linjc16/ctgov huggingface dataset:
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.

Official Title
-----------------
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial

Conditions
-----------------
Actinic Cheilitis, Leukoplakia, Erythroplakia

Intervention / Treatment
-----------------
* Drug: Metil 5-aminolevulinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis with histopathological confirmation of actinic cheilitis Patients will be requested to respect the timeframe of clinical consultations No treatment for actinic cheilitis in the last 3 months Exclusion Criteria: Histopathological diagnosis of squamous cell carcinoma (SCC) Patient presenting any type of immunosupression Recurrent crust of the lip vermilion (high risk of SCC)

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: Metil 5-aminolevulinate arm<br>Metil 5-aminolevulinate arm with photo activation. | Drug: Metil 5-aminolevulinate<br>* Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.<br>|
| Placebo Comparator: Placebo arm<br>Placebo (without metil 5-aminolevulinate) arm with photo activation. | Drug: Metil 5-aminolevulinate<br>* Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clinical response | Expected complete clinical response in 60% of cases | 18 months | 
| Histological cure | Expected histological cure in 40% of cases | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IHC analysis | Expression of immunohistochemical markers of cancer progression | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDT, Actinic Cheilitis, Phase 2 Clinical Trial
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.

Official Title
-----------------
A Phase 2, Multiple-Dose Study of The Efficacy and Safety of Wafermine™ (Sublingual Ketamine) in Participants Experiencing Acute Post-Operative Bunionectomy or Abdominoplasty Pain

Conditions
-----------------
Acute Pain, Bunion, Abdominoplasty

Intervention / Treatment
-----------------
* Drug: Wafermine™ 50 mg
* Drug: Wafermine™ 75 mg
* Drug: Placebos
* Drug: Wafermine™ 25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator. Exclusion Criteria: For those undergoing bunionectomy, other painful conditions involving the surgical foot. Positive lab values for Hepatitis B or C or HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Wafermine™<br> | Drug: Wafermine™ 50 mg<br>* Administered as needed for 12 hours<br>Drug: Wafermine™ 75 mg<br>* Administered as needed for 12 hours<br>Drug: Wafermine™ 25 mg<br>* Administered as needed for 12 hours<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebos<br>* Administered as needed for 12 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale |  | 12 hours |
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

Study Overview
=================
Brief Summary
-----------------
The main objectives of the study are to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of healthy subjects and clinically different asthma patients, based on a non-invasive procedure of sputum induction. Patients will be different in function of age, in relation to the trigger (eg aspirin, without or with association with polyposis), without or with underlying atopic sensitization or different in the type of underlying inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis of molecular phenotyping in the patients. to study the usefulness of asthma molecular phenotyping (by following the balance between the inflammatory markers on the one hand and the regulatory markers on the other hand) in asthma guidance (longitudinally). The final goal of this project is then to develop a sputum non-invasive biomarker array that can be used to distinguish the different inflammatory asthma phenotypes and that can predict steroid resistance and/or sensitivity to other anti-inflammatory medication, using a non-invasive technique that can be used also at young age and repetitively.

Official Title
-----------------
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

Conditions
-----------------
Asthma Patients, Healthy Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asthma diagnosis Exclusion Criteria: viral/bacterial/fungal infection with fever (<1 month ) other airway diseases (CF, ciliar dyskinesia, bronchiectasis) asthma exacerbation (<3 months)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 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 |
| --- | --- |
| Asthma patients<br>Asthmatics of all classes of severity will be included. | |
| Healthy control population<br>A healthy control population will be included to compare with the asthmatics. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum cytokine mRNA |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function parameters |  | one year | 
| asthma symptom scores |  | one year | 
| non-invasive measurements of airway inflammation |  | one year |
Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Serum antibody titre against COVID-19 spike protein will be measured before, after the first dose, and after the second dose (when applicable) in cancer patients who are receiving or received anti-cancer drugs. Side effects of vaccination and actual incidence of COVID-19 will be monitored.

Official Title
-----------------
Immunogenicity and Safety of COVID-19 Vaccine in Cancer Patients

Conditions
-----------------
Cancer, Covid19

Intervention / Treatment
-----------------
* Drug: COVID-19 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years of age or older Patients who are receiving or received anti-cancer drugs Those who are not vaccinated against COVID-19 at the time of enrollment Written informed consent Exclusion Criteria: Any contraindications to COVID-19 vaccines Those who were already vaccinated Those who are on immunosuppressants or infected with HIV Those who underwent organ transplantation Active infections (for example, pneumonia)

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

| Intervention/Treatment |
| --- |
|Drug: COVID-19 vaccine|Subjects will be vaccinated with COVID-19 vaccines approved in Korea. Data on specific vaccines will be gathered.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titre after vaccination | Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG) | 21-28 days after completion of vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titer according to chemotherapy cycle, side effects, and use of corticosteroids or antipyretics | Antibody titre as measured by Anti-SARS-CoV-2 ELISA (IgG) | 21-28 days after completion of vaccination | 
| Incidence of COVID-19 infection | Incidence of actual COVID-19 infection | 6 months after completion of vaccination |
Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

Study Overview
=================
Brief Summary
-----------------
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome. The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.

Official Title
-----------------
Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

Conditions
-----------------
End-stage Heart Failure

Intervention / Treatment
-----------------
* Device: ventricular assist device implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old Who gave his consent to the study With an end-stage heart-failure Under surgery for a ventricular assist device implantation Scheduled or in emergency Exclusion Criteria: Preoperative anemia less than 7 g/dL Subject under the protection of justice Subject under guardianship or curatorship Pregnancy Breastfeeding

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 |
| --- |
|Device: ventricular assist device implantation|Blood sampling in patients under surgery for ventricular assist device implantation at five time points: After anesthetic induction Before starting the device 2h, 6h and 48h after starting the device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Von Willebrand Factor activity | Change of Von Willebrand Factor from Baseline to 48 hours | From Baseline to 48 hours |
Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy

Study Overview
=================
Brief Summary
-----------------
A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.

Official Title
-----------------
A Prospective, Open-Label, Single-Arm, Single-Site, Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy.

Conditions
-----------------
Breast Cancer Screening, MRI Guided Breast Biopsy, Breast Cancer Diagnosis

Intervention / Treatment
-----------------
* Device: IPBS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging. Individuals Capable of giving a free and informed consent. Exclusion Criteria: Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.). Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion. Patients who are not suitable for the procedure will be excluded at the investigators discretion. Patients unwilling to complete associated study questionnaires or follow up visits. Women who are pregnant or who plan to become pregnant within the study duration.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPBS<br> | Device: IPBS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images. |  | Day 1 |
Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to observe whether a brushless cleaning device can be equally as effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people an alternative to bristle brush cleaning if they find they are brushing too hard. The hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless methods in conjunction with flossing.

Official Title
-----------------
Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth

Conditions
-----------------
Plaque Control

Intervention / Treatment
-----------------
* Device: Peri Clean


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 yrs of age healthy gingiva Exclusion Criteria: less than 18 yrs old patients with braces decisionally impaired

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tooth brush<br>Periclean is a soft rubber gentle toothbrush | Device: Peri Clean<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silness Gingival index | using a periodontal probe gently between the tooth and gum | June 2013 |
Adaptive Servo-ventilation Monitoring Study

Study Overview
=================
Brief Summary
-----------------
Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients. This is an observational study to document changes in respiratory parameters in HF patients using ASV for a period of 12 months.

Official Title
-----------------
Feasibilty of Respiratory Monitoring With Adaptive Servoventilation (PaceWave™) to Predict Worsening of Heart Failure in Patients With Severe Heart Failure and Sleep-disordered Breathing

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years old Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines NYHA Class III or IV at the time of inclusion with at least one hospitalization for heart failure in the last 12 months Moderate to severe sleep apnea (AHI ≥ 15/hour). Already using or willing to use ASV-therapy and able to tolerate the mask treatment Exclusion Criteria: Planned or scheduled heart valve interventions and/or CABG Untreated or therapy refractory Restless Leg Syndrome Patients for whom the use of positive airway pressure therapy may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Heart Failure patients using ASV<br>Patients with chronic heart failure who are using or willing to use adaptive servo ventilation (ASV) therapy will be enrolled. Respiratory data will be collected from this group every 3 months over a 12 month period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure | Hypoxemia, as measured by pulse oximetery will be compared with heart failure status to measure if a correlation exists between hypoxemia and deterioration of heart failure | 12 months |
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.

Conditions
-----------------
Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: T2345
* Drug: Prostaglandin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated bilateral newly diagnosed patients with primary open angle glaucoma Exclusion Criteria: Any ocular hypertension other than chronic open angle glaucoma

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prostaglandin<br>One drop. | Drug: Prostaglandin<br>* One drop at 8.00pm.<br>|
| Experimental: T2345<br>One drop | Drug: T2345<br>* One drop at 8.00pm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intra Ocular Pressure (IOP) at 8.00am | Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered. | Day 42 and Day 84 (8.00am for the IOP) |