cyrilzakka/clinical-trials huggingface dataset:
Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada

The global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low level laser) is used for acceleration of wound healing. The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment.

Patients with diabetic foot ulcers will receive standard treatment and in addition will be randomly allocated to receive either active or sham laser device to self treat at home. The patient's wound will be evaluated every 2 weeks. Adverse events will be documented. The study hypothesis is that B-Cure laser treatments as an adjunct therapy to standard treatment, applied, at home, by the patient or personal care-giver, can accelerate diabetic foot ulcers healing compared to standard treatment alone.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or Female
4. Age:18-95 years old at the time of Informed Consent (Adult, Senior)
5. Type 1 or type 2 Diabetes Mellitus
6. Presence of a diabetic foot ulcer located in the ankle area or below that has persisted a minimum of 3 months prior to the screening visit
7. Ulcer grade classified as ≥2 according to Wagner grading system.
8. Area of ulcer (after debridement) is at least 2 cm2
9. Arterial perfusion: Patients who demonstrate adequate arterial perfusion defined as either: Ankle/brachial index (ABI) above 0.5 or that have documented confirmation of adequate arterial perfusion
10. Patient and/or caregiver must be able and willing to learn and perform the duties of dressing changes
11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Exclusion Criteria:

1. Pre-existing conditions - active malignancy,
2. Anemia (Hb\<8 gr/dL)
3. Scheduled to undergo vascular surgery, angioplasty, or thrombolysis at the time of enrollment.
4. History of malignancy on study limb or currently receiving or has received radiation or chemotherapy within 3 months of randomization
5. Taking immunosuppressive medication
6. Received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening
7. HbA1c \> 12% (uncontrolled hyperglycemia)
8. A documented history of alcohol or substance abuse within 6 months of screening
9. Currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results
10. Pregnant at the time of screening
11. Has any photobiomodulation (low level laser) device at home
Brown Adipose Tissue and Body Mass Index

In this study the investigators aim to investigate whether the sympathetic stimulation of BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scan, differs between lean and obese individuals, as an explanation for the diminished metabolic brown adipose tissue activity in obese subjects.

The investigators hypothesis is that sympathetic nervous system activity in the obese is diminished as compared to their leaner counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the obese.

The sympathetic nervous system is the primary activator of Brown Adipose Tissue.

Obese humans are known to have less metabolically active brown adipose tissue as compared to their leaner counterparts.

The reason for this diminished metabolic brown adipose tissue activity is unknown.

However, a lower sympathetic nervous system activation to brown adipose tissue in the obese might explain a diminished metabolic brown adipose tissue.

Therefore, in this study, both the sympathetic nervous system activation to brown adipose tissue and the metabolic activity will be measured in lean and obese subjects.

sympathetic nervous system activity will be measured using 123I-metaiodobenzylguanidine single-photon emission computed tomography scans, metabolic activity will be measured using 18F- fluorodeoxyglucose positron emission tomography CT scans.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Caucasian origin
* Subjects should be able and willing to give informed consent
* 18-40 years old
* BMI range of 19-25 kg/m2 (lean study subjects) or 28-40 kg/m2 (obese study subjects)

Exclusion Criteria:

* Renal failure (creatinine\>135mmol/l)
* Daily use of prescription medication
Be-Active Study - Increasing Physical Activity in Cancer Survivors

Rates of cancer survivorship are on the rise and cancer survivors face unique health challenges that are common across cancer types that last well beyond the cessation of cancer treatment (e.g., increased fatigue, anxiety/depression, fear of recurrence, risk of cardiovascular disease, and lower health-related quality of life). While physical activity (PA) has favorable effects on these health parameters and is highly recommended for cancer survivors, this population engages in lower-than-average levels of PA. Effective PA interventions with high translation potential are important for improving the health of this population. The Internet overcome barriers to traditional face-to-face treatment programs (e.g., high cost, participant burden, geographical constraints) and represents a disseminable intervention approach. While behaviorally-based Internet programs significantly increase PA in other health domains, the application of these programs to cancer survivors is relatively new. This study will randomize 50 cancer survivors to a 12-week Internet PA program or usual-care newsletter condition. Primary outcomes include intervention engagement and program satisfaction related to the Internet program and changes in PA by intervention arm at post-treatment (3 months). Secondary aims include comparison of intervention arms on changes in sleep, weight, fatigue, anxiety/depression, health-related quality of life, and fear of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed cancer diagnosis and have either completed all cancer-directed treatment in the past 3-12 months or be on a maintenance/continuous treatment regimen for which they have been stable for at least 3 months
* Inactive - defined as engaging in \<60 min/week of moderate-intensity PA over the past 3 months
* BMI between 18.5 and 45 kg/m2
* English speaking
* Daily Internet access

Exclusion Criteria:

* Any medical condition for which physical activity is contraindicated
* Unable to attend assessment visits in Providence RI
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
* Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)

Exclusion Criteria:

* Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
* History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery.
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline.

Other protocol-defined inclusion/exclusion criteria applied to the study.
A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China

Nivolumab (BMS-936558) is a fully human, IgG4 (kappa) isotype mAb that binds PD-1 on activated immune cells and disrupts engagement of the receptor with its ligands PD-L1 (B7 H1/CD274) and PD-L2 (B7-DC/CD273), thereby abrogating inhibitory signals and augmenting the host antitumor response. In early clinical trials, nivolumab has demonstrated activity in several tumor types, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

Nivolumab is in clinical development for the treatment of patients with NSCLC, RCC, melanoma, squamous cell carcinoma of the head and neck (SCCHN) and other tumors (eg, glioblastoma multiforme, mesothelioma, small cell lung cancer, gastric).

Nivolumab is approved in the United States (US), European Union, and other countries for the treatment of patients with unresectable or metastatic melanoma, advanced NSCLC with progression on or after platinum-based chemotherapy, advanced RCC whose disease progressed on an antiangiogenic therapy, classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin treatment, and recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.

The proposed study will evaluate the efficacy and safety of preoperative administration of Nivolumab or Nivolumab combined with nab-paclitaxel and carboplatin in neoadjuvant setting and administration of Nivolumab in adjuvant setting in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune microenvironment and circulating immune cells in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting. Ultimately, it is highly desirable to discover prospective biomarkers of response and toxicity to allow patients with NSCLC who are most likely to derive benefit to receive anti-PD-1 treatment, and conversely to minimize the risk of toxicity and ineffective treatment for patients who are unlikely to benefit.


Eligibility Criteria:
Inclusion Criteria:

* Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
* Lung function capacity capable of tolerating the proposed lung surgery
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Available tissue of primary lung tumor

Exclusion Criteria:

* Presence of locally advanced, inoperable or metastatic disease
* Participants with active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria could apply
A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy

This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.\>/= 140/90 mmHg in non diabetics or \>/= 130/80 mmHg in diabetics

Exclusion Criteria:

* Patient having B.P.\>= 180/110 mmHg in non diabetics or \>= 160/100 mmHg in diabetics
* Type 1 Diabetes or uncontrolled type 2 Diabetes.
* PCI in last 12 months.
* Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply
Diffusion Tensor Imaging to Judge the Prognosis of Patients With Diffuse Axonal Injury

The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the ADC(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.By using fiber tractography the investigators can have the extent of recovery of the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).

The investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with DTI(diffusion tensor imaging). The investigators then determine the FA（fractional anisotropy）value and the ADC(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value and GCS(Glasgow Coma Scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.At the same time the investigators rebuild the white matter fiber tract(corpus callosum 、corticospinal tract、optic radiation) of patients using diffusion tensor tractography so that the investigators can judge intuitively the extent of damage and recovery. The investigators Trace the repair of nerve fibers after treatment and guide the further treatment.This trial can exactly determine the relationship between the FA（fractional anisotropy）value and ADC(apparent diffusion coefficient) value in relational interesting area and the extent of damage in patient of DAI（diffuse axonal injury）.Meanwhile the trial confirms that the DTI(diffusion tensor imaging) can exactly judge the prognosis of DAI（diffuse axonal injury）.Obviously by using fiber tractography the investigators can have the extent of recovery of the patient of DAI（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).

Eligibility Criteria:
Inclusion Criteria:

* Has a history of trauma exactly
* Immediate coma after injury
* Increased intracranial pressure level do not agree with clinical illness severity
* No significant changes of CT while with severe clinical manifestations

Exclusion Criteria:

* None
A Study to Characterize Access to Specialty Care Received by American Indians/Alaska Natives

This is an observational study to define current care pathways for American Indian or Alaska Native patients who require specialty care and potential feasibility of conducting clinical research within the existing framework. The study is designed with the flexibility to enroll patients with any indication requiring referral to one of the following specialists: neurologist, ophthalmologist, or oncologist. Eligible patients will have recently (≤6 months) been referred to a specialty care provider and not yet seen a specialist (in addition to meeting the other eligibility criteria). The PPD virtual site can enroll patients from anywhere across the United States.

The study will collect data to determine whether a patient was seen by a specialist, diagnosed with a specialized disease, patient characteristics potentially associated with being seen or not seen by a specialist, and the reasons/barriers why a patient was not seen by a specialist through a number of patient surveys.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read English at 8th grade proficiency or have a household member willing to assist in translation to complete patient surveys
* Self-identification as American Indian or Alaska Native
* Referred to a neurologist, ophthalmologist, or oncologist for the first time within 6 months of screening and has not been seen by the specialist. Exception: Patients referred to an oncologist who have had a first-time visit with an oncologist but have a pending follow-up visit or pending referral visit within 6 months of screening may be included in the study.
* Personal landline or cell phone and/or access to internet
* Willingness to complete all surveys in the study and participate for 12 months

Exclusion Criteria:

* Currently under the care of a specialist (neurologist, ophthalmologist, or oncologist) to whom they are being referred to by the primary care provider (i.e., to be eligible, the specialty care physician should be new to the participant) at time of screening
* Currently or planned to receive care that requires in participant visits for the indication requiring referral from the primary care provider (e.g., radiotherapy, chemotherapy for cancer diagnosis). Exception: Patients referred to an oncologist who have had a first-time visit with an oncologist but have a pending follow-up visit or pending referral visit may be included in the study.
Use of 2% Chlorhexidine Cloths Reduce Surgical Site Infections

Use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line to toes will decrease surgical site infections (SSI) by 30% when compared to patients who receive routine standard of care (use of chlorhexidine cloths night before surgery and morning of surgery).

Patients undergoing colorectal surgery will be randomized in a 1:1 fashion into two groups. One will be standard of care using 2% Chlorhexidine Gluconate wipes night before surgery and morning if surgery. The second group will be randomized into the study arm using 2% Chlorhexidine Gluconate clothes from jaw line to toes night before surgery, morning of surgery and daily post operative. Skin cultures will be obtained at time of consent, prior to surgical procedure before surgical scrub and draping, post operative day 4 and at 30 day follow up visit. Incision lines will be assessed daily by study staff for signs of surgical site infection utilizing the CDC's 3 definitions of surgical site infections, superficial incisional SSI, deep incisional SSI, and organ space SSI.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients \> 18 years old scheduled for a colorectal surgical procedure ASA\>2 OR pre-operatively hospitalized

Exclusion Criteria:

* Unable to consent
* Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate cloths
* Current infection or history of abdominal infections.
* Patients on chronic steroids or immunosuppressive medications.
PeRfusiOn Post tHrombEcTomy (PROPHET)

Endovascular mechanical thrombectomy is the standard of care for treating patients with a large-vessel occlusion acute ischemic stroke. However, in more than half of these patients, remaining distal vessel occlusions limit the benefit of this therapy. Currently the detection of residual vessel occlusions and the decision for further treatment by the operator is based on the 2D digital subtraction angiography (DSA) images. However, this technique has several limitations. Recently, a new imaging technique, with the possibility to acquire 3D time-resolved perfusion images directly in the operating room was introduced (the flat-panel detector computed tomography perfusion imaging, FDCTP). It can overcome the spatial limitations of 2D DSA, but the details on clinical validation and utility of FDCTP are currently lacking.

This clinical investigation is planned as a multi-center, prospective, non-randomized observational study with a primary endpoint to evaluate a potential diagnostic benefit. The diagnostic tool to be studied is clinically indicated 60s Dyna CT Head Perfusion (FDCTP imaging) obtained after or during mechanical thrombectomy for acute ischemic stroke.

The population consists of patients with symptoms of acute ischemic stroke, who were intended to undergo mechanical thrombectomy. This means that patients who did not undergo mechanical thrombectomy and only had diagnostic angiography (e.g. physician team has decided against thrombectomy due to pre-interventional vessel reperfusion), can still be included in the study. Patients can only be included if a FDCTP was acquired immediately after thrombectomy or diagnostic angiography by the treating physician team as part of the standard clinical routine. There is no control group.

The overall objective is to investigate the potential clinical use of FDCTP acquired during or shortly after the endovascular stroke treatment. Primary study objective is to evaluate in how many cases FDCTP maps reveal new, potentially relevant clinical information that may change treatment decisions. The primary research hypothesis is that the proportion of patients where FDCTP reveals new, potentially clinically relevant findings is greater than 25%. Assuming a true proportion of 33% of the primary outcome, we will need 251 patients to reach a power of 80% at a one-sided alpha of 2.5%, based on a one-sample binomial exact test. To account for a drop-out rate of 10%, we plan to recruit 279 patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by a signature
* The patients received mechanical thrombectomy or there was the intention to perform endovascular treatment, but only diagnostic angiography was performed.
* Patients received FDCTP as clinically indicated by the treating physician.

Exclusion Criteria:

* Inability to give consent due to insufficient knowledge of the project language
* Inability to follow the clinically indicated visit at 90 days after the index stroke (e.g. patients living abroad).
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma

The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'

A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
2. Male or Female, ≥12 years of age
3. Documented diagnosis of asthma for at least 6 months prior to Visit 1
4. Patients who are in need of GINA step 2 treatment
5. Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
7. Patients should have reversible airway obstruction
8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period

Exclusion Criteria:

1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission
2. Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
4. Current or previous smoker with a smoking history of ≥ 10 pack years
5. Pregnancy, breast-feeding or planned pregnancy during the study