linjc16/ctgov huggingface dataset:
Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

Study Overview
=================
Brief Summary
-----------------
This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

Official Title
-----------------
A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)

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

Intervention / Treatment
-----------------
* Drug: abacavir/lamivudine/zidovudine
* Drug: tenofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor). Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound. Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks. A CD4+ lymphocyte count less than or equal to 100. Exclusion Criteria: Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously. Have not had an AIDS defining illness within 30 days of screen. Pregnant or breast-feeding. Specified viral genotypes upon screening. And other inclusion or exclusion criteria to be evaluated by the physician.

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

| Intervention/Treatment |
| --- |
|Drug: abacavir/lamivudine/zidovudine|nan|
|Drug: tenofovir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1 TRIZIVIR Tenofovir
Survey on Precision Medicine and Digital Health

Study Overview
=================
Brief Summary
-----------------
The investigators have created an anonymous online survey that queries current topics in precision medicine.

Detailed Description
-----------------
The investigators have created an anonymous online survey to assess the educational requirements and current gaps in knowledge related to advances in precision medicine. These include questions that focus on digital health, wearable technologies, genetic sequencing, and CRISPR to assess survey participants' interest and knowledge level.

Official Title
-----------------
Survey on Precision Medicine and Digital Health

Conditions
-----------------
Health Behavior, Health Knowledge, Attitudes, Practice, Health Attitude

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students and physicians at all levels of training. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|Online survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision medicine | To assess survey participants' knowledge of precision medicine using multiple choice methodologies. | August 2018 - November 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital health | To determine whether participants use a health monitoring device from multiple choice methodologies. | August 2018 - November 2018 |
Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to explore the real-world effectiveness and poteintial predictors in Chinese metastatic breast cancer patients.

Official Title
-----------------
Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Trastuzumab Deruxtecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 18 years old. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer. Plan to receive or has received Trastuzumab Deruxtecan monotherapy Available medical history. Exclusion Criteria: Incomplete medical history. Pregnancy or breast-breeding

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trastuzumab Deruxtecan|Trastuzumab Deruxtecan, 5.4 mg/kg ivgtt q3w|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Overall Response Rate | 6 weeks | 
| CBR | Clinical benefit Rates | 6 weeks | 
| OS | Overall Survival | 6 weeks | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety | 6 weeks |
Breast Tissue Before And After Breastfeeding Or The Use Of A Breast Pump

Study Overview
=================
Brief Summary
-----------------
There will be breast tissue changes after use of a breast pump.

Conditions
-----------------
To Collect Measurements of the Nipple, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding, To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Expressing Milk With 3 Different Electric Breast Pumps.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lactating women who were breastfeeding. Exclusion Criteria: Non breastfeeding or non lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Lactating Women<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Tissue Change | Lactating women used a 1 of 3 breast pumps or breastfed for 10 minutes. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breastfeeding, Breast tissue, Breast pump
Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Study Overview
=================
Brief Summary
-----------------
There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS). Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.

Official Title
-----------------
Effect of Epidural Analgesia on the Parameter ANI During Childbirth

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: NaCl 0.9%
* Drug: Sufentanil
* Drug: lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years, ASA I or II, No history of cardiovascular or respiratory disease No cardiovascular medication No treatment with a tocolytic agent(salbutamol, nicardipine) Desiring epidural analgesia at the early phase of labor pain Exclusion Criteria: Too fast labour A pain score at or above 70 on the pain scale A disturbed EKG signal or extrasystoles Pace-Maker Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group Saline<br>Epidural administration of saline | Drug: NaCl 0.9%<br>* epidural administration of 6 ml of NaCl 0.9%<br>|
| Experimental: Group Sufentanil<br>Epidural administration of sufentanil | Drug: Sufentanil<br>* epidural administration of sufentanil 10 µg<br>|
| Experimental: Group Lidocaine<br>Epidural administration of lidocaine | Drug: lidocaine<br>* epidural administration of lidocaine 50 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the ANI parameter with the VAS during labour | The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of epidural sufentanil and of epidural local anesthetic on ANI | The secondary objective is to compare the effects of epidural sufentanil and a local anesthetic on the parameter ANI. | 2 hours | 
| Effects of anxiety score on ANI | The secondary objective is to study the effects of anxiety on the parameter ANI. | 2 hours |
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

Study Overview
=================
Brief Summary
-----------------
The pharmacogenomic profiles of drug metabolizing enzymes play an important role in pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.

Official Title
-----------------
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

Conditions
-----------------
Neonatal Seizure

Intervention / Treatment
-----------------
* Drug: Phenobarbital


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant treated by phenobarbital monotherapy, diagnosed neonatal seizure Infant taken the drug concentration one more time given the informed consent Exclusion Criteria: progressed CNS disorder severe systemic illness GOT/GPT level more than 2times of normal value,more than 3times elevation of BUN/creatinine level congenital hemolytic anemia genetic disorder

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Phenobarbital|phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pb drug concentration | pb drug concentration, CYP2C9/CYP2C19 polymorphism | 48 hours after administering phenobarbital |
Comparison Between HD+ Endoscopy and Standard Videoendoscopy in Screening Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Colonoscopy is the accepted gold standard for screening of colorectal cancer. However, small and flat neoplastic lesions might be overlooked with standard video endoscopes. The new available EPKi system (Pentax, Japan) enables with HD+ imaging resolution above HDTV standard. Aim of the study was to test the efficacy of HD+ colonoscopy alone and in conjunction with I-Scan (newly developed post processing digital filter)in comparison to standard videoendoscopy

Conditions
-----------------
Polyps, Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients scheduled for screening colonoscopy Exclusion Criteria: Inflammatory bowel disease Cancer Pregnancy Inability to obtain informed consent Prothrombin time < 50% of control Partial thromboplastin time > 50 seconds

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>screening colonoscopy with HD+ endoscopes | |
| 2<br>screening colonoscopy with standardvideoendoscopes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Thoracic-Lumbar Arthrodesis- Implanet Jazz

Study Overview
=================
Brief Summary
-----------------
Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

Detailed Description
-----------------
To collect and organize data into a repository from the Principal Investigator's and other Site Investigators' patients who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz SystemTM at participating centers. This device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from T1 to L5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. Of note, these patients will receive the supplemental support of the Implanet Jazz Sublaminar Band as their clinical standard of care deems necessary and separately from study participation. Clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

Official Title
-----------------
Prospective Follow-up of Patients Undergoing Instrumented Thoracic and Lumbar Arthrodesis Supplemented by the Implanet Jazz System TM.

Conditions
-----------------
Spondylolisthesis, Spinal Stenosis, Degenerative Disease

Intervention / Treatment
-----------------
* Other: Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients, 18 years of age and older Qualified candidate for hybrid thoracolumbar fixation with the Implanet Jazz System TM during arthrodesis surgery. Exclusion Criteria: Individuals who have not yet reached the age of 18.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Prospective follow-up of patients who have received instrumented lumbar arthrodesis supplemented the Implanet Jazz System(TM)|To assess the clinical outcomes of patients receiving standard of care Implanet Jazz System(TM) at the time of their instrumented lumbar arthrodesis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical prospective review- Prospective Database study for future studies | Collecting clinical measurements. Examples of these clinical measurements are the VAS Pain Scale, SF-36, NDI, and ODI. | 5- years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic-Lumbar Arthrodesis, Spinal fusion, back pain
A Study to Determine the Safety and Efficacy of an Ultrasound Device in the Management of Acute Acne Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how effective and safe an experimental ultrasound device is for treating Acute Acne lesions.

Detailed Description
-----------------
Acne vulgaris is a disease that occurs when oil and dead skin cells clog the pores of the skin. When the skin's pores are clogged, red spots and bumps known as pimples are formed, usually on the face, neck, chest, and back. In adolescents and adults, acne vulgaris is commonly called acne. Many factors have been associated with acne. One of the factors is the increased production of fatty substances from an enlarged sebaceous gland (oil gland). The experimental ultrasonic device uses sound waves (called ultrasonic waves) to heat the acute acne lesion and the surrounding sebaceous (oil) glands deep in the skin without affecting the surface of the skin. We hope that heating the sebaceous glands will reduce their size and reduce the symptoms of inflamed acne. Using ultrasonic waves to treat acne is investigational. This is a pilot study. A pilot study is done on a small group of subjects to learn if the device will be effective and safe, before the device is used on a larger group of subjects.

Official Title
-----------------
A Study to Determine the Safety and Efficacy of an Ultrasound Device in the Management of Acute Acne Lesions

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Device: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female or male subjects, greater than 18 years age, with acute acne on the face. Exclusion Criteria: pregnancy, concomitant skin diseases, severe acne, antibiotic therapy.

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

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

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

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: ultrasound<br> | Device: ultrasound<br>* ultrasound exposure on acute acne lesions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clear acute acne lesions |  | 12 days |
The Breathe Light Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.

Official Title
-----------------
The Breathe Light Study: Validation of Carbon Stable Isotope Ratio in Breath as an Indicator of Energy Balance and Substrate Utilization

Conditions
-----------------
Over-eating, Obesity

Intervention / Treatment
-----------------
* Other: 20% fewer calories
* Other: 40% fewer calories


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 years old Overweight (BMI 25-40 kg/m2) Exclusion Criteria: Metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.) Gastrointestinal disorders Disease that affects macronutrient utilization Medication that affects macronutrient utilization Allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy) Use of nutritional/sport supplements Pregnant or currently trying to become pregnant

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20% calorie depletion<br>During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other). | Other: 20% fewer calories<br> <br> Other: 40% fewer calories<br> <br> |
| 40% calorie depletion<br>During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other). | Other: 20% fewer calories<br> <br> Other: 40% fewer calories<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in breath Carbon 13 with overconsumption of calories | A period of positive energy balance following one of negative energy balance increase breath Carbon13. | 11 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, carbon13, over-eating, metabolic chamber, room calorimeter