linjc16/ctgov huggingface dataset:
Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Study Overview
=================
Brief Summary
-----------------
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.

Official Title
-----------------
A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn

Conditions
-----------------
Frequent Heartburn

Intervention / Treatment
-----------------
* Drug: Lansoprazole
* Drug: Lansoprazole
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experiencing heartburn at least 2 days per week during the nighttime period over the past month. Having heartburn that responds to heartburn medication. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. Exclusion Criteria: Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy). Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study. Other protocol-defined inclusion/exclusion criteria may apply

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>15 mg lansoprazole | Drug: Lansoprazole<br>* Lansoprazole 15 mg once per day for 14 days<br>* Other names: Prevacid - United States;|
| Experimental: 2<br>30 mg lansoprazole | Drug: Lansoprazole<br>* Lansoprazole 30 mg once per day for 14 days<br>|
| Placebo Comparator: 3<br>placebo | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frequent heartburn, proton pump inhibitor, lansoprazole, Treatment of, over 14 days
The Study of the Prevalence of Helicobacter Pylori Infection Among HIV/AIDS Cohort

Study Overview
=================
Brief Summary
-----------------
The purpose of the Study is to investigate the prevalence of Helicobacter Pylori infection among the HIV/AIDS group. The study will screen the patients who were confirmed HIV/AIDS in Kaohsiung Medical University Hospital and collect the cases who were suspicious of Helicobacter Pylori infection.

Official Title
-----------------
The Study of the Prevalence of Helicobacter Pylori Infection Among HIV/AIDS Cohort

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of HIV the person who have stomach pain, vomiting or nausea
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 |
| --- | --- | --- |
| all cause stomach pain |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, AIDS, Helicobacter pylori
Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study

Study Overview
=================
Brief Summary
-----------------
This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.

Detailed Description
-----------------
Relapse of hepatocellular carcinoma (HCC) is one of the leading causes of death after liver transplantation (LT). Detection of cancer at an earlier stage of the disease can be critical to improve patient survival. Liquid biopsy is a revolutionary technique that is opening previously unexpected perspectives. It consists of circulating extracellular vesicles, nucleic acids (DNA and RNA) and circulating tumor cells. The detection and isolation of circulating tumor cells, circulating tumor DNA and exosomes, as a source of genomic and proteomic information in patients with cancer. Regarding these promising and potential transformative tools, as well as the issues still needed to be addressed for adopting various liquid biopsy approaches into clinical practice. This study aims to develop a novel, reliable, liquid biopsy-based biomarker system for relapse of HCC associated with hepatitis B after liver transplantation.

Official Title
-----------------
Liquid Biopsy-based Monitoring System for Relapse of Hepatocellular Carcinoma Associated With Hepatitis B After Liver Transplantation: A Multi-center and Prospective Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: Risk model of tumor relapse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: transplants for HCC Exclusion Criteria: Liver transplantation due to other disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapse<br>Relapse of tumor within two years after liver transplantation | Other: Risk model of tumor relapse<br>* High risk factor model of tumor relapse after liver transplantation<br>* Other names: Risk model;|
| Non-relapse<br>Non-relapse of tumor within two years after liver transplantation | Other: Risk model of tumor relapse<br>* High risk factor model of tumor relapse after liver transplantation<br>* Other names: Risk model;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate of tumor |  | two years |
Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy.

Detailed Description
-----------------
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy. Randomized, double-blinded, placebo controlled, study.

Official Title
-----------------
Infrapatellar Nerve Block for Post-operative Analgesia for Knee Arthroscopy

Conditions
-----------------
Internal Derangement of Knee

Intervention / Treatment
-----------------
* Drug: 0.25% Bupivacaine
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned knee arthroscopy with soft tissue intervention age 18+ English speaking Exclusion Criteria: contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy knee arthroscopy with planned bony intervention

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo<br>A sham infrapatellar block performed under US guidance with normal saline | Drug: Normal Saline<br>* 10cc, single dose, US guided injection<br>* Other names: Placebo;|
| Experimental: Infrapatellar nerve block<br>An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine | Drug: 0.25% Bupivacaine<br>* 10cc, single dose, US guided injection<br>* Other names: Nerve block;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post op Pain Score | immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain. | 0 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infrapatellar nerve, saphenous nerve, knee arthroscopy, nerve block
Amplification and Selection of Antimicrobial Resistance in the Intestine II

Study Overview
=================
Brief Summary
-----------------
Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Based on this, regression models will be used to determine the actual selection pressure caused by these drugs, and both selective forces will be compared. The results will reveal if there is a drug that causes a lower selection pressure compared to the other. The study aims to generate knowledge that is required to design effective antibiotic stewardship programs.

Official Title
-----------------
Amplification and Selection of Antimicrobial Resistance in the Intestine II

Conditions
-----------------
Antibiotic Selection Pressure

Intervention / Treatment
-----------------
* Drug: meropenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hemato-oncological disease in neutropenia or with expected neutropenia Need for treatment with meropenem or piperacillin-tazobactam Exclusion Criteria: pregnancy HIV, HBV, HCV

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Meropenem arm<br>Patients receiving meropenem to treat an infection. | Drug: meropenem<br>* Antibiotics to treat infections.<br>* Other names: piperacillin-tazobactam;|
| Pip-Tazo arm<br>Patients receiving piperacillin-meropenem to treat an infection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic Selection Pressure | Degree of the change of the intestinal resistome. | under treatment, max. 10 days |
The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children

Study Overview
=================
Brief Summary
-----------------
To determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.

Official Title
-----------------
The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial

Conditions
-----------------
Nocturnal Enuresis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Monosymptomatic nocturnal enuresis Failed treatment with desmopressin. The enuresis alarm had either been tried without effect, or deemed unfeasible because of the family situation. All patients had either tried and failed combination therapy with anticholinergics or, because of contraindications, been unable to receive such therapy. Severe enuresis with at least seven wet nights out of 14 Exclusion Criteria: Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions Depression Severe psychiatric diseases Untreated constipation

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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
Interventional Model Description: A randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoxetine<br>patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks | Drug: Fluoxetine<br>* Fluoxetine 10 mg capsules once daily for 12 months<br>|
| Placebo Comparator: Placebo<br>patients will undergo maintenance therapy Placebo for 12 weeks | Drug: Placebo<br>* placebo for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. | counting the wet nights numbers between baseline and after 2 weeks of each treatment period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children. | by counting the numbers of complication of each drugs | 6 months |
Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones

Detailed Description
-----------------
While there are several retrospective studies evaluating the efficacy of different lithotripter in percutaneous nephrolithotomy, there are few prospective studies in this regard. This study was designed to compare the efficacy and safety of Ultrasonic versus pneumatic percutaneous nephrolithotomy in treatment of large kidney stones.

Official Title
-----------------
Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Procedure: Pneumatic percutaneous nephrolithotomy
* Procedure: Ultra-sonic percutaneous nephrolithotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients with >2cm kidney stone Exclusion Criteria: Pregnant women patients with coagulopathies patients with scattered stones who needed several accesses

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pneumatic percutaneous nephrolithotomy<br>pneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone | Procedure: Pneumatic percutaneous nephrolithotomy<br>* Pneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone<br>|
| Active Comparator: Ultra-sonic percutaneous nephrolithotomy<br>Ultra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone | Procedure: Ultra-sonic percutaneous nephrolithotomy<br>* Ultra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate |  | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin loss |  | 2 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumatic, ultra-sonic, percutaneous nephrolithotomy
Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases

Study Overview
=================
Brief Summary
-----------------
Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss. Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study. Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions. Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups. The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As secondary outcome the investigators will assume a 5% of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium.

Official Title
-----------------
Prospective Randomized Controlled Trail to Assess the Efficacy of EmbryoGen Culture Medium to Improve Ongoing Pregnancy and Implantation Rates in IVF Treatments of Patients With a Previous History of Pregnancy Loss

Conditions
-----------------
Infertility, Miscarriage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - At least one (maximum 3) miscarriage and/or biochemical pregnancy after ART treatment Exclusion Criteria: Frozen spermatozoa Frozen oocytes women with PCO and PCOS women with more than 4 ART treatments
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVF treatment EmbryoGen<br>Embryo culture in EmbryoGen medium | |
| IVF treatment ISM1<br>Embryo culture in ISM1 medium | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy Rate after 12 weeks of gestation |  | 12 weeks after conception | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Implantation Rate after 12 weeks of gestation |  | 12 weeks after conception | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, Embryo culture, Ongoing Pregnancy rate, Ongoing Implantation rate, Miscarriage
Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the therapeutic effect and treatment results of radiofrequency ablation using the Octopus MP electrode capable of temperature monitoring and drug injection and a variable-length electrode for treatment of small hepatocellular carcinomas (≤ 3cm).

Official Title
-----------------
Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus MP Electrodes or Octopus Electrodes With Adjustable Tips: A Prospective Observational Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child-Pugh Class A or B chronic hepatitis B or chronic hepatitis C or liver cirrhosis presence of hepatocellular carcinoma (HCC) after confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to the Korean Liver Cancer Study Group (KLCSG)-National Cancer Center (NCC) Korea practice guidelines. up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment. Exclusion Criteria: number of recurrent HCCs, more than 3 largest HCC size over 3 cm presence of vascular invasion by HCC platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50% presence of extrahepatic metastasis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Radiofrequency ablation|Radiofrequency ablation will be performed by using the Octopus MP electrodes. It is a method of directly measuring the temperature near the surrounding tissue of the target tumor using the Octopus MP electrode, and stopping ablation when the temperature rises above 60 degrees to prevent adjacent organ (gallbladder, gastrointestinal tracts, diaphragm, and heart). If the shape of the tumor is elliptical or irregular rather than circular, using an adjustable tip that can change the length of the active tip of the electrode according to the size of the tumor has the advantage of tailoring the ablation zone.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjacent organ thermal injury rate | Evaluate adjacent organ thermal injury rate by immediate follow-up computed tomography after radiofrequency ablation. | Immediately after radiofrequency ablation |