linjc16/ctgov huggingface dataset:
Feasibility of Aromatherapy in an Awake Craniotomy Environment

Study Overview
=================
Brief Summary
-----------------
Awake craniotomy for tumor surgery allows for mapping of speech, motor and sensory function during tumor resection. Awake craniotomy is increasingly utilized as it has several advantages over a traditional general anesthetic technique. Though many patients tolerate awake cranial surgery well, recent studies found that roughly 30% of patients experience moderate to severe pain and anxiety, while 50% report moderate fear and 11% report severe fear. Therefore, alternative methods to mitigate pain, anxiety, and fear are needed. In this study, the investigators will employ lavender aromatherapy to reduce anxiety and improve the satisfaction with pain control.

Official Title
-----------------
Feasibility of Aromatherapy in an Awake Craniotomy Environment

Conditions
-----------------
Intracranial Pathology

Intervention / Treatment
-----------------
* Drug: Lavender (Lavandula angustifolia)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient aged 18 and older undergoing awake cranial neurosurgery Exclusion Criteria: Allergy or sensitivity to the aromatherapy agent (Lavender) Aversion to lavender scent History of asthma, COPD History of contact dermatitis following exposure to cosmetic fragrances Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Lavender<br>Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler. | Drug: Lavender (Lavandula angustifolia)<br>* Lavender (Lavandula angustifolia) is an essential oil.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of consented patients | Determine the number of eligible patients enrolled and consented | 8 hours | 
| Protocol completion | Determine the number of consented patients completing the trial protocol | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Visual Analogue Scale for Anxiety (VAS-A) | Measure of anxiety, Total Score (0-10) | 8 hours | 
| Validation of Visual Analogue Scale for Pain (VAS-P) | Measure of pain, Total Score (0-10) | 8 hours | 
| Patient Opinion of Pain Management (POPM) survey | Satisfaction with pain control | 8 hours | 
| Analgesic and anxiolytic dosage | Cumulative dose | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Craniotomy, anxiety, malignant, cancer, brain tumor
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

Study Overview
=================
Brief Summary
-----------------
This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

Conditions
-----------------
Non Cystic Fibrosis Bronchiectasis

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin dispersion for inhalation
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of non-CF bronchiectasis History of P. aeruginosa respiratory infections At least two pulmonary exacerbations treated with antibiotics in the previous year Exclusion Criteria: Have a clinical diagnosis of CF Are pregnant

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 |
| --- | --- |
| Experimental: Ciprofloxacin dispersion for inhalation<br>Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin | Drug: Ciprofloxacin dispersion for inhalation<br> <br> |
| Placebo Comparator: Placebo<br>Liquid formulation of empty liposomes | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first pulmonary exacerbation (from baseline) |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa
Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This non-randomized phase II study is designed to assess the response rate and toxicity of weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic colorectal cancer.

Detailed Description
-----------------
Upon determination of eligibility, patients will be receive: Topotecan

Official Title
-----------------
Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic colorectal cancer One previous chemotherapy for metastatic disease Measurable or evaluable disease Able to perform activities of daily living with assistance Adequate bone marrow, liver, and kidney function All patients must give written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Brain or meningeal involvement Serious active infection or underlying medical conditions Other active neoplasms are ineligible Pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median survival |  |  | 
| one year survival |  |  | 
| toxicity |  |  |
Acceptability of Lactacyd Femina

Study Overview
=================
Brief Summary
-----------------
To demonstrate the safety and acceptability of the gynaecological formulation.

Official Title
-----------------
Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral skin in the tested region Exclusion Criteria: Pregnancy or breastfeeding women Use of anti-inflammatory or immune-suppression drugs Topical medication use at the tested region Active cutaneous gynaecological disease which may interfere in study results Personal history of allergic disease at the area to be treated Allergic or atopic history The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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: 1<br>Lactic Acid once a day during 21 days | Drug: Lactic acid<br>* Once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and local tolerability |  | After 21 days |
Pruritus in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
We believe that knowing characteristics of uremic pruritus is the foundation to investigate its pathophysiology and offer better skin care for patients with chronic kidney disease. We therefore conducted this cross-sectional study to evaluate the characteristics of uraemic pruritus.

Conditions
-----------------
Kidney Failure, Chronic, Pruritus

Intervention / Treatment
-----------------
* Other: Questionnaire based on the McGill Pain Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults older than 20 years old, with CKD stage 3 to 5D, with symptoms of pruritus. Exclusion Criteria: Patients who refused to answer the questionnaire or unable to understand the contents of the questionnaire.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Chronic kidney disease<br> | Other: Questionnaire based on the McGill Pain Questionnaire<br>* Interview questionnaire based on the short form of the McGill Pain Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable | Once at the entry of the study |
Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Study Overview
=================
Brief Summary
-----------------
Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration.

Detailed Description
-----------------
The purpose of this study is to assay human aqueous for concentrations of ofloxacin, ciprofloxacin and levofloxacin after topical or combined topical and oral administration in eyes with filtering blebs.

Official Title
-----------------
Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Ofloxacin 0.3%
* Drug: Ciprofloxacin 0.3%
* Drug: Levofloxacin 0.5%
* Drug: Ofloxacin 400mg
* Drug: Ciprofloxacin 400mg
* Drug: Levofloxacin 250mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with functioning filtering blebs will be evaluated prospectively for inclusion Exclusion Criteria: Any subject who is already scheduled to have cataract surgery performed will qualify for participation with the exception of the following exclusion criteria: Ongoing ocular inflammatory disease Bleb leakage - determined by Seidel test Suspected infection Known contraindications to use of any of these study medications. Pregnancy
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

| Intervention/Treatment |
| --- |
|Drug: Ofloxacin 0.3%|nan|
|Drug: Ciprofloxacin 0.3%|nan|
|Drug: Levofloxacin 0.5%|nan|
|Drug: Ofloxacin 400mg|nan|
|Drug: Ciprofloxacin 400mg|nan|
|Drug: Levofloxacin 250mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous levels of antibiotics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Aqueous absorption, Funtioning Filtering Blebs
Platelet Indices in Decompensated Post Hepatitic Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The aim of the present work is to study platelet indices ( platelet count - mean platelet volume - platelet distribution width ) as noninvasive predictors in decompensated post hepatitic liver cirrhosis .

Detailed Description
-----------------
Cirrhosis is an advanced liver disease characterized by fibrosis and alteration in hepatic architecture with the development of structurally anomalous nodules . Ascites is a condition in which pathological collection of fluid occurs within the peritoneal cavity mainly because of portal hypertension. It is a major complication of liver cirrhosis, The appearance of ascites in cirrhotic patients indicates a poor prognosis , Spontaneous bacterial peritonitis is a severe infection, commonly occurring in cirrhotic ascitic patients. Platelets are attributed to preserve hemostasis. Yet, recently, there has been growing recognition that they also play an essential role in inflammatory and immune response. Platelets release prothrombotic and proinflammatory agents and participate in the induction and advancement of vascular and inflammatory disorders . Larger-sized platelets contain many granules, and are therefore more efficient in their hemostatic and proinflammatory actions . This is why the mean platelet volume (MPV) and platelet distribution width (PDW) are worth considering as potential tests for platelet function and activation . The MPV and PWD can be calculated using almost all automated hematology analyzers. The MPV indicates the average platelet size in femtoliters. The PDW, reflecting homogeneity of platelet size, is calculated from the MPV by the equation (SD of platelet volume divided by MPV×100) or the distribution width at 20% frequency .

Official Title
-----------------
Platelet Indices ( Platelet Count - Mean Platelet Volume - Platelet Distribution Width ) in Decompensated Post Hepatitic Liver Cirrhosis

Conditions
-----------------
MPV, PDW

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post hepatitic liver cirrhotic patients Exclusion Criteria: renal failure patients pregnents diabetic patients patients with bone marrow disorders specially platelet disorders patient with other cause of liver cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| platelet indices ( platelet count - mean platelet volume - platelet distribution width ) in decompensated post hepatitic liver cirrhosis | The aim of the present work is to study platelet indices ( platelet count - mean platelet volume - platelet distribution width ) as noninvasive predictors in decompensated post hepatitic liver cirrhosis . | 3 years |
Knowledge Regarding Diagnosis of MIH Among Dental Interns in Faculty of Dentistry Cairo University

Study Overview
=================
Brief Summary
-----------------
assessment of knowledge of dental interns regarding diagnosis of MIH among Group of interns in faculty of dentistry Cairo university

Detailed Description
-----------------
The study will be done in faculty of dentistry Cairo university in form of survey with data being gathered via a questionnaire. The survey was conducted among the dental interns

Official Title
-----------------
Knowledge Regarding Diagnosis of Molar Incisor Hypomineralization Among Dental Interns in Faculty of Dentistry Cairo University

Conditions
-----------------
Molar Incisor Hypomineralization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any nationality both gender Exclusion Criteria: interns who refuse to participate
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 |
| --- | --- | --- |
| knowledge regarding diagnosis of MIH | questionnaire (yes or no and Multiple choice questions) | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MIH, knowledge , Molar Incisor Hypomineralization
Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents

Study Overview
=================
Brief Summary
-----------------
The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in AA is responsible for ethnic differences in insulin sensitivity and hypertension in AA and EA, as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D. Acronyms: African American (AA), European American (EA), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).

Official Title
-----------------
Serum 25-hydroxyvitamin D, Vascular Functioning, and Insulin Sensitivity in Adolescent Girls [The DIVA Study (Vitamin D, Insulin, and Vascular Associations)] (Pediatric Physician Training in Translational Research)

Conditions
-----------------
Insulin Sensitivity, Flow-mediated Dilation, Arterial Stiffness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American or Caucasian ethnicity Ages 14-18 yrs Healthy Exclusion Criteria: BMI-for age and -sex higher than 95th centile on the Centers for Disease Control and Prevention Growth Charts Use of medication(s) known to influence body composition, vascular function, or glucose metabolism Pregnancy Diabetes or any chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy adolescents<br>Healthy adolescent African American and Caucasian females, ages 14-18 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity |  | Cross sectional study: at the first study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular Function |  | Cross sectional study: at the second study visit, within 2 weeks of first study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin sensitivity, vascular function, flow-mediated dilation, arterial stiffness, ethnicity, adolescents, females, glucose tolerance, diabetes, hypertension, cardiovascular
Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

Study Overview
=================
Brief Summary
-----------------
This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.

Official Title
-----------------
Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light

Conditions
-----------------
Catheter-Related Infections

Intervention / Treatment
-----------------
* Device: Ultraviolet light emitting optical fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Have the ability to provide informed consent Have an implanted dialysis catheter of one of the following models: Medcomp Titan 15.5F x 24 cm or Medcomp Titan 15.5F x 28 cm Positive blood culture drawn from the catheter Exclusion Criteria: Previous inclusion in study Pregnant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultraviolet arm<br>This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber. | Device: Ultraviolet light emitting optical fiber<br>* A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.<br>* Other names: Lumenati Fiber;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter |  | Measured immediately after UV treatment | 
| Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter |  | Measured at study end, expected at 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters |  | Measured after UV treatment, with results expected in 5 days. | 
| Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage. |  | Measured at study end, expected at 1 year. |