cyrilzakka/clinical-trials huggingface dataset:
Utility of Digital Dermoscopy in the Skin Cancer Clinic

This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic. All eligible patients attending the Dermatology outpatient skin cancer clinic will be invited to participate. Patients who consent to the study will undergo standard care which will include medical photography of skin lesion(s) and appropriate management as determined by the Consultant Dermatologist in clinic. In addition to standard care, patients will undergo photography of the same lesion(s) using the BARCO NV digital dermatoscope. There will be no other intervention and no additional hospital visits in relation to the study. Use of the device will not influence the clinical management of the patient.

A detailed experience questionnaire will be administered to all clinicians using the BARCO device to explore their opinion on its ease of use and features.

All standard macroscopic \& dermoscopic images will be taken by OUH medical illustration department and stored on the 'Fotoweb' database (in keeping with current standard practice). Trained Dermatology Consultants, Dermatology Registrars, Research nurses or Medical Photographers, will take BARCO NV device images. A database of all BARCO images will be collected and stored on a dedicated NHS computer separate from the patient clinical record. Standard medical photography images will be stored on Fotoweb as per standard NHS clinical care.

Data will be anonymised and collated and then sent securely to BARCO for further analyses to enable optimization of the BARCO device and for development of diagnostic algorithms in the future.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Patient presenting with any visible skin lesion for Dermatologist review on a body site amenable for optimal photographic imaging
* Able and willing to comply with all study requirements.
* Patient with a skin lesion that is clinically diagnosed by a Consultant Dermatologist as benign OR a suspicious skin lesion requiring excisional biopsy for histological diagnosis
* Patient attending for a 'New' or 'Follow-up' consultation

Exclusion Criteria:

* Patients aged under 18 years old
* Patients unable to provide informed consent
* Skin lesions in an anatomical site which is not suitable for photography including genital lesion, hair-bearing site or subungual lesion
* Maximum size of lesion 25 mm
* Lesion is at a site where previous surgery was undertaken
* Lesion on a mucosal site
Second Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

The primary objective of this clinical study is to collect additional clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility Criteria:
Inclusion Criteria - Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old):

* Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
* Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
* Subjects who agree to participate in the study.

Inclusion Criteria - Pathologic Adults (29-80 years old)

* Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed;
* Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
* Subjects who agree to participate in the study;
* At least one eye with any of the following conditions:
* History of post-op surgical trauma including Pseudophakic or Aphakic bullous keratopathy;
* History of corneal transplant;
* Physical injury or trauma to the cornea;
* Long term Fuch's dystrophy, Guttata, or other corneal endothelial dystrophies
* Keratoconus;
* Long term polymethyl methacrylate PMMA contact lens use (greater than 3 years).

Exclusion Criteria - Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old)

* History of post-op surgical trauma including bullous keratopathy;
* History of corneal transplant;
* Evidence of physical injury or trauma to the cornea;
* Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies;
* Keratoconus;
* Long term PMMA contact lens use (greater than 3 years);
* History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
* Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.

Exclusion Criteria - Pathologic Adults (29-80 years old):

* History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
* Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.
Acupuncture for the Immune System in Radiation Cancer Patients

Purpose/Goal: To investigate how long course radiation therapy (RT), both with or without chemotherapy, affects the immune system, and to determine if acupuncture can modify these effects in patients undergoing curative radiation therapy for gastrointestinal (GI) or genitourinary (GU) cancers.

Clinical or Research Questions:

1. Does RT reduce immune biomarkers in treated subjects?
2. Which biomarkers are most affected by treatment?
3. Is acupuncture a feasible option to help ameliorate any biomarker effects?
4. Does RT affect subject symptoms?
5. Is acupuncture a feasible option to help ameliorate any symptom effects?

Research indicates that patients undergoing curative RT for various cancers experience adverse immune effects, as indicated by reduced biomarker levels and activity. RT has been observed to cause a striking reduction in total lymphocyte count, affecting mainly the T-cells. Furthermore, the reduction in the lymphocyte count after RT has been correlated with poorer outcome for bladder cancer, head and neck cancer, uterine cancer, and brain metastases.

Research into the use of complementary and alternative medicine (CAM) has been conducted to determine the utility of these treatments in addressing the unmet needs of many patients with cancer. There is preliminary evidence that acupuncture, in particular, is successful at improving many cancer and treatment associated effects. Earlier studies have indicated that acupuncture can play a role in regulating immune system response to various morbidities, including chemotherapy induced immunosuppression. However, little research has examined is potential for radiation therapy patients

This pilot study aims to assess a wide range of general immune biomarkers to identify biomarkers most affected by RT. Through use of a symptom assessment survey, changes in self reported symptoms will also be recorded. The feasibility of acupuncture as a strategy to ameliorate any adverse immune or symptom effects will also be examined. This information could be very useful in planning future studies on RT and the immune system, or the potential immune benefits of acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* patients who will receive ≥ 4 weeks of curative intent long course RT for a GI or GU malignancy
* patients may or may not have received / be receiving adjuvant chemotherapy
* anticipated survival of at least 12 months
* able to visit the BCCA VIC for treatment and 2 follow up visits

Exclusion Criteria:

* scheduled to receive RT for a period of less than 4 weeks
* expected survival period is less than 12 months
* are on anticoagulants
Stress and Resilience in Anesthesia Professionals

The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.

This trial will be carried out at the simulation center of the training institute for health professionals of the CHU Grenoble Alpes. Volunteer anesthesia professionals and students will perform a scenario simulating a pediatric laryngospasm during a surgical incision.

Each scenario will be performed by a medical and paramedical anesthesia pair and supervised by simulation trainers.

Stress and resilience measures will be taken at various times during the study. Participants will be debriefed at the end of the simulation.

The primary objective is to analyze the correlation between anesthesia professionals' resilience and measured stress.Secondary objectives are to study the association between: SDNN-measured stress and VAS-reported stress, age and SDNN-measured stress, CD RISC 10 resilience and PSS10-reported stress, CD RISC resilience and VAS-reported stress, the effect of experience on SDNN-measured stress, multiple correlation of the different secondary criteria.

secondary criteria.

Eligibility Criteria:
Inclusion Criteria:

- volunteer in anesthesia

Exclusion Criteria:

* Rhythm disorders
* Endocrine pathology
* High blood pressure
* Pregnancy or breastfeeding in progress
* Taking anti-inflammatory or psychotropic drugs that interfere with the heart rate
* Interruption of professional practice in anesthesia \> 2 years
Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer

In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.

Patients : total 220 patients

* Extrahepatic bile duct cancer : 55 patients for administration of COX2 55 patients for control group
* Pancreas cancer : 55 patients for administration of COX2 55 patients for control group

Indication

* After operation of extrahepatic bile duct cancer or pancreas cancer
* Age : 19 - 70 years old
* The patients who agree to consent sheet.

Contraindication

* Impossible of administration due to severe postoperative morbidities (bleeding, bowel obstruction, pancreatic fistula, biliary fistula)
* Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP\>160)
* Renal insufficiency: CCR \< 50 or serum creatinin \>3.0
* Hepatic insufficiency: Liver cirrhosis or active hepatitis
* Preexisting allergic reaction history for NSAIDs or Sulfonamide
* Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
* Preexisting Asthma. Especially aspirin-sensitive asthma.
* Contraindications to aspirin, clopidogrel or celecoxib
* The patients who refuse trial
* The patients who has Psychogenic problem

Allocation

* We will allocate patients randomly, to administration group or control group

Methods

* From postoperative third day, administration will be started
* celecoxib 200mg bid for 6 months for administration group
* Follow up and assess recurrence rate and survival rate

Eligibility Criteria:
Inclusion Criteria:

* The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
* Between 19 and 70 years old
* Agreed to consent sheet

Exclusion Criteria:

* The patients cannot administration of drug due to severe postoperative morbidities.
* Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP\>160)
* Renal insufficiency: CCR \< 50 or serum creatinin \>3.0
* Hepatic insufficiency: Liver cirrhosis or active hepatitis
* Preexisting allergic reaction history for NSAIDs or Sulfonamide
* Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
* Preexisting Asthma. Especially aspirin-sensitive asthma.
* Contraindications to aspirin, clopidogrel or celecoxib
* When patients refused
* Patients has psychological problem
5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study

Severe pneumonia has a high in-hospital mortality. There are few studies which investigate the long-term mortality in patients that are discharged alive from the hospital. In this study we want to investigate the 5 years mortality after treatment of severe pneumonia in an ICU. We will also investigate the cause of death after discharge from the hospital.

Patients with severe pneumonia who need treatment in an ICU have a high in-hospital mortality (16-46%). There are few studies which investigate the long-term mortality (\> 1year) in patients after discharge from the hospital. There seems to be a higher mortality in this group compared to the general population. The cause(s) of this higher long-term mortality is unclear and few studies have investigated this problem.

We are going to investigate the 5 years mortality rate in this population of patients. We are also going to investigate the cause of death in the patients who are discharged from the hospital alive.

Inclusion criteria: Patients \> 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrive at the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.

The datas are collected from the patients' journals and the local ICU register. Collecting data: Age, sex, comorbidity, SAPSII, mechanical ventilation time, stay in the ICU, stay in the hospital, ICU mortality, hospital mortality, 5 years mortality, type of pneumonia (bacteriology).

Time of death after discharge is collected from Norwegian National Registry. Cause of death after discharge is collected from Norwegian Institute of Public Health.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrived the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.

Exclusion Criteria:

* Patients \< 18 years. Patients with need for mechanical ventilation \< 24 hours
Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.

The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.


Eligibility Criteria:
Inclusion Criteria:

* Male Caucasians aged 18 to 55 years, inclusive.
* Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.
* Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -1.
* Others as defined in the protocol.

Exclusion Criteria:

* History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
* Others as defined in the protocol
Magnetic Resonance Elastography of Myofascial Pain Syndrome

The purpose of this research study is to use a new imaging technique called Magnetic Resonance (MR) Elastography to create new imaging parameters to measure the mechanical properties of myofascial tissues that can be used to assess the impaired myofascial interface in myofascial pain syndrome (MPS).

This is observational research that aims to develop an MRI-based imaging technique (MRE) to quantitatively assess the myofascial tissue properties in healthy subjects and patients with relevant pain conditions. Healthy volunteers and patients with MPS will be recruited to undergo MRI along with MR elastography.

Eligibility Criteria:
Healthy Volunteer Inclusion Criteria:

* Absence of a history of chronic pain in the targeted anatomical location (i.e., lower back and low extremities) that had limited activities of daily living or work
* A numerical current pain index of less than 0.5 (on a 10-point Visual Analog Scale)
* Able to understand the goal of the project and give informed consent.

Healthy Volunteer Exclusion Criteria:

* Pregnancy or breastfeeding
* Any contraindication to an MRI exam
* Previous severe/acute back or low extremity injury (including fracture)
* Previous back or low extremity surgery
* Back and lower limb deformities
* Inability to provide consent.

Myofascial-Related Pain Patient Inclusion Criteria:

* A history of chronic low back or leg pain (the targeted location will be determined based on the findings in Aim 1) for at least 3 months. (Measured by patient history and physical exam)
* A palpable taut band or nodule within the skeletal muscle
* Hypersensitive tender spot within the taut band
* Recognition of current pain complaint by pressure on the tender nodule/taut band
* Painful limit to the full stretch range of motion

Myofascial-Related Pain Patient Exclusion Criteria:

* Pregnancy or breastfeeding
* Any contraindication to an MRI exam
* Previous therapy in the area to be treated within 6 months
* Previous severe back or low extremity injury (including fracture) or surgery
* Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
* Severe osteoarthritis
* Skin injuries in the area to be treated
* Inability to provide consent.
Kinesio Taping Effects on Knee Extension Force Among Soccer Players

Kinesio Taping (KT) is used often, but there is little scientific information on its effect. The aim of this study was to evaluate the effects of KT on knee extension force among soccer players. KT (K-Tape®) and Micropore (3M®) were applied on the right and left thighs of 34 professional soccer players (20 males and 14 females). Half of the participants had KT applied to the left and half to the right thigh. The subjects performed two maximal isometric voluntary contractions of the quadriceps pre, immediately post, and 24 hours after tape application. Isometric knee extension force was measured using a load cell and the following variables were assessed: peak force, time to peak force, rate of force development until peak force, time to peak rate of force development and 200 ms pulse. There were no statistically significant differences between KT and Micropore conditions or among testing sections (pre, post, and 24h after). Therefore, taping (independently of the type of tape used or time since application) did not affect the force-related measures assessed during maximal isometric voluntary knee extension trials performed by healthy professional athletes.

Kinesio taping was applied on the skin over the rectus femoris muscle on one limb and 3M Micropore® (placebo tape) was applied on the contralateral limb. Different tapes were used to evaluate if tape type would affect the findings. The side of application of the different tapes was randomized among the participants. Half of the participants (n = 17) had KT applied to the left thigh and the other half to the right thigh (n = 17). KT was applied using the "V" technique, the knee was positioned at 45º of flexion, the origin of both tapes was located 10 cm below the anterior-superior iliac spine with one tape going laterally and one medially to the rectus femoris muscle belly, passing around the patella and finishing on the tibial tuberosity. The same technique was used for the Micropore tape on the contralateral limb, but because it is not elastic, the knee joint was not crossed and the end points were the medial and lateral aspects of the patella. The mean force values were calculated for each condition (pre, post and 24 hours after tape application). The isometric knee extension force was collected using a load cell (EMG System do Brasil Ltda. ®) with a measuring range from 0 to 200 kg at 1000 Hz, filtered with a low pass filter type Butterworth 4th order and cut-off frequency of 15 Hz, obtained through residual analysis.

Eligibility Criteria:
Inclusion Criteria:

* To participate the athletes had to be at least 18 years old and not have lower limb injuries at the time of testing

Exclusion Criteria:

* Younger than 18 years old
Consequences of Conjugal Bereavement in Adults

Bereavement refers to the expected reactions and sadness associated with the loss of a loved one. It has been reported that the loss of a spouse is rated as the major life stressor among survivors of varying ages and diverse cultural backgrounds. Statistics have shown that in the United States over 800,000 men and women lose a spouse each year.

A wide range of symptoms has been associated with bereavement including; depressed mood, tearfulness, sleep disturbances, and irrational behavior. Previous studies have shown that up to 50% of bereaved individuals can develop major depression. Bereavement has also been associated with dysfunction of the immune system. As a result, bereaved adults are more vulnerable to infection. However, the exact relationship between bereavement and immunity is uncertain.

Researchers firmly believe that a relationship does exist between stress, more specifically bereavement, immunity, and the increased chance of dying following the loss of a long-term spouse.

The objective of this study is to find possible links between bereavement, depression, and the immune system. This study will follow a group of elderly bereaved spouses and a group of elderly people who have not lost a long-term spouse. The group of bereaved individuals will be followed for approximately 13 months after the loss of their spouse and the group of controls will be followed for 13 months after entering the study. Researchers will make note of any clinical, biological, and immunological changes in any participants of the study.

It is estimated that over 800,000 men and women become bereaved each year in the United States (LaRue et al, 1985). While the near certainty of such bereavement is predictable in one spouse or the other, the exact impact and duration of bereavement is much less predictable (Stroebe et al, 1995). It has been reported that the loss of a spouse is rated as the major life stressor among survivors of varying ages and diverse cultural backgrounds (Holmes and Rahe, 1967). As one copes with the loss of a loved one, expected reactions include sadness, tearfulness, and even depression (DeLeon, 1994; Pasternak, 1996). Other complications can include work-related difficulties, sleep disturbances, irrational behaviors, and immunologic dysfunction (Zisook, 1994; Prigerson, et al, 1995). All of these symptoms are common; yet, the underlying biology and relationship with the time course of bereavement are still poorly understood. The purpose of this study will be to prospectively follow a cohort of elderly bereaved spouses and controls from multiple clinical and biological perspectives over thirteen months after the loss of a spouse.

Eligibility Criteria:
People over the age of 50 who have lost their spouse within the last three months.