<br>WC3055 50 mg tablet once daily for 12 weeks | Drug: WC3055<br>* 12.5, 25, 50 or 75 mg dose<br>|
| Experimental: WC3055-04F<br>WC3055 75 mg tablet once daily for 12 weeks | Drug: WC3055<br>* 12.5, 25, 50 or 75 mg dose<br>|
| Placebo Comparator: WC3055-07P<br>Placebo tablet once daily for 12 weeks | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Total IPSS (International Prostate Symptom Score) | Sum of Questions 1-7. | Final Visit (Week 12 or final visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Total IPSS | Sum of Questions 1-7. | Week 4 | 
| Change from Baseline Total IPSS | Sum of Questions 1-7. | Week 8 | 
| Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Week 4 | 
| Change from Baseline IIEF-EF Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Week 8 | 
| Change from Baseline IIEF-EF Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Week 12 | 
| Change from Baseline IIEF-EF Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Final Visit (Week 12 or Final Visit) |
Post Operative Pain Control: Morphine vs Fentanyl

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to compare benefits and disadvantages in using continuous infusion of morphine or fentanyl for post operative analgesia.

Official Title
-----------------
Post Operative Pain Control: Continuous Infusion of Morphine vs Fentanyl. Clinical Outcomes

Conditions
-----------------
Post Operative Analgesia

Intervention / Treatment
-----------------
* Drug: Morphine
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 or 2 patients undergoing major gynaecological surgery Exclusion Criteria: age > 60 years obesity (BMI>30 Kg/m2) cardiac and respiratory diseases renal impairment liver disorders allergies to any drug used in the study

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 59 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine<br>Patients received morphine 0.02 mg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline. | Drug: Morphine<br> <br> |
| Experimental: Fentanyl<br>Patients received Fentanyl 0.3 mcg/Kg/h infused at 2 ml/h for 24 hours. The infusion contained morphine and saline. | Drug: Fentanyl<br> <br> * Other names: Fentanest;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores | data were recorded at 1,6,18 and 24 hours after surgery | data were recorded during the 24 post operative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic requirements | if VAS value was equal or higher than 6 patients received ketorolac 30 mg iv | during the 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post operative analgesia, morphine, fentanyl
Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

Study Overview
=================
Brief Summary
-----------------
Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.

Detailed Description
-----------------
The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.

Official Title
-----------------
A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction

Conditions
-----------------
BPH, Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Alfuzosin 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males 45-75 years of age Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED Men with steady partner and who agree to attempt sex once a week. Exclusion Criteria: Prostate cancer Prostatitis Penile disease Cardiac co-morbidity Pre-existing co-morbid conditions History of sensitivity to the drug or similar drugs Enrollment in another clinical trial Impaired hepatic function Impaired renal function Mental conditions rendering subject unable to understand the study Subjects not likely to comply with protocol

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfuzosin 10 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the medication on erection maintenance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess effect of Uroxatral on BPH and sexual function using questionnaires |  |  |
Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Official Title
-----------------
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: R89674 (generic name not yet established)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logMar or better in each eye; positive bilateral conjunctival allergy challenge reaction - Exclusion Criteria: narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or diagnosis of dry eye; ocular surgical intervention within 3 months; history of refractive surgery within 6 months; known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; presence of active ocular infection positive history of an ocular herpetic infection; preauricular lymphadenopath; manifest signs or symptoms of clinically active allergic conjunctivitis

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: R89674 (generic name not yet established)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching and conjunctival redness post challenge |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ocular, allergic conjunctivitis, ophthalmic