linjc16/ctgov huggingface dataset:
Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.

Official Title
-----------------
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of The 240 mg Formulation Of Neratinib In Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Neratinib
* Drug: Neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women of nonchildbearing potential, age 18 to 50 years. Exclusion Criteria: Any previous or current clinically significant medical condition or disease.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Neratinib Fasted | Drug: Neratinib<br>* 240-mg oral tablet; single dose under fasted conditions<br>* Other names: HKI-272;|
| Experimental: 2<br>Neratinib Fed | Drug: Neratinib<br>* 240-mg oral tablet; single dose with high-fat breakfast<br>* Other names: HKI-272;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2 |  | 6 weeks |
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to evaluate the effect of arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method.

Detailed Description
-----------------
.28 volunteer participants will be assigned in this study. Participants will be randomly divided into two groups(n=14) according to type of toothpaste D where groups D1 patient will use arginine containing toothpaste while groups D2 the patient will used the fluoride toothpaste with a number of 14 patients in each group. The pH will be evaluated according to time in relation to the brushing with toothpaste (T) where (T0) represent salivary pH before brushing with toothpaste , (T1) represent salivary pH 10 minutes after brushing with toothpaste at fixed time of the day.

Official Title
-----------------
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid Using Chair Side(Potential of Hydrogen) pH Meter Assessment Method in Adult Population: Randomized Clinical Trial

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

Intervention / Treatment
-----------------
* Drug: arginine toothpaste
* Drug: fluoride toothpaste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants should be over 18 years of age. Systematically healthy. Not taking any medication interfering with saliva secretion. Participants who signed informed consent. Exclusion Criteria: Participants with a compromised medical history. Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth. Severe or active periodontal disease. History of allergies or other adverse reactions to arginine, or oral care product or their ingredient.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arginine toothpaste<br> | Drug: arginine toothpaste<br>* acid neutralizer toothpaste<br>|
| Active Comparator: fluoride toothpaste<br> | Drug: fluoride toothpaste<br>* bactericidal toothpaste<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary pH | Salivary pH will be determined by use of a digital pH meter .All salivary pH values will be taken immediately following salivary collection at chairside. The salivary pH values measured before usage of toothpaste termed resting pH, while the salivary pH values measured after usage of toothpaste termed terminal pH. | 10 minutes after intervention and control |
Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the gold standard FDG-PET.

Detailed Description
-----------------
The first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of FLT-PET. In this study, 35 patients will be selected to undergoing imaging with both FLT and FDG PET.

Official Title
-----------------
Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgknin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Procedure: FLT-PET scan
* Procedure: FDG-PET scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Women must not be pregnant or breast feeding Histologic diagnosis of non-Hodgkin's lymphoma (any stage) Must undergo treatment with chemotherapy and/or radiotherapy Exclusion Criteria: May not have received previous therapy with radiopharmaceuticals May not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies

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>FLT-PET Scan | Procedure: FLT-PET scan<br>* imaging scan<br>|
| 2<br>FDG-PET Scan | Procedure: FDG-PET scan<br>* imaging scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staging and ReStaging scans |  | after hematopoetic recovery |
Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).

Official Title
-----------------
Epidemiological Study to Evaluate the Prevalence of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV) Exclusion Criteria: Mixed histology of small cell and non-small cell lung cancer

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 |
| --- | --- | --- |
| To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate EGFR mutation status with clinico-pathological characteristics. The study will aim to determine the prevalence of EGFR M+ lung cancers in patients with clinico-pathological characteristics not commonly associated with EGFR mutation positivity |  |  | 
| To describe different EGFR mutation methods used in Spain and testing turn around time associated |  |  | 
| To determine the % of confirmed stage IIIB/IV NSCLC patients who cannot be tested for EGFR mutation and the reasons for not testing (% of EGFR Mnt) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR mutation, Non-small cell lung carcinoma, Spain, Evaluate the prevalence of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC
Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia

Study Overview
=================
Brief Summary
-----------------
Thalidomide is known to have hypnosedative, immuno-modulatory and anti-angiogenic effects. The drug is widely used in several neoplastic disorders (e.g. multiple myeloma and malignant melanoma), inflammatory conditions (e.g. Crohn's disease) and skin disorders (e.g. leprosy). Thalidomide has been successfully used in adult thalassemia patients. The current study explores its role in transfusion-dependent thalassemia patients.

Official Title
-----------------
Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia Patients of Pakistan

Conditions
-----------------
Thalassemia

Intervention / Treatment
-----------------
* Drug: Thalidomide and Hydroxyurea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transfusion dependent thalassemia patients refractory to Hydroxyurea Exclusion Criteria: Those with active systemic comorbidity, with past personal or family history of thrombophilia, recent fracture or recent major surgery

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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: Thalidomide in combination with hydroxyurea<br>All the study patients refractory to hydroxyurea will be given thalidomide at an average dose of 2mg/kg/day (range 1-4mg/kg/day). Participants will also be continued on hydroxyurea at a dose of 10-20 mg/kg/day. | Drug: Thalidomide and Hydroxyurea<br>* Dosage: Thalidomide 1-4mg/kg/day, Hydroxyurea 10-20mg/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin Level | mg/dL | 6-24 months | 
| Response Rate (Excellent, Good, Partial and No response) |  | 6-24 months | 
| Adverse Effects |  | 6-24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thalidomide, Thalassemia
Orthodontic Retention In France - ORIF

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Similar studies have been driven in others European countries (such as Swiss, the Netherlands, Lithuania and Norway), but not in France.

Detailed Description
-----------------
Questionnaire aggregating 27 questions on orthodontic retention strategies, was sent to a professional list of French orthodontists from health authorities. The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.

Official Title
-----------------
Epidemiologic Study of Orthodontic Retention Practices in France

Conditions
-----------------
Orthodontic Retention Procedures

Intervention / Treatment
-----------------
* Other: Orthodontic retention procedures survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All French Specialist orthodontists trained in France who answer the survey Exclusion Criteria: Non-specialist orthodontists, not trained in France

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

| Intervention/Treatment |
| --- |
|Other: Orthodontic retention procedures survey|The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of technics | Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines. | Day0 = Response to the Suvey | 
| Description of materials | Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines. | Day0 = Response to the Suvey | 
| Description of retention strategies used by clinicians. | Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines. | Day0 = Response to the Suvey |
Serial BNP Testing for Heart Failure Management

Study Overview
=================
Brief Summary
-----------------
The scope of the USE-BNP Trial is to investigate whether knowledge of BNP measurements, in conjunction with clinical assessment, in the outpatient setting can guide the management of therapy in patients with heart failure.

Official Title
-----------------
Utilizing, Studying, Evaluating BNP for Monitoring in Patients With Heart Failure (USE-BNP)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: BNP assay (Siemens ADVIA Centaur BNP)
* Other: hidden BNP value


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible subjects must be diagnosed with heart failure and have an abnormal BNP reading.

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 |
| --- | --- |
| BNP Open<br>Subjects treated based on clinical assessment and knowledge of BNP values | Device: BNP assay (Siemens ADVIA Centaur BNP)<br>* Diagnostic test<br>* Other names: Siemens ADVIA Centaur BNP;|
| Control<br>Subjects treated based on clinical assessment alone | Other: hidden BNP value<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite endpoint of all cause mortality, hospitalization due to worsening heart failure and administration of IV drug therapy for worsening heart failure. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA classifications in the two treatment groups |  | 12 months | 
| Quality of life assessments of two treatment groups |  | 12 months | 
| change in therapy based on BNP usage |  | 12 months | 
| number of serious adverse events for the two groups |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, BNP, natriuretic peptide
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old

Study Overview
=================
Brief Summary
-----------------
Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to quantify for planning early intervention to attenuate both functional and occupational disabilities due to cognitive impairment.

Official Title
-----------------
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.

Conditions
-----------------
Memory Impairment, HIV/AIDS, Cognitive Impairment

Intervention / Treatment
-----------------
* Other: assessment of cognitive impairment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Personal or familial cognitive complaints Individual aged ≥ 65 years old and < 81 years old Instrumental activities of daily living (IADL) score between 3-4 French speaking individual Informed consent signed For PLHIV HIV infection Undetectable HIV viral load ≥ 1 year Current cluster of differentiation (CD4) cell count > 100/mm3 For controls negative HIV serology ≤ 6 months Exclusion Criteria: Opportunistic infection < 5 years Contraindications to MRI

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| people living with HIV<br>subjects infected with HIV and with cognitive complaints | Other: assessment of cognitive impairment<br>* Measure of Global Deficit Score<br>|
| control subjects<br>subjects not infected with HIV and with cognitive complaints | Other: assessment of cognitive impairment<br>* Measure of Global Deficit Score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive impairment | cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains | baseline |
Study to Develop a Breath Analyser to Detect Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Measure trimethylamine oxide in the breath.

Detailed Description
-----------------
Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients with kidney disease, and volatile compounds such as TMAO can be detected in the breath. The investigators wish to develop a breath analyser to measure volatile compounds, such as TMAO in the breath in patients with kidney disease.

Official Title
-----------------
Pilot Study to Develop a Breath Analyser to Detect Chronic Kidney Disease

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: breath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with kidney disease under the care of Royal Free Hospital Exclusion Criteria: patients unable to provide informed consent patients unable to exhale into breath analyser

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| patients on dialysis<br>patients with kidney disease treated by dialysis | Diagnostic Test: breath<br>* measurement of volatile compounds, such as TMAO in exhaled breath and blood<br>* Other names: blood sample;|
| patients with chronic kidney disease<br>patients with chronic kidney disease not treated by dialysis | Diagnostic Test: breath<br>* measurement of volatile compounds, such as TMAO in exhaled breath and blood<br>* Other names: blood sample;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of breath TMAO | measurement of breath TMAO by breath analyser | 3 years |
Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.

Detailed Description
-----------------
The Vaporox VHT1 study is a single arm study evaluating the efficacy of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000), as an adjunctive therapy for the treatment of chronic foot ulcers.

Official Title
-----------------
Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds

Conditions
-----------------
Neuropathic Foot Ulcer, Foot Ulcer

Intervention / Treatment
-----------------
* Device: Vaporous Hyperoxia Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers University of Texas Health Science Center classification: Grade 0, 1, and 2 Exclusion Criteria: Ulcers above the medial and lateral malleoli Etiology of cancer/neoplastic Etiology of collagen vascular disease Etiology of gangrene Etiology of osteomyelitis (Grade 3) Etiology of thermal burns Etiology of radiation injury Pregnancy Acute skin conditions Inadequate perfusion to support treatment Wounds where the end cannot be probed Wounds covered with petroleum based dressing Non-compliant patients

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: VHT treatment<br>Patients will be treated with VHT for 1 hour four times per week | Device: Vaporous Hyperoxia Therapy<br>* 1 hour of treatment, 4 times per week<br>* Other names: WTS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing rate at 12 weeks | The percent of subjects that achieved wound healing at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to wound healing | Time to achieve complete wound healing | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic foot, leg ulcer, skin ulcer