cyrilzakka/clinical-trials huggingface dataset:
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus.
2. Male or female at least 18 years old.
3. Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
4. Subject is to be treated on an outpatient basis.
5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
6. Localized mild infection of the ulcer.
7. The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
8. Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion Criteria:

1. IDSA-defined moderate infection, including cellulitis extending \> 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
2. IDSA-defined severe infection, including systemic toxicity or metabolic instability.
3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
4. \> 1 infected foot ulcer.
5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
6. Subject has received a systemic antibiotic within 48 hours prior to Screening.
7. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
8. Bone or joint involvement is suspected based on clinical examination or plain X-ray.
9. Clinically significant peripheral arterial disease requiring vascular intervention.
10. Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.
A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers

This trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: Female: ≥40.0 kg, \<70.0 kg, Male: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained

Exclusion Criteria:

* Scheduled to receive another vaccine during study participation period
* Received influenza vaccine within 180 days prior to the study
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
* Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.

Objectives for this study are two-fold:

1. To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival.
2. To assess the toxicity of SCH66366 in these patients.

Eligibility Criteria:
* Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase;
* Failure to respond to or intolerance to imatinib mesylate (Gleevec);
* Age \>/= 16 years;
* Life expectancy of \>/= 2 months;
* Performance status 2 or better (Zubrod);
* Adequate renal and hepatic functions (creatinine and bilirubin \</= 2 mg/dl);
* Adequate cardiac function;
* Not candidates for or have refused allogeneic transplantation;
* Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.
The Effect of Acupressure on Patients Receiving Brachytherapy

This study aimed to use acupressure to reduce anxiety in gynecologic cancer patients receiving brachytherapy. It was also aimed to investigate the effects of acupressure on anxiety, pain, and vital signs.

Brachytherapy is a type of radiotherapy used in cancer treatment. In this method, the radiation source is placed directly on the tumor or the area to be treated. In this way, high doses of radiation are applied only to the target area, while surrounding healthy tissues are less damaged. Brachytherapy is usually used in the treatment of certain types of cancer, such as prostate, cervix, breast, and skin cancer. Gynecological brachytherapy is the application of brachytherapy in the treatment of gynecological cancers. It can be used especially in cancers of the uterus, cervix, vagina, and vulva. This treatment method is performed by placing the radiation source in the area where the tumor is located. Brachytherapy can be used in combination with surgery, chemotherapy, or other types of radiotherapy in the treatment of these types of cancers. Factors such as cancer burden, the problem of achieving remission, and the need for patients to remain immobile during the procedure, which is performed in a room that needs to be isolated due to radiation, contribute to symptoms such as pain and anxiety before and during treatment. These symptoms can sometimes affect vital signs. The need for patients to remain immobile during brachytherapy, the need to be isolated in a room due to radiation, and the discomfort caused by the applicators also increase anxiety in women. Patients often experience fear and anxiety because there is insufficient information about brachytherapy that could help relieve their pain and anxiety. Despite the complexity of such a procedure and the significant patient population, there are few studies on women's experiences with brachytherapy.

Eligibility Criteria:
Inclusion Criteria:

* Being registered in Selçuk University Faculty of Medicine Hospital Radiation Oncology Polyclinic
* Brachytherapy (intracavital brachytherapy) treatment protocol will be applied due to gynecological cancer.

to be

* Karnofsky Performance Scale being 80 and above (Performance scale for cancer patients)
* Being between the ages of 18 and 65
* Being conscious and cooperative
* Verbal and written approval to participate in the study after an explanation about the study is made.

Exclusion Criteria:

Impaired skin integrity in the acupressure application area

* Refuses to participate in the study after making a statement about the study.
* Bone or spine metastasis
* Amputation of the extremities to be applied
* Not having any mental illness
Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005

The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

* are \>= 18 and \<= 60 years old on the day of screening (for Stratum A only);
* are \> 60 years old on the day of screening (for Stratum B only);
* are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
* will reliably keep a daily record of symptoms;
* understand the nature of the study, agree to its provisions, and give written informed consent;
* if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

* have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season;
* suffer from any kind of immunodeficiency;
* suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence the normal immunologic functions;
* have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
* have received a blood transfusion or immunoglobulins within 30 days of study entry;
* have donated blood or plasma within 30 days of study entry;
* have a history of any vaccine-related contraindicating event (e.g. anaphylaxis or other known contraindications);
* have a rash or dermatological condition which may interfere with injection site reaction rating;
* have a known or suspected problem with drug or alcohol abuse;
* are unable to lead an independent life either physically or mentally;
* were administered an investigational drug within six weeks prior to study entry;
* are concurrently participating in a clinical study including the administration of an investigational product;
* if female, are pregnant or lactating.
EUS-FNA for Patients With Antithrombotic Agents

The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for patients with antithrombotic agents.


Eligibility Criteria:
Inclusion Criteria:

* Undergo EUS-FNA
* take antithrombotic agents

Exclusion Criteria:

* Cystic lesion
Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites:

1. Forsyth Institute in Cambridge, MA
2. Orange County Research Center in Tustin, CA
3. ActivMed Practices \& Research in Methuen, MA

Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.

Eligibility Criteria:
Inclusion Criteria:

* Agree to the terms of this consent form
* Sign this consent form
* Be 18 years or older
* Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15%
* Provide blood samples from your arm and finger
* Come in in the morning of the study visit

Exclusion Criteria:

* Not have a recent history of anemia or hemoglobin concentration above 20%
* Not be pregnant
* Not have previously given a blood sample to the Study Sponsor for a study
Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit

The optimal EAA-containing protein format necessary to maximally stimulate muscle protein synthesis and optimize whole-body net protein balance during caloric deprivation has not been determined. This study will address that gap in knowledge by examining post, whole-body exercise muscle and whole-body protein kinetic responses to ingesting varying EAA-containing protein formats after a 5 day period of negative energy balance. This study will provide the initial evidence to support the development of a recovery-based food product for military combat rations.

Ten resistance-trained adults will complete this \~55-d randomized, cross-over study. Participants will participate in three, non-consecutive 5-d controlled energy deficit periods, each separated by a 14-d washout period (i.e., sufficient time to restore nitrogen and metabolic homeostasis after moderate weight loss). Post-exercise (whole-body exercise model) muscle protein synthesis (MPS) and whole-body protein turnover responses to varying EAA-containing protein formats will be determined the morning after completing the 5-d energy deficit.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 - 35 years
* Body mass index \< 30.0 kg/m2
* Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support
* Resistance exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 mo
* Refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before starting and at least 5 days after completing the study
* Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes); vaping, chewing tobacco, caffeine, and dietary supplement use throughout the entire study period
* Supervisor approval for federal civilian employees and non-HRV active duty military personnel working within the US Army Natick Soldier Systems Center

Exclusion Criteria:

* Musculoskeletal injuries that compromise exercise capability as determined by the USARIEM or home duty station Office of Medical Support and Oversight (OMSO)
* Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
* Abnormal PT/PTT test or problems with blood clotting
* History of complications with lidocaine
* Present condition of alcoholism, anabolic steroids, or other substance abuse issues
* Blood donation within 8-wk of beginning the study
* Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test or self-report for breastfeeding will be obtained before body composition testing)
* Unwillingness or inability to consume study diets or foods provided
Fucidin® Cream in the Treatment of Impetigo

To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients.

To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream.

To investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of impetigo,
* Patients aged 2-11 years,
* Patients of either sex,
* Patients whose parent(s) has(ve) provided written consent, AND
* Patients with a severity score of 1 for at least one of the following signs: pustules/infected bullae, erythema and infiltration/induration.

Exclusion Criteria:

* Patients with other active inflammatory dermatitis at the area of impetigo,
* Patients with a temperature above 38.5 C rectally (or equivalent), OR
* Patients who have been administered topical or systemic Fucidin® or other antibacterial agents within the previous 4 weeks.
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection

The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.

Microwave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.

This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.

This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an MBI scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia# 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Female subjects with an investigator assessed discrete breast abnormality of size \> 1cm
* Able and willing to comply with the requirements of this study protocol
* Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)
* intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)
* Able to comfortably lie reasonably still in a prone position for approximately 15 minutes
* Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable)

Exclusion Criteria:

* Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator
* Are pregnant or breast-feeding
* Have had surgery on either breast within the past 12 months
* Have any active or metallic implant other than a biopsy clip
* Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator
Causes of Traffic Collisions of Ambulance Cars at the Prague Emergency Medical Services

The aim of the project is to increase the protection of patients, employees and the organization by means of data collection about traffic collisions of ambulance cars.

Published research studies have shown not only that approximately half of Emergency Medical Services (EMS) providers show signs of severe fatigue before traffic collision, but also that drowsy or tired EMS providers are significantly more often injured at work. Among the circumstances and factors contributing to the collisions, including environmental, road or equipment factors, the real causes of the collisions remain unclear, but might be investigated through interviews with participating drivers. The aim is to increase the protection of patients, employees and the organization by collect data in both qualitative and quantitative ways and to identify factors and measurable variables that might lead to strengthen healthy driving habits under the blue lights. The factors associated with ambulance accidents are not similar to those of the general driving population. The in-depth analysis of the whole problem aims not only to clarify the causes of collisions, but especially to create prevention steps so that such situations occur as little as possible.

The methodology will use the so-called mixed design - a combination of in-depth interviews with participating members of collisions (employees, or patient / relative), data from the road-scans and qualitative data including measurable variables.

A video-analysis of the collision will be performed. All data will be recorded anonymously - each participant in the accident will receive a special number for coding, under which they will appear. Data will be presented both in descriptive statistics and after statistical analysis (chi square test for independence and Fischer's exact test at the level of significance = 0.05).

In terms of qualitative data, in-depth interviews and their coding will be performed using grounded theory (based on Strauss and Corbin methodology). The aim is to gain the same view of events and their actions as the members of the group.

The sample of participants depends on collision rate, which was 50 incidents in the year 2020 (expecting approx. 100 cases in 2 years).

Eligibility Criteria:
Inclusion Criteria:

* ambulance driver involved in a traffic collision of ambulance car
* consent to participate in the study
* video recording of the collision exists and can be used

Exclusion Criteria:

* disagreement with participating in the study
* video recording of the collision cannot be obtained
Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety

To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.

In the present study, healthy male subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory (STAI). According to subjects' trait anxiety scores, they will be divided into high or low anxiety experimental groups.

Next, experiments will investigate the acute effect (single dose) and chronic effect (3 doses or 5 doses) of oxytocin on brain functional connectivity during resting-state and brain activation in response to watching emotional stimuli using functional magnetic resonance imaging (fMRI). Also the brain structure data (T1 and diffusion tensor imaging, DTI) of subjects will be collected. After finishing the scanning tasks, subjects will be required to rate the emotional valence, intensity and arousal of the pictures shown in the scanner.

During the course of the study subjects will complete a number of questionnaires: Empathy Quotient (EQ), Cheek and Buss Shyness scale (CBSS),Interpersonal Reactivity Index (IRI),Childhood Trauma Questionnaire (CTQ),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS),Positive and Negative Affect Schedule (PANAS),d2 attention test, and the Visual Analogue Scale for anxiety.

Eligibility Criteria:
Inclusion:

* healthy adult males

Exclusion:

* past or current psychiatric or neurological disorder
* head trauma
* substance abuse
* medication
* fMRI contraindications (e.g. metal implants)