linjc16/ctgov huggingface dataset:
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo. Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus those subjects receiving placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Two Fixed Doses (200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: DVS-233 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients Sexually active women participating in the study must use a medically acceptable form of contraception Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S) Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Single Ascending Dose Study of SRA-444 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) after administration of ascending single oral doses to healthy adult subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SRA-444


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy men or women of nonchildbearing potential aged 18 to 50 years, Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Exclusion criteria: Family history of sudden death and/or QT prolongation. An automatic ECG corrected QT (QTc) interval reading at screening >450 ms and >470 ms for male and female subjects, respectively. Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening <110 mm Hg (systolic) and/or <60 mm Hg (diastolic).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SRA-444|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety and tolerability of SRA-444 |  |  |
Ultrasound Cavitation Therapy for CLI

Study Overview
=================
Brief Summary
-----------------
In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral arterial disease (PAD). The primary outcome measure is whether ultrasound exposure to microbubble contrast agents in the inflow artery and at the wound site can accelerate wound healing. A secondary outcome measure is whether cavitation-related changes occur in tissue perfusion in the treated limb and wound measured by ultrasound perfusion imaging and skin flow.

Official Title
-----------------
Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Acoustic cavitation of ultrasound enhancing agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months. Exclusion Criteria: Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV]). Pregnant or lactating females Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol). Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors). Expected amputation or revascularization procedure within the ensuing 1 month.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavitation therapy<br>Subjects treated with cavitation energy | Device: Acoustic cavitation of ultrasound enhancing agents<br>* Cavitation therapy<br>|
| No Intervention: Control<br>Control subjects not treated with cavitation energy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound dimensions | Area of non-healing ulcer | 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound granulation | Area of granulation tissue of the ulcer | 18 days | 
| Tissue perfusion | Laser speckle perfusion imaging | 18 days |
A Phase 1 Study Comparing AVP-786 With AVP-923

Study Overview
=================
Brief Summary
-----------------
To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.

Official Title
-----------------
A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AVP-786
* Drug: AVP-923


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males or females 18 - 60 years of age BMI 18 - 32 kg/m2 Exclusion Criteria: History or presence of significant disease History of substance abuse and/or alcohol abuse with the past 2 years Use of tobacco-containing or nicotine-containing products within 6 months Use of any prescription or the over-the-counter medications within 14 days

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Period 1<br>Twice daily dosing of AVP-786 orally for 8 days | Drug: AVP-786<br> <br> * Other names: deuterated (d6)-dextropmethorphan/quindine sulfate;|
| Active Comparator: Group 1 - Period 2<br>Twice daily dosing of AVP-923 orally for 8 days | Drug: AVP-923<br> <br> * Other names: dextromethorphan/quinidine;|
| Active Comparator: Group 2 - Period 1<br>Twice daily dosing of AVP-923 orally for 8 days | Drug: AVP-923<br> <br> * Other names: dextromethorphan/quinidine;|
| Experimental: Group 2 - Period 2<br>Twice daily dosing of AVP-786 orally for 8 days | Drug: AVP-786<br> <br> * Other names: deuterated (d6)-dextropmethorphan/quindine sulfate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of d6-DM in AVP-786 compared to DM in AVP-923 |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of metabolites |  | 8 days | 
| Safety and tolerability |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine
Transfer of Fresh Versus Frozen/Thawed Embryos in IVF Cycles Where GnRH Agonist is Utilized for Oocyte Maturation.

Study Overview
=================
Brief Summary
-----------------
It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the endometrium and not oocyte quality, therefore better results may be obtained by not returning these embryos in a fresh cycle but rather cryopreserving them and returning them to the uterus and a later stage.

Conditions
-----------------
Female, Ovarian Hyperstimulation Syndrome, Infertility Drugs

Intervention / Treatment
-----------------
* Procedure: Delayed embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman at risk of ovarian hyperstimulation syndrome in IVF cycles for whom GNRH agonist was utilized for final oocyte maturation Exclusion Criteria: Patient's refusal to participate

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Delayed embryo transfer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate per transfer |  |  | 
| Pregnancy rate per embryo transfer |  |  | 
| Implantation rate per IVF cycle |  |  | 
| Pregnancy rate per IVF cycle |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GNRH agonist, ovarian hyperstimulation syndrome, Embryo cryopreservation
HLA-B*5701 And Hypersensitivity To Abacavir

Study Overview
=================
Brief Summary
-----------------
This retrospective case-control study is being conducted to estimate the sensitivity of the pharmacogenetic marker, HLA-B*5701 for hypersensitivity to abacavir (ABC HSR). The specificity of the marker, and its association with ABC HSR, as measured by odds ratios and 95% confidence intervals, will be evaluated as secondary endpoints. Cases will be defined in two ways - subjects who have clinically-suspected ABC HSR and a positive abacavir skin patch test reaction (CS-SPTPos) and subjects with clinically-suspected ABC HSR (CS-HSR), regardless of the results of skin patch testing. The study will include 40 CS-SPTPos Black cases matched with up to 200 abacavir-tolerant controls. In parallel, 40 CS-SPTPos White cases will be matched with up to 200 White controls. Some of the secondary analyses will use cases defined by clinical criteria alone (CS-HSR). Black and White subjects will be analyzed separately because of the differences in ABC HSR rates and in the carriage frequency of HLA-B*5701.

Official Title
-----------------
A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir.

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir. Subjects must provide consent for skin patch testing and pharmacogenetic evaluation. Exclusion criteria: Women found to be pregnant at baseline. Subjects with HIV-1 infection who have tolerated abacavir for at least 12 weeks without experiencing hypersensitivity to the drug.

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 |
| --- |
|Drug: Observational Study|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
-----------------
hypersensitivity to abacavir,, HLA-B*5701, pharmacogenetic marker, retrospective analysis
Reduction of Bacteria in MRSA Positive Ulcers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers

Official Title
-----------------
A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions

Conditions
-----------------
Leg Ulcer, Pressure Ulcer

Intervention / Treatment
-----------------
* Drug: Nitric Oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have given written informed consent Must be 19 years of age or over Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected. Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover Exclusion Criteria: Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence) Is < 19 years of age Has a clinically infected ulcer Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment. Has been using systemic antibiotics during 7 days prior to enrolment into this study. Has an Ulcer / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer) Has an Ulcer / Lesion size beyond the inner borders of the wound cover Is septic or has other signs of an invasive infection Has used any other investigational product within 30 days preceding study participation. Suffers from a condition, which, in the opinion of the Investigator,would compromise his or her safety. Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data. Has a known allergy to any of the products that are part of this protocol Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection. Is using any of the prohibited concomitant medications or treatments

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Nitric Oxide<br>gaseous nitric oxide delivered topically for 30 minutes | Drug: Nitric Oxide<br>* 1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in bacteria |  | Post Treatment Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 3 days |
GS Regimen as the First-line Chemotherapy in Chinese Advanced PC Patients

Study Overview
=================
Brief Summary
-----------------
Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line chemotherapy in Chinese patients with advanced PC, we designed this prospective study.

Official Title
-----------------
Gemcitabine Plus S-1 as the First-line Chemotherapy in Chinese Patients With Advanced Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer, Chemotherapy Effect, Chemotherapeutic Toxicity

Intervention / Treatment
-----------------
* Drug: GS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Histologically confirmed pancreatic adenocarcinoma 2.Locally advanced or metastatic PC 3.Chemotherapy-naïve 4.ECOG performance status of 0 or 1 5. An adequate bone marrow, liver function and kidney function Exclusion Criteria: 1.Age ≥80 years 2.Brain metastasis 3.With other malignancies 4.Chronic diarrhea, cardiac disease, pregnancy or breast feeding

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 |
| --- | --- |
| LAPC or MPC patients with GS first-line chemotherapy<br> | Drug: GS<br>* Gemcitabine plus S-1 (GS) was used to treat advanced pancreatic cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | the time from the beginning of chemotherapy to the date of disease progression or death from any cause. | 2014-01-01 to 2017-12-31 | 
| Overall survival | the time from the beginning of chemotherapy to the date of death from any cause. | 2014-01-01 to 2017-12-31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | the percentage of patients with CR or PR | 2014-01-01 to 2017-12-31 | 
| adverse events |  | 2014-01-01 to 2017-12-31 |
Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Exploratory, 28-Day Study to Examine the Effects of AR9281 on Blood Pressure and Glucose Tolerance in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Conditions
-----------------
Hypertension, Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Drug: AR9281
* Drug: AR9281
* Drug: Placebo
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate hypertension naive to antihypertensive medication or on two or less antihypertensive medications impaired glucose tolerance mild obesity Exclusion Criteria: Diagnosis of Type 1 or Type 2 diabetes History of severe heart failure AST, ALT levels more than twice the normal range

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>AR9281 | Drug: AR9281<br>* AR9281 taken in BID dosing regimen for 28 days<br>|
| Active Comparator: 2<br>AR9281 | Drug: AR9281<br>* AR9281 taken in TID dosing regimen for 28 days<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo taken in BID dosing regimen for 28 days<br>|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Placebo taken in TID dosing regimen for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and Diastolic blood pressure |  | 28 day treatment period | 
| Glucose dynamics and insulin sensitivity |  | 28 day treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, impaired glucose tolerance, s-EH enzyme inhibition, pre-diabetes