linjc16/ctgov huggingface dataset:
A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers

Official Title
-----------------
A Phase I, Single Centre, Open-Label Study to Assess the Pharmacokinetics of Both AZD9056 (Steady State) and Simvastatin (Single Dose) When Co-Administered in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: simvastatin
* Drug: AZD9056 + simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Male or female healthy subjects. Females should not be of childbearing potential Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results Exclusion Criteria: Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate Known allergy to simvastatin (or other statins) or previous complications to simvastatin therapy. Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1<br>simvastatin | Drug: simvastatin<br>* One single dose of 40mg<br>* Other names: Zocor;|
| Experimental: Period 2<br>simvastatin + AZD9056 | Drug: AZD9056 + simvastatin<br>* AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7<br>* Other names: Zocor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during study periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simvastatin, AZD5672
The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching

Study Overview
=================
Brief Summary
-----------------
Explore the correlation and specific relationship between chromaticity parameters and treatment satisfaction before and after tooth bleaching, compare the curative effect of different tooth bleaching programs.

Official Title
-----------------
The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching

Conditions
-----------------
Bleaching; Satisfactory

Intervention / Treatment
-----------------
* Other: Common toothpaste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age around 20 28 years, at least six anterior teeth without restorations, good general and oral health (no dental caries and periodontal disease). Exclusion Criteria: tooth sensitivity, any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure), participants under orthodontic treatment, smokers.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 28 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: SATISI_7<br> | Other: Common toothpaste<br>* different toothpaste<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of tooth color | The certain points of tooth color | baseline, 7 days after treatment, 14 days after treatment |
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Detailed Description
-----------------
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Official Title
-----------------
A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: SER120 Nasal Spray 500 ng/day
* Drug: SER120 nasal spray 750 ng/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male & female greater or equal to 75 years of age, history of nocturia Exclusion Criteria: CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome Unexplained pelvic masses Urinary bladder surgery or radiotherapy Sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 75 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SER120 500 ng/day<br>SER120 Level 1 (500 ng/day) | Drug: SER120 Nasal Spray 500 ng/day<br>* SER120 Level 1<br>|
| Experimental: SER120 750 ng/day<br>SER120 Level 2 (750 ng/day) | Drug: SER120 nasal spray 750 ng/day<br>* SER120 (750 ng/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Sodium Levels at Baseline and During Treatment | Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57. | baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Nocturic Episodes Per Night | Change in mean nocturic episodes per night between baseline and Week 8 | Mean value at Week 8 minus mean value at baseline | 
| Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes | Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline | 8 weeks |
The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients

Study Overview
=================
Brief Summary
-----------------
This is a two-center study aimed to assess the efficacy of Dead Sea Minerals in alleviating symptoms of Psoriasis Vulgaris, in 50 patients undergoing phototherapy. A bilateral left right comparison will be made, after using the study product and the placebo, for 8 weeks, twice daily, on each of the body sides (left right). In addition to the clinical evaluations, skin biochemistry will be studied using non-invasive techniques. The latter will be correlated with the clinical results of the patients. These will serve for future development of diagnostic assays and personalized therapies.

Official Title
-----------------
A Double Blind Controlled Clinical Trial Comparing The Efficacy Of A Dead Sea Mineral Enriched Body Cream vs Its Carrier as an Adjuvant Treatment For Psoriatic Patients Undergoing Phototherapy

Conditions
-----------------
Psoriasis Vulgaris

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having 2 symetrical (left right)moderate to severe chronic stable plaque type Psoriasis for at least 6 months and candidates for phototherapy treatment Exclusion Criteria: Volunteers with a known allergy to one of the tested materials or to their ingredients. Treatment with medication such as anti-inflammatories, anti-histamines, corticosteroids, systemically or topically applied, unless stopped for 4 weeks prior to the trial in the case of systemic treatment and 2 weeks in the case of topical treatment. Volunteers in the process of diagnosis or treatment for cancer / kidney disease / liver disease Pregnant or lactating women

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 |
| --- | --- | --- |
| change from baseline of PASI (Psoriasis Area and Severity Index) | Grade 2 lesions (left and right- each one assigned a different treatment: study product or placebo)as follows:E=Erythema (redness) I=Induration (thickness) D=Desquamation (scales) 0 = Absent = Slight = Moderate 3= Severe 4 = Very severe sum the result: modified PASI=E+I+D (in absence of all 3 symptomes the PASI equals 0, if all 3 are very severe then it equals 12. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline of the Skin Hydration level | corneometric measurement of skin capacitance, which indicates hydration level. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
modified PASI, narrow band UVB phototherapy, Dead Sea Minerals, Skin auto-Fluorescence, Skin wash samples
Comparative Physiologic Technology Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to test two hypotheses: The PADnet+ testing system produces clinically equivalent results as the Parks Flo-Lab testing system in a group of patients referred for evaluation of PAD of the limbs when performed by a Registered Vascular Technologist (RVT). The PADnet+ testing system produces clinically equivalent results when the testing is repeated on the above patients and performed by staff specifically trained on the use of the PADnet+ system but are not vascular technologists nor hold the RVT certification.

Official Title
-----------------
Comparative Physiologic Technology Study

Conditions
-----------------
Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred to the MGH Vascular Labs for diagnostic testing for PAD Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| PADnet + testing<br> | |
| Parks Flo-lab Test<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease.

Conditions
-----------------
Coronary Disease, Coronary Arteriosclerosis, Hyperlipidemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: angiographic evidence of coronary atherosclerosis Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors. Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change coronary artery atheroma volume as measured by intravascular ultrasound. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of lipids and other biomarkers. |  |  |
Comparative Study for the Validity of Various Severity Scoring System

Study Overview
=================
Brief Summary
-----------------
Scoring systems for use in intensive care unit (ICU) patients have been introduced and developed over the last 30 years. They allow an assessment of the severity of disease and provide an estimate of in-hospital mortality

Detailed Description
-----------------
Severity scoring systems that are commonly used in critical care settings include Acute Physiology and Chronic Health Evaluation (APACHE), which was developed in the 1980s for predicting mortality, Simplified Acute Physiology Score (SAPS), and Mortality Probability Model (MPM). Although these scoring systems use different variables and weights for the classification of disease severity, they commonly monitor parameters such as heart rate, blood pressure, neurological state, and clinical data as these factors significantly deviate from physiological normality in the progression of critical disease. Old age and chronic disease are also captured by the scoring systems. Sequential Organ Failure Assessment (SOFA) score, which is based on organ failure over time to evaluate morbidity and multiple organ dysfunction is also used.

Official Title
-----------------
Comparative Study for the Validity of Various Severity Scoring System in the Surgical Intensive Care Unit at Aswan University Hospital

Conditions
-----------------
Head Trauma, Polytrauma, Pre-Eclampsia, Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly admitted patients to the Surgical Intensive Care Unit with head trauma multiple trauma craniotomy sepsis preeclampsia - eclampsia postop. for vascular surgery Exclusion Criteria: less than 16 years old, readmitted to the ICU during the study period as only the first admission will be considered, ICU length of stay (LOS) less than 24 h

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Physiology and Chronic Health Evaluation (APACHE) IV |  | the first 24 hours after ICU admission | 
| Simplified Acute Physiology Score (SAPS III) |  | the first 24 hours after ICU admission | 
| Sequential Organ Failure Assessment (SOFA) score |  | the first 24 hours after ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
APACH IV; SAPS III , SOFA score
Immunohistochemical Expression of Epithelial Cell Adhesion Molecule (EpCAM) in Epithelial Ovarian Carcinoma

Study Overview
=================
Brief Summary
-----------------
Cancer stem cells (CSCs) can undergo self-renewal and differentiation. EpCAM is a 40-kDa type I transmembrane glycoprotein composed of a large extracellular domain, one transmembrane region, and a small intracellular domain of 26 amino acids. Recent insights revealed that it is involved in promoting cancer cell proliferation, migration, and invasiveness. It is used as a diagnostic and prognostic marker. EpCAM has also recently been identified as a marker for CSCs.

Detailed Description
-----------------
Ovarian carcinoma is one of most frequent cancer in women worldwide. Epithelial ovarian carcinoma is a group of neoplasms with different histologic pictures. Serous carcinoma is the most common type. Cancer stem cells (CSCs) can undergo self-renewal and differentiation. EpCAM is a 40-kDa type I transmembrane glycoprotein composed of a large extracellular domain, one transmembrane region, and a small intracellular domain of 26 amino acids. It is abundantly expressed by the majority of human epithelial carcinomas, including colorectal, breast, lung, prostate, ovarian, and endometrial cancers. it is overexpressed in various neoplasms. Recent insights revealed that it is involved in promoting cancer cell proliferation, migration, and invasiveness. It is used as a diagnostic and prognostic marker. EpCAM has also recently been identified as a marker for CSCs.

Official Title
-----------------
Immunohistochemical Expression of Epithelial Cell Adhesion Molecule (EpCAM) in Epithelial Ovarian Carcinoma

Conditions
-----------------
Ovarian Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with epithelial ovarian carcinoma and underwent surgery Exclusion Criteria: - Cases received pre-operative chemotherapy or radiotherapy. Cases with insufficient clinical data.
Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate EpCAM expression in ovarian carcinoma | IHC | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian carcinoma, CSCs, EpCAM
Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.

Official Title
-----------------
Comparison of RAM Cannula NCPAP Versus Infant Flow NCPAP

Conditions
-----------------
Acute Respiratory Deficiency, Prematurity, Assisted Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than or equal to 7 kg order for nasal continuous positive pressure Exclusion Criteria: patients greater than 7kg patients that do not have informed consent

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RAM Cannula Nasal Continuous Positive Airway Pressure<br> | |
| Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who achieve unassisted breathing |  | One year |