cyrilzakka/clinical-trials huggingface dataset:
Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.

The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.

Eligibility Criteria:
Group A:

Inclusion criteria:

* healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion criteria:

1. anaphylactic reaction to a previous dose of LAIV or TIV
2. known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
3. history of asthma
4. medically diagnosed or treated wheezing within 42 days before enrollment
5. Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
6. anaphylactic reaction to gentamicin
7. anaphylactic reaction to gelatin
8. anaphylactic reaction to neomycin
9. anaphylactic reaction to arginine
10. pregnancy
11. household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)
12. use of aspirin or salicylate-containing products within 30 days before enrollment.

Group B:

Inclusion Criteria

* other Hutterite community members that are not in Group A

Exclusion Criteria:

* there are no exclusion criteria for this category of participants
Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters

The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.

The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.

Pulmonary function tests will be performed.

Eligibility Criteria:
Case group

Inclusion Criteria:

* Premature birth \< 37 weeks
* 5 years old ≤ Age ≥ 3 years old

Control group

Inclusion Criteria:

* Full-term birth
* 5 years old ≤ Age ≥ 3 years old

Exclusion Criteria of both groups:

* Pulmonary bronchodysplasia (BDP)
* Acute respiratory infection
* Immunological and metabolic system disease
* Malformation of upper respiratory tract
* Topical or systemic therapies, with antibiotics, antihistaminics and corticosteroids, in the previous 30 days
* Patients with neurological pathologies
* Patients that are not able to perform the lung function tests
Study of Eye Movement Testing and Therapy

The purpose of this study is to determine the ability of several eye movement monitors, used in clinical practice, to identify children with poor reading eye movements. A second purpose of the study is to evaluate the effectiveness of eye movement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 8 to 13 with saccadic eye movement deficit

Exclusion Criteria:

* Previous saccadic eye movement therapy
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)

This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in addition to standard chemotherapy in the treatment of patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
2. At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI);
3. Aged 20 years old or above;
4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2;
5. Adequate bone marrow reserve (hemoglobin \> 9 g/dl, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L);
6. Adequate renal and hepatic functions: total bilirubin \< 1.25 x upper normal limit, creatinine \< 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 x upper normal limit;
7. Patients willing to participate in the trial and giving written informed consent.

Exclusion Criteria:

1. Pregnant or lactating patients;
2. Patients (male or female) with reproductive potential not using adequate contraceptive measures;
3. Patients with evidence of central nervous system metastasis;
4. Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
5. Current history of chronic diarrhea;
6. Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
7. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
8. Concurrent treatment with any other anticancer therapy;
9. Patients with congestive heart failure (New York Heart Association Functional Classification III or IV), epilepsy, or other significant medical conditions as judged by the investigator;
10. Patients treated with another investigational drug within 4 weeks of entry into this study.
A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib

Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.

Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Axial Spondylarthritis (axSpA) according to the ASAS criteria.
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 at Baseline.
* Total back pain score \>= 4 at Baseline.
* Inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to contraindication for NSAIDs as defined by the investigator.
* Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.

Exclusion Criteria:

* Prior exposure to any Janus kinase (JAK) inhibitor.
* Participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis.
* Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
* Unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires.
* Participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications).
* Vulnerable or protected adult patients with lack of capability to give informed consent.
Ramipril in Rheumatoid Arthritis

The present study is designed to evaluate the hypothesis that the Angiotensin-Converting Enzyme (ACE) inhibitor Ramipril improves vascular function and reduces markers of low-grade chronic inflammation and oxidative stress in patients with Rheumatoid Arthritis.

The effect of an 8-week treatment with either ramipril or placebo is studied using a randomized, double-blind, and crossover protocol. After given written informed consent, baseline characteristics including physical examination, ECG, blood sample and a noninvasive assessment of endothelial function are obtained. The patients are randomly assigned to receive either ramipril 10mg (up-titration-scheme: starting with 2.5mg in Week1, then 5mg in Week2 followed by 2-5mg for the final 6 weeks) followed by placebo or vice versa.The individual disease-modifying antirheumatic drug therapy is continued throughout the study. The examinations are repeated after 8 weeks treatment of the first and 8 weeks after the second study drug. At week 1 and 2 in each treatment period a safety visit is scheduled.

Eligibility Criteria:
Inclusion Criteria:

* patients with rheumatoid arthritis (4 out of 7 ARA criteria must be fulfilled to establish diagnosis) on stable background therapy for the last three months
* endothelial dysfunction (FMD \< 4%, FMD:Flow-Mediated-Dilatation)
* non-smokers

Exclusion Criteria:

* previous myocardial infarction, coronary intervention or coronary surgery
* previous treatment with statins in the last 6 months
* previous treatment with ACE-inhibitors in the last 6 months
* uncontrolled hypertension SAP/DAP \> 160/90 mmHg (SAP:Systolic Arterial Pressure, DAP:Diastolic Arterial Pressure)
* dyslipidemia (LDL-cholesterol \> 4.9 mmol)
* normal CRP \< 3 mg/l
* overweight BMI \> 35kg/m2
* anaemia (hemoglobin \< 10g/dl)
* kidney disease (creatinine \> 150 umol/l)
* insulin-dependent diabetes mellitus
* congestive heart failure (\> NYHA I)
* AV-Block\>I
* pregnancy
* angio-edema
* malignancy or chronic infection
* drug abuse
Microbiome Alterations With Xylitol (MAX) in Pregnancy

The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease), and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi.

After consenting to the study, pregnant participants who have a singleton gestation and are \<20 weeks' gestation will be randomised into either the intervention arm ( 6.36grams of daily xylitol; Epic dental gum, 1.06 grams Xylitol per piece of gum; chew two pieces for 5 minutes after meals, thrice a day) or the placebo control arm (Sorbitol Gum base; Epic sorbitol-containing gum, 0 grams/day of xylitol; chew two pieces for 5 minutes after meals, thrice a day) by randomly picking from a group of opaque, sealed envelopes containing group allocation. The participants will also undergo a dental assessment and sampling, and vaginal sampling at enrolment, 28- 30 weeks of pregnancy, at birth - 48 hours and 4-6 weeks after birth. In addition, placental specimens will be obtained at the time of delivery, and stored in a biobank for future analyses. The investigators will also obtain oral and meconium (and stool at 4-6 weeks) samples of their newborns at birth and 4-6 weeks after birth.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent. For those under 18 years of age, consent will additionally be sought from the parent or guardian.
* A singleton at \<20 weeks' gestation (based on ultrasound or best obstetric measurement)
* Planning to deliver at Area 25 health center.
* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy.
* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks, at delivery/within 48 hours and 4-6 weeks after giving birth.
* Willing to have at least two vaginal sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks, at delivery/within 48 hours and 4-6 weeks after giving birth.
* Able to speak Chichewa or English.
* Cognitively aware enough to be able to participate in the study.
* Willing to consent to all required aspects of protocol including allowing collection of placenta specimens, infant oral swab and meconium/stool sampling at birth/within 48 hours and 4-6 weeks after.

Exclusion Criteria:

* Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy.
* Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others).
* Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy.
* Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta).
A Survey of Acceptance and Factors Associated With Hesitancy Vaccination in Northeast Brazil

The objective of this study is to investigate vaccination acceptance and identify the reasons why people are not vaccinated.

People over 18 years of age who live in neighborhoods with socioeconomic vulnerability and with many cases of infectious diseases, as well as health professionals, will respond to a research questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are over 18 years old and are residents of the PAJUÇARA, FELIPE CAMARÃO, LAGOA AZUL, or PLANALTO neighborhoods, willing to answer the study questionnaire.
* Healthcare professionals who work in Natal, willing to answer the study questionnaire.
Impact of an Online Positive Affect Journaling Intervention

In this study the investigators plan to recruit 70 patients reporting high levels of stress to test the impact of Positive Affect Journaling. Patients randomized to use the online intervention will be asked to journal about one of seven topics, several days each week, for three months. The topics (e.g., "What went well") are designed to help the individual focus on some positive aspect of their life or themselves over the past day. Each topic is based on prompts shown to be effective in studies of up to one week in duration. In the summer of 2012, our research team pilot tested each prompt with 20 patients with high levels of anxiety, which led to important changes to the prompts, to increase their potential impact. The main aim is to understand the impact of Positive Affect Journaling on psychological distress, as measured by the National Health Interview Survey.


Eligibility Criteria:
Inclusion Criteria:

* Fluently speaks, writes, and read English
* Report elevated levels of stress
* Be between 21-80 years of age
* Have access to the Internet
* Have an ECOG Performance Status of 0 (Fully active) through 3 (Limited self-care)

Exclusion Criteria:

* High risk for suicidality on the Structured Clinical Interview for DSM Disorders (SCID).
* Pregnant or planning to get pregnant in the next 3 months
* Moving in the next 6 months
Pathogen Detection in Infectious Uveitis

Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection.Current study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection.

Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection.

The study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection, including multiple molecular bio-techniques. We also plan to explore the distribution of pathogens in infectious uveitis.

Eligibility Criteria:
Inclusion Criteria:

* Patient at a referal hospital eye clinic with clinically suspected infectious uveitis

Exclusion Criteria:

* Patients not eligible for the Inclusion Criteria
* Confirmed auto-immune uveitis
Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study

This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour). Patients with no OSA over the last year will sign an informed consent after receiving explanations from authorized physician (Professor Asher Tal). The patient will than undergo a sleep study using a mobile device PAT (Peripheral Arterial Tomography, Itamar Medical, Israel) ,an approved device in Israel, USA and many other European countries,, approved for use by the USA FDA). This sleep study is needed in order to rule out OSA, namely AHI of more than 15 events per hour of sleep.

The study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home.

Recordings over the nights with or without the "Forrest" epic device will be carried out at the patient's home, after verification that each patient sleeps alone in his/her room. The recording and data processing of snoring will be performed through the application "SNORLAB" on IPHONE 6 mobile device. Ambulatory sleep studies with PAT device will be carried out during two nights (with and without the Forrest Device) with most patients.

During the examination, respiratory index will be tested such as: obstructive respiratory events during sleep, oxygen saturation in blood at rest (measured non-invasively) during sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of oxygen saturation in blood.


Eligibility Criteria:
Inclusion Criteria:

* The patient age range : 20-70 years old.
* The patient / legal guardian able and willing to sign conscious written agreement.
* The patient / legal guardian able and willing to comply with the study protocol.
* The patient is suffering from snoring.
* The patient underwent a sleep study over the last year.

Exclusion Criteria:

* The patient suffers from sleep apnea that requires CPAP treatment: more than 15 AHI per hour in a sleep study or due to significant background diseases.
* Patient less than 20 years old.
Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

This study is being performed to measure the amount of the antibiotic doripenem (study drug) found in the fluid and cells of the lung and blood after receiving three doses of doripenem. The major objectives of this research are to see how much and for how long doripenem gets into the fluids and cells of the lungs of healthy adult subjects.

The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) concentrations following multiple intravenous doses of doripenem in healthy, non-smoking adult subjects. In brief, each subject who qualifies for the study will be randomized to one of two dosing regimens: doripenem 500 mg or doripenem 1000 mg every 8 hours for a total of three intravenous doses. Each dose of doripenem will be administered as an intravenous infusion over 4 hours. Serial blood samples for determining plasma doripenem concentrations will be collected prior to and after the start of the intravenous infusion of the third doripenem dose. Each subject will undergo one standardized bronchoscopy with BAL in the outpatient bronchoscopy suite at one of four sampling times after the start of the intravenous infusion of the third doripenem dose. BAL collection will provide samples to determine drug concentration in ELF and AM. Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests, and vital sign monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women at least 18 years of age who have no history of smoking within the last 1 year.
* Subjects must be healthy with no clinically important abnormalities in the medical history, physical examination, or laboratory values.

Exclusion Criteria:

* Subjects must not have a history of allergic or other serious reactions to doripenem or any beta-lactam antibiotic, benzodiazepines or lidocaine.
Foley Catheter vs a Self-contained Valved Urinary Catheter

The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.

The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.

Exclusion Criteria:

* Intra-operative bladder injury during index surgery
* Intra-operative complication requiring continuous bladder drainage
* Dementia / altered cognitive function