linjc16/ctgov huggingface dataset:
Analysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life

Study Overview
=================
Brief Summary
-----------------
Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.

Official Title
-----------------
Comparison of Risk Factors, GERD Symptoms and PPI Responses in the Reflux Esophagitis, Non-erosive Reflux Disease and Functional Heartburn Using GERD Impact Scale Questionnaire

Conditions
-----------------
Reflux Esophagitis (RE), Non-erosive Reflux Disease (NERD), Functional Heartburn (FH)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Subjects (From 16 to 85 years old) The subjects with GERD symptom who received 8 week PPI therapy Exclusion Criteria: Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus) Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 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 |
| --- | --- |
| Reflux esophagitis (RE)<br> | |
| Non-erosive reflux disease (NERD)<br> | |
| Functional heartburn (FH)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The GIS score at baseline |  | Before 8 weeks PPI treatment(baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the GIS score from baseline |  | After 8 weeks PPI treatment |
Epidural Waveforms: Pressure Transducer vs CompuFlo

Study Overview
=================
Brief Summary
-----------------
The purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer.

Detailed Description
-----------------
40 patients who had an epidural functioning catheter previously positioned for anesthesia or analgesia will be enrolled. After removing the epidural filter and after having zeroed the instrument, the investigator will connect in a random fashion sequence, a standard pressure transducer attached to a standard invasive blood pressure monitor or to the CompuFlo CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform. The investigator will also note and evaluate: The volume of saline priming necessary to obtain the waveform The effects of patient's position on the occurrence and amplitude of epidural pulsatile waveform

Official Title
-----------------
Reliability of Pressure Waveform Analysis to Determine Correct Epidural Catheter Placement; a Comparison Between Pressure Transducer and the CompuFlo® CathCheck™ System

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

Intervention / Treatment
-----------------
* Device: CompuFlo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with an epidural lumbar catheter for anesthesia or analgesia Exclusion Criteria: patients with malfunction or dislodgement of the epidural catheter

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard Pressure Transducer<br>Epidural pressure waveforms will be measured by using a standard invasive monitor pressure transducer | Device: CompuFlo<br>* The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer<br>* Other names: Standard Pressure Transducer;|
| Active Comparator: CompuFlo<br>Epidural pressure waveforms will be measured by using the CompuFlo Instrument | Device: CompuFlo<br>* The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer<br>* Other names: Standard Pressure Transducer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Wave | Occurrence of epidural pulse wave | up to 15 minutes |
Study of Karenitecin (BNP1350) in Patients With Brain Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.

Official Title
-----------------
Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

Conditions
-----------------
Brain Neoplasms, Malignant Neoplasms, Brain, Brain Tumors

Intervention / Treatment
-----------------
* Drug: Karenitecin (BNP1350)


Participation Criteria
=================
Eligibility Criteria
-----------------
Confirmed diagnosis of a newly diagnosed glioblastoma multiforme or recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma. Evidence of measurable recurrent or residual primary CNS neoplasm. An interval of at least 3 weeks between prior surgical resection or 6 weeks between prior radiotherapy or chemotherapy, and enrollment on this protocol unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy. Hematocrit > 29%, ANC > 1,500, platelets > 125,000 Serum creatinine < 1.5 mg/dl, BUN < 25 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal Negative pregnancy test for female patients

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: 1<br>Karenitecin for intravenous use | Drug: Karenitecin (BNP1350)<br>* Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity.<br>* Other names: Karenitecin also referred to as BNP1350;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response Rate |  | Randomization to end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Randomization to date of death due to any cause | 
| Overall Safety |  | Randomization to end of study participation |
Survey of Patients Taking IOP-Lowering Eye Drops

Study Overview
=================
Brief Summary
-----------------
Survey to assess perspectives of patients prescribed IOP-lowering eye drops at a single office visit.

Official Title
-----------------
A Multi-Site Questionnaire-Based Study to Assess Attitudes Regarding Current IOP-Lowering Eye Drops and Products in Development for Sustained Release of Medication in Glaucomatous and Ocular Hypertensive Subjects

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prescribed IOP-lowering eye drops Exclusion Criteria: Can complete survey instrument in English
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive Statistics of Subject Perceptions of Different IOP-Lowering Treatments |  | A Single Office Visit |
Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The ventilation of the patient under general anesthesia is an old problem and extensively studied, especially in visceral surgery, higher risk of postoperative complications. Studies have recently shown the impact of a lung-protective ventilation in visceral surgery, however obese patients are often excluded, and alveolar recruitment maneuver has never been studied independently. The investigators are conducting a randomized controlled prospective study to investigate the clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing bariatric surgery. The objective is to show the reduction in dyspnea, oxygen dependency: reflection of atelectasis and the incidence of postoperative complications.

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

Intervention / Treatment
-----------------
* Procedure: Anesthesia: alveolar recruitment maneuver
* Procedure: Anesthesia: standardized


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients surgery for bariatric surgery (sleeve, gastric bypass, gastric banding ablation) planned surgery, ASA 1-2-3, Exclusion Criteria: Severe COPD Severe emphysema, Pneumothorax, Right sided heart failure, Severe heart failure Emergency surgery, ASA 4

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Control group<br> | Procedure: Anesthesia: standardized<br> <br> |
| Experimental: Protocol Group<br> | Procedure: Anesthesia: alveolar recruitment maneuver<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of dyspnea |  | 2 hours | 
| oxygen saturation |  | 2 hours |
Antigen-specific Immune Response to Hepatitis B Virus in Utero

Study Overview
=================
Brief Summary
-----------------
This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers.

Detailed Description
-----------------
Despite the development of an effective preventive HBV vaccine, the spread of HBV virus continue, particularly in Asia, where the majority of HBV infection is acquired at birth by vertical transmission from mother to baby. HBV vertical transmission has been hypothesized to cause immune tolerance to HBV and thus promoting the subsequent HBV chronicity. Such hypothesis has never been tested and nothing is known about HBV-specific adaptive immune response occurring before birth in baby born form HBV chronically infected mothers. This study aims to gain an understanding of the key components of the immune response to hepatitis B present in cord blood of HBV infected mothers. The characterization of the HBV immune response in utero will provide informations about the cause of HBV chronicity in Asian patients in the management of baby born from HBsAg+ mothers.

Official Title
-----------------
Antigen-specific Immune Response to Hepatitis B Virus and Influenza A (H1N1 Strain) in Utero

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with HBsAg+ Exclusion Criteria: Pregnant women without HBsAg+

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti - viral immune response in cord blood of newborn infants born to HBV+ mothers | Immune response was defined as activation of innate immune effectors (NK cells, monocytes) and production of TH1 cytokines IL - 2, TNF - a and IFN - g from T cells. | At birth (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of immune genes from immune cells | Expression of immune gene cells was measured using Nanostring technology and epigenetic analysis. | At birth (baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B carrier
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. The study will last about 6 weeks, and includes 4 visits.

Official Title
-----------------
A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Lasmiditan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have a history of migraine headaches for more than 6 months Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months Participants must weigh between 15 and 55 kilograms (kg) Participants must not have a migraine headache on the day of lasmiditan administration Exclusion Criteria: Participants must not be pregnant or nursing Participants must not have any acute, serious, or unstable medical condition Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator Participants must not be on a medicine that acts in the brain and spinal cord

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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 |
| --- | --- |
| Experimental: Lasmiditan<br>Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 milligrams (mg) Lasmiditan in Cohort 1 and higher body weight (>40 to ≤55 kg) participants received single oral dose of 200 mg Lasmiditan in Cohort 2. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan. | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose | 
| PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan | PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan. | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose |
A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the safety, pharmacokinetics and pharmacodynamics of BMS-707035 in subjects infected with HIV-1

Official Title
-----------------
Randomized, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-707035 in HIV-1 Infected Subjects

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: HIV Integrase Inhibitor (BMS-707035)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1-infected subjects with CD4+ lymphocyte count ≥ 200 cells/mm3 and with plasma HIV-1 RNA ≥ 5000 copies/mL who have not been on antiretroviral (ARV) therapy for ≥ 8 weeks or who are naive to ARV, and who are otherwise medically stable as determined by medical history, physical examination, 12 lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. In addition, subjects must have had no prior exposure to the Integrase Inhibitor class of compounds. Female subjects must not be nursing, pregnant, or of childbearing potential

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: HIV Integrase Inhibitor (BMS-707035)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the antiviral activity of selected doses of BMS-707035 administered orally to HIV-1 infected subjects for 10 days. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability with 10 days of dosing |  |  | 
| Effect on QTc intervals |  |  | 
| Effect on CD4+, CD8+, and CD8+CD38+ lymphocyte |  |  | 
| Pharmacokinetics of multiple doses of BMS-707035 in HIV-1 infected subjects |  |  | 
| Assess relationship of EC90 and exposures of BMS-707035 to the magnitude of change in viral loads |  |  | 
| Assess plasma protein binding and intracellular concentration in PBMC for BMS-707035 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Treatment Experienced
A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.

Official Title
-----------------
Open Label, Randomized, 3-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Ambroxol HCl and Levodropropizine in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Ambroxol and Levodropropizine
* Drug: Ambroxol
* Drug: Levodropropizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Age between 20 and 55 Signed informed consent Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypotension or hypertension Has a history of acute infection within 14 days of screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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: Ambroxol and Levodropropizine<br> | Drug: Ambroxol and Levodropropizine<br>* Ambroxol HCl 30mg & Levodropropizine 60mg, PO, Single dose<br>|
| Active Comparator: Ambroxol<br> | Drug: Ambroxol<br>* Ambroxol HCl 30mg, PO, single dose<br>|
| Active Comparator: Levodropropizine<br> | Drug: Levodropropizine<br>* Levodropropizine 60mg, PO, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0-48hrs | 
| Cmax |  | 0-48hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | 0-48hrs | 
| T1/2 |  | 0-48hrs | 
| AUCinf |  | 0-48hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ambroxol, Levodropropizine, Drug-drug interaction