linjc16/ctgov huggingface dataset:
Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New LDL-C Target Goal

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.

Official Title
-----------------
REALISTIC: Protocol for an Observational Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New EAS LDL-C Target Goal

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk patients High doses of other statins LDL-C known, starts with Crestor 10 mg Permission to use patient data by AstraZeneca (AZ)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High risk patients, Crestor, Rosuvastatin, LDL cholesterol, observational
Monitoring Patients With Uncontrolled Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate patients with uncontrolled seizures. Seizures can be associated with and monitored by abnormal electrical activity in the brain. In this study researchers will use video-electroencephalography (EEG) to monitor patients with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The video-EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur. In addition to monitoring electrical activity of the brain, researchers will take frequent antiepileptic drug blood levels. These measures will allow researchers to learn more about how each drug is absorbed and metabolized in the body. The information collected in the study will be used to place patients into other scientific studies testing new therapies for epilepsy.

Detailed Description
-----------------
In this study we will use standard clinical studies, including simultaneous Video-EEG monitoring, to evaluate patients referred for uncontrolled or suspected seizures. The protocol will be used to screen patients for inclusion in other protocols, follow the natural history of seizure disorders, and train fellows in the evaluation and treatment of epilepsy. Both inpatients and outpatients will be studied.

Official Title
-----------------
Monitoring of Seizures, EEG and Serum Antiepileptic Drug Concentrations in Patients With Uncontrolled Epilepsy

Conditions
-----------------
Epilepsy, Seizures

Participation Criteria
=================
Eligibility Criteria
-----------------
History of uncontrolled seizures, at the present time, at least during 6 months of the past 3 years, and preferably a continuous pattern of seizures during the few months prior to admission. Seizure frequency, by history, must be sufficient to make video monitoring effective. Priority will be given to patients whose seizures occur once or more per day. Patients of any age may be accepted. Patients (and parents or guardians, if applicable) must express willingness to cooperate with the entire protocol, to be willing to undergo further diagnostic tests if needed, and to return for follow up evaluation at intervals as needed.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anticonvulsants, Intensive Monitoring, Epilepsy
Study of Celecoxib Bioavailability in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To evaluate the bioavailability of celecoxib administered as capsule contents sprinkled onto applesauce relative to intact capsule

Official Title
-----------------
A Relative Bioavailability Study Of Celecoxib Administered As Capsule Contents Sprinkled On Applesauce In Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects Exclusion Criteria: Standard criteria for healthy volunteer studies

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability of celecoxib administered as capsule contents sprinkled onto applesauce relative intact capsule after a single dose |  |  |
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

Study Overview
=================
Brief Summary
-----------------
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

Detailed Description
-----------------
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Official Title
-----------------
An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Drug: Glycopyrronium Topical Wipes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance Male or females Exclusion Criteria: Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 9 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: Glycopyrronium<br>Glycopyrronium Topical Wipes | Drug: Glycopyrronium Topical Wipes<br>* Glycopyrronium Topical Wipes<br>* Other names: DRM04;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Safety Assessed Through Adverse Events and Local Skin Reactions | The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug. | Day 1 - Week 44 |
Satavaptan Dose-Ranging Study in the Prevention of Ascites

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

Official Title
-----------------
Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

Conditions
-----------------
Ascites, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: satavaptan (SR121463B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months 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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: satavaptan (SR121463B)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to repeat therapeutic paracentesis |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in ascites judged by body weight and ascites volume |  | within 12 weeks | 
| frequency of paracentesis |  | 12 weeks | 
| quality of life |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhotic ascites
Vagal Nerve Stimulation for Post COVID Fatigue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.

Detailed Description
-----------------
Patients, after consenting, will perform questionnaires, have a blood samples taken, and undergo PET/CT scans of the brain. Patients will then be randomized to either receive vagal nerve stimulation, or continue standard clinical care. For those randomized to receive treatment, they will be given a device and asked to follow a specific regimen daily for 12 weeks.

Official Title
-----------------
Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study

Conditions
-----------------
Post COVID Syndrome, Fatigue, Headache

Intervention / Treatment
-----------------
* Device: vagal nerve stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of fatigue and post exertional malaise. Presence of headache Clinical diagnosis of post COVID syndrome. They have consented to participate in the study They have the ability to participate in all aspects of the study. Exclusion Criteria: Pregnant. Prior adverse reaction to 14FDG. Active implantable medical device e.g. pacemaker, hearing aid implant Metallic device e.g. stent, orthopedic hardware in neck Using another electronic device at the same time e.g. TENS, mobile phone. Any other condition deemed exclusionary by the study principal investigator

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VNS Treatment<br>Subjects with post COVID syndrome with fatigue and headache will have vagal nerve stimulator applied to the neck for 2 minute intervals with two sets administered three times daily | Device: vagal nerve stimulator<br>* Non-invasive vagus nerve stimulator<br>|
| No Intervention: Non-VNS Treatment<br>Subjects with post COVID syndrome with fatigue and headache will receive current standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-COVID Functional Status Score | Measurement is the change in scoring determined through patients self-reported Post-COVID Functional Status Score survey that assesses COVID-19 symptom impact on a grading scale of 0= no limitations to 4= severe limitations. | Baseline to 12 weeks |
A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.

Study Overview
=================
Brief Summary
-----------------
Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who have failed selected other therapies.

Official Title
-----------------
A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: SU011248


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anthracycline and taxane-refractory or intolerant metastatic breast cancer Female Exclusion Criteria: Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines/taxanes.

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: SU011248|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-tumor efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control survival safety pharmacokinetics |  |  |
Inguinal Hernia Study Using Biodesign IHM

Study Overview
=================
Brief Summary
-----------------
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.

Official Title
-----------------
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Device: Biodesign IHM
* Device: Polypropylene mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Diagnosis of Unilateral inguinal hernia repair Able to provide written consent Exclusion Criteria: Incarcerated hernia Allergic or religious beliefs that disallow porcine material Previous hernia repair on the designated hernia site Class IV or V anesthesia requirements Bowel obstruction Peritonitis Life expectancy < 3 years

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: 1<br>Biodesign IHM Graft placement | Device: Biodesign IHM<br>* Biodesign IHM is placed to reinforce the hernia repair<br>* Other names: SurgiSIS IHM;|
| Active Comparator: 2<br>Polypropylene mesh placement | Device: Polypropylene mesh<br>* Polypropylene mesh is used to reinforce the hernia repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Inguinal Hernia Recurrence |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, polypropylene, Biodesign IHM, lichtenstein
Assessment of Spread of Transversus Abdominis Plane Block

Study Overview
=================
Brief Summary
-----------------
For the purpose of assessing the spread of the local anaesthetic after injecting it between abdominal muscles on both sides, the investigators will test if the patient can feel a change in the perception of cold and warm, as well as being pricked with a blunt needle. The investigators will also take several blood samples, together with routine samples, to measure the concentration of the local anesthetic in the blood.

Official Title
-----------------
Assessment of Spread of Transversus Abdominis Plane Block After Administration of 20 ml Ropivacaine 0,5% Bilaterally

Conditions
-----------------
Transversus Abdominis Plane Block

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0,5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergo abdominal surgery, eligible for TAP block, over 18, BMI 20-40 Exclusion Criteria: does not speak danish, does not consent, does not fulfill inclusion criteria

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAP block<br>Patients before undergoing laparoscopic or other abdominal surgery | Drug: Ropivacaine 0,5%<br>* Injection of ropivacaine 0,5% 20 ml bilaterally before surgery<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
-----------------
Transversus Abdominis Plane Block
Comparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PET/CT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors.

Detailed Description
-----------------
5 healthy volunteers with whole body 99mTc-FAPI quantitative SPECT/CT scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software. Forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mTc-FAPI quantitative SPECT/CT scans will be performed on the first day, and whole body 68Ga-FAPI PET/CT scans will be performed on the next day.According to the scans results of the two agents, with SUVmax and SUVmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.

Official Title
-----------------
Comparative Study of 99mTc-FAPI Quantitative SPECT/CT and 68Ga-FAPI PET/CT in Clinical Diagnosis and Staging of Gastrointestinal Tumors

Conditions
-----------------
99mTc-FAPI-positive Gastrointestinal Tumor

Intervention / Treatment
-----------------
* Diagnostic Test: 99mTc-FAPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with gastrointestinal tumors: diagnosed by pathological needle biopsy Exclusion Criteria: refuse or cannot endure surgery pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 99mTc-FAPI|inject the tracer to subjects and perform SPECT/CT scans|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV of primary and metastases lesions | The standardized uptake values (SUV) in deferent organs and lesions | 2 hours after injection |