linjc16/ctgov huggingface dataset:
Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.

Official Title
-----------------
Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: MK0507A, dorzolamide hydrochloride (+) timolol maleate
* Drug: Comparator: timolol maleate
* Drug: Duration of Treatment: Part 1) 6 wk timolol maleate run in
* Drug: Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with glaucoma or ocular hypertension Exclusion Criteria: Other eye conditions Poor vision Recent eye surgery Use of contact lenses Nursing or pregnant women Use of some other selected medications Drug or alcohol abuse Asthma Slow heart beat Allergy or previous reaction to study drugs

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0507A, dorzolamide hydrochloride (+) timolol maleate|nan|
|Drug: Comparator: timolol maleate|nan|
|Drug: Duration of Treatment: Part 1) 6 wk timolol maleate run in|nan|
|Drug: Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour diurnal IOP reduction after 8 weeks of treatment |  | After 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night |  | At 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular hypertension (excessive pressure in the eye)
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.

Official Title
-----------------
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Conditions
-----------------
Kidney Failure, Chronic, Renal Dialysis

Intervention / Treatment
-----------------
* Device: Renal Denervation with a catheter-based procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure of 160 mmHg or greater On 3 or more antihypertensive medications On dialysis for more than 6 months Exclusion Criteria: Renal artery abnormalities Known secondary hypertension attributable to a cause other than sleep apnea MI, angina, CVA within 6 months Others

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Renal Denervation with a catheter-based procedure|Disruption of the renal nerves with a catheter-based procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. |  | Through 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic response to denervation (e.g., blood pressure reduction) |  | Through 1 year |
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

Study Overview
=================
Brief Summary
-----------------
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

Detailed Description
-----------------
The study will compare multiple doses of aldafermin against placebo in a compensated NASH cirrhosis population for 48 weeks of treatment.

Official Title
-----------------
Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

Conditions
-----------------
Compensated Cirrhosis, Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Biological: aldafermin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Liver biopsy consistent with NASH cirrhosis. Compensated cirrhosis due to NASH. Key Exclusion Criteria: Other causes of liver disease including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, primary biliary cirrhosis, drug-induced hepatotoxicity, Wilson's disease, hemochromatosis, and alpha-1-anti-trypsin definition based on medical history and/or centralized read of liver histology. Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis. History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy. Model of end stage liver disease (MELD) score >12. Other protocol-defined inclusion/exclusion criteria could apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily 0.3 mg dose<br>Administered by subcutaneous injection | Biological: aldafermin<br>* aldafermin<br>|
| Experimental: Daily 1 mg dose<br>Administered by subcutaneous injection | Biological: aldafermin<br>* aldafermin<br>|
| Experimental: Daily 3 mg dose<br>Administered by subcutaneous injection | Biological: aldafermin<br>* aldafermin<br>|
| Placebo Comparator: Placebo<br>Administered by subcutaneous injection | Other: Placebo<br>* Placebo for aldafermin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Enhanced Liver Fibrosis (ELF) score. |  | 48 weeks | 
| Safety assessed by reported and observed adverse events. |  | 48 weeks |
A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess steroid induced skin atrophy by sonography.

Official Title
-----------------
A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess Steroid Induced Skin Atrophy on Healthy Skin

Conditions
-----------------
Skin and Connective Tissue Diseases

Intervention / Treatment
-----------------
* Drug: Clobetasol propionate 0.05 % ointment
* Drug: Betamethasone dipropionate 0.064 % ointment
* Drug: Petrolatum ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, 25 to 40 years old inclusive. Healthy skin on volar arms with a hairless area sufficient for measurements Exclusion Criteria: Clinical skin atrophy, telangiectasia or striae on volar arms. Presence of any skin condition or colouration that would interfere with test sites or the response or assessment. Fitzpatrick skin type IV - VI. History or current evidence of infection, eczema or other relevant skin disease.

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clobetasol propionate 0.05 % ointment<br>Active drug | Drug: Clobetasol propionate 0.05 % ointment<br> <br> |
| Experimental: Betamethasone dipropionate 0.064 % ointment<br>Active drug | Drug: Betamethasone dipropionate 0.064 % ointment<br> <br> |
| Placebo Comparator: Petrolatum ointment<br>Placebo drug | Drug: Petrolatum ointment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin thickness from baseline to end of treatment |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment |  | 4 weeks |
Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine, which is currently given to lower blood ammoniac levels.

Detailed Description
-----------------
Hepatic encephalopathy (HE) is a complex neuropsychiatric syndrome related to chronic/acute hepatic failure. Sleep architecture is disturbed in this syndrome, and patients complain mainly of excessive daytime sleepiness and sleep disturbances. Hypothesis to explain these symptoms is, among others, disturbed melatonin metabolism. Few studies have been conducted in order to study sleep disorders during HE, and effect of treatment is unknown. Recently, rifaximine, an oral broad spectrum antibiotic, have been proved to decrease ammoniac production in patients with HE. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine.

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: rifaximine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18y hepatic encephalopathy: positive Conn score Exclusion Criteria: <18y pregnancy inability to fulfil questionnaires acute infection unstable clinical condition bone or articular disease resulting in significant disability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: rifaximine<br> | Drug: rifaximine<br> <br> * Other names: Targaxan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Slow Wave Sleep and REM Sleep | sum of percentage of sleep spent in slow wave sleep and REM sleep during sleep per 24h ; assessed by 24-h polysomnography | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency | total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep quality, physical activity, daytime sleepiness, actigraphy, quality of life
Plaque Psoriasis Study in Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.

Official Title
-----------------
A Multicenter, Randomized, Double Blind, Parallel Group, Vehicle Controlled, Study of the Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 8 Weeks in Pediatric Subjects (2 to 12 Years of Age) With Mild to Moderate Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: calcitriol ointment
* Drug: placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 2 to 12 years of age Clinical diagnosis of stable mild to moderate plaque psoriasis Exclusion Criteria: Other forms of psoriasis Hypercalcemia Past history of kidney stones Vitamin D deficiency Other concomitant dermatological disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: calcitriol ointment<br>calcitriol 3 mcg/g ointment | Drug: calcitriol ointment<br> <br> |
| Placebo Comparator: placebo<br>placebo comparator | Drug: placebo comparator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Investigator's Global Assessment (IGA) | The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF). The IGA was evaluated at each visit on the following 0 to 4 point scale: 0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation - Almost Clear: Just perceptible erythema, no induration, and no scaling - Mild: Mild erythema, no induration, and mild or no scaling - Moderate: Moderate erythema, mild induration, and mild or no scaling - Severe: Severe erythema, moderate to severe induration, and scaling of any degree | Baseline to Week 8 |
Radiation Planning Study for High Grade Brain Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to see if a higher strength MRI procedure provides better images to use in planning radiation treatments for patients with brain tumors in the future.

Official Title
-----------------
3T Versus 1.5T MR Approaches in Target Definition for Malignant Gliomas: Is There a Significant Difference in Tumor Extent and Radiation Treatment Volume?

Conditions
-----------------
High Grade Glioma

Intervention / Treatment
-----------------
* Other: 3T MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed, newly diagnosed Grade III-IV glioma Planning to undergo radiation therapy Exclusion Criteria: Grade I or II glioma Patients unable to undergo MRI imaging

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 |
| --- | --- |
| 3T MRI<br>Patients receiving 3T MRI | Other: 3T MRI<br>* 3T MRI in addition to standard 1.5T MRI for treatment planning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment volume | To assess the difference in treatment volume for radiation planning in gliomas as calculated using 1.5T versus 3T magnets | 1 year average |
The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema

Study Overview
=================
Brief Summary
-----------------
The aim of the work is to Assess the incidence of weaning induced pulmonary adema(WIPO). Assess the risk factors of WIPO. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT). Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.

Official Title
-----------------
The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema

Conditions
-----------------
Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema

Intervention / Treatment
-----------------
* Other: lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT). Exclusion Criteria: Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.

Ages Eligible for Study
-----------------
Maximum Age: 60 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 |
| --- | --- |
| group 1<br>patient who will develop weaning induced pulmonary adema | Other: lung ultrasound<br>* patient with or without weaning induced pulmonary adema<br>|
| group 2<br>patient who will nor develop weaning induced pulmonary adema | Other: lung ultrasound<br>* patient with or without weaning induced pulmonary adema<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema |  | 1 year |
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.

Official Title
-----------------
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss

Conditions
-----------------
Bone Loss

Intervention / Treatment
-----------------
* Drug: zoledronic acid
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Age 18 years and older Spinal cord injury within 8 weeks of study entry ASIA AIS A or B Medically stable in the opinion of their physiatrist Able to have dexa performed Able to return for follow-up at 6 and 12 months Exclusion Criteria: Vitamin D deficiency Hypocalcemia Renal insufficiency (estimated creatinine clearance <30ml/min) Abnormal thyroid hormone status Abnormal mental status Osteoporosis at the hip or spine by dexa

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zoledronic acid<br> | Drug: zoledronic acid<br>* zoledronic acid, 5mg, iv<br>* Other names: Reclast, zoledronic acid;|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* iv<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mass Density (BMD) at Total Hip | bone mineral density measured by DXA at the total hip | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD at Other Skeletal Sites | BMD at spine, femoral neck, distal femur, proximal tibia, heel | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord injury, osteoporosis, bone loss, zoledronic acid, bisphosphonate