linjc16/ctgov huggingface dataset:
Safety And Tolerability Study Of BID Titration Scheme With PF-05089771

Study Overview
=================
Brief Summary
-----------------
The most notable tolerability finding from these multiple dosing studies has been the occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this finding, the current four week study is designed to examine whether a slow titration regimen up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.

Official Title
-----------------
An Investigator And Subject Blinded, Sponsor Open, Randomized, Placebo Controlled, Multiple Dose Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-05089771 In Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: PF-05089771
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate Exclusion Criteria: Evidence or history of clinically significant hematological, renal (ie, recurrent nephrolitisis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). History of, or presence of allergic skin reactions or active skin disease (except for subjects with acne who may be included in the study) at the time of screening.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A - active treatment<br> | Drug: PF-05089771<br>* titration from 150mg BID to 450mg BID<br>|
| Placebo Comparator: Arm B - placebo<br> | Drug: Placebo<br>* matched placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) |  | 28 days | 
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) |  | 12h | 
| Maximum Observed Plasma Concentration (Cmax) |  | 12h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum Observed Plasma Trough Concentration (Cmin) |  | 12h post dose |
Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to show the frequency of endothelial dysfunction in patients suffering from ectatic coronary arteries as compared to those who have normal coronary arteries. Should this frequency be significant we would recommend initiating conventional treatment in those patients with ectatic coronary arteries as is the practice in patients with endothelial dysfunction without ectatic arteries

Official Title
-----------------
Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries

Conditions
-----------------
Coronary Artery Ectasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ectatic coronary arteries defined by cardiac catheterization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
the function of the endothelium of the arteries in patients suffering from ectatic coronary arteries
A Comparison Between The Analgesic Efficacy of Adductor Canal Block Alone and Adductor Canal With IPACK (Interspace Between Popliteal Artery and Capsule of the Knee) Block for Knee Surgeries

Study Overview
=================
Brief Summary
-----------------
A comparison between The analgesic efficacy of adductor canal block alone and adductor canal with IPACK (interspace between popliteal artery and capsule of the knee) block for knee surgeries

Official Title
-----------------
A Comparison Between The Analgesic Efficacy of Adductor Canal Block Alone and Adductor Canal With IPACK (Interspace Between Popliteal Artery and Capsule of the Knee) Block for Knee Surgeries

Conditions
-----------------
Nerve Blocks

Intervention / Treatment
-----------------
* Procedure: Adductor canal block and IPACK block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing knee surgery i.e. arthroscopy, total knee replacement, ACL repair. ASA physical status I to III Sex (males and females) Age 21-70 years. Exclusion Criteria: Hypersensitivity to local anesthetics. Preexisting peripheral neuropathy. Infection near site of infections e.g. osteomyelitis, septic knee joint. Etc. Patient refusal. PAny contraindications for spinal anesthesia. ( eg: coagulopathy, use of anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (adductor canal only)<br>Will recieve adductor canal block only | Procedure: Adductor canal block and IPACK block<br>* Peripheral nerve blocks<br>|
| Active Comparator: Group AB (adductor canal + IPACK)<br>Will recieve both adductor canal block and IPACK | Procedure: Adductor canal block and IPACK block<br>* Peripheral nerve blocks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of post operative pain | Using visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain) | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of movement and ambulation | the range of movement (ROM) by assessing the degree of knee extension one day after the surgery, and ambulation distance assessed by the number of steps walked by the patient three days after the surgery. | One year |
Cardiovascular Health Improvement Project

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.

Detailed Description
-----------------
The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls. The aims of the study are to collect biological specimens (blood, plasma, serum, aortic tissue) and family history; establish a biobank, establish a comprehensive database with information from consented patients, and provide researchers with high quality well annotated DNA samples with demographic and clinical information.

Official Title
-----------------
Cardiovascular Health Improvement Project

Conditions
-----------------
Aortic Aneurysm, Aortic Dissection, Bicuspid Aortic Valve (BAV), Heart Failure, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient over the age of 18 who is able/willing to give informed consent Patients <18 years of age with parental consent and assent (if assent is applicable for their age) Diagnosis of: aortic pathology potentially due to a known or suspected inherited condition Idiopathic aortic aneurysm Interesting of novel vascular pathology in the aorta or main branches Family history of aortic or vascular disease Other cardiovascular disease Healthy controls with no apparent cardiovascular disease Exclusion Criteria: - Not willing or able to sign the consent
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 |
| --- | --- |
| Aortic Disease<br>Patients with a diagnosis of any form of Aortic Disease | |
| Controls<br>Patients without a diagnosis of Aortic Disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishing a biobank of patients with Aortic Disease | Establish a biobank of blood, serum, plasma, tissue, and clinical data of patients with any form of aortic disease | 40 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aorta, Abdominal Aortic Aneurysm (AAA), Thoracic Aortic Aneurysm (TAA), Bicuspid Aortic Valve (BAV), Aortic Dissection
Influenza Vaccination in Patients Living With HIV in the Northern Region

Study Overview
=================
Brief Summary
-----------------
Anyone living with the Human Immunodeficiency Virus (HIV) has an indication for annual influenza vaccination. (Vaccination schedule and vaccination recommendations 2019). Influenza is a viral infection that has a significant impact on the health care system. However, vaccination coverage in France is still insufficient with regard to the objectives set at 75% by the WHO and the European Commission. For the 2019-2020 seasonal influenza vaccination campaign, flu vaccination by volunteer pharmacists has become possible throughout the country. Studies that have estimated vaccination coverage among HIV-positive populations are rare and show very low rates.

Detailed Description
-----------------
Cross-sectional study via a self-questionnaire given to all HIV-infected patients coming for a scheduled consultation as part of their HIV follow-up in the spring of 2020. Non-opposition letter given to the patient. Collection of data a posteriori from the medical file recorded in the eNadis patient file.

Official Title
-----------------
Influenza Vaccination in Patients Living With HIV in the Northern Region: An Observational Monocentre Study of Blankets, Modalities, Drivers and Brakes

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult person living with HIV presenting for a follow-up consultation in the spring of 2020 People who do not read French may participate if they wish with the help of a medical or paramedical staff member. Patient did not object Exclusion Criteria: Minor patients Major under guardianship, curatorship, protected person

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 |
| --- | --- | --- |
| questionnaire influenza vaccine coverage | The objective of this questionnaire is to estimate the influenza vaccine coverage among PVVIH followed at the Tourcoing Hospital Center. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modalities of influenza vaccination | To identify the modalities of influenza vaccination when it is carried out | through study completion, an average of 1 year | 
| the drivers and disincentives to influenza vaccination | Estimate from patient reports the drivers and disincentives to influenza vaccination in a specific risk population. | through study completion, an average of 1 year |
Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)

Study Overview
=================
Brief Summary
-----------------
This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.

Official Title
-----------------
Accelerated Partial Breast Irradiation (PBI) With Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 50 years old Low to intermediate DCIS Tumor size < or = to 2cm Exclusion Criteria: BRCA positive Lobular histology Angiolymphatic invasion

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SBRT<br>Patients treated with Stereotactic Body Radiation Therapy (SBRT) | Radiation: Radiation Therapy<br>* Either SBRT or IMRT radiation therapy<br>|
| IMRT<br>Patients treated with Intensity Modulated Radiation Therapy (IMRT) | Radiation: Radiation Therapy<br>* Either SBRT or IMRT radiation therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0. | Toxicity will be assessed using the CTCAEv4.0 and recorded. | Through study completion, an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ipsilateral breast recurrence | Number of participants with pathologically confirmed ipsilateral breast recurrence. | Through study completion, an average of 12 months |
Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.

Official Title
-----------------
Antiviral Efficacy of Continuing Lamivudine Plus Adefovir or Switching to Telbivudine Plus Adefovir in HBeAg-positive Lamivudine-refractory Chronic Hepatitis B Patients Who Have Suboptimal Response to Lamivudine Plus Adefovir for at Least 12 Months

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: telbivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBeAg positive lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients HBV DNA over 300 copies/ml Exclusion Criteria: decompensated cirrhosis renal failure prior interferon usage evidence of HCC or prior organ transplantation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: telbivudine|600mg, oral daily over 12 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, virologic breakthrough and biochemical response |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lamivudine, telbivudine, adefovir, lamivudine resistance
PECS Block in Breast Surgery: an Observational Multicenter Study

Study Overview
=================
Brief Summary
-----------------
We will enroll patients submitted to breast surgery (in and outsettings) with regional anesthesia. The blinded observers, in the first 48 hours post-operative, will evaluate (telephone interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10 = worst possible pain) thereby recording the treatment procedures in accordance with usual clinical practice. At the same time we will evaluate the presence of intraoperative or postoperative complications related to regional anesthesia, the PONV rate (post-operative nausea and vomiting) and the analgesic/antiemetic therapy.

Official Title
-----------------
PECS Block in Breast Surgery: an Observational Multicenter Study

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Other: regional anesthesia in breast surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II-III Patients Written Informed Consent Exclusion Criteria: ASA IV Active Heart Failure Coagulation Disease Chronic Pain Allergies to Local Anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: regional anesthesia in breast surgery|In the Hospitals involved in this study are performed routinely wall blocks (PECS I-II blocks and serratus block) during breast surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Misure |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications Regional Anesthesia Related |  | 1 days | 
| PostOperative Nausea Rate |  | 2 days | 
| Intraoperative Opioids Use |  | surgical time | 
| Postoperative Analgesics |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast surgery
Effect of the Involvement of a Medical Clown on the Labor Experience

Study Overview
=================
Brief Summary
-----------------
The experience of labor for a woman can be rewarding but can be traumatic. Medical clowning may alleviate the potential for trauma.

Detailed Description
-----------------
The investigators plan to administer questionnaires to women who will agree to host a clown during their labor and to compare the feedback to those from women who did not.

Official Title
-----------------
Effect of the Involvement of a Medical Clown on the Labor Experience

Conditions
-----------------
Affective Symptoms

Intervention / Treatment
-----------------
* Other: clown
* Other: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy, Older than 18 years, Younger than 40 years, uncomplicated pregnancy Exclusion Criteria: Pregnancy complicated by PET, premature contractions Muktiple pregnancy, Older than 40 years, Younger than 18 years

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Medical clown | Other: clown<br>* A medical clown will be offerred to the parturient and will spend time with her during labor as long as she will want it<br>|
| Sham Comparator: No Intervention<br>No clown in the room | Other: Sham<br>* No clown will be present in the room during labor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and satisfaction after labor | Women will answer questionairs which will be summarized and analyzed | the day after delivery |