cyrilzakka/clinical-trials huggingface dataset:
Lamivudine(LAM) Good Responder Study

This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.

This is to evaluate the proportion of subjects who show good responses to LAM treatment such as HBV DNA negativity, HBV DNA less than 4 log, no resistant mutation, HBeAg seroconversion and normalization of ALT in naïve CHB patients with certain pre-treatment characteristics, i.e. HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive subjects, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative subjects.

Eligibility Criteria:
Inclusion Criteria:

1. CHB or liver cirrhosis due to Hepatitis B virus who had started LAM between Jan 1, 2003 and Dec 31, 2004 and maintained LAM at least 6 months
2. HBsAg positive at least for 6 months at the beginning of observation
3. HBV DNA positive before LAM administration
4. Subjects with certain pre-treatment laboratory findings as follows; HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive patients, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative patients

Exclusion Criteria:

1. Documented co-infection with HCV, HIV at the beginning of LAM treatment
2. Decompensated liver cirrhosis at the beginning of LAM treatment
3. HCC at the beginning of LAM treatment
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.

Exclusion Criteria:

* Patients eligible to receive chemotherapy as treatment for ANKL
MRD-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allo-HSCT

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD) using immune or molecular techniques.DLI is an effective post-transplantation therapy for prophylaxis of leukemia relapse, but is associated with a substantial risk of GVHD. Whether MRD-directed DLI could improve outcomes remains unclear. In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute leukemia
* receiving allo-HSCT

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
The Lamina Cribrosa (LC) Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)

The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study. In the present study, the investigators intended to investigate whether the changes of the deep and superficial structures around ONH exist or not using EDI OCT.


Eligibility Criteria:
Inclusion Criteria:

* the myopic patients who were supposed to undergo LASIK surgery in the Samsung Medical Center

Exclusion Criteria:

* Optic nerve head abnormalities at preoperative examination
* Previous ocular surgical history
Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries

The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Difficult airway increases by 30% with obesity and so awake extubation are the preferred technique. Coughing can be alleviated by opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an ultra-short acting opioid and its effect swiftly and predictably disappears after cessation. An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI), and the expected effective effect-site concentrations investigated have ranged from 1.5 to 2.5 ng.ml/L.

The investigators designed this study to examine the effect of different small doses of Remifentanil on the incidence of cough reflex during emergence from anesthesia in obese patients undergoing bariatric surgery. The investigators will study if these small doses will delay the recovery of the patient or not. The other expected side effects will be observed eg. Respiratory depression. Time to the first painkiller required will be registered

Eligibility Criteria:
Inclusion Criteria:

1. Age≥ 18 years
2. Subject has signed informed consent for bariatric laparoscopic surgery.
3. Subject must be ASA I or ASA II according to the American Society of Anesthetists classification.

Exclusion Criteria:

1. Age \< 18 years.
2. Smoking patient.
3. Hypertension.
4. Bronchial asthma.
5. Obstructive sleep apnea syndrome.
Self-Selected Brief Alcohol Intervention for Adolescents

Alcohol use among youth continues to be a major concern for this nation, with a large proportion of adolescents increasing their alcohol consumption as they transition from the 6th to the 8th grade. Although many adolescents experience alcohol-related problems, few actually seek help or treatment. This may be because traditional intervention approaches are not well suited for this age group. It is important to understand where adolescents turn to when they want to get help. The current project focuses on developing an alcohol intervention program for younger adolescents. We will conduct biannual surveys at two middle schools to assess alcohol and drug use patterns over three years. In years 2 and 3, we will implement an intervention in one of the schools.We will examine whether the intervention has an impact on subsequent alcohol use.

Alcohol use among youth continues to be a major concern for this nation, with a large proportion of adolescents increasing their alcohol consumption as they transition from the 6th to the 8th grade. Although many adolescents experience alcohol-related problems, few actually seek help or treatment. This may be because traditional intervention approaches are not well suited for this age group. The aims of this project are to assess factors that impact younger adolescents' alcohol-related help-seeking behavior and to develop and standardize a developmentally sensitive self-change facilitation program. We will also preliminarily test the efficacy of the program in modifying the alcohol involvement (e.g., initiation, use, and problems) of middle school students. The focus of this grant is on younger adolescents (e.g., 12-15 years old), as they are particularly vulnerable to initiating alcohol use due to unique developmental issues. For example, peer conformity peaks during 6tn, 7th and 8th grade and declines thereafter. In addition, this age group is less likely to consider future consequences in the decision making process. Biannual surveys at two middle schools will assess alcohol and drug use patterns, help-seeking behavior and preferences, self-change efforts, and level of motivation for change. Year 1 data will be used to develop a voluntary brief intervention program that targets a variety of youth, including those who are just beginning to experiment with alcohol and those who may have experienced some problems due to their use. Primary objectives are: 1) to explore barriers and facilitative factors that promote/hinder younger adolescents' use of services, 2) use detailed survey information to design and pilot a self-change program, 3) examine alcohol involvement in relation to program utilization, and 4) preliminarily evaluate the efficacy of the intervention and overall patterns of service use. This study will extend facilitation of self-change research, as this program will be one of the first voluntary alcohol focused intervention programs to target middle school students.

Eligibility Criteria:
Inclusion Criteria:

* middle school student

Exclusion Criteria:

* none
Preventing Drug Abuse Among Hispanic Adolescents

The planned research aims to delay the onset of drug use and reduce harmful use and abuse among Hispanic youths. The culturally-tailored prevention program will be delivered to youths by computer. Over 5 years, the program will be developed and tested in a randomized clinical trial. The intervention program will include 10 initial sessions, followed by annual booster sessions. Outcome measurements will involve baseline, post-intervention, and three annual follow-up data collections.

The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among participants assigned to receive the intervention. If proven to be efficacious, the program will be revised and disseminated nationally.

America's largest ethnic minority group, Hispanics are also a youthful population: one-third of Hispanic Americans are less than 18 years old. Unfortunately, young Hispanic Americans are an at-risk population more likely than their majority culture peers to drop out of school, become involved in the criminal justice system, fall prey to violence, and face lifelong economic problems. Hispanic youths are also at risk for early drug use and subsequent harmful use and abuse. As early as eighth grade and relative to their Black and White peers, Hispanic adolescents report higher rates of most harmful substances. Drug use continues to pose problems for Hispanic youths throughout adolescence and into adulthood.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 15 years old
* Hispanic ethnicity

Exclusion Criteria:

* None
Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.

demonstrate that FD-OCT guidance is feasible and possibly results in reduction of frequency-domain Optical Coherence Tomography-defined residual thrombus burden after thrombus-aspiration.


Eligibility Criteria:
Inclusion Criteria:

* ST elevation myocardial infarction
* Ages Eligible for Study: \>18 years old
* Genders Eligible for Study: Both (female sex with child-bearing potential excluded)

Exclusion Criteria:

* occluded (TIMI 0) or sub occluded (TIMI 1) proximal vessel of estimated diameter ≥3mm
* intended use of thrombus aspiration
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.


Eligibility Criteria:
Inclusion criteria:

* A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential.

Exclusion criteria:

* Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
* Administration of an influenza vaccine other than the study vaccines during the entire study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.
* lactating women
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction

Anti-inflammatory brace technology has demonstrated superior clinical outcomes in the management of knee osteoarthritis and accelerate recovery time for Major League Soccer players. Authors have postulated that embedding germanium into cotton garments increases circulation and augments the inflammatory process through a transdermal micro-electromagnetic field. In addition to immunomodulatory effects, knee braces immobilize and stabilize the joint through tactile feedback from the skin. Thus, a germanium-embedded knee brace may provide inflammatory control to augment pain and edema while concomitantly enhancing proprioception. ACL Reconstruction rehabilitation goals during the acute post-operative phase include diminishment of pain and edema as well as restoration of knee range-of-motion. The presented study intends to assess the impact of a germanium-embedded knee brace on patient recovery after ACL reconstruction.

Single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing ACL reconstruction. Patients will be randomized into germanium-infused knee brace group and compared to a replica knee brace group. Inclusion criteria will include skeletally mature individuals undergoing primary ACL reconstruction. Exclusion criteria will include autoimmune disorders and history of surgery on ipsilateral joint. The presented protocol intends to assess the impact of a germanium-embedded knee brace on patient recovery after ACL reconstruction. The primary outcome measure was chosen for its implications for the design and conduct of the study,1 including well-validated outcome instrument for comparison, facilitation of a priori power analysis, randomization, and blinding. Secondary outcomes were chosen for their pertinence to surgeon decision-making during patient rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years old
* Male or female
* Compliant patient
* BMI less than 35
* Undergoing ACL reconstruction within 30 days

Exclusion Criteria:

* Rheumatoid Arthritis
* Poorly controlled diabetes (HgA1c \> 7.5)
* Previous blood clots
* BMI greater than 35
* Varicosities on operative leg
Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA)

The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery.

All patients undergoing laparoscopic and open colorectal surgery are randomized to receive either IV acetaminophen or placebo. All patients received an opioid patient controlled anesthesia (PCA). IV acetaminophen (1 gram) or placebo is given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.

The investigators primary endpoint is to evaluate opioid consumption during the patient's hospital stay. The investigators secondary endpoints are to evaluate return of gastrointestinal function (ROGIF), time to diet ordered (TTDO), length of hospital stay (LOHS) and occurrence of ileus. Pain is measured with the pain visual analog scale score (PVASS) at 3, 8, 24 and 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing colorectal operation (Hartmann's procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileo-colonic anastomosis, low anterior resection, or abdominoperineal resection)
* Age range from 18 to 90 years old
* Patient providing signed, written informed consent before participation in the study

Exclusion Criteria:

* Patient younger than 18 years old or older than 90 years old
* Patient or family is unable to give consent
* Patient who use opioids or tramadol daily for \>7 days before study medication administration(patient who, in the investigator's opinion, had or was developing opioid tolerance)
* Patient who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator's judgment, could have compromised the subject's welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation
* Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication
* Patient who had known or suspected history of alcohol or drug abuse or dependence within the previous 1 year
* Patient who had impaired liver function
* Patient who had fever within first 48 hours post-operatively and required acetaminophen for fever reduction
IQP-PO-101 for the Regulation of Bowel Movement Frequency

The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency


Eligibility Criteria:
Inclusion Criteria:

* A subject must have experienced 2 - 4 bowel movements per week and at least 2 of the following symptoms over the preceding 3 months (self-reported):

  * Excessive straining
  * Lumpy or hard stools
  * Sensation of anorectal obstruc-tion
  * A sense of incomplete evacua-tion of bowel movements
  * A need for digital manipulation to facilitate evacuation
* Recorded between 4 and 9 defecations in the 14-day bowel movement diary during the run-in period
* Subjects of childbearing potential must agree to use appropriate contraceptive methods during run-in and treatment period
* Commitment to avoid the use of any laxatives and/ or other medicinal products/ supplements that may interfere with bowel movement frequency during the run-in and treatment period
* Written informed consent.

Exclusion Criteria:

* Known sensitivity to the ingredients of the device
* Any organic gastrointestinal diseases, congenital or otherwise
* Presence of occult blood on screening
* Constipation that may have been drug-induced
* Use of any laxative/ products that help ease bowel movements within 7 days of the screening visit
* Constipation other than idiopathic constipation
* Presence of other factor(s) that, in the in-vestigator's judgement, should preclude subject participation
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol

According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.


Eligibility Criteria:
Inclusion Criteria:

Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required.

Exclusion Criteria:

1. Patients who have been treated with antibiotics for peritonitis before taking the sample.
2. Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
3. The sample size is insufficient.
4. Repeated cases.
5. The samples whose permeate is red in visual inspection.
Reimbursement Study of Continuous Glucose Monitoring in Belgium

Type 1 diabetes mellitus (T1DM) is an autoimmune disease caused by an immune mediated destruction of the pancreatic β-cells. Once the pancreas has been depleted of a critical mass of β-cells the need for exogenous insulin therapy emerges. Several methods exist to administer insulin. An alternative way to administer insulin is by means of continuous subcutaneous insulin infusions (CSII) or insulin-pump therapy.The frequent execution of self-monitoring of blood glucose (SMBG) accomplished by a capillary finger-stick test is essential in the management of diabetes, but this is very limited and also lacks information about rising or falling trends in the actual glycaemia. A solution for this is the use of a Real-Time Continuous Glucose Monitoring (RT-CGM) device. Contrary to SMBG, RT-CGM measures glycaemia 24 hours a day, provides information about glucose direction and rate of change during multiple days a week. Since September 2014, RT-CGM is reimbursed in Belgium for a selected group of type 1 diabetic patients by means of a so-called "CGM convention". The main objective of the study is to evaluate the impact of real time continuous glucose monitoring reimbursement on real-life clinical care parameters of type 1 diabetic patients in Belgium after 12 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with T1DM included in the RT-CGM reimbursement system and followed in one of 17 diabetes centers.

Exclusion Criteria:

* Patients who are not included in the RT-CGM reimbursement system.
Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention

The aim of this study is to investigate the cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention from the perspective of a Danish healthcare system.


Eligibility Criteria:
Inclusion Criteria:

(1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) ST-segment elevation ≥ 0.1 mV in two or more contiguous electrocardiogram (ECG) leads

Exclusion Criteria:

(1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous CABG, and (4) chest pain \> 12 hours prior to admission