linjc16/ctgov huggingface dataset:
Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.

Official Title
-----------------
Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue

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

Intervention / Treatment
-----------------
* Device: RFA Applicator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age greater than or equal to 18 years. Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate. Because there is no patient contact with the device no medical contraindications are foreseen.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bi-lateral mastectomy<br> | Device: RFA Applicator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation Depth | Ablation depth is the extent to which tissue has been completely desiccated from the wall of the cavity. It will be assessed by pathologic analysis using H&, PCNA, and Ki67 stains. The ablation depth of each slide processed is to be the smallest distance of completely necrotic tissue. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast, Mastectomy
EEG in Resuscitated In-hospital Patients

Study Overview
=================
Brief Summary
-----------------
In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. This study will address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and EEG will be recorded for 24 hours.

Official Title
-----------------
Integrating EEG Into Acute Medicine: EEG in Resuscitated In-hospital Patients

Conditions
-----------------
Sudden Cardiac Arrest, Seizures

Intervention / Treatment
-----------------
* Device: Acute EEG with fast applicable EEG electrode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resuscitated in-hospital patients Exclusion Criteria: Patients with Do Not Attempt to Resuscitate-decision Patients who are not going to be treated in ICU after resuscitation

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: Acute EEG with fast applicable EEG electrode|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours of EEG monitoring starting from resuscitation and quantity of non-convulsive status epilepticus found |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, cardiac arrest, resuscitation, seizures
The Safety and Efficacy of Neramexane in Patients With Moderate to Severe Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist).

Official Title
-----------------
A Randomized, Double-Blind,Placebo-Controlled Evaluation of the Safety and Efficacy of Neramexane Monotherapy in Patients With Moderate to Severe Dementia of the Alzheimer's Type

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Neramexane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of moderate to severe Alzheimer's disease; ambulatory patients Exclusion Criteria: folate deficiency; clinically significant central nervous system disease other than Alzheimer's disease; clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Neramexane|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
-----------------
Neramexane, NMDA receptor antagonist, Memory Loss, Alzheimer Disease
Sodium-Potassium Blood Pressure Trial in Children

Study Overview
=================
Brief Summary
-----------------
To examine the effects of nutritional intervention on the rate of rise of blood pressure in late childhood and early adolescence.

Detailed Description
-----------------
BACKGROUND: Since 1970, children and adolescents with hypertension have been detected with increasing frequency. Many of them were thought to have primary or essential hypertension and it remained unclear how they should be managed. Additionally, since tracking of blood pressure occurred even in early life, it was believed that youngsters with blood pressures persistently in the upper deciles for age were at increased risk for later hypertension. No clinical trials had been performed in this age group to examine the effects of non-pharmacologic or drug therapy in lowering blood pressure. The trial was one of the first attempts to examine the effects of a nutritional intervention on the rate of rise of blood pressure in late childhood and early adolescence. DESIGN NARRATIVE: Randomized, partial-blind. After 19,542 fifth to eighth grade students were screened, 210 (105 boys and 105 girls) from the upper 15 percentiles of blood pressure distribution were randomly assigned to one of three groups: low sodium diet (70 mmol sodium intake per day), potassium chloride supplementation (normal diet plus 1 mmol/kg potassium chloride per day), and placebo (normal diet plus placebo capsule). Capsules for the potassium chloride and placebo groups were administered in a double blind protocol. Blood pressure was measured every three months for three years. The effect of the intervention was determined by comparing the rate of rise (slope) of blood pressure among the groups using a random-coefficient growth curve model.

Official Title
-----------------
Sodium-Potassium Blood Pressure Trial in Children

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

Intervention / Treatment
-----------------
* Behavioral: diet, sodium-restricted
* Behavioral: diet, potassium-supplemented


Participation Criteria
=================
Eligibility Criteria
-----------------
Children in grades 5 through 8 whose systolic blood pressure was greater than or equal to 120 mm Hg on two visits.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 13 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, sodium-restricted|nan|
|Behavioral: diet, potassium-supplemented|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?

Study Overview
=================
Brief Summary
-----------------
To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias

Official Title
-----------------
Are Postoperative Patient Patient Reported Outcome Measures Influenced by Recall of Preoperative Scores? - a Randomized Controlled Trial

Conditions
-----------------
Degenerative Diseases, Spinal Cord

Intervention / Treatment
-----------------
* Behavioral: PROMs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients with valid preoperative PROM scores submitted to spine surgery due to degenerative pathology from January 2019 to April 2020 at our center (spine unit of a neurosurgical department in a Portuguese university hospital) were included in the study and received PROMs questionnaires with a letter of consent. Exclusion Criteria: Patients without valid preoperative questionnaires were excluded from the study while patients were lost to follow-up if mail questionnaires were not completed two months after PROMs remittance or if they had submitted incomplete or invalid answers.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>no recall PROMs group ; without knowledge of previous PROMs scores | |
| Active Comparator: intervention group<br>recall PROMs group ; with knowledge of previous PROMs scores | Behavioral: PROMs<br>* evaluate the impact of recall bias on post proms scores<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median COMI score results | Core outcome measures index. Scale 0 to 10 where 0 means the best score | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median ODI score | Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score | 4 weeks | 
| Median EQ-5D score | EuroQol 5 D where 1 is the best score and -0,500 the worst score | 4 weeks | 
| Median NDI | Neck disability index Scale 0 to 100 where 0 means the worst score | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PROM, Recall bias
Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Drug: Sugammadex 1 mg/kg
* Drug: Sugammadex 2 mg/kg
* Drug: Sugammadex 4 mg/kg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General anaesthesia Neuromuscular blockade induce by rocuronium Body Masse Indice ≥ 40 kg/m2 informed consent Exclusion Criteria: Contraindication to rocuronium or sugammadex Pregnant women Severe renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Sugammadex 1mg/kg<br>for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients | Drug: Sugammadex 1 mg/kg<br> <br> |
| Experimental: Sugammadex 2mg/kg<br>for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients | Drug: Sugammadex 2 mg/kg<br> <br> |
| Experimental: Sugammadex 4mg/kg<br>for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients | Drug: Sugammadex 4 mg/kg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine a profound neuromuscular blockade reversal on ideal body weight | A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare dosages based on ideal body weight to real body weight |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
General anaesthesia, Curarization with rocuronium
Study Evaluating rFIX; BeneFIX® in Hemophilia B

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).

Official Title
-----------------
An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ≤2%)

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Drug: rFIX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemophilia B (FIX:C less than 2%) Previous treatment of at least 150 exposure days using any FIX product 12 years of age and older Exclusion Criteria: The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient) Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins Patient has a genetic coagulation disorder other than hemophilia B

Ages Eligible for Study
-----------------
Minimum Age: 12 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
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Acetyl-L-Carnitine in the Treatment of Septic Shock

Study Overview
=================
Brief Summary
-----------------
This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.

Detailed Description
-----------------
This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.

Official Title
-----------------
Prospective, Randomized, Placebo-controlled, Double-Blinded, Phase II Pilot Study of Acetyl-L-carnitine in the Treatment of Patients With Septic Shock

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: Acetyl-L-Carnitine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented or presumed infection shock requiring vasopressors Exclusion Criteria: dialysis hepatic failure seizures

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours | Drug: Acetyl-L-Carnitine<br>* Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours<br>* Other names: ALC;|
| Other: B<br>Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours | Drug: Acetyl-L-Carnitine<br>* Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours<br>* Other names: ALC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Blood Pressure | Mean Arterial blood pressure measured non-invasively at 18 hours | 18 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressor Dose | Change in vasopressor dose between 6 and 24 hours. | 6-24 hours | 
| Serum Lactate | Latest serum lactate between 12 and 36 hours | 12-36 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Septic shock, Acetyl-L-carnitine
Northern Board Beet Breathlessness Trial

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease. Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if it improves their overall exercise tolerance.

Conditions
-----------------
Exercise Tolerance (Measured in Minutes)

Intervention / Treatment
-----------------
* Dietary Supplement: Beetroot Juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Already planned to attend the pulmonary rehabilitation class Exclusion Criteria: Angina Prescribed regular nitrates, a resting heart rate >100bpm, a resting blood pressure <110 systolic, postural hypotension, prescribed PDE5 inhibitors.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beetroot<br> | Dietary Supplement: Beetroot Juice<br>* Give subjects 500ml beetroot juice in the 24 hour period prior to class begins. They will receive this during 3 of the 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Tolerance | Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption | 6 weeks |
Selective Lasertrabeculoplasty and Ocular Hemodynamics in Glaucoma

Study Overview
=================
Brief Summary
-----------------
Selective Laser Trabeculoplasty (SLT) is known to reduce intraocular pressure in glaucoma patients. This study investigates, if there are changes in different ocular hemodynamic parameters prior and after SLT.

Detailed Description
-----------------
Ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) prior and 3 month after SLT.

Official Title
-----------------
Effect of Selective Lasertrabeculoplasty (SLT) on Ocular Hemodynamics in Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Selective Laser Trabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma patient over 18 years needs further intraocular pressure regulation Exclusion Criteria: age under 18 years debilitated no 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glaucoma patients<br>Glaucoma patients undergoing selective laser trabeculoplasty for further IOP reduction | Procedure: Selective Laser Trabeculoplasty<br>* 360° selective laser trabeculoplasty, 100 non-overlapping spots, energy 0,5-1,2 mJ<br>* Other names: Lasertrabeculoplasty;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular hemodynamics after Selective Laser Trabeculoplasty (SLT) | Pulsatile ocular blood flow, ocular pulse amplitude and ocular pulse volume are measured prior and 3 month after SLT with the Blood Flow Analyzer (Paradigm Medical Industries, Inc.) | baseline and 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Selective Laser Trabeculoplasty, pulsatile ocular blood flow