cyrilzakka/clinical-trials huggingface dataset:
A Prehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients

This research study is evaluating a prehabiliation intervention designed to improve postoperative functional capacity (measured by 6-minure walking distance) in individuals undergoing lung resection for cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed of stage I, II, or IIIA Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation
2. Patients scheduled to undergo lung resection surgery at least two weeks from recruitment
3. Patients with a Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at recruitment
4. Patients with no evidence of recurrent or progressive disease
5. Patients aged 45-80 years
6. Patients able to communicate in Cantonese, Mandarin, or English
7. Patients is absence of any cognitive impairment
8. Patients with a score of 6 minutes walking test (6MWT) ≤ 500 meters at baseline. \[rationale: a threshold value of 500 meters preoperative 6MWT predicts a higher risk of postoperative complications and prolonged LOS after lung resection\]
9. Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months

Exclusion Criteria:

1. Patients who had engaged in at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity per week in the past three months
2. Presence of another concurrent, actively treated malignancy
3. Presence of chronic obstructive pulmonary disease
4. Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopedic disorders of the lower limbs, respiratory failure, or the need for portable oxygen therapy for activities of daily living
5. Not having a smart device to receive WhatsApp messages
Mobile Interventions for the Prevention and Detection of Distress

Stress, anxiety, distress and depression are exceptionally high among healthcare providers at the frontline of the COVID-19 pandemic. Knowledge of factors underlying distress and resilience and evidence based interventions to impact the mental wellbeing of frontline healthcare providers is limited. This study will evaluate a novel mobile platform to gather the "distress experience" of healthcare workers at Unity Health Toronto in real time during and after the COVID-19 pandemic, use automated personalized mobile interventions (e.g. routine, sleep, exercise) to nudge active/passive parameters to manage distress.


Eligibility Criteria:
Inclusion Criteria:

* Staff or healthcare providers working at Unity Health Toronto
* 18 years of age or older
* Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher)

Exclusion Criteria:

* Non-Unity Health Toronto staff
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers

Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years, willing and able to provide written informed consent.
* Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
* Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1) with duration less than 24 months
* Subjects whose ulcer is no smaller than 2cms in any one direction
* Subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width)
* Subjects' whose index leg ulcer has a moderate to heavy level of exudate.
* Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control
* Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.

Exclusion Criteria:

* Subjects with a history of skin sensitivity to any of the components of the study dressings (AQUACEL® Extra™, AQUACEL®, \& DuoDERM™ Extra Thin)
* Subjects whose wounds are considered clinically infected at baseline
* Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
* Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
* Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
* Subjects who have participated in a clinical study within the past month.
Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy

To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (\> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Any stage NHL or breast cancer and received the first cycle of a new chemotherapy course.
* Received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (\> 20%) FN risk according to published data or guidelines (dose modifications +/-10% in Cycle 1 are allowable).
* Initiated treatment in Cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (SmPC). Enrolment must occur after the first pegfilgrastim dosing in Cycle 1 and before the second day of Cycle 2.

Exclusion Criteria:

* Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the national competent authorities for any indication.
* Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).
Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control

To demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and HbA1c.

Study Overview This is a multi-centre pilot study across 6 study sites, recruiting 50 subjects. Each subject will use a FreeStyle Navigator Continuous Glucose Monitor for a period of 20 days at the start of the study, after which their Healthcare Professionals (HCPs) may recommend changes to their glucose management based on the continuous glucose monitoring(CGM) data. Subjects will then return to self-managing their diabetes with a blood glucose meter. After 2 months, subjects will use the FreeStyle Navigator for a further 5 days and review their results and glucose management with their HCPs. Subjects will again return to self-managing their diabetes with a blood glucose meter until the end of the study, when the last FreeStyle Navigator 5 day wear is completed and HbA1c and measures of glycaemic variability are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Subject with Type 1 or Type 2 diabetes requiring Multiple Daily Injections (MDI) (for \>1yr)
* Age 18-65 years
* HbA1c above 8.0% for previous 2 HbA1c tests; the last HbA1c result being obtained within 3 months prior to enrolment
* Completed a structured education programme meeting NICE criteria between 6 to 24 months prior to enrolment.
* Testing Blood Glucose ≥ 4 times a day for previous 12 months

Exclusion Criteria:

* Subject is currently on an insulin pump.
* Subject has known allergy to medical grade adhesives
* Subject has concomitant disease that influences metabolic control
* Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
* Subject is currently using another continuous glucose monitoring device or has previously used real-time continuous glucose monitoring.
* Subject is receiving peritoneal dialysis solutions containing icodextrin
* Subject is pregnant / planning to become pregnant during study
Construction and Validation of a Tool for Automatic Identification of Care Pathways At Risk of Sub-optimality in the Management of Severe Infections in Children (DIABACT IV)

Community bacterial infection remains to this day a common cause of morbidity and mortality in children, which preventability is a challenge for clinicians. In a previous work, the investigators found that 76% supported children admitted to the ICU for severe bacterial infection were appraised as suboptimal and significantly associated with an increased risk of death. In this context, the investigators seek to identify indicators of extractable data PMSI and SNIIR -AM associated with a higher risk of suboptimal early taking care of children with severe bacterial infection in order to combine them and use them as a score or decision tree that the investigators will validate data from a national prospective multicenter study including 512 children admitted to the ICU for severe infection. The investigators then propose a score associated with a risk of suboptimality care to evaluate the performance of the healthcare system .


Eligibility Criteria:
Inclusion Criteria for retrospective inclusions:

* All children from 1 month to 15 years and 3 months admitted in pediatric resuscitation;
* Community with severe bacterial infection defined by a bacterial infection documented by the presence of a bacterium from a normally sterile site (pleural cerebrospinal fluid joint fluid, blood, bone biopsy ...), a positive urine culture on a sampling done in aseptic conditions accompanied by a febrile illness (eg pyelonephritis), or purpura fulminans in the absence of documentation.

Inclusion Criteria for prospective inclusions:

* The inclusion criteria DIABACT III will be expanded to include children 0-1 months.
* Parents and patient (if applicable) who signed the consent biocollection for participation in the substudy.

Exclusion Criteria:

* Nosocomial Infections as defined by the Ministry of Health in its January 2007 issue on nosocomial infections namely: Nosocomial infections are infections acquired in a healthcare facility. Infection is considered nosocomial if it was absent at the time of admission of the patient in the health facility. When the infectious status of the patient at admission is unknown, the infection is generally considered nosocomial if it occurs after a period of at least 48 hours of hospitalization or a period longer than the incubation period of the infection. In case of surgical site infection, the period commonly allowed is 30 days, or if it has been set in place a prosthesis or implant, a year after the intervention.
* Children with whooping cough, bronchiolitis or viral infections
Zonulin Biomarker for Diagnosis of Hip and Knee Infections

Prior studies investigating the etiopathogenesis of surgical site infection (SSI) traditionally suggested three main ways for the infection to occur: local contamination occurring during the surgery, hematogenous translocation of bacteria during concomitant bacteraemia, and contamination from adjacent infected tissues by the progression of the infective process. While most of the research on SSI focused on minimizing any source of pathogens at the time of the surgery, emerging evidence shows how acute and chronic SSI can emerge more often from bacteraemia or other tissues in the body, such as the gastrointestinal system, especially when dysbiosis and high permeability are retrieved.

Intercellular tight junctions (TJs) tightly regulate paracellular antigen trafficking. TJs are extremely dynamic structures that operate in several critical functions of the intestinal epithelium under both physiological and pathological circumstances. This paradigm was subverted in 1993 by the discovery of zonula occludens 1 (ZO-1) as the first component of the TJ complex 11 now being comprised of more than 150 proteins, including occludin, claudins, junctional adhesion molecules (JAMs), tricellulin , and angulins . However, despite major progress in our knowledge on the composition and function of the intercellular TJ, the mechanisms by which they are regulated are still incompletely understood. One of the breakthroughs in understanding the role of gut permeability in health and disease has been the discovery of zonulin, and the only physiologic intestinal permeability modulator described so far.

Since then, zonulin has been used as a marker for increased intestinal permeability and associated with soluble CD14 (sCD14) and lipopolysaccharide (LPS), other common markers associated with surgical complication, inflammation, and bacterial translocations.

As such, Zonulin could be a biomarker for mid- and long-term complications after total joint replacement such as infection, loosening, and mechanical complications associated with painful symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent primary or aseptic revision total hip and knee arthroplasty.
* Patients who underwent revision total hip and knee arthroplasty for infective reasons
* Patients 18 years of age or older

Exclusion Criteria:

- Patients younger than 18 years old
Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this population relies on repeated CT-scans which are more accurate for detection of peripheral lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using automate cytometry may be of interest in this population, alone or in combination with CT-scan.

An ancillary study will evaluate the interest of blood predictive biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* High professional asbestos exposure
* Member of a former cohort recruited between 2000 and 2006 in Caen, Rouen and Le Havre (inclusion criteria: 50-75 years at the time of initial recruitment, high intermittent asbestos exposure \>= 1 year, or high discontinuous asbestos exposure \>=10 years). All the living members of the cohort will be contacted: a maximum of 1000 subjects is expected, probably less.
* Informed consent signed

Exclusion Criteria:

* Personal history of lung cancer
* Refusal of the study protocol
* Uncontrolled asthma or lung failure
Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy

This randomized controlled trial (RCT) aims to evaluate the effects of intensive Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy.

This randomized controlled trial (RCT) will investigate the impact of two weeks of HABIT-ILE therapy versus conventional rehabilitation on spinal, muscular, and functional outcomes in adults (18-50 years old) with bilateral cerebral palsy (CP). Key assessments will include changes in gross motor function, spinal and muscular adaptations assessed via EMG and ultrasound, strength testing, clinical motor function tests, pain assessment, and questionnaires on activity and participation. This study aims to provide a comprehensive analysis of HABIT-ILE's effects especially on motor function, daily life activities and participation across a wide range of age.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed bilateral cerebral palsy,
* Adults aged 18 to 50 years old,
* Level of manual ability : level I to V of MACS
* Level of gross motor function : level I to IV of GMFCS
* Ability to follow instructions and complete testing,
* Ability to walk 10 meters independently without human assistance (technical aids such as orthoses or walking aids are permitted).

Exclusion Criteria:

* Unstable seizure
* Programmed botulinum toxin or orthopedic surgery in the 6 months before the intervention, during intervention period or 6 months after the intervention time
* Alcohol/drug abuse
* Pregnancy
* Severe visual or cognitive (severe aphasia, psychiatric conditions) impairments likely to interfere with intervention or testing session completion
* Uncontrolled health issues (cardiac, metabolic...)
Percent Body Fat in Breast Fed Infants

The purpose of this study is to learn about normal body composition (% body fat) during the first six months of life in healthy breast-fed babies.


Eligibility Criteria:
Inclusion Criteria:

* Term birth
* Infant must weigh at least 5.5# at birth
* Single birth
* Healthy mother/infant as determined by the investigator
* Intention to breast feed

Exclusion Criteria:

* Significant perinatal morbidity
* Having health, environmental, or economic constraints on growth
* Infants of a mother with diabetes or gestational diabetes
Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain

A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

A 2-part study. In the first part the safety, tolerability and pharmacokinetics will be assessed in up to 6 participants. In the second part, the safety, tolerability and efficacy of PP353 will be assessed in up to 40 participants.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years, inclusive.
* Chronic low back pain in the area associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2) at a single lumbar level.
* Average LBP NRS score at screening and at Day 1 pre-randomisation ≥ 4 on chronic pain medication and ≥ 6 if not on chronic pain medication; it should be higher than the leg pain NRS score
* RMDQ-23 score ≥ 9 at screening and at Day 1 pre-randomisation.
* Current episode of chronic low back pain has lasted for ≥ 6 months at the time of randomisation.
* Bodyweight of ≥ 50 kg and ≤ 120 kg.
* Failure of standard of care therapies used by their treating physician

Exclusion Criteria:

* Any vertebra with Modic 2 only lesions which:

  1. in the opinion of the investigator, after deep palpation of the vertebral spine, is contributing to the low back pain and/or
  2. are present within 2 vertebrae from the target lumbar disc.
* The target lumbar disc has lost more than half its original anticipated height at the centre or it is \< 5mm in height over the central 15 mm portion
* A clear alternative cause for back pain
* Gross facet joint degeneration or cases where the investigator believes the primary pain generator to be the facet joints
* Interventional back procedure in the 6 months prior to screening or major surgery in the 12 weeks prior to screening
* History of alcohol abuse or drugs of abuse in the past 2 years
* Any other significant illness
* Previously been treated with antimicrobial agents for their low back pain or previously received any antimicrobial intradiscal injection.
Validation of the NeuroTec Loft

The progression of neurodegenerative disorders and the increasing number of elderly people intensifies the need of institutional care, which contrasts with the desire of most elderly and patients to live independently at home. The rapid evolution of assistive technology offers new possibilities in providing medical professionals preventive services in real-time. Therefore, the main focus of this study is on the individual sensors and how they can be combined to one unobtrusive system to assess the human behaviour and daily activities during day and night in an instrumented apartment in healthy participants.

The higher prevalence of age-associated neurodegenerative disorders (e.g. Parkinson, Alzheimer), is in line with a steady increase of the average life expectancy in Switzerland. With the progression of neurodegenerative disorders and the increasing number of elderly people, the need for institutional care intensifies, which contrasts with the desire of most elderly and patients to live independently. The rapid evolution of assistive technology offers new possibilities in providing medical professionals preventive services in real-time. An extended stay in the hospital could influence independent ageing negatively and thus, monitoring has great potential to prevent critical events. In this study, the main focus is on the individual sensors and how they can be combined to one unobtrusive system. In addition, to get an understanding which parameters of the sensors are important and how the data can be extracted and processed (algorithms). Therefore, the aim of this study is to validate the accuracy to assess human behaviour and daily activities during day and night by unobtrusive sensors in an instrumented apartment in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Aged ≥18 years
* German speaking

Exclusion Criteria:

* Infected by multidrug-resistant bacteria according to current medical history
* Incontinence
Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide

The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus treated with Biguanide.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with Biguanide treatment
* Criteria for postprandial plasma glucose and HbA1c are met

Exclusion Criteria:

* Type 1 diabetes
* Patients treated with other antidiabetic drugs or Insulin