linjc16/ctgov huggingface dataset:
Metabolic Abnormalities in Children With Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study is designed to use positron emission tomography to measure brain energy use. Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Researchers can label a sugar with a small radioactive molecule called FDG (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG and show the areas of the brain that are active. By using this technique researchers hope to answer the following questions; 4. Are changes in brain energy use (metabolism) present early in the course of epilepsy 5. Do changes in brain metabolism match the severity of patient's seizures 6. Do changes in metabolism occur over time or in response to drug therapy

Detailed Description
-----------------
We propose to study children with recent onset partial epilepsy, cryptogenic infantile spasms, and idiopathic Lennox-Gastaut Syndrome with serial FDG-PET to elucidate the natural history and evolution of metabolic abnormalities associated with such epilepsies. The severity of the seizure disorder, and cognitive impairment, when present, will be correlated with the presence and extent of focal and global cerebral metabolic abnormalities.

Official Title
-----------------
Natural History of Metabolic Abnormalities in Children With Epilepsy

Conditions
-----------------
Generalized Epilepsy, Infantile Spasms, Metabolic Disease, Partial Epilepsy, Seizures

Intervention / Treatment
-----------------
* Drug: 18 FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected. EXCLUSION CRITERIA: Evidence of a structural lesion as cause for epilepsy. Degenerative or metabolic disease. Inability to comply with the protocol.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 18 FDG|nan|

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
-----------------
Metabolism, Positron, Tomography, Seizures, Epileptic Focus, Electroencephalography, Glucose, Cerebral, Positron Emission Tomography, Lennox Gastaut Syndrome
Impact of OCT Imaging on Decision Making During PCI in ACS Patients

Study Overview
=================
Brief Summary
-----------------
Optical coherence tomography (OCT) provides valuable information to guide percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation, stent sizing, and stent optimization.

Detailed Description
-----------------
OCT can be used in acute coronary syndrome (ACS). ACS has more complex culprit lesion morphologies and larger extent of coronary atherosclerosis compared with stable coronary artery disease. The detailed vascular information obtained by OCT may impact PCI in ACS, and which may improve acute results and late outcomes of PCI. Stent expansion immediately after PCI is a strong predictor of late outcomes of PCI, and it is associated with late clinical outcomes in many previous trials.

Official Title
-----------------
Impact of Optical Coherence Tomography Imaging on Decision-making During Percutaneous Coronary Intervention in Patients Presented With Acute Coronary Syndromes

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Device: OCT-guided PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presented with acute coronary syndrome. PCI was done to them with stent implantation. Exclusion Criteria: Multivessel PCI at the index procedure. Patients with ACS due to graft failure post CABG. Patients treated with no stent implantation.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| OCT-guided PCI<br>PCI procedure was done with intra-coronary imaging OCT. | Device: OCT-guided PCI<br>* using optical coherence tomography imaging to help PCI procedure<br>|
| Angiography-guided PCI<br>PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent difference in lumen expansion in stent treated lesion | Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups. | Immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes at 1 year follow up | Cardiac death, MI, clinical-driven target-lesion revascularization (TLR), and stroke | During 1 year following the index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT, stent implantation
Pain Quality Study

Study Overview
=================
Brief Summary
-----------------
One way to better understand how various treatments for pain differ is to determine the effects of these treatments on different pain qualities or characteristics. For example, pain can be described as hot, electrical, cold, achy, and piercing. In order to determine which pain quality/qualities that a pain treatment affects, researchers must develop measures of these pain qualities or characteristics. The purpose of this study is to learn more about the different pain qualities individuals who have low back pain, headaches and fibromyalgia experience. Identifying the common qualities of pain experienced by these groups will help researchers evaluate and develop more comprehensive pain quality measures, which will ultimately help them to be able to test the effectiveness of treatments for these different pain qualities.

Official Title
-----------------
Pain Quality in Individuals With Low Back Pain, Headache, and Fibromyalgia

Conditions
-----------------
Low Back Pain, Headache, Fibromyalgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Speaks and understands English; At least 18 years of age; Confirms a diagnosis from a physician or certified medical provider of one of the three medical conditions (low back pain, headache, fibromyalgia), and that pain related to this diagnosis is still bothersome. Has experienced bothersome pain associated with their diagnosis in the past three months of a sufficient intensity; English is their first and primary language. Exclusion Criteria: Individuals would be excluded if they have more than one of the three pain diagnoses to be studied.

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 |
| --- | --- |
| Low Back Pain<br>Individuals who experience bothersome low back pain. | |
| Headache<br>Individuals who experience bothersome headaches. | |
| Fibromyalgia<br>Individuals who experience bothersome fibromyalgia-related pain. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Quality Assessment Scale | Assesses qualities (e.g. hot,cold) of pain | The assessment scale was administered once within a month following enrollment in the study; the assessment scale was not administered within a timeframe specific to an event or onset of condition. |
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.

Official Title
-----------------
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

Conditions
-----------------
Gastroesophageal Reflux Disease (GERD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6 month history of GERD symptoms Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period Remaining GERD symptoms despite optimized PPI treatment Able to read and write in US English, and able to comply with study requirements Exclusion Criteria: Patients that have not experienced any GERD symptom improvement at all during PPI treatment Involvement in the planning or conduct of the study Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months

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>552 GERD patients, partial responders to PPI treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use |  | Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months) | 
| Utility values |  | Collected at enrollment visit and at 6 month follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, PPI, partial responders
Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation. Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in patients with acute severe sepsis and septic shock.

Official Title
-----------------
Cerebrovascular Autoregulation in Patients With Severe Sepsis and Septic Shock, Influence of Renal Replacement Therapy

Conditions
-----------------
Severe Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Procedure: continuous veno-venous hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe sepsis or septic shock adult patients possibility of transcranial Doppler ultrasound Exclusion Criteria: traumatic brain injury known cerebrovascular diseases Infection of the brain chronic renal failure 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 |
| --- | --- |
| Hemodialysis<br>Patients with severe sepsis or septic shock with acute renal failure and requirement of continuous veno-venous hemodialysis | Procedure: continuous veno-venous hemodialysis<br> <br> * Other names: Renal replacement therapy;|
| No hemodialysis<br>Patients with severe sepsis or septic shock without acute renal failure and no requirement of continuous veno-venous hemodialysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrovascular autoregulation | Cerebrovascular autoregulation measured daily at the first 4 days of severe sepsis and septic shock | during the first 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Incidence of Delirium at day 4 after severe sepsis or septic shock | at day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, cerebrovascular autoregulation, delirium
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.

Official Title
-----------------
The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

Conditions
-----------------
Dupuytren's Contracture

Intervention / Treatment
-----------------
* Biological: Injectable clostridial collagenase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects (> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of > 20 degrees of the thumb First web space contracture with a palpable cord due to Dupuytren's contracture Exclusion Criteria: Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb. Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day). Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation. Any subject with known allergy to Xiaflex (Clostridial collagenase). Pregnant or nursing female Any subject who cannot conform to the study visit schedule

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injectable clostridial collagenase<br>Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase | Biological: Injectable clostridial collagenase<br>* Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections<br>* Other names: Xiaflex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) |  | 30 days after last injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dupuytren, Dupuytren's Disease
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fed and fasted conditions.

Official Title
-----------------
Comparative, Randomized, 3-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fed and Fasted Conditions

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions
* Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions
* Drug: Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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>Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions. | Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions<br> <br> |
| Experimental: 2<br>Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions. | Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions<br> <br> |
| Active Comparator: 3<br>Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions. | Drug: Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 53 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck

Study Overview
=================
Brief Summary
-----------------
This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck. Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.

Official Title
-----------------
Endotracheal Tube Intracuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck - Comparison of a Tapered Shaped- and Cylindrical Shaped Cuff

Conditions
-----------------
Thyroidectomy

Intervention / Treatment
-----------------
* Device: Mallinckrodt, COVIDIEN
* Device: Endotracheal tube, Unomedica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy Exclusion Criteria: difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tapered<br>Mallinckrodt, COVIDIEN | Device: Mallinckrodt, COVIDIEN<br> <br> |
| Active Comparator: Cylindrical<br>Endotracheal tube, Unomedical | Device: Endotracheal tube, Unomedica<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intracuff pressure |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distance from carina to tip of tube |  | 1 year |
Dysphagia on the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Recording of routine practice patterns to detect and/or treat Dysphagia on the ICU via interview of local colleagues. This will not allow to record generalizable data, but will reflect the actual routine standard of care.

Official Title
-----------------
Dysphagia on the Intensive Care Unit - a Multinational European Analysis

Conditions
-----------------
Deglutition Disorders

Intervention / Treatment
-----------------
* Other: NO interventions apply


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All senior ICU physicians in charge for adult critically ill ICU patients. Respective ICUs must be accredited by the Schweizerische Gesellschaft für Intensivmedizin. ICUs located in Switzerland. Senior ICU physicians willing to voluntarily fill in the provided questionnaire.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NO groups<br>no groups apply. | Other: NO interventions apply<br>* does not apply<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of centers using fibre-optic endoscopic evaluation of swallowing (FEES) vs. non-instrumental methods to detect/ treat dysphagia on the ICU. | Analysis of number of ICUs using instrumental methods (FEES) vs. non-instrumental methods in local (Swiss) centers to detect dysphagia in the ICU. | through study completion, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment standards, diagnostical approaches, descriptive