cyrilzakka/clinical-trials huggingface dataset:
The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

To explore the relationship between blood eosinophil counts, asthma exacerbations and patient asthma control using a large primary care based research database

Sputum eosinophil levels have been shown to predict asthma exacerbation and inhaled corticosteroid (ICS) responsivenesss. Managing asthma based on sputum eosinophils leads to fewer exacerbations than management adhering to Global Initiative for Asthma (GINA) guidelines. However the use of sputum to measure eosinophil levels is expensive and impractical within a clinical setting. This study explores the use of blood-eosinophil levels as a clinical predictor for exacerbations and asthma control within a UK primary care dataset.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 12-80 at date of last eosinophil count
* Asthma diagnosis at any time
* Blood Eosinophil reading in patient record (numeric count expressed in µl) at least one year prior to last data extraction
* Two years of continuous data

Exclusion Criteria:

* Any other chronic respiratory diseases
* Eosinophil counts \>5000/µl (outliers)
Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations

This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, the study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.

Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of MPA until it reaches the large surface of the small bowel. Approximately half of all the kidney transplant recipients in the United States have diabetes mellitus. A recent analysis of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of patients develop diabetes after transplantation, a condition that is commonly known as post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA absorption is minimally affected by diabetes (4). Limited data is available in the current literature on Myfortic® and Simulect® based therapy in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
2. Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
3. Written inform consent obtained. The patients are willing to participate in the study at UTMB.
4. Female with negative pregnancy test.
5. PRA \< 20 %.
6. En-blocks and two kidneys (tx'd at the same time) will be allowed.
7. Cold Ischemia time ≤ 30 hrs
8. Hep C patients will be allowed to enroll in this study

Exclusion Criteria:

1. Multi-organ transplants
2. Transplant from non-heart beating donor (NHBD) or dual transplants
3. A-B-O incompatible or positive cross match
4. Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
5. Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
6. Inability to tolerate oral medications
7. Inability to sign a written consent form or to cooperate with investigators
8. Use of an investigational medication in the past 30 days.
9. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
10. HIV positive patients
11. History of psychosocial instability
12. Mental incompetence
The GlucoPred Investigation II

Diabetes mellitus type 1 (DM1) is an autoimmune metabolic disease in which the insulin producing cells in the pancreas are destroyed and the subject is left totally dependent of external supply of insulin. There is no known cure for DM1 except for in very specific situations. Thus, management of DM1 concentrates on keeping blood glucose levels as close to normal levels.

As an aid to subjects with DM1 for managing their blood glucose levels as close to normal as possible, blood glucose monitoring systems have been developed. Available blood glucose monitoring systems today require a capillary blood sample that is analysed by a glucose meter. Subjects are normally advised by health care professionals on the appropriate blood glucose monitoring regime for their condition. However, many subjects fail to measure blood glucose as often as needed to achieve good blood glucose control despite every effort from health care professionals.

Research and development of non-invasive interstitial blood glucose monitoring methods is ongoing. All attempts to develop a non-invasive continuous glucose measuring device have so far failed. Prediktor Medical AS has developed a non-invasive sensor, GlucoPred, based on the combination of several non-invasive measurement principles and multivariate analysis and dynamic models of glucose/insulin interaction. The device will be body mounted in the form of a bracelet or a watch communicating with a mobile phone or a tablet for data presentation and collection. Development of GlucoPred is now at a stage where testing of the sensor in subjects under controlled settings is required before further development can take place.

If successful, this will be a major step ahead for all patients with diabetes and markedly increase their possibility to take care of their disease on a day to day basis without the burden of frequent blood sampling or wearing an invasive device.


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type 1
* has read and understood the informed consent documentation and is willing to participate in the investigation and willing to sign the informed consent form
* willing to participate in the investigation using one or two GlucoPred sensors for a period of 8 days
* willing to attend 2 investigational visits with duration of up to 4 hours during the investigational period
* willing to take and record up to 16 finger-stick blood samples on Day 1 and up to 8 finger-stick blood samples daily for measuring reference values for the duration of the investigation
* Uses a blood-glucose monitoring system for self-testing on a daily basis
* Willing to use the provided blood-glucose monitoring system during the investigation
* Has access to and is willing to use a computer for downloading data and charging the sensor

Exclusion Criteria:

* not fit for the investigation due concurrent illness
* Unfit for participation for any reason judged by the investigator
* pregnancy
Novel Robotic Surgical System for Minimally Invasive Surgery

This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index \<35 kg/m2
2. Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
3. Willingness to participate as demonstrated by giving informed consent

Exclusion Criteria:

1. Contraindication to general anesthesia
2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
3. Untreated active infection
4. Noncorrectable coagulopathy
5. Presence of another malignancy or distant metastasis
6. Emergency surgery
7. Vulnerable population (e.g. mentally disabled, pregnancy)
Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care.

Objectives: To evaluate the effectiveness of a structured educational intervention in physical exercise "Active Legs" as an adjuvant treatment to improve the healing of chronic venous ulcers at 3 months of follow-up, compared with the usual practice in people treated in primary care. Secondary objectives: To evaluate if the intervention active legs as an adjuvant treatment produces better results than usual practice in: degree of healing, recurrence, complete healing at 6 months, pain and quality of life. Describe degree of adherence and satisfaction with the intervention. Design: Randomized, multicenter, pragmatic, open clinical trial of parallel groups with 6 months of follow-up. Setting: Primary Care Health Centers (Madrid). Subjects: Patients with venous ulcers, with treatment in the nursing consultation of the participating centers. Sample: 224 participants (112 in each group). Intervention: Both groups will receive the usual treatment of cleaning, debridement based on humid environment cure and multilayer compression therapy according to the recommendations of Community of Madrid. The intervention group will also receive the structured educational intervention of lower limbs physical exercise and daily walking patterns. Variables: Main: complete healing at 3 months follow-up. Secondary: Degree of healing; ulcer area; quality of life; pain, related to the healing process, prognosis and recurrences; Sociodemographic and related adherence and satisfaction. Data analysis: Main effectiveness: comparison of the incidence of ulcers with complete healing at 3 months of follow-up in both groups, time to complete healing (Kaplan-Meier and Log-rank test). Adjustment of prognostic factors (Cox regression).


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of venous ulcers registered in electronic clinical history (history of chronic venous insufficiency and/or venous ulcer) and presence of an ankle brachial index (ABI) greater than 0.8 and less than 1.3.
* Presence at least a venous ulcer of 1cm or more in diameter. If the participant has more than one lesion, the nurse will select the lesion with the highest Resvech 2.0 score for the study.
* Independent ambulation or with the help of devices.
* Individuals who able to follow the demands of the trial and who provide their written informed consent to participate.

Exclusion Criteria:

* Patients with mixed ulcers.
* Acute phase deep vein thrombosis.
* Patients on treatment with antineoplastic agents.
* Decompensated heart failure.
* Rheumatoid arthritis.
* Acute phase dermatitis, at the time of the study.
* Patients immobilized at home, institutionalized or displaced residing outside the area where the research is conducted for more than 6 months a year or during the performance of the intervention.
* Absolute contraindication to perform physical exercise.
* Patients who are simultaneously participating in another clinical trial.
Integrated Testing Strategy for Simultaneous Detection of ESR-1 and GBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients,

Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+/HER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm

Breast cancer is the most prevalent type of tumor and the primary cause of cancer-related deaths among women globally (1). Approximately two-thirds of these tumors express hormone receptors (HR) and lack HER2 overexpression and/or amplification (2). Throughout treatment, resistance frequently develops, with underlying mechanisms that remain largely undefined (3).

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a confirmed diagnosis of estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PgR+) breast cancer through histological and/or cytological examination by the local laboratory Participants must exhibit HER2-negative breast cancer

  1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.

     * Participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (CDK)4/6 inhibitors. However, the primary tumor should be treated according to the standard of care.
     * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.

Exclusion Criteria:

* Unable to provide written informed consent
Safety and Efficacy Study of Hydromorphone and Morphine

To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.

There is widespread agreement that pain is under-treated in the Emergency Department (ED). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED.

Eligibility Criteria:
Inclusion Criteria:

* adults between the ages of 21 and 65 who presented to the ED with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ED attending to warrant use of IV opioids.

Exclusion Criteria:

* previous allergy to morphine or hydromorphone
* systolic blood pressure less than 90 mmHg
* alcohol intoxication as judged by the attending physician
* use of other opioids within the past 7 days
* use of an Monoamine Oxidase (MAO) inhibitor
* chronic pain syndromes (such as sickle cell disease or fibromyalgia)
Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients

A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.

Patient characteristics, tumour characteristics including the BRAF mutation status and baseline serum S100B and LDH levels of each patient will be retrospectively determined from the electronical patient file. In each patient, tumour burden and 18F-FDG uptake of the tumour lesions will be measured using multiple standard quantification parameters of the baseline 18F-FDG-PET scan. Tumour burden will also be measured on the baseline contrast enhanced CT scan. The correlation of each FDG-PET parameter with baseline LDH and S100B levels, respectively, will be analyzed using univariate and multivariate regression analysis.

Eligibility Criteria:
Inclusion Criteria:

- All patients \>18 years with histologically proven metastatic melanoma (American Joint Committee on Cancer \[AJCC\] stage IV melanoma) treated in the UMCG between May 2014 and December 2015.

Exclusion Criteria:

* participation in interventional studies
* missing baseline 18F-FDG PET scan and/or baseline contrast enhanced CT scan
* missing baseline serum LDH level
* missing BRAF mutation status, concurrent malignancies or a history of previous malignancies.
Hypocholesterolemic Effect of Fibracep

FIBRACEP is an onion based fiber that has demonstrated in vitro and in animal models the capacity to increase HDL cholesterol levels as well to improve other lipid profile species. This intervention aims to demonstrate FIBRACEP's blood lipid profile improvement effect. For that purpose, hypercholesterolemic subjects will be recruited and given a daily dose of 7 g of FIBRACEP for two months. Changes in blood lipid profile will be the end-point of the study.


Eligibility Criteria:
Inclusion Criteria:

* Total cholesterol levels above 200 mg/dL, observed in at least 3 different days
* Body mass index between 25 and 35 (Overweight and obesity type 1 diagnosis)

Exclusion Criteria:

* Type 1 and Type 2 Diabetes
* Allergy to any compound described in FIBRACEP
Risk-Targeted Behavioural Activation for the Management of Treatment-Resistant Depression.

Depression is the leading cause of disability worldwide. Major Depressive Disorder (MDD) is the most common diagnosis made for individuals seeking treatment for depression. Although a wide range of treatments have been developed for the treatment of MDD, a significant proportion of patients fail to respond. This study examined the effectiveness of a 10-week behavioural activation intervention for individuals with treatment-resistant depression.

Objective: The purpose of the present study was to examine the acceptability and impact of a standardized 10-week risk-targeted behavioral activation (RTBA) intervention as an augmentation strategy in the clinical management of treatment-resistant depression (TRD). Methods: The study sample consisted of 118 individuals with TRD, who were currently absent from work and referred to an occupational rehabilitation service. The RTBA intervention was a 10-week standardized program consisting of weekly visits with a trained clinician. The objectives of treatment included symptom reduction, resumption of important life activities (including return to work) and improvement in quality of life. Measures of depression, perceived injustice, and catastrophic thinking were completed pre-, mid- and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Major Depressive Disorder
* The date of diagnosis of MDD preceded referral by at least 12 months
* At least one previous prescription of an antidepressant failed to yield therapeutic response
* Currently taking an antidepressant
* A PHQ9 score in the moderate to severe range of depression at the time of enrolment

Exclusion Criteria:

- Participating in another psychotherapeutic intervention.
Contact Allergy to Rubber Accelerators - a Clinical Study

This study will investigate what concentrations of the most common thiurams and carbamates that elicit allergic contact dermatitis under patch test and what concentrations of the rubber accelerators that elicit allergic contact dermatitis by repeated exposures under simulated use conditions. Further, it will investigate whether a damaged skin barrier as caused by wet work increase the severity of the allergic contact dermatitis.

The participants will be assigned to either the SLS (sodium lauryl sulfate)-group or non SLS-group. For the participants of the SLS-group, one volar forearm will be randomized to be pre-irritated with a soap i.e. detergent: sodium lauryl sulfate (SLS) for 24 hours to simulate wet work. The participants of the non SLS-group will not be pre-irritated with SLS.

Following this, the participants' volar forearms will be exposed to thiurams or carbamates and a control solution every night for 7 nights to simulate the repeated exposure to rubber gloves with accelerators. The skin reactions will be read cf. current international guidelines and further quantified using laser Doppler flowmetry.

During the study, all participants will be patch tested on the upper back with rubber accelerators to investigate their current degree of sensitization and the dose-response relationships.


Eligibility Criteria:
Allergic participants

Inclusion Criteria:

* Adults ≥18 years old
* Sensitized to thiurams, carbamates or both.
* Received written and oral information about the study.
* Signed written consent form

Exclusion Criteria:

* Dermatitis on back or arms
* Tattoos or significant scar tissue on exposure areas
* Pregnancy
* Breast feeding
* Recently given birth
* Treatment with systemic immunomodulators within the last 4 weeks
* Treatment with local immunomodulators on arms or back within the last 4 weeks
* Excessive ultraviolet light on arms or back within the last 4 weeks

Healthy Controls:

Inclusion Criteria:

* adults ≥18 years old
* Received written and oral information about the study.
* Signed written consent form

Exclusion Criteria:

* Sensitized to thiurams, carbamates or both.
* Occupational or domestical use of rubber gloves.
* History of atopic dermatitis or contact dermatitis
* Dermatitis on back or arms
* Tattoos or significant scar tissue on exposure areas
* Pregnancy
* Breast feeding
* Recently given birth
* Treatment with systemic immunomodulators within the last 4 weeks
* Treatment with local immunomodulators on arms or back within the last 4 weeks
* Excessive ultraviolet light on arms or back within the last 4 weeks
IMMUNONUTRITION IN FAST-TRACK SURGERY

Compare the results in terms of morbidity, mortality and hospitalization among patients with input from immunonutrients and patients with enteral nutrition intake of high calorie and high protein undergoing colorectal surgery within a multimodal rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colorectal surgery.
* Signing informed consent.

Exclusion Criteria:

* Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
* Patients with contraindications for electrical stimulation.
* Psychiatric Disorders
* HIV
* Pregnant or breastfeeding
* intestinal obstruction
* uncontrolled infection
* ASA IV
* No acceptance or failure to follow protocol multimodal rehabilitation.