cyrilzakka/clinical-trials huggingface dataset:
ED Physical Therapy for Chronic Low Back Pain

Emergency department (ED)-initiated physical therapy is a rapidly growing resource and represents a promising treatment approach to low back pain. This clinical trial will evaluate an innovative model of an emergency department "embedded" physical therapist to treat patients with chronic low back pain, with a focus on improving patient functioning and reducing opioid use.

This trial is ancillary to an ongoing single-center physician-randomized trial of an embedded physical therapy intervention versus usual care in ED patients with acute low back pain (NEED-PT, NCT04921449), comparing a primary outcome of pain-related functioning and a secondary outcome of opioid use at three months. The main trial aims to enroll up to 360 participants with acute low back pain, defined as ≤ 30 days in duration and no history of lumber surgery or chronic low back pain. Using the same procedures and physician-randomization assignments as the main trial, this ancillary trial will enroll an additional 200 participants with chronic low back pain (i.e. non-acute low back pain) in order to obtain initial point estimates for the outcomes of interest and assess participant enrollment and retention rates in this population. The ancillary trial's sample size of 200 participants is an estimate of patient accrual over the anticipated remaining duration of the main trial (i.e., there is not a separate power calculation for this ancillary trial given its exploratory nature), and the actual number accrued may differ depending on the main trial's actual end date.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Low back pain (originating between 12th rib and buttocks)
* Evaluated by a physician randomized to either study arm
* Evaluated when ED physical therapy is available (e.g., Mon-Fri, 8am-4pm)
* Likely to be discharged home (based on physician assessment)
* Ability to complete follow-up data collection electronically or by telephone
* English-speaking

Exclusion Criteria:

* Enrollment in the main trial (NEED-PT, NCT04921449)
* Serious red-flag signs/symptoms (bladder/bowel incontinence, saddle anesthesia, debilitating motor weakness)
* Obvious non-musculoskeletal etiology for low back pain (e.g., shingles, kidney stone)
* Other concomitant injuries or pain (e.g., closed head injury, shoulder pain)
* Unable to ambulate at baseline
* Known pregnancy, under police custody, unable to consent
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy.

The hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.

Pancreaticoduodenectomy is part of the curative treatment of periampullary neoplasms. Postoperative mortality for this procedure is between 1 and 5 %, and morbidity ranging from 30 to 50%. Infectious complications, with pancreatic fistula and gastric delayed empting, are an important part of this morbidity, affecting nearly 35% of patients.

One of the risk factors of infectious complications is the presence of a preoperative obstructive jaundice, due to obstruction of bile ducts by the tumor. In this case, it is proposed to perform a preoperative drainage of the bile ducts, preferably by endoscopic procedure (ERCP), associated with the placement of a endoprosthesis. However, this procedure is controversial, this one increasing postoperative morbidity, and in particular the rate of infectious complications. One explanation of these events is the bacteriological contamination of the bile ducts during the endoscopic procedure. In addition, it has been observed for the patients who have benefited from preoperative drainage, the biliary flora is predominantly polymicrobial and may contain multiresistant nosocomial germs, unlike patients who have not benefited from this procedure, whose biliary flora is predominantly sterile or monomicrobial. This colonization by multiresistant germs may have consequences in the postoperative period, in fact, up to 49% of the germs found in the bile samples are also found in the samples taken during postoperative infectious events. This microbial release could make it more difficult to take care of postoperative infections, with less efficacy of conventional antibiotic treatments.

The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality in patients who underwent pancreaticoduodenectomy. Patients whit colonized bile and patients with sterile bile were compared for these outcomes.

Eligibility Criteria:
Inclusion Criteria:

* patients over the age of 18
* patients underwent programmed pancreaticoduodenectomy

Exclusion Criteria:

* Patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours)
* Patients had not been taken of a biliary sample in intraoperative period
Functional Task Kinematic in Musculoskeletal Pathology.

The aim of this project is to create references values to patients with musculoskeletal pathology using functional tasks and measuring with a smartphone and video imaging (3D motion capture cameras).

Musculoskeletal pathologies can affect bones, muscles, joints and other structures related to this system. These disorders are extremely common and can have an origin from autoimmune, inflammatory, traumatic, etc. The risk of developing this pathologies increases with age.

The diagnosis could delayed by lack of information, expensive assessment or difficult execution.

Currently, you can use a Smartphone to get the same information as sensors. In addition to Smartphone, 3D motion capture systems with a camera have been frequently used to analyse kinematics and are being integrated as a rehabilitation tool in patients. The use of Smartphones and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.

Eligibility Criteria:
Inclusion Criteria:

* Persons with diagnosis of musculoskeletal pathology.
* Age between 20-65 años.
* Subjects able to get up from the chair at least 5 times.
* Be able to complete questionnaires and perform functional tasks.

Exclusion Criteria:

* Subjects who are participating in a study with an experimental treatment.
* Severe cardiovascular disease.
* Being pregnant, in case of women.
Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

This study evaluated the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple intravenous (IV) doses of ALXN1210 administered to participants with PNH who have not previously been treated with complement inhibitor.

The data presented is up to the Primary Completion date of the study and is for the 24-week Primary Evaluation period. The study also includes an Extension Period of up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age
2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry
3. Documented meningococcal vaccination not more than 3 years prior to dosing
4. Female participants of childbearing potential used highly effective contraception starting at screening and continuing until at least 24-weeks after the last dose of ALXN1210
5. Willing and able to give written informed consent and comply with the study visit schedule

Exclusion Criteria:

1. Treatment with a complement inhibitor at any time
2. Females who were pregnant, breastfeeding or who had a positive pregnancy test at screening or Day 1
3. Participation in an interventional clinical study within 30 days before initiation of dosing on Day 1, or use of any experimental therapy within 30 days prior to dosing on Day 1, or within 5 half-lives of the product, whichever is greater
4. History of allergy to excipients of ALXN1210 or known allergy to Chinese hamster ovary cell proteins
5. Inability to comply with study requirements
6. History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or rheumatoid disease that, in the Investigator's judgment, would preclude participation
7. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, made the participant unsuitable for enrollment
Virtual Agent Feasibility in Oncology Patients (NTT Data)

The purpose of this study is to compare the use of a virtual agent vs. a human agent when onboarding oncology patients over the telephone to Remote Patient Monitoring (RPM) devices. RPM devices are instruments that a patient can use to measure their own weight and vital signs. Both the virtual and human agents will be available by telephone to instruct the patient on how to use the RPM devices to measure weight, blood pressure, heart rate, temperature, and oxygen saturation. Patients will be randomized to either the virtual or human agent, have assessments of their medical and oncological history, overall well-being, body measurements, and vital signs, and will complete questionnaires about their experience.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
2. Age ≥18
3. Lung cancer
4. Planning to return to Duke Cancer Center clinic for three days in a row

   * Patients whose treatment does not require that they return to clinic for three days in a row, but who are willing to voluntarily return to participate in this study are permitted to enroll.
5. Eastern Cooperative Oncology Group (ECOG) score of 0-2
6. Native fluency of spoken English as determined by the investigator

   * Non-native English speakers are permitted to enroll if they have achieved native fluency.
7. Vitals as collected by the clinic using Duke maintained equipment must be within the ranges specified by the remote patient monitoring devices.

   * Weight ≤ 180 kg
   * Systolic blood pressure ≤ 300 mmHg
   * Pulse rate of 40-200 bpm
   * SpO2 of 70-100%
   * Temperature 34.0-42.2°C
8. Arm circumference of 22-42 cm

Exclusion Criteria:

1. Vision, speech or auditory impairment that has the potential to interfere with the use of the remote patient monitoring device or agent, in the opinion of the investigator.
2. Has an implanted pacemaker, arterio-venus (A-V) shunt, a history of mastectomy or lymph node clearance, history of severe blood flow problems or blood disorders, or a history of severe circulatory deficit in the arm.
3. Is pregnant
4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the investigator.
FOODLIT-Trial: Digital Behaviour Change Intervention to Improve Food Literacy Amidst the COVID-19 Pandemic

Given that healthy food-related habits are protective of both malnutrition and multiple noncommunicable diseases (including diabetes, heart disease, and cancer), and acknowledging that poor diets constitute a greater risk to mortality, it is essential to improve individuals' food-related knowledge, skills, and behaviours. Furthermore, the current public health context caused by the COVID-19 pandemic has reinforced the need for an adequate diet as a protective factor for one's global health.

In the ambit of the FOODLIT-PRO: Food Literacy Project (ref. SFRH/BD/128528/2017), a digital intervention to promote food literacy - that is, food-related knowledge, competencies, and behaviours - encompassing behavioural change strategies and psychological determinants (such as intention, planning, and self-efficacy) was developed.

With the online deliver of personalised evidence-based materials concerning food literacy, adult participants receive weekly challenges that promote their food-related knowledge (e.g., recognising food's origin and seasonality), competencies (e.g., as cooking and planning skills), and behaviours (e.g., tracking food intake, interpret nutritional labels). Matched with tailored behavioural change strategies (experimental group), both food literacy content and psychological aspects that relate to health behaviour are assessed weekly in order to evaluate the intervention's efficacy. Follow-ups at 3-, 6- and 9-months post intervention will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Having a minimum of digital literacy to access, visualise and download online material related to the intervention;
* Having the availability to participate in the intervention (11 weeks) and posterior follow-up moments.
the Impact of Occupational Therapy : a Multicenter Randomized Controlled Trial

The purpose of this randomized controlled superiority trial is to evaluate the impact of occupational therapy assessment and intervention on the quality of life of elderly cancer patients.

Patients will be randomized into 3 parallel, multicenter arms with patient-reported outcome and blinded evaluator.

* Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
* Experimental group B will have only the MCRO assessment because the occupational problems assessment alone (without intervention) could improve quality of life and occupational performance outcomes, according to the Nielsen, 2019 study
* Group C will have the usual cancer management care combining specific treatments and supportive care.

in order to limit the potential grading bias associated with the open-label design, the reassessment at 3 and 6 months will be performed by a different occupational therapist than the one who performed the initial assessment and occupational therapy intervention. For this reason, at least two occupational therapists per geographic area of the centers that include the patients will be included in the project.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 70 years;
* Colorectal, breast, prostate or lung cancer;
* Between 1 and 3 months after the start of cancer treatment depending on the type of treatment (Surgery and/or systemic treatment and/or radiotherapy);
* For curative purposes;
* Affiliated to a social security scheme;
* Living at home;
* Agreeing to participate in the research and having given a free, informed and signed consent

Exclusion Criteria:

* person caring for a patient meeting the above criteria;
* Living with the patient;
* Agreeing to participate in the research and having given free, informed and signed consent
Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury

The aim of this study is to investigate the effect of an animal assisted mindfulness intervention (AAMI) on patients with acquired brain injuries on their global severity of psychological distress.

In addition, the effects on the patients' symptoms of depression, anxiety, perceived stress, mood, coping and mindfulness/self-compassion will be assessed.

The study experimental condition consists of 6 weeks of intervention, containing 6 different modules. In every session, an animal will be present.

In the control condition, the same program and same exercises will be used without the presence of or reference to animals. Sessions take place two times a week for 6 weeks (leading up to a total of 12 experimental/control sessions), each lasting for about 60 minutes.

24 participants are planned to be included, 12 patients in each group.

It was estimated that a total sample of 24 participants (12 patients in each group) would provide enough power to detect a medium effect. Since we had several dropouts, two additional groups (one intervention and one control) were started. This lead to the inclusion of 31 participants with a total sample size of 25 participants finishing the program.

Eligibility Criteria:
Inclusion Criteria:

* Patients of REHAB Basel
* Acquired Brain Injury (ABI); FIM (Functional Independence Measure) cut-off score defined as \> 60
* Depressive or/and anxiety symptoms
* Psychological difficulties coping with the actual life situation
* 18 years or older
* Willing to work with therapy animals
* German speaking
* Willingness to participate/informed consent

Exclusion Criteria:

* Communication and articulation is not possible
* Allergy to animals
* Aversion against animals
* Schizophrenic-related comorbidity
* Mobilization to "Therapietiergarten" not possible
Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied

The researchers in this trial want to learn how the drug aflibercept works in in Japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or NVG). They also want to find out how patient tolerate the application of the drug that is injected in the vitreous humor of the eye and if this will cause any medical problems during the trial (vitreous humor, also called vitreous body is the clear gel that fills the space between the lens and the retina of the eyeball).


Eligibility Criteria:
Inclusion Criteria:

* Japanese men and women aged 20 years or older
* Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the anterior segment (both iris and anterior chamber angle)
* Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization

Exclusion Criteria:

* Patients with angle-closure due to conditions other than NVG or complete angle-closure due to NVG
* Patients with a known or suspected ocular or peri-ocular infection
* Patients with severe intraocular inflammation in the study eye
* Women who are pregnant, suspected of being pregnant or lactating
* Patients with known allergy to aflibercept
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System

To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older at the time of the study.
* Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
* Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (\<50% open-set sentence recognition in quiet scores in the ear to be implanted and \<60% in the best-aided condition)
* English spoken as the primary language.
* Willingness to participate in and to comply with all requirements of the study
* Subject may receive bilateral simultaneous cochlear implants.

Exclusion Criteria:

* Previous cochlear implant experience
* Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
* Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
* Normal hearing in one or both ears.
* Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
* Active middle-ear infection.
* Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
Immune Cells Phenotypes During COVID-19

The ongoing pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) has infected more than one hundred twenty million peoples worldwide one year after its onset with a case-fatality rate of almost 2%. The disease due to the coronavirus 2019 (i.e., COVID-19) is associated with a wide range of clinical symptoms. As the primary site of viral invasion is the upper respiratory airways, lung infection is the most common complication. Most infected patients are asymptomatic or experience mild or moderate form of the disease (80 %). A lower proportion (15%) develop severe pneumonia with variable level of hypoxia that may required hospitalization for oxygen therapy. In the most severe cases (5%), patients evolve towards critical illness with organ failure such as the acute respiratory distress syndrome (ARDS). At this stage, invasive mechanical ventilation is required in almost 70 % and the hospital mortality rises to 37 %.

Immune cells are key players during SARS CoV-2 infection and several alterations have been reported including lymphocytes (T, B and NK) and monocytes depletion, and cells exhaustion. Such alterations were much more pronounced in patients with the most severe form of the disease. Beside, a dysregulated proinflammatory response has also been pointed out as a potential mechanism of lung damage. Finally, COVID-19 is associated with an unexpectedly high incidence of thrombosis which probably results from the viral invasion of endothelial cells.

The investigators aim to explore prospectively the alterations of innate and adaptive immune cells during both the acute and the recovery phase of SARS CoV-2 pneumonia. Flow and Spectral cytometry will be used to perform deep subset profiling focusing on T, B, NK, NKT, gamma-gelta T, monocytes and dendritic cells. Each specific cell type will be further characterized using markers of activation/inhibition, maturation/differenciation and senescence as well as chemokines receptors.

T-cell memory specificity will be explore using specific SARS CoV-2 pentamer. Platelet activation and circulating microparticles will be explore using flow cytometry. Serum SARS CoV-2 antibodies (IgA, IgM, IgG), serum cytokines, and serum biomarkers of alveolar epithelial and endothelial cells will be analyze using ELISA and correlate with the severity of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y
* Laboratory confirmed SARS CoV-2 infection (positive RT-PCR).
* Ground-glass opacity on chest computed-tomography
* Time from hospital admission to inclusion \< or equal to 72 h

Exclusion Criteria:

* Pregnant
* Under legal restriction