linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)

Study Overview
=================
Brief Summary
-----------------
To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

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

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician) Patient is having both eyes treated Exclusion Criteria: Contraindications per product labelling will apply. Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.

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 |
| --- | --- |
| 1<br>bimatoprost 0.03% latanoprost 0.005% travoprost 0.004% | Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%<br>* 1 drop in eye(s) every evening<br>* Other names: Travatan®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement). | Baseline, 1 Year |
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).

Official Title
-----------------
Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy

Conditions
-----------------
Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
-----------------
* Radiation: radiochemotherapy with 70 Gy
* Radiation: radiochemotherapy with 77 Gy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy measurabel disease by CT and/or MRT and/or FDG-PET-CT fit for chemotherapy no prior radiotherapy or major surgery in the head/neck region Karnofsky Index > 60% informed consent Exclusion Criteria: uncontrolled secondary cancer distant metastases pregnancy expected malcompliance

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: Standard therapy<br>Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks) | Radiation: radiochemotherapy with 70 Gy<br> <br> |
| Experimental: dose escalation<br>Standard plus 10% dose escalation to the hypoxic volume | Radiation: radiochemotherapy with 77 Gy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to local recurrence |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Local control
Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) Dose-Ranging Study

Study Overview
=================
Brief Summary
-----------------
This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.

Detailed Description
-----------------
This is an open labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses according to the following chart: Group / N* / rFla-MBP A / 8/ 25 micrograms B / 8/ 125 micrograms C / 8/ 625 micrograms D / 8/ 1000 micrograms * minimum of 6 volunteers per group An interval no less than 60 days following the first dose will separate the first dose of each volunteer group receiving different rFla-MBP doses. All volunteers will receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+/- 1 day), the third is day 28 (+/- 2 days). Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.

Official Title
-----------------
Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) in Volunteers

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Biological: rFla-MBP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult 70% accuracy on comprehension test Availability for required visits and telephone follow up Exclusion Criteria: Pregnancy or breastfeeding Chronic health problems Abnormalities found on physical examination Use of immunosuppressive drugs, such as corticosteroids or chemotherapy Positive blood test for HIV-1, hepatits B surface antigen (HBsAG) or hepatitis C virus (HCV) Abnormalities found on basic laboratory screening Prior exposure to Campylobacter Current smoker Chronic sinusitis or seasonal rhinitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rFla-MBP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic reactions |  |  | 
| Mucosal immunogenicity |  |  | 
| Systemic immunogenicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Campylobacter, Bacterial enteritis
Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetiks, and Pharmacodynamics of ILV-094 Administered Intravenously and One Dose of ILV-094 Administered Subcutaneously to Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ILV-094


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years. Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ILV-094|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics |  |  |
New-DES vs BMS in SVG -1 Year Outcomes

Study Overview
=================
Brief Summary
-----------------
Data regarding the efficacy of the percutaneous coronary intervention (PCI) with new-designed drug-eluting stent (new-DES) vs. bare metal stent (BMS) of saphenous vein grafts (SVG) stenosis is scarce. The primary objective was to compare one-year clinical outcomes of PCI in stenosis of SVG using new-DES vs. BMS in a real-world population. We carried out a multi-center registry comparing new-DES with BMS in all consecutive patients undergoing PCI of SVG. The primary composite endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 1 year.

Official Title
-----------------
New-generation Drug Eluting Stent vs. Bare Metal Stent in Saphenous Vein Graft - 1 Year Outcomes by a Propensity Score Ascertainment (SVG Baltic Registry)

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

Intervention / Treatment
-----------------
* Device: new-DES
* Device: BMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after CABG with significant SVG stenosis referred for PCI Exclusion Criteria: patients who had both types of stents implanted in the same procedure patients with the old-DES patients who had PCI of other vascular territories during the same procedure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SVG PCI<br> | Device: new-DES<br>* with ot without embolic protection device<br>Device: BMS<br>* with ot without embolic protection device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac and cerebrovascular event |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 1 year | 
| myocardial infarction |  | 1 year | 
| target vessel revascularization |  | 1 year | 
| target lesion revascularization |  | 1 year | 
| stroke |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous coronary intervention, Saphenous vein graft, New generation drug-eluting stent, Bare metal stent
TG Gene Mutations and Congenital Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to identify mutations in the thyroglobulin gene that might be present in patients with fetal goiter and congenital goiter hypothyroidism.

Detailed Description
-----------------
Congenital goitrous hypothyroid is commonly linked to thyroglobulin (TG) gene mutations.We aim to identify mutations in the TG gene that might be present in patients with fetal goiter and congenital goiter hypothyroidism.Four related patients with congenital goiter hypothyroidism from an inbred family were studied.Recombinant human TSH stimulation test, DNA sequencing and protein computer analysis were performed.We identified a novel compound heterozygous constellation (IVS30+1G>T/A2215D) in two siblings. It was also identified a homozygous intronic mutation (IVS30+1G>T) in their cousins, one of them with fetal goiter. The mutation IVS30+1G>T promotes an aberrant splicing and loss of the entire exon 30 (138 nt) in the resulting messenger RNA. The recent described mutation A2215D is located in the ACHE-like domain, which functions as a dimerization domain, facilitating efficient intracellular transport of the protein. Protein computer analysis suggested that the A2215D mutation causes TG structural alterations.A novel compound heterozygous constellation (IVS30+1G>T/A2215D) and the previously described mutation (IVS30+1G>T) that cause severe congenital hypothyroidism due to defective TG synthesis have been identified. The mutation IVS30+1G>T may be related to fetal goiter and hypothyroidism due to TG instability and impaired TG export to the colloid. This study shows the efficiency of the use of rhTSH in the differential diagnosis of CH due to TG defective synthesis and the importance of molecular diagnosis of CH for possible intrauterine treatment, thereby avoiding damage to the neuropsychomotor system.

Official Title
-----------------
Congenital Hypothyroidism Due to Thyroglobulin Mutations in an Inbred Brazilian Family: A Novel Compound Heterozygous Constellation and Intronic Mutation Related to Fetal Goiter.

Conditions
-----------------
Congenital Hypothyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with congenital hypothyroidism due to thyroglobulin defective synthesis. Exclusion Criteria: Patients with another disease.
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
-----------------
thyroglobulin gene, congenital hypothyroidism, gene mutations, fetal goiter, iodine nutrition
Improving Community Based Tuberculosis Care in Ethiopia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if involving community health workers improves tuberculosis case finding and treatment outcome.

Detailed Description
-----------------
Tuberculosis suspects in the study area Outcome smear positive tuberculosis cases identified smear positive tuberculosis cases treated

Official Title
-----------------
Community Health Workers Improve Tuberculosis Case Notification and Treatment Success in Southern Ethiopia

Conditions
-----------------
Pulmonary Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspects of pulmonary tuberculosis Exclusion Criteria: not in the study area
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>communities where tuberculosis patients followed the conventional health facility based tuberculosis case finding and treatment | |
| 2<br>community where suspects of pulmonary tuberculosis were identified by community health workers and received treatment in the community | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smear positive tuberculosis case notification rate |  | september 2006 - setmeber 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smear positive treatment success rate |  | september 2006 - April 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TB, community, community health workers, Ethiopia, identify suspects of pulmonary tuberculosis, collect sputum specimen for examination, treat smear positive cases in the community
A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.

Official Title
-----------------
A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Lipinon® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: atorvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20   79 People who have not reached LDL-C targeted level in accordance with the guidelines for hyperlipidemia management released by Korean Society of Lipidology and Atherosclerosis In case of female participants taking combination HRT or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Generic<br> | Drug: atorvastatin<br>* 20 mg<br>* Other names: Lipinon;|
| Active Comparator: Lipitor<br> | Drug: atorvastatin<br>* 20 mg<br>* Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetic Study of Effect of Cardiac Output on the Uptake of Isoflurane

Study Overview
=================
Brief Summary
-----------------
This study examines the effect of blood flow through the lungs and the body on the consumption and hence requirement of the anesthetic agent isoflurane.

Detailed Description
-----------------
The effect of cardiac output on the uptake of isoflurane is yet to be quantified. This study aims to obtain a quantifiable relationship between isoflurane uptake and cardiac output. The study patients will be cardiac patients in whom anesthesia is induced with fentanyl , propofol and maintained on isoflurane . The baseline cardiac index from the pulmonary artery catheter as displayed on the continuous cardiac output monitor will be used to classify the patients into two groups with cardiac index of 2.1 liters per minute per square meter as the differentiating criteria. No change in the anesthesia protocol will be done for the two groups.The study is designed such that all vascular catheterisations and the dose of isoflurane administered is as per prevailing institutional protocols and that no other intervention particular or unique to the study is done. As such the data that the study will use is also routinely acquired during the procedure but not systematically stored, which is what the study will do. This, we suggest, makes the study an observational study.The continuous cardiac output data and the inspired and expired concentration of isoflurane as displayed on the monitor will be recorded online. Data will be collected from the start of isoflurane till 30 minutes or till the surgeon starts cannulating the great vessels. The data so obtained will be analysed in two groups based on the baseline cardiac index using Statistical Package for the Social Sciences (SPSS) for difference in uptake between the groups.

Official Title
-----------------
Effect of Cardiac Output on Uptake of Isoflurane

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of valve stenosis / valvular regurgitant lesion/ coronary artery disease with Ejection fraction >40% Posted for open cardiac surgery under general endotracheal anesthesia Exclusion Criteria: Shunt lesion Allergy to propofol Psychotropic drug use Preinduction hemodynamic instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| Reference<br>Baseline cardiac index more than or equal to 2.1 liters per minute per square meter | |
| Low cardiac output<br>Baseline cardiac index less than 2.1 liters per minute per square meter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of isoflurane in milliliter of vapor per minute |  | Every minute from 1 to 30 minutes |