cyrilzakka/clinical-trials huggingface dataset:
Cervicogenic Headache, Cognitive Dysfunction

The goal of this study was to determine the frequency of cognitive dysfunction in patients with cervicogenic headache.

participants will be asked questions to determine their cognitive status at once.

A set of survey-type questions will be asked to the participants. Pain and fatigue levels of the patients were measured by visual pain scale (VAS), mood states by Beck depression scale (BDI) and Pain catastrophizing scale (Pain catastrophizing scale), quality of life by Short Form-36 (SF-36), and cognitive status by Standard Mini. mental test (SMMT) and Montreal cognitive assessment scale (MOCA).

Eligibility Criteria:
Inclusion Criteria:

Clinical Diagnosis of cervicogenic headache be over 18

Exclusion Criteria:

those under the age of 18 Those with neurological deficits Those with rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, rheumatoid arthritis Surgery in the cervical region in the past 6 months Those with widespread pain, significant pain in another anatomical location (eg, gonarthrosis) Those who use drugs or substances (alcohol, drugs, etc.) that may cause cognitive impairment Those with known neurological diseases such as cerebrovascular disease, MS, Parkinson's, dementia Those with major psychiatric illness Those with communication problems Those who have started psychiatric medical treatment in the last three months Those with significant hearing or vision problems Those with a history of uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, endocrine..)
A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing inform consent
* Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (Visit 1)
* Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (Visit 1)
* Using an external CSII system for the previous 6 months prior to screening (Visit 1)
* HbA1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory
* Body Mass Index (BMI) 20.0-35.0 kg/m\^2

Exclusion Criteria:

* History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening (Visit 1)
* History of abscess at the infusion site within 6 months prior to screening (Visit 1)
* Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (Visit 1)
Ocular Surface Changes in Patients With Cystic Fibrosis

Cystic fibrosis(CF) is an inherited disease affecting children, adolescents and young adults with dysfunction of secretory glands.It is caused by mutations in the protein-coding gene which function as the cystic fibrosis transmembrane regulator (CFTR), responsible for the secretion of chloride ions in epithelial cells, adenocytes, sweat gland cells, pancreatic ducts,alimentary and respiratory tracts and eye. Assessment of the relationship between the inflammatory processes and apoptosis in the eye in the course of cystic fibrosis will allow determination of immunological exponents which may facilitate diagnosis.

The aim: To assess the role of chosen parameters of immunological response in the induction of ocular changes in cystic fibrosis patients, particularly chosen chemokine concentrations in the tear fluid and analysis of chosen apoptotic markers expression on conjunctival epithelial cells.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients aged 3-25 with clinically definite diagnosis of cystic fibrosis
* all patients must give written consent for participation in the study at screening

Exclusion Criteria:

* patients with a history of chronic disease of the immune system
* patients with the history of systemic diseases
* patients with the history chronic ocular diseases
* patients who have been treated with corticosteroids in the past 3 months prior to the screening visit
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.

This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL \& PLACE™ Dressing Kit) on incidence of post-operative wound complications in patients undergoing above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately five (5) participating sites will be randomized to receive either the Prevena dressing or a standard care dressing. The incision will be assessed for complications at post-op day 5 or day 6 and at approximately 30 days after discharge. The primary outcome of this study is reported wound complications, including dehiscence (opening of the incision), seroma, lymph leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood supply), and necrosis (tissue death) A major complication is defined as any wound complication requiring intravenous or oral antibiotics, reoperation and/or hospital readmission. All data (demographics, medical history, and clinical outcomes) will be collected via medical record review

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults 18 years or older
2. Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
3. Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
4. Informed Consent signed by patient

Exclusion Criteria:

1. Minors under 18 years
2. Women who are pregnant or breastfeeding
3. Patients undergoing emergent or guillotine amputation
4. Patients having BOTH legs amputated
5. Patients with sensitivity to silver
6. Unwilling or unable to provide informed consent
7. Inability to comply with planned study procedures
Weighted Blanket Use to Reduce Anxiety in Oncology Patients

This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) to decrease adverse side effects such as anxiety and distress in cancer (oncology) patients. Feeling safe, comforted, and grounded in the world are some of the benefits noted by individuals who use weighted blankets. Deep touch pressure (DTP) has been found to reduce symptoms of stress and anxiety and is defined as a sensation one feels when being hugged, squeezed, or held. DTP affects the nervous system by creating a calming effect which may lower stress and increase feelings of well-being. The use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions.

PRIMARY OBJECTIVE:

I. To assess the efficacy of weighted blankets on anxiety in patients receiving infusion therapy.

SECONDARY OBJECTIVE:

I. To assess the efficacy of weighted blankets on distress in patients receiving infusion therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients use a weighted blanket for 30 minutes during the infusion appointment.

ARM II: Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age and older
* About to begin either targeted or cytotoxic chemotherapy
* Able to comprehend and sign a consent form
* Able to read and complete surveys
* Alert and oriented

Exclusion Criteria:

* Currently using a weighted blanket at home
* Non-English speaking
* Peripheral neuropathy
* Fibromyalgia
* Open pressure ulcer
* Recent surgical flap
* Claustrophobic
* Weight 45 kg or less
Effect of Metallic Nanoparticles on Nosocomial Bacteria

This research aims to study the properties of metallic nanoparticles"MNPs" (silver nanoparticles "AgNps" and copper nanoparticles "CuNps") on the 2 most common nosocomial bacteria which are highly resistant to antibiotics including Staphylococcus aureus and Pseudomonas aeruginosa, to evaluate the growth inhibiting properties of MNPs on all bacterial isolates, to evaluate the biofilm inhibitory effect on biofilm forming bacterial isolates and the synergistic effect of these MNPs in combination with antibiotics on the antibiotic resistant isolates.

There is a rapid increase in the number of health care associated infections (HAIs) due to multi-drug resistant (MDR) bacterial strains which have a worse prognosis being associated with significant morbidity and mortality, particularly in critically ill patients. The main problem with MDR strains is their limited treatment options, posing a major challenge for health care providers.The increasing utilization and immense studies of nanoparticles have brought new perspectives towards new antimicrobial material that could hinder the MDR bacteria pandemic currently faced. Particularly, metallic nanoparticles exhibit strong biocidal properties on different bacterial species, including MDR bacteria. Another important aspect of the antimicrobial properties of metallic nanoparticles is their potential to eradicate or inhibit microbial biofilm formation, which is an important virulence factor in many localized chronic infections.

Eligibility Criteria:
Inclusion Criteria:

* Urinary tract infections (UTI)
* Surgical site infections (SSI)
* Catheter related blood stream infection (CRBSI)
* Infected burns
* Chest infection

Exclusion Criteria:

* Patients less than 18 years.
* Community acquired infections
A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma

The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?

The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* subjects 18 to 65 years of age
* a \>2 year history of asthma
* FEV1 \> 80% for subjects currently using Advair®.

Exclusion Criteria:

* severe asthma
* current smokers
* pregnant or breast-feeding women
* other chronic significant illnesses
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
* Participants who have a diagnosis of asthma as defined by the National Institutes of Health \[NIH, 2020\] at least 1 year prior to Visit 0.
* Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of \>250 to \<=500 microgram (mcg)/day fluticasone propionate, or equivalent).
* In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent).
* Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.
* A best pre-bronchodilator FEV1 \>40% to \<=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.

Exclusion Criteria:

* Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
* Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration)
* History of Life-threatening Asthma
* Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
* Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to Visit 1.
Local Anesthesia Spread After an Erector Spinae Plane Block.

This a single-center prospective spread-evaluation study where the primary objective is to assess the spread of local anesthesia in an ESPB using magnetic resonance imaging (MRI).

The investigators will include 10 healthy volunteers from the hospitals internal website. All volunteers will receive a one-sided Erector Spinae Plane (ESP) block. 30 min after the block sensitivity to cold and pinprick will be assessed before an MRI is performed after 60 min postblock. An radiology specialist will evaluate the MR images pertaining to the spread of the local anesthesia.

Healthy volunteers working at Ostfold Hospital will be recruited by a message put up on the hospitals intranet front page. As participants makes contact, they will receive a mail sent by a study nurse. The mail will include the patient information sheet and a consent form. There will be offered compensation in the form of a gift card of 1000 NOK to cover any travel expenses. Any travel expenses exceeding 1000 NOK will not be covered. If the volunteer fulfills the eligibility criteria and consent is obtained, the study nurse will contact the volunteer per phone or mail to set up an intervention date.

The investigators aim to enroll 10 healthy volunteers and perform the intervention within six months. The planned project end is during December 2022.

All volunteers will be given the choice of procedural pain relief in the form of rapifen 0,5-1 mg. All volunteers included will receive an unilateral ESPB at the T7 level with 30 ml of 2,5 mg/ml ropivacaine and a total of 0,3 mmol gadolinium. The intervention will be performed by the PhD candidate connected to the study. The ESPB will be performed under ultrasound guidance, where the needle target is the transverse process of the Th7 vertebra, under the musculus (m.) erector spinae. All volunteers will be tested for cold and pinprick sensation 30 minutes after block completion, and the results plotted on a dermatome map before they undergo an MRI.

Magnetic resonance imaging study A 3T MRI examination (Magnetom Skyra, Siemens) will be performed 60 minutes after the injection, covering spine levels Th3 to Th12. 3D T1-weighted sequences with fat suppression as well as a T2-weighted sequence will be performed. The distribution pattern of the ropivacaine-gadolinium solution will be evaluated in the following structures: superficial, paravertebral and intercostal musculature, neural foramina and epidural space. All images will be reviewed and analyzed by the same radiologist.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* No comorbidity

Exclusion Criteria:

* Allergy to latex, gadolinium and local anesthesia
* BMI \>40
* Severe renal and/or hepatic disease
* Local infection at the site of injection
* Systemic infection
* AV block 2-3
* Inability to understand written or spoken Norwegian
* Inability to cooperate
* Claustrophobia
* Pregnancy - All fertile women will be asked to perform a pregnancy test to ensure that they aren't pregnant before inclusion.
* Metal implants not MRI-compatible
Measuring Core Body Temperature Using a Novel Non-invasive Sensor

The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.

12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria:

* History of heat injury.
* The existence or suspicion of existing cardiac or respiratory disease.
* Diabetes.
* Obesity.
* Infectious disease 3 days prior to the experiment.
The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)

The purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol by evaluating tolerability (The probability that administered maintenance dose reaches the maximum will be determined as an indicator) as a primary endpoint when bisoprolol or carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In addition, the safety and efficacy of bisoprolol will be investigated.


Eligibility Criteria:
Inclusion Criteria:

As a result of diagnosis and tests before registration, a patient who is considered by an investigator to meet all requirements and to have ability to consent can be enrolled.

1. Primary disease: In principle, ischemic heart disease or dilated cardiomyopathy.
2. Heart failure patients with 40% or less of left ventricular ejection fraction (LVEF) .
3. Patients in NYHA functional classification Class II, III, or IV (including a medical history).
4. Basic treatment: In principle, patients undergoing treatment with an ACE inhibitor (or angiotensin receptor blocker (ARB)), a diuretic, a digitalis preparation, etc.
5. Patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date.
6. Age: Patients aged 20 to less than 85 on the day of obtaining written informed consent.
7. Hospitalized/outpatient: Either hospitalized or outpatient status.
8. Gender: Male or Female

Exclusion Criteria:

Patients who meet any of the following exclusion criteria at the time of registration will be excluded:

1. Patients who are considered not to be candidates for administration of bisoprolol or carvedilol.
2. Patients who have developed acute myocardial infarction within 8 weeks before the registration day.
3. Patients who have history of stroke or serious cerebrovascular accident within 1 year before the registration day.
4. Patients with poor prognosis and life-threatening disease, such as malignant tumor, or such medical history within 5 years before the registration day.
5. Patients who are scheduled to undergo coronary revascularization (Coronary artery bypass grafting; CABG, Percutaneous coronary intervention; PCI) during the study period.
6. Patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study.
7. Patients from whom written informed consent cannot be obtained.
8. Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery.

Optimal pain management is very important in obese patients. In the postoperative period, narcotic analgesics are often used to pain management. However, the use of narcotic analgesics in the postoperative period causes many undesirable adverse effects, especially sedation, dizziness, constipation, nausea, vomiting, muscle rigidity, tolerance, and respiratory depression.

The morbidly obese patients treated with narcotic analgesics increased risk for adverse effects such as atelectasis, hypoxemia, and postoperative ileus. Consequently, these are caused postoperative pulmonary complications, hypoxemia and longer lenght of hospital stay. Multimodal analgesia including local and regional anesthesia is recommended for morbidly obese patients.

In recent years, the ultrasound (USG) guided ESP block has been frequently used to eliminate postoperative pain and reduce narcotic analgesic use. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia and decrease the analgesia requirements after laparoscopic cholecystectomy. Some case series and case reports has also been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries.

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. For this purpose, ASA II-III, patients over 18 years of age, BMI 40-60 kg/m2 and elective bariatric surgery planned patients will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) II-III
* 18-65 years
* body mass index (BMI) 40-60 kg/m2
* elective bariatric surgery

Exclusion Criteria:

* ASA ≥4
* under 18 years of age or over 65 years of age
* declining to give written informed consent
* have neurological and/or psychiatric disorders
* cooperation cannot be established
* accompanying laparoscopic cholecystectomy or paraumbilical hernia repair
* history of bariatric surgery
* the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
* with hepatic, neuromuscular, cardiac and/or renal failure
* history of allergy to the local anesthetics
* patients undergoing open surgery
* patients with severe obstructive or restrictive lung disease