cyrilzakka/clinical-trials huggingface dataset:
Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

• The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.

Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.

The improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.

Negative-pressure wound therapy is a non-invasive therapy system that employs a controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a container.

An earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.

As most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.

NPWT provides a moist wound environment ideal for re-epithelialization, growth factor action, angiogenesis, and granulation promotion.

Edema reduction produced by NPWT decreases interstitial pressure and positively promoting wound vessel formation and improving wound circulation and lymphatic drainage, increasing the availability of nutrients, oxygen and antibiotic therapy in the wound area. Some studies showed that NPWT promotes an improvement of balance between proteases and their inhibitors and influences cytokine modulation and promotes a positive wound environment.

Accurate classification of diabetic foot ulcers according to Wagner's classification of ulcers is essential for inter-clinician communication, assessment of healing tendency during management by NPWT.

Eligibility Criteria:
Inclusion Criteria:

* Acute and chronic diabetic wounds, pressure ulcers.
* Wagener's Grade I superficial diabetic ulcer.
* Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.
* Ischemic wounds after revascularization.

Exclusion Criteria:

* - Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.
* Wagener's Grade IV, localized gangrene e.g. toe ,heel.
* Wagener's Grade V, extensive gangrene involving the whole foot.
* Septicemia. .
* Gas forming organism.
* Wounds resulting from venous insufficiency.
* Peripheral vascular disease (absent distal pulse).
* Patients being treated with corticosteroids, immunosuppressive drugs or chemotherapy
* Any other serious pre-existing cardiovascular, pulmonary and immunological disease.
CryoSpray Ablation (TM) GI Patient Registry

The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.

The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:

  * Barrett's esophagus with or without dysplasia
  * Squamous dysplasia of the esophagus
  * Esophageal cancer, any stage

Exclusion Criteria:

* Subjects with esophageal lesions whose pathology was not one of the above.
* Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.
i-Sleep: Internet-based Treatment for Insomnia

In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Meet ICSD-3 diagnostic criteria for Insomnia as confirmed by the telephone administered Interview
* Acess to the Internet
* Written informed consent

Exclusion Criteria:

* Physiological Insomnia
* Serious psychiatric co-morbidity that requires alternative treatment including major depression disorder, anxiety disorder, substance dependence, bipolar affective disorder, psychotic illness
* Epilepsy (seizure disorder)
Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with HIV-related non-Hodgkin's lymphoma that has relapsed or has not responded to chemotherapy.

OBJECTIVES: I. Evaluate the response rate and duration of response to etoposide, mitoxantrone, and prednimustine in patients with relapsed HIV-associated non-Hodgkin's lymphoma (NHL). II. Evaluate the response rate and duration of response to cyclophosphamide, doxorubicin, and etoposide in patients with refractory HIV-associated NHL. III. Assess the toxic effects of these regimens in these patients.

OUTLINE: Patients with relapsed non-Hodgkin's lymphoma (NHL) receive oral etoposide and prednimustine on days 1-5 and intravenous mitoxantrone on day 1 every 3 weeks. Patients with refractory NHL receive cyclophosphamide, doxorubicin, and etoposide as a continuous infusion over 4 days every 4 weeks. All patients receive concomitant antiretroviral therapy with zidovudine or didanosine. G-CSF is given for hematologic support as indicated. All patients are evaluated for response after 2 courses of chemotherapy. Patients with a complete response (CR) receive 2 additional courses. Patients with a stable or partial response receive 2 additional courses and are re-evaluated; those with a CR receive 2 more courses, while those with a stable or partial response are treated off study at the physician's discretion. Patients with progressive disease are removed from study.

PROJECTED ACCRUAL: 15-20 patients will be treated on each regimen.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma at first presentation No documented CNS involvement (i.e., primary CNS or meningeal lymphoma) Positive serologic test for HIV antibodies required No opportunistic infection unless effectively treated Disease relapsed, refractory, or unresponsive to first-line chemotherapy No more than 1 prior combination chemotherapy regimen Chemotherapy consisted of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like regimen, ACVBP, or other similar regimen

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: At least 1 month Hematopoietic: Not specified Hepatic: Bilirubin less than 5 times normal OR Transaminases less than 5 times normal Renal: Creatinine less than 2 mg/dL

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Role of Dynamic Ultrasound in Assessment of Shoulder Impingement Syndrome

This study aims to evaluate the effectiveness of dynamic high-resolution ultrasonography in identifying various abnormalities of the shoulder impingement syndrome, especially the subacromial type, and to determine the added value of dynamic ultrasonography compared to static examination of such cases. Furthermore, we will compare these findings to MRI, which we regard as the standard in our cases.

Patients with shoulder impingement syndrome often experience pain primarily in the anterior and lateral areas of the acromion, which can radiate to the lateral aspect of the mid-arm. This pain typically worsens at night and when lying on the affected side. Additionally, some patients may experience stiffness and weakness due to the pain.

When assessing a patient with signs of impingement, it is essential to evaluate the condition of the rotator cuff and the extent of any tears. This information allows surgeons to create an effective strategy for ongoing patient management.

Ultrasound (US) and magnetic resonance imaging (MRI) are effective tools for diagnosing rotator cuff disorders, especially when it comes to detecting full-thickness rotator cuff tears, due to their high sensitivity. However, their overall sensitivity for identifying partial rotator cuff tears and tendinopathy is lower. Impingement-related conditions, such as bursitis and changes or ruptures in tendons, can be visualized using a linear sonography.

Ultrasound (US) offers several advantages over MRI. One key benefit is that ultrasonography is a dynamic form of imaging, while MRI provides static images. US is also portable, better tolerated by patients, and allows for direct interaction with patients; this enables patients to point to the symptomatic area, which can enhance diagnostic accuracy. Additionally, ultrasound is less time-consuming, more cost-effective, and more readily available in secondary and tertiary care settings compared to MRI.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients present with shoulder pain with positive clinical tests suggestive of shoulder impingement syndrome

Exclusion Criteria:

* History of shoulder surgery, instability disorders, shoulder girdle fracture, radiation therapy to the shoulder, neoplastic lesions, and congenital anomalies of the shoulder. Patients having contraindications to perform MRI (Patients with electrically, magnetically, or mechanically activated implants, pacemakers, cochlear implants, or any metallic orthopedic implants) and claustrophobic patients).
Sex Hormones, Postoperative Pain and Opioid Use

Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid use.

Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors

After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected.

In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.

Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected.

In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.

Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.

Eligibility Criteria:
Inclusion Criteria:

Pediatric female patients between the ages 11-16 undergoing an orthopedic (trauma and non-trauma) surgical procedure involving a long bone or joint, or the spine, English speaking

Exclusion Criteria:

Pregnancy; Diagnosis of chronic pain, Psychiatric, developmental or neurological disorders, Disorders that are associated with pubertal maturation (e.g., precocious puberty).
Technology Assisted Physical Activity Among Hospitalised Medical Patients

Research show that inactivity during hospitalization is the norm and that the negative effects on muscle mass and the fitness of the patient will take a long time and hard work to recover afterwards.

Especially for weaker elderly patients, just a few days in bed could mean that they are not able to take care of themselves afterwards, with increased care expenses and increased risk of relapse as a consequence. Even though this is known, the work to motivate patients to be active during their hospitalization is limited to few training sessions with only the most vulnerable patients. No tools are today available for objectively tracking and motivating patients to be active during their stay. Having such a professional tool would not only motivate but also shift the attention of the health professionals towards the importance of physical activity in the treatment of the patient.

The aim of the studys is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple visual feedback about physical activities from a mobile bedside device.

The study will be conducted as a quasi-randomised trial using a large tertiary public hospital in Copenhagen, Denmark. Patients admitted to Department of Respiratory Medicine (2 wards), Department of Cardiology, and Department of Geriatrics will be included, and they will have their physical activity level measured either with or without a bedside monitor providing visual feedback of time spent bedridden, sitting, standing and walking.

All participants will have their physical activity measured during hospitalisation. Approximately half of the participants will receive visual feedback about the amount of physical activity from a mobile device placed on the bedside table.

Eligibility Criteria:
INCLUSION CRITERIA

An individual will be eligible for study participation if he/she meets the following criteria:

1. Is admitted to one of the participating departments
2. Has signed informed consent
3. Reads and speaks Danish

EXCLUSION CRITERIA

An individual will be excluded from the study if he/she meets any of the following criteria:

1. Any condition that, in the opinion of the investigator, makes the person unfit for participation
2. Expected hospitalisation less than 24 hours
3. Has no independent ambulatory abilities (e.g. wheel chair user)
4. Needs personal assistance in body transfers and ambulation (Cumulated Ambulation Score 0, 1, 2, or 3)
5. Has allergy towards band aid
Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

While ABCB1 (P-glycoprotein 1) upregulation after paclitaxel administration is well known, there is currently no clinically available method for preventing or overcoming it. To develop a therapy able to prevent ABCB1 upregulation and paclitaxel resistance, several ABCB1 inhibitors have been evaluated in combination with paclitaxel in preclinical model systems. Pulsed-dose lapatinib and paclitaxel are synergistic and inhibition of ABCB1 by lapatinib increases sensitivity to paclitaxel. Lapatinib is FDA approved, orally available, and previously studied in combination with weekly paclitaxel for breast cancer at doses of 1000mg to 1250mg daily (7000-8250mg per week). This trial will use twice-daily dosing of lapatinib at a starting dose of 750 mg for 2 days (1500mg a day and 3000mg weekly dose), which is less than half of the continuous dose and has been shown to achieve plasma concentrations at 48 hours that are associated with synergy. Therefore, these findings can be translated into a novel, well-tolerated, and convenient combination regimen with significant potential for clinical activity. This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed ovarian cancer who recur within 12 months of platinum-based chemotherapy
* ECOG performance status less than or equal to 2
* Adequate organ and marrow function at baseline
* ability to sign a written informed consent document

Exclusion Criteria:

* hypersensitivity to lapatinib or paclitaxel
* uncontrolled intercurrent illness
* receiving medications that inhibit or induce CYP3A4
* malabsorption syndrome
* congestive heart failure
* receiving any other anti-cancer investigational agents
* baseline neuropathy greater than Grade 1
MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

This exploratory study utilizes ferumoxytol, an iron oxide nanoparticle MR contrast agent for imaging various inflammatory processes in the head and neck region, spine, including the central nervous system. The protocol enrolls subjects with radiological or histological diagnosis of unknown, dural, or parenchymal CNS lesions, multiple sclerosis, TIA or stroke, vasculitis, or other vascular lesions; arterial vasculopathy and venous thrombosis; or enlarged cervical lymph nodes. The main purpose of this study is to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinical, radiological or established histological diagnosis of dural or central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions, radiological suspected diagnosis of vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or vasculopathy involving the carotids (including diagnosed carotid stenosis \>50%), the aorta, the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins, or clinical or radiological diagnosis of enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
* Subjects must be 18 years or older
* Subjects will be followed for at least 1 month after the infusion of ferumoxytol.
* All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.
* Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.
* Karnofsky must be 30% or greater

Exclusion Criteria:

* Subjects with clinically significant signs of uncal herniation
* Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to Gd contrast material.
* Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
* Subjects with known hepatic insufficiency or cirrhosis
* Subjects with known or suspected iron overload
* HIV-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
* Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.
Electrical Impedance Tomography in One-Lung Ventilation

Mechanical ventilation can cause damage to the lung parenchyma, this is known as ventilatory induce lung injury (VILI).To avoid this damage, ventilatory strategies have been created, focused on the reduction of tidal volume, airway pressures and use of PEEP (positive end-expiratory pressure), which together are called "protective ventilation".

Although ventilation with protective parameters seems to reduce VILI in one-lung ventilation, the optimal parameters are not clear.

This research aims to describe the ventilation, perfusion and pulmonary mechanics on one-lung ventilation with different levels of tidal volume and PEEP.

An extreme situation of VILI occurs in thoracic surgery, where the atelectasis of a lung is required, ventilating throughout the surgery only the contralateral one. This generates an inflammatory state, with the release of alveolar cytokines from both the non-ventilated and ventilated lungs, which potentiates the development of damage in the lung parenchyma. In addition, one lung ventilation has traditionally been performed with high tidal volume (Vt) values and low PEEP. In this context, the development of VILI is even more probable, so extreme measures of protection in this kind of ventilation are necessary.

The electrical impedance tomography will allow the investigators to obtain a visual and quantitative representation of the areas of ventilation and perfusion of the lung. By relating the tidal volume and PEEP with the tomographic results, it is expected to define mechanical ventilation parameters that achieve the best ventilation/perfusion ratio for patients in one-lung ventilation. Specifically, analyze the distribution and deformation of the ventilated areas in the different lung regions and its correlation with respiratory mechanics and volumetric capnography. This will allow the investigators to make a better definition of the tidal volume and PEEP in patients undergoing one-lung ventilation.

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Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) classification I-III
* Age 18-75 Years
* Elective thoracic surgery
* One-Lung Ventilation
* Healthy non ventilated lung

Exclusion Criteria:

* ASA classification \> III
* BMI (Body mass index) \> 30
* Emergency surgery
* Pregnancy
* Patients includes in other protocols