linjc16/ctgov huggingface dataset:
Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.

Study Overview
=================
Brief Summary
-----------------
Chemotherapy-induced mucositis is an important complication after autologous stem cell transplantation. It is mainly responsible for pain and dysphagia requiring opioids and artificial nutrition. It can also induce infectious complications. A few medication has demonstrated efficacy in this setting. It has been suggested that selenium can reduce the intensity of mucositis due to its antioxydant activity. The investigators therefore perform a randomized study to confirm this preliminary data.

Official Title
-----------------
A Randomized Trial to Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.

Conditions
-----------------
Mucositis Oral, Stem Cell Transplant Complications

Intervention / Treatment
-----------------
* Drug: Selenium
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients receiving autologous stem cell transplantation for lymphoma or myeloma. Signed informed consent. Exclusion Criteria: Autologous stem cell transplantation for another medical condition than lymphoma or myéloma. Intolerance to selenium. High selenium levels before study. Pregnancy or patients breast-feeding.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Usual care | Drug: Placebos<br>* NaCl 0,9% (IV infusion)<br>|
| Active Comparator: Selenium<br>Usual care + selenium 300 µg/day (IV infusion) | Drug: Selenium<br>* Selenium 300 µg/day (IV infusion)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe oral mucositis (grade 3-4) |  | 31 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any grade oral mucositis |  | 31 months | 
| Number of days with severe oral mucositis |  | 31 months | 
| Incidence of infectious complications |  | 31 months | 
| Number of days with artifical nutrition |  | 31 months | 
| Number of days with opioids |  | 31 months | 
| Duration of hospitalization |  | 31 months |
Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.

Official Title
-----------------
A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Vehicle ointment
* Drug: Ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 18 or over Subjects with a history of AD Written and dated informed consent Satisfactory medical assessment with no clinical relevant abnormalities. Exclusion Criteria: Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments. Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial. Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study. Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle ointment<br> | Other: Vehicle ointment<br>* Topical vehicle cream<br>|
| Experimental: SRD441 Ointment<br> | Drug: Ointment<br>* SRD441 Ointment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure efficacy in treating acute exacerbations |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and local dermal tolerability |  | 4 weeks |
Optimal Exercise Regimens for Persons at Increased Risk

Study Overview
=================
Brief Summary
-----------------
To assess exercise training adherence and compliance over two years in subjects who were at relatively high risk for coronary artery disease. Also, to test strategies for improving adherence and compliance and to assess the effect of exercise training.

Detailed Description
-----------------
BACKGROUND: Regular physical exercise is associated with lower coronary heart disease mortality, favorably affects coronary risk factors, and increases cardiovascular functional capacity. Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so. This is largely because effective strategies for increasing the exercise habit in a broadly-based segment of Americans have not been developed. This study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting. DESIGN NARRATIVE: Following stratification by gender and cigarette smoking status, subjects were randomized to one of four groups: home exercise of moderate intensity which was individually monitored; home exercise of high intensity which was individually monitored; exercise of high intensity which was group supervised; and a no program control group. The intervention program was conducted for one year followed by a one-year maintenance program. Main outcome measures included treadmill exercise test performance, exercise participation rates, and heart disease risk factors. Variables measured over two years included plasma lipids, lipoproteins, apoproteins, lipase activity, glucose and insulin, sex hormones, cardiovascular reactivity to psychological stress, cigarette smoking, nutrient intake, psychological status, and cardiovascular functional capacity.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia

Intervention / Treatment
-----------------
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Sedentary men and women, ages 50 to 65. Women were postmenopausal and not taking hormone replacement therapy. All subjects were free from, but at increased risk for, coronary heart disease.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Methylnaltrexone (MNTX) for the Relief of Constipation

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Detailed Description
-----------------
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.

Official Title
-----------------
A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.

Conditions
-----------------
Advance Illness Patients With OIC

Intervention / Treatment
-----------------
* Drug: SC Methylnaltrexone
* Drug: SC Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Negative pregnancy test (serum or urine) at screening for all women of childbearing potential Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month patient must sign ICF Exclusion Criteria: Women who are pregnant and/or nursing Previous treatment with MNTX Participation in any other studies involving investigational products within 30 days prior to screening

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: SC Methylnaltrexone<br>* Dose 1<br>|
| Placebo Comparator: Arm 2<br> | Drug: SC Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. | To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours. To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI. | 2 weeks |
Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study was to document the pharmacokinetic parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam in epileptic pediatric subjects, aged 1 month to less than 4 years.

Official Title
-----------------
An Open-Label, Single Dose, Pharmacokinetic Study of 20 mg/kg of Levetiracetam Oral Solution in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female between 1 month and less than 4 years diagnosis of any type of epilepsy at least 5 kg body weight using no more than two antieplieptic drugs Exclusion Criteria: a treatable seizure etiology epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease history of status epilepticus during the 2 weeks prior to the Selection Visit history of or the presence of pseudoseizures epilepsy surgery within one year prior to the Selection Visit on a ketogenic diet taking felbamate at the Selection Visit

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 4 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 |
| --- |
|Drug: Levetiracetam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Keppra
Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form

Study Overview
=================
Brief Summary
-----------------
Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form on Clinician Decision: observational study

Detailed Description
-----------------
A main factor for planning any preventive program is to accurately assess a person's risk of developing a caries. Dental caries is a multifactorial disease and is affected by several factors, such as the patient's general health and diet, the amount and type of bacteria present in the oral cavity, salivary factors and exposure to fluoride. Thus, caries risk assessment approaches should take into account risk implications from various factors that influence carious activity Many caries risk assessment models had been developed to assess the caries for certain individual, this study will be carried out to measure the reproducibility between CAMBRA and cariogram model to evaluate if one of them is enough to be used as they give the same result or not

Official Title
-----------------
Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form on Clinician Decision: Observational Study

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Diagnostic Test: reproducability of caries risk assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be in range of 18-40 years old. Patient should have good periodontal health Exclusion Criteria: Patient below 18 years and above 40 years old Patient with periodontally affected teeth and mobility. Patient with multiple extraction

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Cariogram | Diagnostic Test: reproducability of caries risk assessment<br>* reproducability of caries risk assessment CAMBRA verses cariogram<br>|
| B<br>CAMBRA | Diagnostic Test: reproducability of caries risk assessment<br>* reproducability of caries risk assessment CAMBRA verses cariogram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducability degree of matching between cariogram and cambra | reproducability of cariogram and cambra | one day |
Intralesional Bevacizumab Injection on Primary Pterygium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.

Detailed Description
-----------------
To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment

Official Title
-----------------
A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results

Conditions
-----------------
Pterygium, Inflammation

Intervention / Treatment
-----------------
* Drug: Intralesional injection of bevacizumab
* Drug: Topical antihistamine and vasoconstrictor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary pterygium Exclusion Criteria: previous ocular surgery
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 |
| --- | --- |
| Active Comparator: bevacizumab<br>intralesional bevacizumab injection | Drug: Intralesional injection of bevacizumab<br>* single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day<br>* Other names: Avastin;|
| Active Comparator: Topical antihistamine and vasoconstrictor<br>combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04% | Drug: Topical antihistamine and vasoconstrictor<br>* combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%<br>* Other names: Hista-oph;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of corneal pterygium area | Prior to receive the treatments, patients were asked to evaluate grading of their own symptoms and underwent clinical grading of the elevation and inflammation of the lesions using slit lamp biomicroscopy by an opthalmologist (OE). Digital photographs of each eye with pterygium were obtained for corneal pterygium area analysis [Sony Mavica digital still camera MVC-FD83, Japan]. Each patient was randomly assigned into either treatment group or control group using computer-generated random numbers table. Number of patients with adverse events will be recorded. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, pterygium, treatment, elevation
Azathioprine in Recurrent Implantation Failure

Study Overview
=================
Brief Summary
-----------------
Azathioprine increase pregnancy rate in patients with recurrent implantation failure

Official Title
-----------------
Azathioprine in Recurrent Implantation Failure

Conditions
-----------------
Recurrent Implantation Failure, In Vitro Fertilization, Intracytoplsmic Sperm Injection

Intervention / Treatment
-----------------
* Drug: Azathioprine Pill
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20-39 previous 3 or more failed ivf Exclusion Criteria: intrauterine anomalies chronic systemic illness chronic pelvic conditions sensitivety to azathioprine

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azathioprine<br> | Drug: Azathioprine Pill<br>* Azathioprine increase pregnancy rate in cases with recurrent implantaion failure<br>|
| Placebo Comparator: Control<br> | Drug: Placebo Oral Tablet<br>* Placebo tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 2 weeks |
Telmisartan Versus Ramipril After Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the antinflammatory and endothelial progenitor cell (EPC) mobilizing effect of Ramipril and Telmisartan in patients presenting with acute coronary syndrome

Official Title
-----------------
Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome, Myocardial Infarction, Coronary Disease

Intervention / Treatment
-----------------
* Drug: TELMISARTAN
* Drug: RAMIPRIL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biochemical evidence of myocardial infarction as indicated by elevation of cTnT, presence of ECG ischemic changes, angiographic evidence of a primary coronary event, such as plaque erosion and/or rupture, fissuring, or dissection at coronary angiography, successful coronary revascularization of at least one culprit coronary vessel. Exclusion Criteria: Age>80 years, current ACE inhibitor or ARB treatment, ejection fraction <35%, infarction secondary to ischemia due to an imbalance of O2 supply and demand, ECG abnormalities that could affect the recognition of ST segment shift, recent or chronic infective or inflammatory diseases, malignancy, and myocardial infarction, surgery or trauma in the previous month.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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: R<br>Twenty-five patients assigned to ramipril 5 mg daily | Drug: RAMIPRIL<br>* 5 mg daily<br>|
| Active Comparator: T<br>Twenty-five patients assigned to Telmisartan 80 mg daily | Drug: TELMISARTAN<br>* 80 mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High sensitivity C-Reactive Protein |  | 20 days after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Progenitor Cells |  | 20 days after hospital discharge |