cyrilzakka/clinical-trials huggingface dataset:
Intradermal LPS and Antibiotics

Erythromycin and clindamycin are believed to have anti-inflammatory aspects. This study investigates the possible anti-inflammatory effects of erythromycin and clindamycin.

Convincing mechanistic reports on the immunomodulatory action of erythromycin and clindamycin are scarce, rarely based on experiments in freshly isolated human immune cells, and potentially contradicting. Moreover, direct immunomodulatory effects of both antibiotics have never been demonstrated in vivo. The Centre for Human Drug Research Biomarker lab has studied in depth the immunomodulatory actions of erythromycin and clindamycin in vitro. These in vitro experiments on primary human immune cells demonstrated that both erythromycin and clindamycin are able to modulate the immune response of peripheral blood mononuclear cells upon stimulation with different immune triggers such as lipopolysaccharide (LPS) and polyI:C. In this current study the in vitro work will be translated to an in vivo study where it will be made into an intradermal LPS skin challenge model in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, blood serology and urinalysis;
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg;
3. Fitzpatrick skin type I-III (Caucasian);
4. Able and willing to give written informed consent and to comply with the study restrictions.
5. Able to work with the eDiary app.

Exclusion Criteria:

1. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients;
2. Type 1 or type 2 diabetes mellitus;
3. Any vaccination within the last 3 months;
4. Family history of psoriasis;
5. History of pathological scar formation (keloid, hypertrophic scar);
6. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis);
7. Hypersensitivity for dermatological marker at screening;
8. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study;
9. Excessive sun exposure or a tanning booth within 3 weeks of enrollment;
10. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
11. Loss or donation of blood over 500 mL within three months prior to screening. Or the donation of plasma within 14 days prior to screening;
12. Current smoker and/or regular user of other nicotine-containing products (e.g., patches);
13. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.
Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s

Study design: Prospective, single arm

Timeline: six month enrollment period and 12 months follow-up period.

Sites: The study will be conducted at McGill University.

Study population: Ten adult patients diagnosed with facet related low back pain.

Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet related low back pain.

Safety would be evaluated by the incidence and severity of treatment related adverse events Efficacy would be evaluated by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the study forms and to communicate with investigator
3. Patient with uni or bilateral lumbar facetogenic pain of \> 6 months duration
4. Patients presenting with a) a positive (\>70% pain relief) to a previous L1 to L5 lumbar medial branch block and / or b) with a positive (\>70% pain relief) to a previous lumbar facet thermal RF denervation within the last 6 months)
5. Average pain score of 4 or higher in the last month, (on a scale of 0 to 10)

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 18 or older than 80 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not radicular pain).
4. History of spine surgery
5. Presence of metal hardware at the lumbosacral spine
6. Lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI)
7. Patients unable to understand and complete the research questionnaires in English or French
8. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
9. Patient with extensive scarring in the skin and tissue overlying the treatment area.
10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Effect of perineurial dexamethasone on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

This study proposes to explore the effect of perineurial Dexamethasone on erector spinal plane block duration for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for idiopathic scoliosis surgery
* age \>10 and \<18 years

Exclusion Criteria:

* age \< 10 years
* age \< 18 years
* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
A Single Centre, Prospective, Observational Study to Assess the Use of the Rehabilitation Tool, GripAble, in Patients With Upper Limb Spasticity Receiving Botulinum Toxin-A (BoNT-A) in the United Kingdom (UK).

The purpose of this study is to explore how a rehabilitation tool (GripAble) could be used to monitor the effect of BoNT-A during an injection cycle and understand its potential value as a home rehabilitation tool in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hemiparesis with spasticity in the Primary Target Muscle Group (PTMG) for whom a decision to treat with BoNT-A has been made prior to inclusion in the study
* BoNT-A injection must be administered in the PTMG; injection into additional upper limb muscles must be based on investigator's judgment in line with the relevant Summary of Product Characteristics (SmPC)
* Naïve or non-naïve to BoNT-A treatment; if non-naïve, at least 4months elapsed after the last BoNT-A injection, of any marketed formulation prescribed in accordance to the relevant SmPC
* Must be able to use the GripAble tool and have access to the internet through wireless connection in the home setting
* Patients for whom the use of the GripAble tool aims to train:

  1. Wrist extension,
  2. Supination,
  3. Grip and release

Exclusion Criteria:

* Surgery on any upper limb or intrathecal baclofen therapy (ITB) for spasticity within the last 3 months
* Progressive neurological (e.g. Parkinson's Disease)
* Patients with no active muscle recruitment in the affected upper limb
* Patients with significant cognitive impairment
A Randomized Clinical Evaluation of the BioFreedom™ Stent

The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.


Eligibility Criteria:
Inclusion Criteria:

* Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Exclusion Criteria:

1. Pregnancy
2. Patients expected not to comply with 1 month DAPT
3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
4. Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy
5. Active bleeding at the time of inclusion
6. Reference vessel diameter \<2.25 - \>4.0mm
7. Cardiogenic shock
8. Compliance with long-term single anti-platelet therapy unlikely
9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated.
10. Participation in another clinical trial (12 months after index procedure).
Pilot Study of High Risk Lung Cancer Screening

This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.

This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Adult 40-82 yrs of age.
2. Presenting for lung cancer screening evaluation.
3. Calculated 6 yr lung cancer risk \>1.5% for patients 40-77 years of age or \>4% for patients 78-82 years of age.
4. Able and willing to provide informed consent.

Exclusion Criteria:

1. Eligible for clinically indicated lung cancer screening (55-80 yr old, \>30 pky smoking history, still smoking or quit smoking within the last 15 yr).
2. Chest CT performed within the last year.
3. Life expectancy less than 6 months.
4. Symptoms clinically consistent with lung cancer.
5. Unable or unwilling to undergo treatment for lung cancer.
6. Any individual who does not give oral and written consent for participation.
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.


Eligibility Criteria:
Inclusion Criteria:

* Hearing impaired adult and or child (above 2 years old) who uses ABIs or cochlear implants.
* No diagnosis of any other communicative or cognitive disorder other than hearing impairment. The individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments.
* Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.

Exclusion Criteria:

* Diagnosed cognitive or communicative disorders (other than hearing impairment)
* Severe neurological disorders
* No useable electrodes in their implants
Long-term Coated and Non-coated Tibia Nails

For this retrospective cohort study, medical records of patients treated between 2005 to 2019 with the UTN PROtect and/or ETN PROtect for tibia fractures or tibia revision cases will be examined. In comparison to this cohort, patients who received an uncoated tibia nail are examined as well. Demographics, pre-surgical health status, details on fracture type or on revision, treatment decision and surgery details, postoperative reoperation and revision, surgical site infections, time to union, and adverse events will be registered. In a subgroup, additional information including clinical outcomes and patient satisfaction will be assessed by clinical exam. Patients who still carry a nail and feel discomfort at the surgical site or present with a medical condition which demands an imaging will receive an x-ray of the tibia. The xray is not part of the standard study protocol.

Primary Objective:

The primary objective is to assess the proportion of patients who experienced a surgical site infection. Surgical site infection is defined as either deep or superficial. The presence of tibia infection will be defined by the criteria of CDC.

Secondary Objective(s):

* Proportion of patients with reoperation (secondary procedures)
* Bone union (until radiographically healed)
* Proportion of patients with complications / Adverse Events related to implant or surgery
* Only Subgroup: WOMAC-Score, AOFAS, SF36, EQ5D.

Hypothesis and Statistical considerations and estimated enrollment:

We hypothesize that with the use of antibiotic coating implants like the ETN/ UTN-PROtect the risk of implant-associated infections and osteomyelitis is reduced in treatment of Tibia fractures or in cases of revision surgery in the tibia. In a retrospective manner the implanted gentamicin-coated and uncoated tibia nail procedures are evaluated. In the subgroup of patients with a currently implanted gentamicin-coated nail the incidence of surgical site infection and implant-associated infections will be assessed prospectively.

This study is exploratory in nature. Therefore, there is no formal statistical hypothesis and no formal sample size calculation. Approximately 620 tibial shaft fractures are expected to be included in the 12 months enrollment period.

Data will be analyzed with the use of simple summary statistics. Depending on the volume and quality of the collected data, different statistical analyses will be applied. Exploratory analyses will be conducted to investigate relationships between the different treatment options and the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) treated operatively with an intramedullary nail as Standard of care.
* Signed informed consent, if required by IRB/EC

Exclusion Criteria:

- Prisoner at date of inclusion
Predicting Visceral Leishmaniasis in HIV Infected Patients

In this cohort study, the investigators will study the asymptomatic period preceding the onset of active Visceral Leishmaniasis (VL) in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL.

HIV co-infection drastically increases the risk of developing active VL. Clinical outcomes are dire in immune-compromised patients even with the best available treatment, and relapse is frequent. The incubation period may provide an important window of opportunity for a pre-emptive "screen an treat" approach in HIV co-infected patients to prevent progression from infection to the active disease. However, no recommendations exist to date due to lack of solid evidence.

It is not known which patients are at highest risk of disease progression, which role parasite/host/HIV factors play in the asymptomatic infection phase, and what the diagnostic values of existing Leishmania infection markers are. Such information is needed to develop a prognostic clinical tool for the detection of HIV patients at high risk of developing active VL.

Therefore, the aim is to study the asymptomatic period preceding the onset of active VL in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL. This will be a prospective cohort study with one year of follow-up for patients who remain VL free. Patients developing active VL during the study period will be followed until the end of the study duration.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-positive
* Enrolled in HIV care at the study site

Exclusion Criteria:

* Age under 18 years
* Diagnosis of active Visceral Leishmaniasis at enrolment
* Unlikely to seek health care again at this site during the next two years
* Not able or willing to provide informed consent. For patients not able to provide informed consent: No guardian available or willing to provide IC
* Medical emergency, underlying chronic medical condition, or other circumstances that make adherence to the study unlikely, or participation in the study medically inadvisable.
Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients

The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC).

Transversal study design like a "proof of concept".

Primary objective:

The main objective is try to stablish a descriptive panel (first phase of a score system) based in the conjunction or sum of several clinical and laboratory parameters (molecular and genetic factors). The aim is to detect in a fast, early and successful way those patients that presents a high risk to develop an hepatocellular carcinoma (HCC) in the future in a specific population: HIV and HCV coinfected patients. The establishment of this panel will allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and HCC.

Eligibility Criteria:
Inclusion Criteria:

* Human immunodeficiency virus chronic infection
* Hepatitis C virus chronic infection
* No other liver viral coinfections

Exclusion Criteria:

* Alcohol consume
* Immunosuppressor or immunoactive treatment
Alzheimer's Caregiver Coping: Mental and Physical Health

This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information.

The burden of caring for a loved-one with Alzheimer's disease is associated with adverse psychological and general health consequences for the caregiver. These consequences including risk for depression, cardiovascular disease, and earlier mortality. Because preliminary work has demonstrated that an educational programs for caregivers reduce the negative affect associated with caregiving, the investigators wish to determine whether improving mood can also modify pathophysiological changes that have been linked to risk for developing cardiovascular disease.

The investigators aims are to determine whether a 6-week Behavioral Activation (BA) intervention, followed by 3 booster sessions over a period of 6 months, compared to an Information-Support (IS) intervention will be associated with significant improvement in indicators of vascular pathology, modification of psychobiological markers that have been associated with cardiovascular parameters, and to determine whether improvements in indicators of vascular parameters will be mediated by treatment related change in measures of distress and markers of cardiovascular disease risk.

Eligibility Criteria:
Inclusion Criteria:

* Aged 55 years or older.
* Providing in-home care to a spouse with dementia.

Exclusion Criteria:

* Taking Coumarin anticoagulants.
* Taking nitrates or niacin.
* Taking non-selective β-blockers.
* Glucocorticoid use in the 2 weeks prior to enrollment.
* Taking Aldomet or labetalol.
* Neither the caregiver nor Alzheimer's patient can be diagnosed with a terminal illness with a life expectancy of less than 1 year
* Cognitive impairment
* Caregivers enrolled in another intervention study or receiving psychotherapy to improve well-being or reduce distress
* Blood pressure \>200/120 mm Hg
A Study of OV101 in Individuals With Fragile X Syndrome

The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Is male and 13 to 22 years old (inclusive) at the time of informed consent.
* Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).

Exclusion Criteria:

* Concomitant disease or condition that are clinically significant and would limit study participation
* Clinically significant lab abnormalities or vital signs at the time of screening
* History of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months.
* Unable or does not have a caregiver able to comply with study requirements.
* Enrolled in any clinical trial within the 30 days before screening.
Salvage Surgery for Patients With Metastatic GIST With Rego

Some researches have shown surgery may acquire progression-free (PFS) benefit for selected patients with metastatic gastrointestinal stromal tumor (GIST) who received first-line imatinib and second-line sunitinib. However, impact of salvage surgery on pre-treated GIST patients receiving third-line regorafenib facing progression is not yet reported. Investigators retrospectively reviewed patients with regorafenib treatment with salvage surgery.

Between 2014 and 2019, 41 metastatic GIST patients received regorafenib therapy. 35 out of 41 metastatic GIST patients who were on regorafenib therapy facing progression and 15 experienced local progression underwent salvage surgery. Thirty-five of 41 (85.4 %) pre-treated GIST patients receiving regorafenib who experienced disease progression after a median follow-up of 12.4 months of regorafenib use. 15 out of 35 (42.9%) metastatic GIST patients receiving regorafenib facing progression underwent salvage surgery.

Eligibility Criteria:
Inclusion criteria:

1. Patients who is taking regorafenib after treatment failure by 1st line and 2nd line tyrosine kinase, namely Imatinib and Sunitinib.
2. Patients with aforementioned condition and is facing local progression of disease or stationary disease.

Exclusion criteria

1. Systemic progression of disease
2. ASA classification \> 3