linjc16/ctgov huggingface dataset:
Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)

Conditions
-----------------
Hearing Loss, Deafness, Hearing Loss, Sensorineural, Hearing Disorders, Ear Diseases

Intervention / Treatment
-----------------
* Drug: Ancrod
* Drug: Saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB Symmetric hearing prior to onset of SSHL Enrollment has to be accomplished within 7 days after SSHL onset Exclusion Criteria: Bilateral SSHL Incomplete recovery after previous SSHL Previously existing, known retrocochlear hearing loss Any history of any ear operation or local inflammatory disease in the past one year History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops. Treatment with steroids for any reason within the preceding 30 days. Body weight > 140 kg

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ancrod<br>Ancrod | Drug: Ancrod<br>* Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections<br>* Other names: NM-V;|
| Placebo Comparator: Saline solution<br>Saline solution | Drug: Saline solution<br>* Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTA (pure tone audiogram) in the affected ear |  | From baseline to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in speech recognition in the affected ear |  | From baseline to Day 8 |
Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as Eslax) in daily clinical settings.

Detailed Description
-----------------
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Protocol for Eslax Intravenous Drug Use Investigation

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation. Exclusion Criteria: Patients with a history of hypersensitivity to Eslax or bromide. Patients with myasthenia gravis or myasthenic syndrome.
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>Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation | Drug: Rocuronium<br>* Normally, for adults, 0.6 mg/kg of rocuronium bromide is intravenously administered to support endotracheal intubation. If additional administration is necessary, 0.1 - 0.2 mg/kg is intravenously administered. In the case of continuous infusion, infusion is initiated at a rate of 7 μg/kg/min. Dosage should be adjusted based on the age or symptom. The upper limit of this drug for the intubation is 0.9 mg/kg.<br>* Other names: Eslax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events |  | The standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation score |  | From administration of Eslax to completion of intubation | 
| intubation completion time |  | From administration of Eslax to completion of intubation |
A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170 0.24% in Healthy, Adult Subjects when used twice daily for one week.

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

Intervention / Treatment
-----------------
* Drug: AC 170 0.24%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 and no older than 55 years of age be able to self-administer eye drops or have a parent/legal guardian available for this purpose have blood and urine analysis within normal limits have ocular health within normal limits Exclusion Criteria: known contraindications or sensitivities to the study medication or its components have any active systemic or ocular disorder (other than refractive disorder) have inability to comply with controlled diet have used prescription or non prescription drugs within washout period and throughout study have used alcohol or tobacco within the washout period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: AC 170 0.24%<br> | Drug: AC 170 0.24%<br>* 1 drop in each eye 2 times daily for 1 week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax values of AC 170 0.24% | Plasma samples will be drawn at specified time points and then analyzed to determine Cmax values of AC 170 0.24% in the plasma | 1 week | 
| Tmax values of AC 170 0.24% | Plasma samples will be drawn at specified time points and then analyzed to determine Tmax values of AC 170 0.24% in the plasma | 1 week | 
| AUC values of AC 170 0324% | Plasma samples will be drawn at specified time points and then analyzed to determine AUC values of AC 170 0.24% in the plasma | 1 week | 
| T 1/2 values of AC 170 0.24% | Plasma samples will be drawn at specified time points and then analyzed to determine T 1/2 values of AC 170 0.24% in the plasma | 1 week |
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin

Official Title
-----------------
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Dapagliflozin
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Body Mass Index (BMI) of 18 to 32 inclusive Women who are not of childbearing potential and men, ages 18 to 45 Exclusion Criteria: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations Glucosuria Abnormal liver function tests

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dapagliflozin/Rifampin<br> | Drug: Dapagliflozin<br>* Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days<br>Drug: Rifampin<br>* Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data |  | Days 1 to 3 and Days 9 to 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data |  | Days 1 to 3 and Days 9 to 11 | 
| Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data |  | Days 1 to 3 and Days 9 to 11 |
Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler

Study Overview
=================
Brief Summary
-----------------
Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD) performed and a comparison of timing, sensitivity and intensity of intravenously injected bubbles will be determined.

Official Title
-----------------
Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler

Conditions
-----------------
Patent Foramen Ovale

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients needing a TEE evaluation to rule out a cardiac source of brain emboli Exclusion Criteria: Patients unable to comply with protocol requirements Patients unable or unwilling to sign informed consent

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bubble Detection | The amount of time until bubbles are detected will be measured | 3 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patent Foramen Ovale
Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Study Overview
=================
Brief Summary
-----------------
Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.

Detailed Description
-----------------
Many individuals who take opioids for chronic pain abuse the opioid medication. Buprenorphine is an opioid partial agonist that may be effective in treating individuals who abuse opiate pain medication. The purpose of this study is to compare two buprenorphine dosing regimens in order to determine which regimen is more effective in reducing opiate pain medication use and facilitating successful opioid detoxification. This study will last 27 weeks. Participants will receive a maintenance dose of 8 mg of buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of the following 20 weeks. All participants will attend weekly clinical management sessions for the duration of the study.

Official Title
-----------------
Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current opioid analgesic dependence History of at least 2 years of oral opiate analgesic use Prescribed opioids for chronic pain Pain episode of at least 6 months duration within the 5 years prior to study entry Available for the duration of the study Good general health Exclusion Criteria: Currently using any illicit substance Meets criteria for alcohol dependence History of heroin use History of opiate replacement therapy, including Levo-Alpha Acetyl Methadol (LAAM) or methadone Evidence of current maximal primary pain

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use |  |  | 
| medication compliance |  |  | 
| treatment retention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral and psychological measures (measured during the dose reduction phase) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid dependence
Efficacy and Safety of IQP-VV-102 in Weight Management

Study Overview
=================
Brief Summary
-----------------
Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the subjects' body weight, body fat and safety parameters are monitored

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-VV-102 in Reducing Body Weight in Overweight and Obese Subjects

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: IQP-VV-102
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 60 years 25 kg/m2 ≤ BMI ≤ 35 kg/m2 Written informed consent Exclusion Criteria: Known sensitivity to sources of the active ingredients and excipients Pregnancy or nursing Inability to comply with study requirements, e.g. due to language difficulties Participation in another study during the last 30 days of the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IQP-VV-102<br>2 tablets twice a day | Dietary Supplement: IQP-VV-102<br> <br> |
| Placebo Comparator: Placebo<br>2 tablets twice a day | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight at End of Study Compared to Baseline | Change in body weight at the end of study compared to baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Waist Circumference (in cm) at End of Study From Baseline | Difference in waist circumference (in cm) at end of study from baseline | 12 weeks | 
| Change in Mean Body Fat at End of Study From Baseline | Measured in kg using calibrated weighing scales | 12 weeks |
A Clinical Comparison of Three Bronchial Blockers for One-Lung Ventilation in Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial comparing surgical conditions during one-lung ventilation with three different bronchial blockers or with double-lumen endobronchial tubes.

Conditions
-----------------
Thoracic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Left thoracotomy Exclusion Criteria: Contraindication to lung isolation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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
-----------------
Bronchial blockers, Lung isolation, Thoracic Anesthesia
COVID-19 Immunity Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.

Detailed Description
-----------------
The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing. The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427). The samples may also be used for assessing immunity or protection post COVID-19 vaccination.

Official Title
-----------------
Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ≥13 years old. Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19. Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects). Provides informed consent and completed questionnaire. Able to register the collection kit on the DxTerity portal. Able to collect and ship blood samples back to DxTerity. Exclusion Criteria: Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects). Unable to complete informed consent and/or questionnaire. Unable to complete the study activities in a timely manner.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| COVID-19 Vaccinated Individuals<br>Males and females, 13years old and above, vaccinated for COVID-19 | |
| Previously positive for COVID-19 and unvaccinated individuals<br>Males and females, 13years old and above, unvaccinated for COVID-19 and previously tested positive for COVID-19. | |
| No previous COVID infection or vaccination<br>Males and females, 13years old and above, unvaccinated for COVID-19 and previously not tested positive for COVID-19. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing Antibody Levels | Measuring neutralizing antibody levels with COVID-19 immunity assessment test | 3 months |