cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma

This clinical trial aims to explore and evaluate the efficacy and safety of combined chemotherapy with arsenic trioxide for stage 4/M neuroblastoma.

This study is a prospective, single-arm, open-lable, multi-center clinical trial. Children≤ 14 years old are eligible for this study if they were newly diagnosed with neuroblastoma and assessed as stage 4 according to the International Neuroblastoma Staging System (INSS) or stage M according to the International Neuroblastoma Risk Group (INRG) respectively. Patients enrolled in this study will receive combined induction chemotherapy with arsenic trioxide following an modifed protocol based on N7 and NB2004 protocols. Objective response rate (ORR) at 4 weeks after completing induction chemotherapy was defined as the main outcome and adverse events were monitored and graded in the meantime.

Eligibility Criteria:
Inclusion Criteria:

1. Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System（INSS) or the International Neuroblastoma Risk Group (INRG) staging system;
2. Patients not more than 14 years old;
3. There are measurable lesions;
4. Guardians agreed and signed informed consent.

Exclusion Criteria:

1. Patients who had suffered from other tumors and received chemotherapy or abdominal radiotherapy.
2. Patients with one or more critical organs failure such as heart, brain, kidney failure.
Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?

This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART among HIV infected individuals who neither use nor require HAART, and who have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study initiation.


Eligibility Criteria:
Inclusion Criteria:

* adult (aged 18 years or older or as per Local/Provincial Guidelines)
* documented HIV-1 infection (determined by EIA and Western blot, sites' standard assays are acceptable if approved in advance by the PIs for the study, Dr. Darrell Tan and/or Dr. Sharon Walmsley)
* no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
* antiretroviral naïve (no more than 14 days of total prior ARV exposure)
* CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 30 days of initiating trial (baseline visit)
* does not meet recommendations for initiating ARV therapy according to current guidelines

Exclusion Criteria:

* pregnancy or actively planning to become pregnant
* receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)
* Estimated creatinine clearance \<30 mL/min
* Other medical condition likely to cause death within 24 months
* Enrolled in a therapeutic HIV vaccine or immunotherapy trial
* Enrolled in another trial investigating the impact of another intervention on HIV disease progression
* HIV elite controller (EC), phenotypically defined here as documented duration of HIV infection of ≥5 years, a persistent CD4 cell count ≥500 cells/mm3, and a persistent plasma HIV viral load of \<1000 copies/mL in the absence of antiretroviral therapy
Spanish Validation Frustration Discomfort Scale

This is an observational study aimed at validating the Frustration Discomfort Scale (Harrington, 2005). A back-translation process was followed to obtain a translated version of the scale, which was refined after a discussion with several clinicians.

In the study, the Spanish adaptation of the Frustration Discomfort Scale will be disseminated with an online questionnaire using the Qualtrics platform. Additional questionnaires to explore the validity of the adapted scale will also be administered. Participants who complete the questionnaires and provide a valid ID number will enter a participate in a raffle to win an Amazon coupon of 40 euros. Ten coupons will be offered in total amongst participants.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Signs the informed consent
* Can read and understand Spanish
* Has access to a computer, a tablet or a smartphone with an internet connection

Exclusion Criteria:

* Being younger than 18 years of age
* Does not sign the informed consent
* Cannot read or understand Spanish
* Does not have access to a computer, a tablet or a smartphone with an internet connection
Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing

The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.

Umbilical cord blood mononuclear cells are a type of cell group containing hematopoietic stem cells, mesenchymal stem cells, neural stem cells, endothelial cells, immune cells, etc.In this study ,umbilical cord blood mononuclear cells will be used in promoting traumatic fracture healing,and the effectiveness and safety of the treatment plan was evaluated by twelve months of follow-up after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic long bone fracture.
* Noninfectious bone nonunion, delayed bone union.
* 3 months after the operation of the fracture, the examination showed no callus growth, no signs of progressive repair at the fracture site, fracture piece space \< 5mm.
* No shortening, angulation and displacement.
* There was no obvious callus growth 8 months after local bone grafting.

Exclusion Criteria:

* There are infection foci at and near the fracture end after fracture.
* 3 months after the fracture, tests showed partial callus growth.
* Combining shortening, angulation and displacement phenomena.
* Partial callus grew 8 months after local bone grafting.
SynRinse Irrigation Pilot (SIP) Trial

Assess if the use of SYNRINSE can improve short-term subjective and objective outcome measures after one week in patients with active Chronic Rhinosinusitis (CRS) who have had prior sinus surgery.

SYNRINSE is osmotically balanced and also contains soluble chitosan-argininamide, a modified natural glycopolymer that has a number of properties important to relieving the symptoms of mucus build up and bacterial biofilms. First, SYNRINSE reduces the viscosity of biofilms, the protective environment of infective bacteria that prevents topical antibiotics and other rinses to penetrate to reach the bacterial. By disrupting biofilms, SYNRINSE allows them to be cleared from the sinuses. Second, SYNRINSE has been shown to interact with the polymers comprise mucus, loosening thick, sticky layers and reducing their ability to adhere together and to mucosal surfaces. Third, all of the components in SYNRINSE are biocompatible and soothing to sensitive nasal cavities.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* Meet diagnostic criteria for CRS (as defined by the AAO-HNS 2015 Clinical Practice Guidelines for Adult Sinusitis).
* Have undergone at least one functional endoscopic sinus surgery, be at least 6 weeks out from surgery, be free of any complication from surgery, and have patent sinuses confirmed by nasal endoscopy.
* Have active sinus disease as defined as purulent sinus discharge visualized on nasal endoscopy.
* Have more than mild symptoms as determined by the SNOT-22 with a score \>20.
* Be willing to hold off on standard therapy for chronic sinusitis for 1 week including oral antibiotics and/or oral steroids.
* If on topical steroids for greater than 1 month (sprays, drops, or irrigation) these will be continued based on the patients' current use (continued if they are already on them, not initiated if they are not on them).
* Must be able to irrigate with large volume/low pressure nasal lavage throughout the study.

Exclusion Criteria

:• Have an allergy to shell fish.

* Be able to return for follow up evaluation in 1 week (+ up to 5 days if needed)
* Have obstructive nasal polyps
* Participants who have used topical antibiotics within 4 weeks of treatment or are actively using them and unwilling to stop
* Participants who have used systemic steroids within 4 weeks of treatment
* Are unable to give informed consent or complete self-administered questionnaires written in English because of cognitive impairment, language barrier, or severe medical conditions.
* Have a terminal illness or significant immune dysfunction.
* Have severe or emergent complications from CRS or presence of a sinus tumor.
* Patients with Cystic Fibrosis will be recruited in a parallel study.
* Participants who are unwilling to discontinue other sinus irrigations treatments and steroid lavage if already on them (including baby shampoo, surfactant, colloid silver, manuka honey, iodine, alcohol, tea tree oil, or any other compound).
Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)

This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose CT (LDCT) lung cancer screening. Using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (NRT) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources.

Evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. Nicotine patch is an FDA-approved cessation aid. The optimal duration of counseling and pharmacotherapy for patients undergoing low-dose CT (LDCT) lung screening is not clear. In addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. This randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine CT lung cancer screening. Patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo LDCT-LCS at a participating Mass General Brigham Health Care System LCS site
* Speak English or Spanish.
* Current smokers: smoked a cigarette, even a puff, in the last 30 days.
* Medicare coverage requirement (age 50-80 years, 20+ pack/years).
* Residing within the USA.

Exclusion Criteria:

* Undergoing lung CT as part of a diagnostic or abnormal follow-up evaluation.
* Unable to give informed consent due to psychiatric or cognitive impairment as determined in consultation with study PI or treating clinician.
* No access to a telephone or cannot communicate by telephone.
Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

Selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. This prospective, randomized controlled study aims to compare the prognosis of posterior continuous curvilinear capsulorhexis (PCCC) with or without anterior vitrectomy (A-Vit) in treating congenital cataracts.

Due to the particularity of children's eye structure, selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. The major concerned postoperative problem is the after-cataract formation. As a result, PCCC with A-Vit is usually performed to prevent the formation of secondary cataracts. However. Debate over the indication and surgical procedure still persists since A-Vit and excessive manipulations may interfere with the development of the eye and increase the risk of postoperative inflammation, unstable intraocular pressure, macular edema, retinal detachment and so on. Thus, it is necessary to evaluate the safety and effectiveness of PCCC without A-Vit in congenital cataract surgery.

In this randomized clinical trial, children with equal degree of congenital cataract in both eyes are enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit. PCCC+A-Vit procedure includes anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), PCCC, and A-Vit. Primary intraocular lens implantation (IOL) is performed in children older than age of two. Investigators then compare the incidence of visual axis opacity, uveitis, iris/pupil abnormality and intraocular pressure between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Children with bilateral congenital cataracts without other ocular abnormalities
* Gestational age at birth \>37 weeks
* No more than 18 years old
* Pupils could dilate normally pre-operation
* Have signed a consent form
* Can be followed

Exclusion Criteria:

* Intraocular pressure \>21 mmHg
* History of ocular trauma and intraocular surgery
Tygacil Drug Use Investigation

Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice


Eligibility Criteria:
Inclusion Criteria:

* All patients who are prescribed tigecycline (Tygacil).

Exclusion Criteria:

* Subject who have not been prescribed tigecycline (Tygacil).
Interstitial Lung Disease Registry Construction

The purpose of this study is investigating the clinical course, treatment course, and prognosis of patients with interstitial lung disease.

Interstitial lung disease refers to pulmonary disease that occurs in the interstitium of the lung.

It can be broadly classified into lung disease secondary to the cause of systemic disease or drug, and lung disease whose cause is unknown, and the latter is known as idiopathic interstitial pneumonia.

Idiopathic interstitial pneumonia is a lung disease showing various aspects of inflammatory response and fibrosis reaction, and the cause of the onset is not accurately known yet, also there is no effective treatment.

Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis, progresses very slowly, but sometimes acute exacerbation without any obvious cause leads to death, rapidly.

Therefore, it is important to collect data prospectively for changes in clinical features, pulmonary function, imaging findings, and quality of life of these patients.

A prospective study of idiopathic interstitial pneumonia will provide important information on the clinical characteristics and admission history of patients with idiopathic interstitial pneumonia, and the idiopathic interstitial pneumonia registry system will serve as the basis for further prospective observational studies.

The aim of this study is to establish the registry of patients with interstitial lung disease and to prospectively review the clinical features and progression of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years diagnosed with interstitial lung disease
* Diagnostic criteria for interstitial lung disease. If one of the following is met:

  1. clinical suspicion of idiopathic pulmonary fibrosis (IPF); Characteristic chest CT findings with honeycomb cysts and fibrosis and reasonable clinical signs
  2. suspected interstitial pneumonia, or confirmed by biopsy with no evidence of infection : IPF, Non-specific interstitial pneumonia(NSIP), Cryptogenic organizing pneumonia(COP), unclassified fibrosis
  3. interstitial lung disease suspects with underlying rheumatic disease

Exclusion Criteria:

* No specific criteria
The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis

This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.

Selection of the study population: Adults, who consult at the departement of Periodontology at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria will be asked to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Patients with at least one implant\* diagnosed with initial peri-implantitis.
* Willing and able to give written informed consent
* No signs of acute periodontitis
* presence of keratinized tissue around treated implant(s)

Exclusion Criteria:

* patients who smoke
* patients with periodontitis
* pregnant or lactating woman
* patients with poorly controlled diabetes
* patients taking bisphosphonate mediation
* patient who had taken systemic antibiotics 3 months prior to treatment
* peri-implantitis treatment 12 months prior intake
VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty

This study is being done to compare two commonly available types of body contouring, VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one procedure is preferred by patients and/or surgeons over the other. Participants will have VAL on one side of their body and SAL on the opposite side.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary, signed informed consent in accordance with institutional policies
* be between the ages of 18-50 years old
* Be willing and able to appear for all scheduled, post-operative visits with their doctor
* Have moderate to good skin tone
* Have excess fatty tissue in the arms, medial thighs, lateral thighs, or back where the extra tissue is expected to be composed of adipose tissue.
* Have a body mass index between 20-30
* Are non-smokers

Exclusion Criteria:

* under the age of 18
* over the age of 50
* are undergoing boy contouring for reconstruction following injury or disease are deemed inappropriate candidates for surgery due to medical or mental health reasons
* are concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to surgery
* elect not to participate in the study
Evaluation of ABO Isoagglutinins Level in Blood Group O Donors

Our study is aiming for evaluation f the titre of anti-A and anti-B in plasma of blood grop O donors, study the effect of pooling of blood product on the level of A and B isoagglutinins in blood group O donors and screening for the safest group o donors(who have the lowest anti-A antd anti-B titre) for transfusion in urgent need of blood.

the use of O blood group transfusion to patients of all groups has continued since the second world war, nevertheless the transfusion of group O plasma/ platelet concentrate to group A, B and AB recipient sometimes causes severe red cell destruction , Acute haemolysis has been reported following transfusion of non-iso group single donor platelet (PLT) concentrates and may be more common than is appreciated.

This red blood cells destruction happens based on the fact that the sera from group O people contain two separable antibodies, anti-A and anti-B .

When it comes to PLT transfusion therapy we are dealing with issues arising from the fact that PLTs contain both significant amounts of ABO antigen on their surface, as well as anti ABO isogglutinins in the donor's plasma which caused reduction the volume of incompatible plasma administrated.

From another point of view the risk of high titer units is considered low with group O, post storage, pooled PLT concentrate. However its necessary to establish a (golden standard) method for the determination of antibody titer in order to be able to differentiate accurately the high titer donors.

So, for improving the safety of group O plts we need to define a safe level of antibody titer or reduce the volume of incompatible plasma administrated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults blood group O donors

Exclusion Criteria:

* Other blood groups donors.
* Donors with history of chronic or autoimmune diseases
Assessment of CFTR-Modulator Treatment in Cystic Fibrosis Lung Disease Using Novel Structural and Functional MRI

This is a prospective, longitudinal observational study conducted at The Hospital for Sick Children (SickKids). The purpose of this study is to evaluate the ability of MRI to detect changes in lung structure and function in CF patients receiving CFTR-modulator therapy. Participants who meet eligibility criteria and consent to the study will undergo study procedures which include spirometry and body plethysmography (optional), multiple breath washout testing, MRI and measurement of quality of life. The study will consist of three to six study visits for Group 1, 2 and 3: baseline, one month (±1 week) and 6 month (±2 week) and if they re-consent then 3 additional visits of 1 year (±6 months). (2 years (±6 months) and 3 years (±6 months) follow-up. Some participants in Group 2 may transition to Group 3.

This study includes three populations of interest: Group 1: 25 healthy volunteers, Group 2: 25 patients with stable CF lung disease , Group 3: 20 patients with CF lung disease anticipated to receive treatment with CFTR-modulator therapy and Group 4: 18 patients with CF who are between 4-8 years old and are starting triple combination modulator therapy using the rapid lung and abdominal imaging methods.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be greater than or equal to 4 years of age
* Informed consent by patient or parent/guardian consent and participant assent when appropriate.
* Able to perform reproducible spirometry and achieve a breath hold duration sufficient for MRI acquisition

Exclusion Criteria:

* Medical instability that would preclude the ability to undergo the required investigations
* FEV1 % predicted \< 40%
* Severe claustrophobia
* Does not meet MRI screening criteria
* Cough within the past 3 days prior to study visit
* Usage of oral antibiotics within 3 weeks prior to study visit
Analysis of Methicillin Resistant Staphylococcus Aureus (MRSA) Obtained Through the Emergency Department in a Tertiary Care Hospital in Vancouver Canada From 2001-2005

To analyze microbiological data from MRSA samples obtained through the emergency department from 2001-2005. There is a strong clinical suspicion that we are now seeing an outbreak of a new strain of MRSA and we plan to better characterize the Vancouver population and complete a chart review to assess specific associated factors.

Pulse field gel electrophoresis, SCC mec typing, antibiotic susceptibilities, presence of the Panton-Valentine Leukocidin gene will be carried out. Clinical manifestations and associated factors will be assessed via chart review. These include: recent antibiotic use, recent hospitalization, IV drug use, HIV status, number of co-morbidities identified, presence of soft tissue abscess, post operative status, presence of bacteremia, residence in Vancouver's downtown eastside (an area of particularly low socioeconomic status).

Eligibility Criteria:
Inclusion Criteria:

* Patient had a microbiological sample submitted from the emergency department of the study hospital from 2001- 2005 which grew MRSA.