linjc16/ctgov huggingface dataset:
Verapamil and Catamenial Epilepsy

Study Overview
=================
Brief Summary
-----------------
One in 3 epilepsy patients have refractory seizures. This drug resistance is likely related to the over expression of multidrug resistance proteins (MDR). Progesterone is a known inhibitor of MDRs and the low level of this hormone during the menstrual cycle may exacerbate seizures, perhaps explaining catamenial epilepsy; i.e. seizures occurring during the menstrual cycle. Verapamil suppresses seizures in animal models of epilepsy perhaps by inhibiting MDRs and thus may help patients with refractory seizures. If the study shows improved seizure control, the results will help establish the role of MDRs in refractory epilepsy.

Official Title
-----------------
Study of Verapamil in Refractory Catamenial Epilepsy

Conditions
-----------------
Catamenial Epilepsy

Intervention / Treatment
-----------------
* Drug: verapamil hyrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females at least 2 seizures per month more than 50% of the seizures occur 7 days before or 7 days after the onset of menses patient of the Toronto Western Hospital Epilepsy Clinic Exclusion Criteria: cardiovascular history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: verapamil hyrochloride|80 mg daily by mouth, 5 days prior to menses for 3 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent reduction in seizure frequency |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, seizures, menstrual cycle
New Biopsy Technique for Uveal Melanoma

Study Overview
=================
Brief Summary
-----------------
This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.

Detailed Description
-----------------
Uveal melanoma is the most common primary malignancy of the eye and is one of the few fatal diseases that are detected initially through an eye examination. For many years, clinical decision-making regarding which patient with uveal melanoma required treatment has been based solely on clinical features observed at the time of diagnosis. These features include: tumor size as measured by ultrasound, associated subretinal fluid, presence of orange lipofuscin pigment, lack of drusen, posterior location, and ciliary body involvement. All of these clinical features have been demonstrated to be associated with tumor growth which is associated with the eventual development of metastases. However, these clinical features are not adequately sensitive or specific enough to predict which patients will develop metastases. More recently, researchers studying the genomics of uveal melanoma have focused on identifying genetic abnormalities present in tumor tissue in order to characterize these lesions more fully. Several landmark papers over the past 15 years have reported cytogenic and genomic abnormalities in uveal melanoma tumor tissue that are associated with a poorer prognosis. Although rare, there have been at least five cases in which patients undergoing biopsy of these lesions have developed extraocular spread of melanoma from the biopsy sites. With this new technique, the possible rate of extraocular spread should be lower, making the biopsy a safer technique than what is currently in practice.

Official Title
-----------------
New Biopsy Technique for Uveal Melanoma

Conditions
-----------------
Uveal Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with uveal melanoma Scheduled for enucleation surgery Exclusion Criteria: Patients under 21 years old Patients unable to undergo surgery Patients with known metastatic uveal melanoma or other cancer.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Uveal Melanoma<br>Scheduled for enucleation surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with melanotic cells present at biopsy needle site |  | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uveal melanoma, biopsy, enucleation, ocular cancer
Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.

Official Title
-----------------
A Comparison of Two Methods for Intubation With Double-lumen Endobronchial Tube to Reduce Laryngeal Injuries

Conditions
-----------------
Laryngeal Injuries

Intervention / Treatment
-----------------
* Procedure: 90 degrees rotation
* Procedure: 180 degrees rotation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes Exclusion Criteria: Preoperative hoarseness or sore throat History of upper airway diseases Anticipated difficult airway Operation time longer than 6 hours

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 90 degrees rotation<br>Double-lumen tube intubation with 90 degrees rotation | Procedure: 90 degrees rotation<br>* Double-lumen tube intubation with 90 degrees rotation<br>|
| Experimental: 180 degrees rotation<br>Double-lumen tube intubation with 180 degrees rotation | Procedure: 180 degrees rotation<br>* Double-lumen tube intubation with 180 degrees rotation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hoarseness |  | up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative sore throat |  | up to 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
during double-lumen, tube intubation
The Effect of Obesity on Growth Hormone Response to Anaerobic Exercise

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to asses the effect of obesity on anaerobic exercise's growth hormone (GH) response.

Detailed Description
-----------------
Exercise is a potent physiological stimulator of growth hormone (GH) release. GH is an important factor in the distribution of fat and lean tissue in the body. Previous studies suggested that the GH response to aerobic exercise may be attenuated by obesity. The effect of obesity on GH response to anaerobic effort is unclear. The aim of the present study is to asses the effect of obesity on anaerobic exercise's GH response. We will recruit 12 obese (BMI > 30) healthy adults and 12 age and gender matched normal weight (BMI < 25) controls. All the participants will conduct a wingate anaerobic test (30 seconds of intense effort against resistance calculated by the individual's body weight). Blood sample for GH level will be collected at 5 different time (0, 20, 30, 40 and 60 minutes after the test). We will compare the GH response in the two groups.

Official Title
-----------------
The Effect of Obesity on Growth Hormone Response to Anaerobic Exercise

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female Age 18-40 Exclusion Criteria: Male Age <18, >40 Heart, Liver, Kidney or Hypophyseal disease Medications that may alter GH secretion (eg Steroids, Eltroxin)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Obese<br>BMI>30 | |
| Group 2: control<br>Group 2:Normal weight (BMI <25). age and gender matched. | |

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
-----------------
Obesity, Growth hormone secretion, Anaerobic exercise
Early Waning of Maternal Measles and Meningitis C Antibodies

Study Overview
=================
Brief Summary
-----------------
Maternal antibodies (measles and meningitis C) may wane in the first six months after birth. Geometric mean titers(GMTs) of measles and meningitis C. Follow-up on 0 month, 3rd month,5th month and 7th month after birth.

Detailed Description
-----------------
Measles and meningitis C are hot topics in China in recent years. Although China had set the goal of measles elimination, many measles cases were found to be those aged < 8 months and meningitis C is becoming public health issue since meningitis group A has been controlled at a very low level and little is known on C group. So the investigators designed the observation study on the two antibodies. Maternal antibodies are supposed to wane after birth. Serums of the placenta(0 month), children of 3 months, 5 months and 7 months old will be collected and the geometric mean titers (GMTs) of measles and meningitis C will be confirmed by using the ELISA test.

Official Title
-----------------
Observation Study on Early Waning of Maternal Measles and Meningitis C Antibodies

Conditions
-----------------
Measles

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants. Exclusion Criteria: Infants with poor score.

Ages Eligible for Study
-----------------
Maximum Age: 7 Months

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 |
| --- | --- |
| GMT<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer |  | Up to six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Measles, Meningitis C, waning, Geometric Mean Titer, China
Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients admitted to the surgical trauma intensive care unit (STICU).

Official Title
-----------------
Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit: A Randomized, Double Blind, Controlled Trial

Conditions
-----------------
Mucus Obstruction, Intubation

Intervention / Treatment
-----------------
* Drug: mucomyst
* Drug: sodium chloride (saline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubated and admitted to the Surgical Trauma Intensive Care Unit (STICU) Subjects must be eligible to start treatment within 24 hours of their initial intubation Exclusion Criteria: Patient anticipated to be extubated within 24 hours following STICU admission Hypersensitivity to acetylcysteine. 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mucomyst|nan|
|Drug: sodium chloride (saline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of pulmonary mucus obstruction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of mechanical ventilation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mucus obstruction, ventilator management
A Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease

Study Overview
=================
Brief Summary
-----------------
The research aim to collect large samples of COVID-19 disease patients with clinical symptoms, laboratory and imaging examination data. Screening the biological indicators which are related to the occurrence of severe diseases. Then, investigators using artificial intelligence (AI) technology deep learning method to find a prediction model that can dynamically quantify COVID-19 disease severity.

Official Title
-----------------
a Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease

Conditions
-----------------
COVID-19 Disease

Intervention / Treatment
-----------------
* Other: other


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of COVID-19 disease confirmed by virus nucleic acid RT-PCR and CT Exclusion Criteria: unconfirmed suspected cases Patients during pregnancy and lactation incomplete clinical data inestigators considered patients ineligible for the trial

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observed group<br>The patients who were detected COVID-19 disease by RT-PCR and CT imaging. | Other: other<br>* clinical diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discrimination | The performance of our prediction model is evaluated with the receiver operating characteristic (ROC) curves, areas under the curves (AUCs) and concordance index (c-index). | up to 3 months | 
| Calibration | The calibration curves analysis is used to show error between the predicted clinical phenotype with prediction model and actual clinical phenotype. | up to 3 months | 
| Net benefit | Decision curve analysis was used to determine whether the models could be considered useful tools for clinical decisionmaking by comparing the net benefits at any threshold. | up to 3 months |
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

Official Title
-----------------
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0017

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: NX-1207
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide signed informed consent prior to enrolment in the study IPSS ≥ 15 Prostate Volume ≥ 30 mL ≤ 70 mL Qmax < 15 mL/sec based on a minimum void of 125 mL Agree not to use any other approved or experimental BPH or OAB medication anytime during the study Exclusion Criteria: History of illness or condition that may interfere with study or endanger subject Use of prescribed medications that may interfere with study or endanger subject Presence of a median lobe of the prostate Previous surgery or MIST for treatment of BPH Post-void residual urine volume > 200 mL PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL Participation in a study of any investigational drug or device within the previous 90 days Prostate cancer

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NX-1207<br> | Drug: NX-1207<br>* Single intraprostatic injection of 2.5 mg NX-1207<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single intraprostatic injection of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) |  | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) |  | 90 days | 
| International Prostate Symptom Score (IPSS) |  | 180 days | 
| International Prostate Symptom Score (IPSS) |  | 270 days | 
| Peak urine flow rate (Qmax) |  | 365 days | 
| Peak urine flow rate (Qmax) |  | 90 days | 
| Peak urine flow rate (Qmax) |  | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign prostatic hyperplasia, BPH, Enlarged prostate
Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.

Official Title
-----------------
Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia

Intervention / Treatment
-----------------
* Procedure: Mucosectomy
* Procedure: Rubber Band Ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years of age or older. Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy. Subject agrees to participate and signs consent form. Exclusion Criteria: Patient is pregnant. Patient has a hiatal hernia greater than 2cm. Presence of persistent daily solid food dysphagia, unplanned weight loss over ten pounds, esophageal bleeding, or vomiting more than once per week). Active medical condition that would preclude the subject from finishing this study. BMI > 39.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Mucosal Resection (EMR) Group<br> | Procedure: Mucosectomy<br>* Endoscopic mucosal resection in the upper GI tract.<br>|
| Experimental: Banding Group<br> | Procedure: Rubber Band Ligation<br>* Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of reflux symptoms measured by GERD HRQL | HRQL = Health Related Quality of Life Questionnaire | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in total esophageal acid exposure measured by 48 hour pH monitoring |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia