linjc16/ctgov huggingface dataset:
A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: 0.15% Brimonidine Tartrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of open-angle glaucoma or ocular hypertension Exclusion Criteria: Used Alphagan® in previous 3 months
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: 0.15% Brimonidine Tartrate<br>0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months. | Drug: 0.15% Brimonidine Tartrate<br>* 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.<br>* Other names: Alphagan® P;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, Month 3 |
Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

Study Overview
=================
Brief Summary
-----------------
Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.

Detailed Description
-----------------
Study design Multi-center, randomized clinical trial Study population Adults with chronic wound Investigational device treatment procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed,and apply the Study Device or Comparator on their wound in a randomized manner. Post-Treatment: All subjects will take pictures of the wound area and measured the number of microorganism and wound size.

Official Title
-----------------
Clinical Trial to Evaluate Efficacy and Safety of Ultrasonic Surgical Device (ULSC-12D)in Chronic Pressure Ulcer

Conditions
-----------------
Pressure Ulcer, Wound, Necrosis

Intervention / Treatment
-----------------
* Device: ULSD-12D
* Device: SONOCA-180


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 20 years of age subject who has untreated wounds subject who has wound size over 3cm x 3cm subject who has wound over stage 2 Exclusion Criteria: cellulitis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ULSD-12D<br>ultrasound surgical device made by Ultech. | Device: ULSD-12D<br>* wound cleansing and debridement using ULSD-12D<br>|
| Active Comparator: SONOCA-180<br>ultrasound surgical device made by Soering | Device: SONOCA-180<br>* wound cleansing and debridement using SONOCA-180<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of microorganisms on wound bed | Investigator measured the number of microorganisms on wound bed at pre and post debridement using nitrocellulose filter. | Baseline and 30minuts post debridement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| necrotic tissue region | Area calculation of necrotic tissue region at pre and post debridement | Baseline and 30minuts post debridement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pressure ulcer, chronic wound, tissue necrosis, slough, ultra sound
Cerebral Microembolism in the Critically Ill With Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to investigate the impact of continuous renal replacement therapy and intermittent renal replacement therapy on microbubble / cerebral microemboli generation in a cohort of critically ill patients with dialysis-dependent acute kidney injury.

Official Title
-----------------
Cerebral Microembolism in the Critically Ill With Acute Kidney Injury: A Prospective Multi-Center Randomized Controlled Trial Comparing Continuous With Intermittent Renal Replacement Therapy.

Conditions
-----------------
Cerebral Embolism

Intervention / Treatment
-----------------
* Device: Renal replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 yrs. Signed IC Exclusion Criteria: Heart disease (PFO, ASD, VSD, severe valvular disease) Atrial fibrillation Cerebrovascular pathology Missing temporal bone window Allergy to plastic contained in the investigative device (transcranial Doppler) Chronic kidney disease Pregnancy Participation in another study

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 |
| --- | --- |
| Active Comparator: CRRT group<br>the CRRT group receives continuous renal replacement therapy for acute kidney injury | Device: Renal replacement therapy<br>* Patients receive renal replacement therapy according to institutional standards<br>* Other names: Hemodialysis;|
| Active Comparator: IRRT group<br>the IRRT group receives intermittent renal replacement therapy after termination of CRRT. | Device: Renal replacement therapy<br>* Patients receive renal replacement therapy according to institutional standards<br>* Other names: Hemodialysis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound |  | During hemodialysis therapy |
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is do describe the experience in the use of omalizumabe, in a real life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations, emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma medication).

Detailed Description
-----------------
Omalizumab is indicated in children over 6 years of age, with diagnosis of difficult to control asthma, presenting a component of atopy demonstrated preferably positive skin tests (prick test) or in vitro reactivity (rast) allergens common inhalants. Patients must also present the total serum IgE levels between 30 and 700UI/mL. Children until 12 years the IgE level is between 30 and 300 IU/ml.

Official Title
-----------------
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on optimal asthma treatment, good compliance and no response to treatment according to asthma consensus (GINA/NAEEP and the Latinamerican Consensus for Difficult to treat Asthma)

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of asthma hospitalization |  | ONE YEAR Of Omalizumab USE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the doses of oral steroids |  | ONE YEAR Of Omalizumab USE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DIFFICULT TO CONTROL ASTHMA, OMALIZUMABE
Cardiac Safety of Indacaterol

Study Overview
=================
Brief Summary
-----------------
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.

Official Title
-----------------
A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects

Conditions
-----------------
Healthy Volunteers, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Indacaterol 150 µg
* Drug: Indacaterol 300 µg
* Drug: Indacaterol 600 µg
* Drug: Placebo
* Drug: Placebo/moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, non-smoking Body mass index (BMI) 18.5-32 kg/m2 Body weight at least 50 kg Exclusion Criteria: Recent/concurrent use of concomitant medications (except acetaminophen) Recent participation in other clinical trials Recent donation or loss of blood History/presence of a range of medical conditions, including electrocardiographic (ECG) abnormalities, diabetes mellitus, hyperthyroidism and impaired renal function Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol 150 µg<br>Indacaterol 150 µg | Drug: Indacaterol 150 µg<br>* Once daily (QD) via single-dose dry powder inhaler (SDDPI)<br>|
| Experimental: Indacaterol 300 µg<br>Indacaterol 300 µg | Drug: Indacaterol 300 µg<br>* QD via SDDPI<br>|
| Experimental: Indacaterol 600 µg<br>Indacaterol 600 µg | Drug: Indacaterol 600 µg<br>* QD via SDDPI<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* QD via SDDPI<br>|
| Active Comparator: Placebo/moxifloxacin<br>Placebo/moxifloxacin | Drug: Placebo/moxifloxacin<br>* Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in QTc interval (Fridericia's) |  | Change from baseline (prior to the first dose) to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in uncorrected QT interval |  | Change from baseline (prior to the first dose) to Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indacaterol, Moxifloxacin
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy

Study Overview
=================
Brief Summary
-----------------
Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.

Official Title
-----------------
A Pilot Study Assessing the Efficacy and Safety of Ciclosporin as a Second -Line Drug in Patients With Type 1 Reactions Who Have Not Responded to a 12 Week Course of Prednisolone.

Conditions
-----------------
Leprosy

Intervention / Treatment
-----------------
* Drug: ciclosporin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment Aged 18-65 Weigh more than 30Kg Exclusion Criteria: Unwillingness to give informed consent Patients with severe active infections such as tuberculosis Pregnant or breastfeeding women (see Appendix II) Those with renal failure, abnormal renal function, hypertensive Patients taking thalidomide currently or within the last 3 months Patients not willing to return for follow-up Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II) HIV positive

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciclosporin<br>ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks) | Drug: ciclosporin<br>* Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in nerve function |  | at 24 weeks and 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse effects |  | throughout 32 weeks | 
| Skin lesion inflammation improvement |  | up to 36 weeks | 
| rate of improvement of reaction |  | up to 36 weeks | 
| Time to next reactional episode |  | up to 2 years | 
| extra prednisolone needed to control reaction |  | up to 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leprosy, Type 1 Reaction, Prednisolone, Ciclosporin
Ultrasound Elastography in Patients With Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score. The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.

Official Title
-----------------
Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Other: Ultrasonic Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge. T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR < 5 mm. Life expectancy of more than 3 months. Age ≥18 years. Performance status ≤ 2 according to WHO. Patient able to observe protocol guidelines. Signed informed consent. Exclusion Criteria: Previous radiation treatment for the pelvis. Known distant metastases. Serious disease contraindicating treatment, including cardiovascular disease. Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri. Pacemaker other disease making the patient unfit for study participation as assessed by investigator

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 |
| --- | --- |
| Rectal cancer patients in chemoradiation<br> | Other: Ultrasonic Elastography<br>* Non-invasive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor regression grade |  | 8 weeks after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound elastography, Rectal cancer, Preoperative chemoradiation
Efficacy of LAMA Added to ICS in Treatment of Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess its safety.

Official Title
-----------------
A Multicentre, Randomised, Double-blind, Placebo-controlled, 2-way Cross-over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on Top of QVAR® pMDI for the Treatment of Patients With Uncontrolled Asthma on Low-Medium Dose of Inhaled Corticosteroids

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: CHF 5259 12.5 µg
* Drug: CHF 5259 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of asthma ≥ 5 years and diagnosed before 40 years old Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5 Pre-bronchodilator FEV1 ≥40% and <90% of their predicted normal value Positive reversibility test Exclusion Criteria: Pregnant or lactating women Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Patients treated for asthma exacerbation in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 5259 12.5 µg<br>CHF 5259 12.5 µg: 2 inhalations bid (50µg daily dose) | Drug: CHF 5259 12.5 µg<br>* comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks<br>* Other names: glycopyrrolate bromide;|
| Placebo Comparator: CHF 5259 placebo<br>CHF 5259 placebo: 2 inhalations bid | Drug: CHF 5259 placebo<br>* comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 (Forced Expiratory Volume in the first second) AUC0-12h (Area Under the Curve for 0-12 hours) normalised by time on Day 42 |  | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak FEV1 (Peak of Forced Expiratory Volume in the first second ) on Day 42 |  | Day 42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Anticholinergics
Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status

Study Overview
=================
Brief Summary
-----------------
The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men.

Detailed Description
-----------------
The aim of this study was to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.

Official Title
-----------------
Impact of Coenzyme Q10 and Selenium on Seminal Fluid Parameters and Antioxidant Status in Men With Idiopathic Infertility

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Dietary Supplement: Coenzyme Q10
* Dietary Supplement: Selenium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of infertility of at least 12 months despite regular unprotected intercourse. Oligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm concentration (<15 million/ml), progressive motility (<32%), total motility (<40%) and morphology (<30% WHO criteria) as defined by WHO manual for semen analysis 2010 Exclusion Criteria: Azoospermia, Varicocele, Genital tract infection, Cryptorchidism, Testicular trauma or scrotal surgery, Endocrine disorder, Systemic illness, Smoking The presence of female factor

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coenzyme Q10<br>Coenzyme Q10 200mg/day for 3 months | Dietary Supplement: Coenzyme Q10<br>* Coenzyme Q10<br>|
| Active Comparator: Selenium<br>Selenium mcg/day for 3 months | Dietary Supplement: Selenium<br>* Selenium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen volume (WHO 2010 guidelines) | Semen volume in ml | 3 months | 
| Sperm concentration in semen (WHO 2010 guidelines) | Sperm concentration in million/ml | 3 months | 
| Sperm motility in semen (WHO 2010 guidelines) | Sperm motility (%) | 3 months | 
| Sperm morphology in semen (WHO 2010 guidelines) | Normal sperm morphology (%) | 3 months | 
| Seminal plasma TAC (Colorimetric assays) | Seminal plasma total antioxidant capacity in mmol/ml | 3 months | 
| Seminal plasma CAT (Colorimetric assays) | Seminal plasma catalase in U/ml | 3 months | 
| Seminal plasma SOD (Colorimetric assays) | Superoxide dismutase in U/ml | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male infertility, Coenzyme Q10, Selenium, Antioxidants