cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.

Surgery currently remains the only potentially curative treatment for biliary tract cancer (BTC), and most patients develop recurrence. Therefore, effective adjuvant chemotherapy is required to increase the curability of surgery and to prolong the survival in these patients. However, to date, no standard adjuvant chemotherapy has been established, and a guideline for BTC treatment recommends that trials of adjuvant chemotherapy be carried out.

Based on results from clinical studies in unresectable BTC, gemcitabine, platinum agent, fluoropyrimidine are considered to have activity against BTC. These agents are expected to be effective in the postoperative adjuvant therapy for BTC, Thus, randomized controlled trials with gemcitabine are ongoing, and the results are expected. Recently, in the ABC-02 study, the first prospective multicenter phase III study in patients with unresectable BTC, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged MST (from 8.1 to 11.7 months; P \< 0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for unresectable BTC, and we expect this regimen to be effective for postoperative adjuvant therapy.

Though hepatectomy is frequently performed in surgery for BTC, it is unclear that the effect of anticancer agent is affected by hepatectomy. Because gemcitabine is metabolized by cytidine deaminase primarily in the liver, it considered to have decreased the metabolic ability of gemcitabine after hepatectomy. Some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine. In the adjuvant chemotherapy with gemcitabine, it is necessary to examine separately whether hepatectomy was undergone or not.

In this study, we aimed to assess the safety and efficacy of gemcitabine/cisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Biliary tract cancer (BTC) with more than stage IB
2. BTC undergoing R0 or R1 resection without major hepatectomy
3. Older than 20 years old
4. PS0 or 1
5. No treatment other than surgery
6. No dysfunction of main organs
7. Possible oral intake
8. Treatment start; after 4 weeks and within 12 weeks after surgery
9. Obtained written informed consent

Exclusion Criteria:

1. Patients with resection of major hepatectomy
2. Patients with double cancers
3. Patients having severe allergy
4. Patients with severe organ dysfunction
5. Patients with active infectious disease
6. Pregnancy
7. Patients with severe psychological disease
8. Patients seem inadequate for this study by investigators
Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)

The goal of this cluster randomized trial is to learn if eDrugSafe, a mobile web platform for drug electronic labeling (e-labeling) and medication management, can improve medication adherence and self-efficacy in adults who take multiple medications. This study will also assess whether eDrugSafe is feasible and acceptable for use in real clinical settings, especially in local pharmacies.

The main questions it aims to answer are:

* Can eDrugSafe improve medication adherence, self-efficacy, and quality of life for adults taking multiple medications and reduce hospitalizations?
* Is eDrugSafe acceptable and feasible for implementing drug e-labeling and supporting medication management in community settings?

Researchers will compare eDrugSafe to usual care (traditional paper methods) to see if eDrugSafe is effective in supporting adults who take multiple medications, and if it can be feasibly implemented in local pharmacies.

Participants will:

* Visit a local pharmacy randomly assigned to use eDrugSafe or traditional care methods and decide if they wish to join the study.
* Use either eDrugSafe to access medication information and manage their medication history, or receive usual care with paper-based methods, for 6 months.
* Complete surveys at the start of the study, at 3 months, and at 6 months to measure effectiveness and implementation outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 to 79 years.
2. Individuals who can speak and understand Korean.
3. Possession of a personal electronic device capable of accessing mobile applications and web services over wireless internet (bring participants' own device, BYOD).
4. Patients taking three or more medications with at least one medication prescribed for 28 days or longer.
5. Individuals who have provided direct consent to participate in the study.

Exclusion Criteria:

1. Individuals using any mobile web platform other than eDrugSafe for medication safety information purposes after enrollment.
2. Individuals who do not consent to participate in the study or who withdraw their consent.
Microbial and Pharmacological Assessment of Chlorhexidine

Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in patients' saliva at the same time-points after CMW.

Ventilator associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in the ICU. Oropharyngeal colonization with bacterial pathogens is the first step toward lung infection. Oral hygiene with Chlorhexidine mouth wash (CMW) is among the most widespread preventive measure to prevent VAP. Although many guidelines and expert opinions recommend oral hygiene with chlorhexidine, optimal conditions of CMW use remain unknown. In addition, precise microbial documentation of CMW efficacy on oropharyngeal colonization is lacking. Investigators wish to determine CMW antimicrobial efficacy in ICU ventilated patients and to measure chlorhexidine residual concentration in the saliva at the same time-points after CMW.

In the participanting unit, CMW is performed every 6 hours with a 0.12% chlorhexidine solution.

Hence, microbial oropharyngeal sampling will be performed 6h after the last CMW (and just before the next one), to assess oropharyngeal colonization and then 15 minutes, 1 hour, 2 hours, 4 hours, and 6 hours after a new CMW to assess CMW efficacy in terms of bacterial growth.

In a subset of patients, 0.5 mL of saliva will be collected with a syringe at the same time points, with an additional T30 time (at 30 minutes) to measure chlorhexidine concentration.

Eligibility Criteria:
Inclusion Criteria:

* critically-ill patients admitted to the ICU and receiving invasive mechanical ventilation for more than 48 hours

Non-inclusion criteria:

* cervical or mouth surgery in the last 15 days;
* history of oropharyngeal neoplasm or of cervical or oropharyngeal radiotherapy,
* tracheotomy,
* age under 18

Exclusion Criteria:

* Patients whose samples retrieved less than 10 to the 3 colony forming unit (CFU)/mL bacteria and those who had two or more missing microbiological samples were secondarily excluded
Effect of HMG-CoA Reductase Inhibitors on the Meibomian Gland Morphology in Patients With Meibomitis

This study intends to evaluate the relationship between meibomitis and statin use. Meibomitis is the predominant cause of evaporative dry eye. Higher cholesterol levels were noted in patients with meibomitis when compared to controls without meibomitis. We would like to investigate the effect of statin use on meibomitis among patients with dyslipidemia.

The purpose of our study is to assess the change of meibomian gland structure in patients during treatment with 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors using meibography. Patients with dyslipidemia with or without HMG-CoA reductase inhibitor (statin) treatment were recruited. Medical records are collected prospectively from Dec. 8th 2016 to Dec. 31st 2019. Meibomian gland (MG) morphology described by meiboscores, lid margin abnormality scores, meibum quality, and dry eye parameters were compared between the two groups. This study may also provide information about possible treatment options in patients with meibomitis in the future.

Eligibility Criteria:
Inclusion Criteria:

* patients with regular HMGCR inhibitor (statin) treatment, and those with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy

Exclusion Criteria:

* patients with active eye infection, previous history of chemical or thermal injury to ocular surface, previous operation history of eyelid or conjunctiva, any known allergy or contraindications to statins, history of percutaneous coronary intervention, cerevascular accident, acute coronary syndrome, or rheumatological diseases, fish oil supplements or pregnancy were excluded
Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures

The purpose of this study is to test the efficacy of radiofrequency ablation of the medial branch nerves (RFA-MBN) in relieving pain and improving physical function in patients with subacute and chronic vertebral compression fractures (VCF).

The study examines a novel approach to treat pain associated with VCFs. The usual care therapy currently involves utilizing physical therapy, non-steroidal anti-inflammatory medications, opioids, and bone re-building medications known as bisphosphonates. A usual treatment plan may include some, if not all the above. There is growing evidence that the posterior spinal elements contribute to pain that patients with VCFs experience. RFA-MBN, which targets these posterior spinal elements, may provide more sustained pain relief and improved physical function compared to usual care for these fractures. The procedure essentially "ablates with heat" the medial branch nerves which send pain signals from the posterior elements to the brain.

Patients will be randomly selected into one of two groups. The treatment group will receive the RFA-MBN procedure along with usual care therapy. The control group will undergo usual care. The control group will have the option to cross over to receive RFA-MBN at a defined interval during the study. There will be follow up visits at various intervals to compare pain relief and function based on various surveys of the treatment, control, and cross-over groups.

Eligibility Criteria:
I• Inclusion

* 18-90 years old
* Male or female
* Age of fracture greater than or equal to 6 weeks
* Single Level Vertebral Compression Fracture
* Vertebral compression fracture Thoraic-9 to Lumbar-5
* NRS \>6/10

  • Exclusion
* \<18 or \>90 yo
* Uncorrectable Coagulopathy
* Multiple Level Vertebral Compression Fractures
* Surgery within 60 days of presentation
* Active infection
* Rhuematologic disease
* Significant neurologic deficit
* Radicular pain
* Chronic low back pain in last year
* Inability to give consent
* Cognitive impairment
* Patients with Ongoing Litigation or Worker's Compensation Cases
Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss

Considering the extent to which HAs play a role in sound perception and residual hearing preservation among patients with tinnitus and co-existing HL remains a lack of compelling extensive evidence, investigators designed this single-blind, 6-months randomized, controlled trial with two parallel groups. One is the HA treatment group, and the other is the waiting list control (WLC) group which receives no interventions during this period.

In clinical practice, chronic subject tinnitus poses an important challenge. This condition can negatively affect an individual's emotional and functional well-being. In most cases, tinnitus is highly associated with hearing impairment, particularly in cases of high-frequency sensorineural hearing loss (SNHL). The occurrence of tinnitus in patients with HL is one of the most prevalent sensory disabilities, causing a deleterious effect on patients' lives. Nowadays, the mild to moderate SNHL can be effectively managed with a fitting hearing aid (HA) by providing sound amplification, and several findings suggest that the HA may also be helpful for people with tinnitus. Nevertheless, in terms of the effects of HA use for residual hearing protection for patients with tinnitus and co-existing hearing loss, inadequate attention is still paid by medical personnel, and relevant evidence remains preliminary at this point in time.

To assess the full extent of tinnitus patients, investigators need to carry out a series of tests, including hearing assessment and psychometric tests. Pure tone audiometry (PTA) and otoacoustic emission (OAE) tests are used to calculate the average hearing thresholds and the outer hair cell function, while the Tinnitus hazard Index (THI), the Visual Analogue Scale (VAS), the Hospital Anxiety and the Depression Scale (HADs) and the Athens Insomnia Scale-8 (AIS-8) questionnaires were for patients' psychology status.

Investigators hypothesize that in patients with tinnitus and hearing loss, HA intervention results in better conditions of tinnitus and lower hearing threshold reduction. Here investigators planned to enroll patients into two groups, the HA and non-HA (served as the control) intervention patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged older than 18 years old and less than 70 years;
2. Chronic (\>6 months) subjective tinnitus, unilateral or bilateral;
3. Diagnosed with a high-frequency SNHL;
4. Be available for six months after starting the study to complete the follow-up questionnaires;
5. Readiness to participate in the study and sign the informed consent.
6. Be covered by public health insurance and eligible for reimbursement.

Exclusion Criteria:

1. Objective tinnitus;
2. Conductive HL;
3. Unstable medical history that limits participation;
4. Undergoing any other concurrent treatments on tinnitus or HL;
5. Having used HAs in the past 1 year;
6. Unwilling or unable to use HAs daily;
7. Alcohol or drug abuse;
8. Unable to read or write.
Retrospective Epidemiological Study on Botulism in Intensive Care Units in France

Botulism poisoning is a rare but serious illness. Because of it's low incidence, it is not well known by physicians. Most studies describing botulism date back to the last century and do not take into account recent advances in intensive care.

The objective of this study is to describe the clinical course, interventions and outcomes of patients with severe botulism poisoning requiring a hospitalisation in an intensive care or high dependancy unit.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of botulism
* Admission in an intensive care or high dependancy unit

Exclusion Criteria:

* None
Training Resiliency in Youth (TRY) Study

The aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (EVO) that targets the cognitive control network (CCN) will improve executive functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric symptoms. The primary goals are to 1) determine if EVO will result in improved EF and lower internalizing (e.g., mood, anxiety) and externalizing (e.g., attention deficit/hyperactivity disorder, AD/HD) psychiatric symptoms, 2) evaluate whether the benefit experienced by youth changes depending on their level of life stress (e.g., academic or social difficulties), 3) determine if EVO will promote resilience to stress. The investigators will measure EF, symptoms, and stress using self- and parent-report questionnaires. Other secondary outcomes include information on behavior in the classroom and academic performance (i.e., grades) that we will collect via school records. The investigators hypothesize that engagement with EVO 20-minutes per day, 5-days a week across 4-weeks will improve EF, lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease maladaptive responses to stress.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in 6th grade during the 2017-2018 school year at Lucille Umbarger Elementary School in the Burlington-Edison School District
* Physical ability to use a touchscreen iPad
* Cognitive ability to assent, complete questionnaires, and play EVO game
* English speaking child, English or Spanish speaking parent
* Child has legal parent/guardian (i.e., not a ward of the state)

Exclusion Criteria:

* The child is identified by parent or school as diagnosed with an intellectual disability
* The child is identified by parent or school as diagnosed with a physical disability (i.e., unable to use hands or fingers) that would preclude use of a touchscreen iPad and appropriate engagement with EVO
* The child is identified by parent or school as unlikely to engage for 20 minutes with EVO
* Child unable to read or understand English
* Parent unable to read or understand English/Spanish
* Child is in public (i.e., child welfare) custody
Validation and Comparison of the Appendicitis Inflammatory Response Score and Adult Appendicitis Score

Acute appendicitis is one of the most frequent reasons of emergency laparotomy in adults. Symptoms of acute appendicitis overlap with other clinical conditions and might present as a challenge, especially in the early phases. Despite the advances and widespread use of imaging modalities, still negative laparotomies are performed with the initial diagnosis of acute appendicitis. Several scoring systems are developed by using various clinical and laboratory parameters in order to improve the diagnostic accuracy and prevent unnecessary laparotomies.

In the recent guideline of World Society of Emergency Surgeons (WSES) recommendations regarding the clinical scoring systems for acute appendicitis are remarkable. It is stated that clinical scoring systems, on their own, can be used to exclude acute appendicitis and decrease negative laparotomy rates. Currently Appendicitis Inflammatory Response Score (AIR) and Adult Appendicitis Score (AAS) are the best clinically performing scoring systems. As a result, based on strong evidence the use of these two systems are recommended. Both scoring systems are developed on the basis of clinical findings and laboratory parameters.

The aim of this study is to validate both systems as well as to compare the efficiency of both systems on excluding negative laparotomies and on the determination of severity of acute appendicitis.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to ER with right lower quadrant pain
* Patients between 18-65 years old.

Exclusion Criteria:

* Patients receiving immun-suppressive therapy
* Patients with diagnosed malignancy
* Presence of mental retardation
* Patients with previous right hemicolectomy
* Patients with previous appendectomy
* Pregnant women
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
* Stable body weight (less than 5% selfreported change within the last 3 months)

Exclusion Criteria:

* Obesity induced by drug treatment
* Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
* Type 1 or type 2 diabetes
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 to 80 years
* Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before
* Body Mass Index (BMI) between 20 and 45 kg/㎡
* Patients with 7% ≤ HbA1c ≤ 10% at screening
* Subject who has conducted a stable diet and exercise for at least 8 weeks

Exclusion Criteria:

* Type 1 diabetes mellitus or secondary diabetes
* Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis)
* Clinical significantly renal disorders
* Creatinine clearance \< 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) \< 60mL/min/1.73
* Severe gastrointestinal disorder
* Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)
* History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia
Adjuvanted Influenza Vaccination Year 2 Follow-On Survey

The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.

This study will enroll facilities who participated in the adjuvanted influenza vaccine study in 2016-2017 to document the vaccine choice for the 2017-2018 influenza season through a survey. Additional facilities will be enrolled that did not participate to answer a survey responding to questions regarding the vaccine choice for the 2017-2018 and 2018-2019 flu season. Both groups will also gather information on vaccination rates for residents and staff, policies and procedures, and influenza outbreaks.

The facility will complete a profile and answer questions regarding influenza vaccination in their facilities for the 2017-2018 and 2018-2019 flu seasons.

The study team will obtain data from the Centers for Medicare \& Medicaid Services in 2019 to determine the study outcomes. None of the data used in the analysis will be linked to individual residents in facilities.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study
* OR
* Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites

Exclusion Criteria:

* Facilities having fewer than 50 long-stay residents
* Hospital based facilities
* Facilities with more than 20% of the population under age 65
* Facilities not submitting Minimum Data Set (MDS) data