cyrilzakka/clinical-trials huggingface dataset:
AR for Pediatric Central Venous Catheterization

This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial.

After obtaining informed consent from patients' legal guardian, children aged 6 or less undergoing surgery with need for central venous catheterization will be enrolled to the study.

Patients will be divided into either study group or control group. After anesthetic induction, central venous catheterization will be performed under ultrasound guidance. For patients in study group, the practitioner will be equipped with smart-glasses, while conventional ultrasound-guided catheterization will be performed for patients in control group.

Success rate of first trial, overall success rate, elapsed time during catheterization, complication regarding catheterization will be recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned to undergo surgery under general anesthesia
* Patients in need for central venous catheterization during anesthesia

Exclusion Criteria:

* Patients who have any of infection, hematoma, skin lesion, recent attempt of puncture at right internal jugular vein
* Patients with unstable vital sign prior to anesthetic induction
* Patients who are not eligible for catheterization at right internal jugular vein
* Refusal of legal guardian of patient
Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)

This is a phase 2 trial investigating the effect and safety of afatinib in previously treated recurrent or metastasic esophageal squamous cell carcinoma with EGFR overexpression or EGFR amplification.


Eligibility Criteria:
Inclusion Criteria:

1. Having signed informed consent.
2. Age 18 to 70 years old.
3. Histologically confirmed esophageal squamous carcinoma
4. Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
5. Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
6. Refractory or intolerant to at least one regimen.
7. Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
8. Life expectancy of ≥3 month
9. Eastern Cooperative Oncology Group (ECOG) 0-2
10. WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.5 times ULN，Serum creatinine \<1.5 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
11. No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃.
12. Good compliance

Exclusion Criteria:

1. Contraindications of afatinib.
2. Unable to take afatinib orally because of esophageal stenosis.
3. Currently receiving other effective regimens.
4. Previous anticipate other clinical trial within 4 weeks before entering this study.
5. No measurable lesions, eg. pleural fluid and ascites.
6. With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
7. Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
8. Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.
9. HIV infection, active hepatitis B or hepatitis C.
10. Unstable systemic diseases such as poorly controlled diabetes.
11. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.
12. Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.
13. Pregnancy or lactation period.
14. Active severe infection within 14 days.
Incidence and Risk Factors for Developing Infections in Patients Colonized by CP-KPC

The worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem.

Infections caused by carbapenem-resistant Klebsiella pneumoniae (CR-KP) are associated with high morbidity and mortality. Mortality of up to 70% and, in survivors, a readmission rate of up to 72% within 90 days of discharge have been reported.

CR-KP infection is usually preceded by colonization. However, the incidence rate and risk factors for CR-KP infections among carriers is poorly understood.

Multiple studies have focused in risk factors to develop infections among carriers.

In order to identify patients at low risk of CR-KP bloodstream infections, Gianella et at developed a predictive score to stratify patients according to their risk for acquisition of CR-KP infections.

However, further studies are needed to validate these results, particularly in high-risk patients, such as haematological patients, solid organ trasplant recipients and patients admitted in ICU.

Italian Hospital is an acute tertiary care university teaching hospital with more than 45,000 admission-years, in Buenos Aires, Argentina, with a great proportion of haematological and solid organ transplant recipients, and patients with substantial comorbidities and immunosuppression.

With the aim of developing an adequate risk assessment for CR-KP infections among CR-KP carriers, we performed a retrospective cohort analysis, in a tertiary teaching hospital in Buenos Aires, Argentina.

The main purpose of our study is to describe the incidence of CR-KP infections among CRKP colonized patients, to demonstrate the risk factors for acquisition of CR-KP infections and to develop a clinical predictive score that could stratify patients to guide therapeutic decisions in CR-KP carriers, and avoid overuse of broad-spectrum therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized from 01/2014 to 01/2019

Exclusion Criteria:

* Unwillingness to participate
Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience

To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy

To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy Randomized clinical trial comparative study will be carried out on 50 patients underwent laparoscopic cholecystectomy in general surgical department, Sohag University. An informed written consent will be obtained from the patients. Every patient will receive an explanation of the purpose of the study and will have a secret code number. Research results will be only used for scientific purposes. Any unexpected risks appearing during the course of research will be clarified to the participants and to the ethical committee on time.

Patients will be randomly classified into two equal groups; 25 patients will be enrolled in each group using computer generated random number in closed sealed envelope.

Group I (3-ports): 25 patients undergo a three-port LC. Group II (4-ports): 25 patients undergo a four-port LC. All patients will be subjected to thorough history taking (age, sex, symptoms, and duration of symptoms) and full clinical evaluation.

Abdominal ultrasound will be done in all patients. Baseline laboratory (complete blood count and coagulation profile) will be ordered in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years.
* Both sexes.
* Patient with clinical, laboratory and/or radiological evidence that is a candidate for cholecystectomy operation.

Exclusion Criteria:

* Patient's refusal.
* Bile duct stones.
* History of obstructive jaundice.
* Severe acute calculus pancreatitis.
* Severe co-morbid diseases (uncontrolled diabetes, hypertension, and severe direct hyperbilirubinemia).
* Prior surgery or adhesion.
* Radical cholecystectomy.
* Pregnancy.
* Malignancy.
Individual Treatment of Ustekinumab in Perianal Fistulizing Crohn's Disease

This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease.

Participants in the study receive ustekinumab injections as part of routine medical care. The study just observes the efficacy retrospectively and does not interfere with treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Perianal Fistulizing Crohn's Disease
* Receive ustekinumab therapy

Exclusion Criteria:

* Ustekinumab combined with hormones, immunosuppressants, other biologics or small molecule drugs
* Combined with other autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Graves disease, etc.
* Combined with serious infectious diseases, such as active tuberculosis, EBV infection, cytomegalovirus infection, etc.
* Combined with malignant tumor
* Clinical data missing ≥30% or no follow-up
Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)

This is a multi-national trial. The goals of the trial are to study the growth response to LUM-201 administration in children with idiopathic growth hormone deficiency (GHD) previously treated with daily rhGH for 12 months in the LUM-201-01 trial.

This trial will have one screening/baseline visit with tests to assess if subjects are eligible to start study therapy. The screening/baseline visit can coincide with the Month 12 visit in the LUM-201-01 trial. Subjects will receive the same dose of LUM-201 as a daily oral dose each morning. LUM-201 will be adjusted for body weight increments at each clinic visit, as applicable.

The trial consists of 12 months of treatment. After screening, subjects will return to the clinic for 5 visits. During four of these clinic visits, safety laboratory samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable.
* Must have previously completed 12 months of daily rhGH treatment as part of the LUM-201-01 PGHD trial.
* Is eligible for study participation as confirmed by the principal investigator (PI)

Exclusion Criteria:

* Has a medical condition that, in the opinion of the PI and/or MM, adds unwarranted risk to use of LUM-201.
* Uses any medication that, in the opinion of the PI and/or MM, can independently cause short stature or limit the response to exogenous growth factors.
* Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.

Eligibility Criteria:
Inclusion Criteria:

* Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
* Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301

Exclusion Criteria:

* Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
* Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma

Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* signed written consent
* 18 years and older
* severe trauma (ISS \> 15)
* burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface)
* SIRS

Exclusion Criteria:

* not fulfilling the inclusion criteria
* failure to adhere
Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.

This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24.


Eligibility Criteria:
Inclusion Criteria:

* Men or women must be at least 18 years of age at the time of screening
* Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
* PASI score of \>10
* Affected body surface area (BSA) \> 10%
* DLQI \>10
* Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.

Exclusion Criteria (abbreviated):

* Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline
* Ongoing use of other prohibited psoriasis and non-psoriasis treatment.
* Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations
* Patients with severe liver diseases
* Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers
* Patients with severe kidney diseases or serum creatinine above 1 x ULN
* Patients with known hematological disease or lab abnormalities
* Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary)
Identifying Optimal Smoking Cessation Intervention Components (Cessation)

The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Report smoking at least 5 cigarettes per day for the previous 6 months;
* Able to read and write English;
* Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
* Plans to remain in the intervention catchment area for at least 12 months;
* Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
* All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.

Exclusion Criteria:

* Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
* Study candidate is pregnant, trying to get pregnant, or nursing.
* A history of psychosis or bipolar disorder
* A history of skin or allergic reactions while using a nicotine patch.
* Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
Gazelle COVID-19 Test Clinical Accuracy Protocol

Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.


Eligibility Criteria:
Symptomatic study:

Inclusion Criteria:

The presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms include:

* Fever
* Coughing
* Shortness of breath
* Recent loss of sense of smell or taste
* Chills
* Repeated shaking with chills
* Muscle pain
* Headache
* Sore throat
* Vomiting or diarrhea

  * Within 1-5 days of symptom onset
  * Informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor
  * All ages
  * All genders
  * Pregnant women

Exclusion Criteria:

* Severe disease requiring immediate medical intervention
* Inability to tolerate sampling procedure (nasal swab)
* Failure to provide informed consent
* Nasal deformities preventing sampling by swab
* Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
* Asymptomatic patients

Asymptomatic study:

Inclusion criteria:

* Present to the facility for a COVID-19 test without symptoms
* Informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor

Exclusion Criteria:

Exclusion criteria include one or more of the following:

* Severe disease requiring immediate medical intervention
* Inability to tolerate sampling procedure
* Is below 2 years old
* Failure to provide informed consent
* Nasal deformities preventing sampling by swab
* Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
* Presence of typical symptoms of COVID-19 (fever, sore throat, fatigue, etc.)
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.

This is a randomized controlled clinical trial with three parallel arms. This trial aims to evaluate the effectiveness of electroacupuncture on P6 acupoint for patients with hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old
* Have not recently had any changes in anti-hypertensive medications
* Have not recently been discharged from hospital/are stable
* Is not having any acute infection.

Exclusion Criteria:

* Trypanophobia
* Below 18 years of age
* Is currently having an acute infection
* Is unstable or have been discharged recently from hospital
* Changes made to anti-hypertensive medications
The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury

This study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment

Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.

So, we conducted a randomized controlled trials to verify the efficacy and safety of trapezuis MSAT. From July 2019 to September 2019, we collected 100 inpatients who were suffered from posterior nick pain with the numeric rating scale(NRS) over 4 after whiplash injury by acute traffic accident(TA). For experimental group(n=50), we conducted MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=50), just Korean medical treatment except MSAT was conducted. For these two groups, we compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Nthe amount of pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Neck Disability Index (NDI), and EuroQol 5-Dimension (EQ-5D).

Eligibility Criteria:
Inclusion Criteria:

* Patients who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident
* Patients with NRS ≥ 5 for posterior neck pain
* Patients aged 19-70 years on the date they sign the consent form
* Patients who provide consent to participate in the trial and return the informed consent form

Exclusion Criteria:

* Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.
* Patients with progressive neurological deficits or with severe neurological symptoms
* Patients who have had surgery or procedures within the last three weeks
* The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
* Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
* If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
* Patients who are pregnant or planning to become pregnant
* Patients with a serious mental illness
* Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
* Patients who are difficult to complete the research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic