linjc16/ctgov huggingface dataset:
A Study Assessing the Safety and Efficacy of DE-117 in Subjects With POAG or OH Who Are Non-/Low-responders to Latanoprost: FUJI Study

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.

Official Title
-----------------
A Phase III, Open-label, Single-arm, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension Who Are Non-/Low-responders to Latanoprost Ophthalmic Solution: FUJI Study

Conditions
-----------------
Primary Open Angle Glaucoma or Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DE-117 ophthalmic solution
* Drug: Latanoprost ophthalmic solution 0.005%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma or ocular hypertension Exclusion Criteria: Patients at risk of progression of visual field loss Patients with severe visual field defect Patients with any diseases that preclude participation in this study for safety reasons

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Other: DE-117 ophthalmic solution and Latanoprost<br>DE-117 is Experimental. Latanoprost is Active Comparator. | Drug: DE-117 ophthalmic solution<br> <br> Drug: Latanoprost ophthalmic solution 0.005%<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | Week 4 |
Risk Factors for Quinolone Resistance Among ESBL Producing Klebsiella Species

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed.

Detailed Description
-----------------
This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. This research is (c) important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. Additionally, we will identify whether horizontal spread is responsible for this increasing trend.

Official Title
-----------------
Risk Factors for Quinolone Resistance Among Extended-Spectrum Beta-Lactamase-Producing Klebsiella Species

Conditions
-----------------
Quinolone Resistance, ESBL, Klebsiella Species, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be quinolone resistant among ESBL producing klebsiella species Exclusion Criteria: Those not meeting entry criteria

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quinolone resistance, ESBL, Klebsiella species, Infection
Acute Heart Failure Monitoring Via Inferior Vena Cava Ultrasound

Study Overview
=================
Brief Summary
-----------------
Known before diagnosed heart failure and used diuretic therapy patients will be admitted in this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be used for management of Acute Heart failure therapy. And investigators will calculation correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers will not interfere to standard recommended treatment protocol, researchers will correlated the urine amount and changed vital signs with therapy with Vena cava inferior diameter.

Official Title
-----------------
The Role of Inferior Vena Cava in Emergency Treatment of Acute Decompensated Heart Failure and Deciding Hospitalization

Conditions
-----------------
Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 years of age) of both sexes) Non-trauma patients Non- pregnant patients All patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload Exclusion Criteria: Cardiac tamponade Aortic dissection Patients who had suffered cardiopulmonary arrest or been intubated
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 |
| --- | --- | --- |
| Vena cava inferior diameter change end of each 500cc urination |  | Maximum 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vena cava inferior diameter change with classic treatment at each hour |  | Maximum 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inferior vena cava ultrasound, acute, heart failure, management, decompensation
Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.

Study Overview
=================
Brief Summary
-----------------
Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting. It has been suggest that antagonism of residual neuromuscular block with a mixture of neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea and vomiting. Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse effects include slight coughing, movement, an altered taste sensation in the mouth, transient prolongation of the QT interval, hypersensitivity, and a short term prolongation of the activated partial thromboplastin time. The aim of this study was to compare the sugammadex versus neostigmine plus atropine for reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative nausea and vomiting.

Conditions
-----------------
Incidence of Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Neostigmine
* Drug: sugammadex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1 and 2 endotracheal intubation and general anesthesia scheduled for elective surgery Exclusion Criteria: age < 18 years, > 65 years pregnancy refusal to participate and patients already participating in another study allergy to study drugs communication difficulty psychiatric and neurological disorders use of analgesics or sedative or antiemetic drugs within 24 hours before surgery. emergency surgery history of drug or alcohol abuse ASA 3 and above patients with vertigo Laparoscopic surgery, oncologic surgery, strabismus and mid ear surgery neurosurgery, gynecologic surgery, breast surgery

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: neostigmine<br> | Drug: Neostigmine<br>* for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine<br>|
| Active Comparator: sugammadex<br> | Drug: sugammadex<br>* for reversal of neuromuscular block: sugammadex 2 mg kg-1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Descriptive Scale | 0: no nausea 1: mild 2: moderate 3: severe | within postoperative 24 hours |
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor

Study Overview
=================
Brief Summary
-----------------
Capture of anxiety for anomalies, stillbirth and preterm Labor of pregnant women during COVID-19 pandemia

Official Title
-----------------
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor - CAASPtrial

Conditions
-----------------
Anxiety State

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consenting ability Exclusion Criteria: language barrier uncompleted questionary

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire) | Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison with different empiric studies of anxiety for anomalies in pandemics | 6 months | 
| anxiety for stillbirths during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire) | Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison with different empiric studies of anxiety for stillbirths in pandemics | 6 months | 
| anxiety for preterm labour during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire) | Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison with different empiric studies of anxiety for preterm labour in pandemics | 6 months |
China Health Big Data

Study Overview
=================
Brief Summary
-----------------
In this nationwide multi center study the investigators combine the low dose chest CT scan data with QCT technology, to measure the BMD of spine, VAT and liver fat in the health check subjects. The aim of this study is to evaluate the performance of QCT in the health check field, and further to evaluate the prevalence of osteoporosis, obesity and liver steatosis in health check population across China.

Detailed Description
-----------------
Low dose Chest CT scan is the standard for lung cancer in the health check center in China. Quantitative computed tomography (QCT) is utilizing the CT raw data to measure the bone mineral density (BMD), the visceral fat (VAT) and liver fat content in human, which can be widely used in the diagnosis of osteoporosis, the assessment of obesity and liver steatosis. In this nationwide multi center study the investigators combine the low dose chest CT scan data with QCT technology, to measure the BMD of spine, VAT and liver fat in the health check subjects. This study is to evaluate the performance of QCT in the health check field, and further to evaluate the prevalence of osteoporosis, obesity and liver steatosis in health check population across China.

Official Title
-----------------
China Nationwide Multi Center Big Data Study on the Quantitative Computed Tomography (QCT) and Health Status of Check -up Population

Conditions
-----------------
Osteoporosis, Obesity, Liver Steatoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health check subjects 30-90 years old low dose chest CT scan Exclusion Criteria: pregnant women metal implant in the CT scan area

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| The spinal volumetric bone mineral density (vBMD) | The volumetric bone mineral density of L1-2 measured by QCT | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visceral adipose tissue (VAT) | The visceral adipose tissue (VAT) measured by quantitative computed tomography (QCT) | 2 year | 
| Liver fat | Liver fat measurement by quantitative computed tomography (QCT) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone mineral density, quantitative computed tomography, Osteoporosis, obesity, liver steatosis
A Clinical Trial of Ginseng in Diabetes

Study Overview
=================
Brief Summary
-----------------
a clinical study of Ginseng its potential affect on diabetes

Detailed Description
-----------------
Comparing three groups (those with & without normal blood sugar levels) to see if there is any clinically significant change in blood sugar levels in relationship to those taking: ginseng ginsenoside RE (a type of metabolized ginseng) placebo

Official Title
-----------------
A Clinical Trial of Ginseng for Glucose Intolerance

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Ginseng
* Drug: Ginseng
* Drug: ginsenoside RE
* Dietary Supplement: Placebo (sugar pill)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-65 healthy, non-diabetic healthy, impaired glucose tolerance/mild diabetes (no medications required) Exclusion Criteria: impaired glucose tolerance (borderline diabetes that requires medications) diabetes (requiring medications) caffeine sensitivity known cardiac, peripheral vascular diseases arrhythmias (irregular heart rhythms)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Ginseng<br>Ginseng group | Drug: Ginseng<br>* Each of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups<br>|
| Active Comparator: 2. Ginsenosdie RE<br>Ginsenoside RE (a metabolite of ginseng) group | Drug: Ginseng<br> <br> Drug: ginsenoside RE<br>* active metabolite of ginseng<br>|
| Placebo Comparator: 3. Placebo<br>placebo (sugar pill) group | Dietary Supplement: Placebo (sugar pill)<br>* placebo group<br>|

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
-----------------
Health Supplements, Ginseng, Diabetes
Therapeutic Potential of Kappa-Opioids Against Cocaine - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the effects of enadoline compared to hydromorphone and butorphanol.

Official Title
-----------------
Therapeutic Potential of Kappa-Opioids Against Cocaine

Conditions
-----------------
Cocaine-Related Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: opiate experienced, healthy Exclusion Criteria: physical dependence on opioids, barbiturates or alcohol

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Effects of Relaxation and Guided Imagery Training on Pain at Childbirth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether relaxation and guided imagery techniques are effective in reducing childbirth pain.

Official Title
-----------------
Effects of Relaxation and Guided Imagery Training on Rate and Time of Receiving Regional Anesthesia (Epidural), and on the Experience of Childbirth

Conditions
-----------------
Pain at Childbirth

Intervention / Treatment
-----------------
* Behavioral: relaxation (breathing and muscles) and guided imagery (safe place)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who carry their first child women that carry only one embryo women who speaks hebrew Exclusion Criteria: women who experienced complications in pregnancy. women who planning on having an elective Caesarean section. women who suffer from background systematic condition (such as high-BP, diabetes). women who have psychiatric background. women who take chronic medication that might effect childbirth, woman or baby's health.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>55 third trimester women will receive a CD of relaxation and guided imagery (of safe place), to practice daily at home until childbirth | Behavioral: relaxation (breathing and muscles) and guided imagery (safe place)<br>* intervention group: daily practice of relaxation and guided imagery CD, for a rew weeks, until childbirth.<br>|
| No Intervention: control<br>55 third trimester women who does not receive the relaxation and guided imagery CD. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rating of pain experienced during childbirth on pain VAS |  | one time - during hospitalization after childbirth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate and the starting time of receiving regional anesthesia (epidural) |  | at childbirth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, childbirth, relaxation, guided imagery, VAS, epidural
Study of Bimatoprost Gel on Eyelash Growth

Study Overview
=================
Brief Summary
-----------------
A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.

Official Title
-----------------
The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety

Conditions
-----------------
Madarosis, Hypotrichosis

Intervention / Treatment
-----------------
* Drug: Bimatoprost eyelash gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 YO females madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer only breast cancer patients Exclusion Criteria: inability to follow up, apply gel active eye/eyelid infection or inflammatory process cancer not related to breast cancer, healthy patients males

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost treated eyelid<br>one eyelid of the patient was randomized to the treatment arm and given the gel to use | Drug: Bimatoprost eyelash gel<br>* Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months<br>* Other names: lumigan;|
| No Intervention: control arm - no gel<br>the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eyelash length | eyelash ruler used to measure eyelash length | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eyelash pigment | blinded grader used digital photos to grade degree of pigment on scale of 1-5 | 6 mos | 
| eyelash thickness | blinded grader used digital photos to grade degree of thickness on scale of 1-5 | 6 mos | 
| eyelash amount | blinded grader used digital photos to grade degree of amount by counting lashes | 6 mos | 
| eyelash side effects | any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed | 6 mos |