linjc16/ctgov huggingface dataset:
Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria. II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is an unblinded, dose ranging study. Patients receive heme arginate alone or in combination with tin mesoporphyrin. Patients receive tin mesoporphyrin IV as a single dose. Heme arginate is administered as a single intravenous infusion. Patients are entered in cohorts of 4. Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate. Subjects must maintain a constant diet. Patients experiencing adverse reactions are followed as clinically indicated.

Conditions
-----------------
Porphyria

Intervention / Treatment
-----------------
* Drug: heme arginate
* Drug: tin mesoporphyrin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented acute intermittent porphyria in remission for at least 1 month Increased excretion of porphyrin precursors Absence of neurovisceral symptoms due to porphyria for at least 1 month --Prior/Concurrent Therapy-- At least 1 month since prior heme preparation therapy Concurrent medication for coexisting condition is allowed, as long as dose and pattern of administration is held constant during study --Patient Characteristics-- Renal: Urinary porphobilinogen excretion of at least 20 mg every 24 hours Other: Not pregnant Fertile female patients must use effective contraception during and at least 6 months before study At least 1 month since any symptoms of disease No concurrent acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to heme arginate, tin mesoporphyrin, another heme preparation, or related heme analogue No other condition that may increase risk to patient

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: heme arginate|nan|
|Drug: tin mesoporphyrin|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
-----------------
inborn errors of metabolism, porphyria, rare disease
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and corticosteroids in patients receiving a kidney transplant

Official Title
-----------------
A Two-year Extension to a One-year, Multicenter, Open-label, Randomised Study to Evaluate the Safety and Efficacy of FTY720 Combined With Tacrolimus and Steroids Versus Mycophenolate Mofetyl Combined With Tacrolimus and Steroids, in de Novo Adult Renal Transplant Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Completed the 12 month core study Informed consent Exclusion Criteria N/A Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FTY720|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant |  |  | 
| Permanent resumption of dialysis within 36 months post transplant |  |  | 
| Surgical removal of graft within 36 months post transplant |  |  | 
| Death within 36 months post transplant |  |  | 
| Withdrawal of consent, death, or lost to follow up within 36 months post transplant |  |  | 
| Serum creatinine, estimated creatinine clearance, assessment of other laboratory abnormalities and vital signs and measurement of urine protein. at Months 18, 24, 30 and 36 |  |  | 
| Pulmonary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36 |  |  | 
| Absolute lymphocyte count at Month 18, 24, 30 and 36. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examinations at Months 18, 24, 30 and 36 |  |  | 
| Vital signs at Months 18, 24, 30 and 36 |  |  | 
| Electrocardiogram at Months 24 and 36 |  |  | 
| Chest X-ray Months 24 and 36 |  |  | 
| Safety laboratory tests 18, 24, 30 and 36 |  |  | 
| Ophthalmic evaluations 18, 24, 30 and 36 |  |  | 
| AEs and SAEs |  |  | 
| FTY720/CsA levels at Months 18, 24, 30 and 36 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplantation, kidney, and organ transplant
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2 - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the abuse liability and reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent volunteers

Detailed Description
-----------------
not available at this time

Official Title
-----------------
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2

Conditions
-----------------
Heroin Dependence, Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Opioid-Related Disorders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Opioid-Related Disorders|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective dose estimate |  |  | 
| Observed withdrawal rating |  |  | 
| Opioid antagonist rating |  |  | 
| Pupil diameter |  |  | 
| Analog rating scale for drug effects |  |  | 
| Drug effect characteristics |  |  | 
| Drug/Money Preferences |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heroin Dependence
Cohort Study for Patients Using Fuzeon (Enfuvirtide)

Study Overview
=================
Brief Summary
-----------------
The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new antiretroviral combination therapy (ART) are eligible to participate in this observation. Physicians may register patients online via the internet. They are offered to get an expert advice suggesting therapeutics for a new ART. Observation interval is every three month. However physicians are allowed to initiate new diagnostics, expert advice and therapeutic changes independently from these intervals if necessary. Total observation time for each patients is planned for two years.

Official Title
-----------------
The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy

Conditions
-----------------
HIV Infections, Antiretroviral Treatment

Intervention / Treatment
-----------------
* Drug: Fuzeon (Enfuvirtide)
* Procedure: Laboratory diagnostic (CD4-cells)
* Procedure: Laboratory diagnostics (HIV-1 viral load)
* Drug: antiretroviral co-medication beside Fuzeon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HIV-Infection Planned to switch to a Fuzeon-containing antiretroviral therapy Exclusion Criteria: Inability to understand or sign inform consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fuzeon (Enfuvirtide)|nan|
|Procedure: Laboratory diagnostic (CD4-cells)|nan|
|Procedure: Laboratory diagnostics (HIV-1 viral load)|nan|
|Drug: antiretroviral co-medication beside Fuzeon|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
-----------------
Treatment Experienced
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.

Official Title
-----------------
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices

Conditions
-----------------
Arrhythmias, Cardiac

Intervention / Treatment
-----------------
* Radiation: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed. Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional exclusion criteria include: ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: MRI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death during the MRI scan |  | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in battery voltage >0.04v |  | 6 months | 
| Change in pacing lead impedance ≥ 50 Ω |  | 6 months | 
| Change in high-voltage lead impedance ≥ 3 Ω |  | 6 months | 
| Increase in pacing threshold ≥ 0.50 V @ 0.4 ms |  | 6 months | 
| Decrease in P wave measurement ≥ 50% |  | 6 months | 
| Decrease in R wave measurement ≥ 25% |  | 6 months | 
| Generator failure requiring immediate replacement |  | Immediate | 
| Lead failure requiring immediate replacement |  | Immediate | 
| New onset atrial or ventricular arrhythmia during MRI |  | Immediate | 
| Loss of pacemaker capture during MRI |  | Immediate | 
| Electrical reset of the device |  | Immediate |
The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.

Official Title
-----------------
The Significance of Sodium Balance for Blood Pressure in Patients With Essential Hypertension and the Value of Salt-blood Test in Identifying Salt Sensitive Patients With Hypertension

Conditions
-----------------
Hypertension,Essential

Intervention / Treatment
-----------------
* Behavioral: Sodium restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≤ 35 kg/m2 Essential hypertension eGFR > 15 ml/min/1,73m2 Albumine-to-creatinine-ratio < 500 mg/g Safe anticonception if women in childbearing age. Able to adhere to dietary regimen Exclusion Criteria: Secondary hypertension Clinically significant heart failure (NYHA 3-4) Clinically significant liver disease Diabetes mellitus (type 1 and 2) Active cancer (except skin cancer) Renal transplant Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months) Proliferative glomerulonephritis or ANCA-related disease Continuous immunosuppressant treatment Pregnancy or lactation Alcohol abuse If the investigator finds the participant unfit to complete the project

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 |
| --- | --- |
| Experimental: Sodium restriction<br> | Behavioral: Sodium restriction<br>* Participants will be guided in minimizing sodium intake. Guidance will be both oral and written. Bread with low sodium content will be offered to the participants.<br>|
| No Intervention: Usual diet<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic 24-hour blood pressure | Difference in systolic blood pressure measured before and after intervention | Measured before and after 4 weeks' intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salt sensitivity, Sodium sensitivity, Salt restriction, Salt-blood test, Dietary intervention, Hypertension
Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Detailed Description
-----------------
To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.

Official Title
-----------------
Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients

Conditions
-----------------
Keratoconjunctivitis, Conjunctivitis

Intervention / Treatment
-----------------
* Drug: FK506


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study Patients who wish to receive continuous administration of FK506 ophthalmic suspension Exclusion Criteria: Subjects who needed prohibited concomitant therapy at the initiation of the study Subjects who needed to wear contact lenses during treatment period on a testing eye Subjects with complicating an eye infection

Ages Eligible for Study
-----------------
Minimum Age: 6 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: 1<br>FK506 ophthalmic suspension | Drug: FK506<br>* Ophthalmic suspension<br>* Other names: tacrolimus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change from the baseline (before the treatment) in total score for objective clinical signs |  | length of study | 
| Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign |  | Length of study | 
| Subjective symptom score (Visual Analog Scale) |  | Length of study | 
| The improvement rate |  | Length of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FK506, Keratoconjunctivitis, Vernal keratoconjunctivitis, Tacrolimus
Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

Study Overview
=================
Brief Summary
-----------------
Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).

Detailed Description
-----------------
According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort. The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.

Official Title
-----------------
Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions

Conditions
-----------------
Contact Lens Solution Toxicity

Intervention / Treatment
-----------------
* Other: RevitaLens
* Other: OptiFree PureMoist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and over inclusive. Males or females Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. Are willing/able to return for all required study visits. Are willing/able to follow instructions from the study investigator and his/her staff. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee. Exclusion Criteria: Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RevitaLens<br>AMO's RevitaLens contact lens solution | Other: RevitaLens<br>* Multi-purpose disinfecting solution<br>* Other names: AMO's RevitaLens;Other: OptiFree PureMoist<br>* Multi-purpose disinfecting solution<br>* Other names: Alcon's OptiFree PureMoist MPS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported comfort scores with contact lens care systems | Comfort measured by questionnaires covering positive and negative attributes of contact lens wear | 14 days |