cyrilzakka/clinical-trials huggingface dataset:
Delineating Swallowing Impairment and Decline in ALS

The purpose of this study is to 1) evaluate the discriminant ability of simple clinical markers to detect swallowing impairment in individuals with ALS, 2) develop and validate a minimally invasive clinical screening tool for use at multidisciplinary ALS clinics, and 3) determine the natural history of swallowing impairment and decline in ALS.

This research study is being performed to determine screening tools or tests that are able to identify and track swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS) over time. Also, this study will provide insight into the natural progression of swallowing impairment in persons with ALS over time.

Participants enrolled in this study will complete an evaluation at the University of Florida Aerodigestive Research Core laboratory located at Shands Hospital, Gainesville every three months. Each evaluation will take approximately 90 minutes. During these evaluations, a videofluoroscopy (X-ray of swallowing) examination, cough tests and questionnaires will be completed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of probable or definite ALS

Exclusion Criteria:

* allergies to barium or capsaicin
* History of stroke
* Head and Neck Cancer
* Other disorder that might contribute to swallowing impairment
* Not enrolled in other research investigations that might impact swallowing
* Not pregnant
Melatonin for Circadian Sleep Disorders in the Blind

This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1). The second study phase identifies the optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle (including sub-study 2). The third study phase introduces a new independent variable, light (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.

Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm. Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how individuals' endogenous melatonin production responds to bright outdoor light and Sub-study 4 tests a previous finding that artificial bright light exposed daily behind the knee can regulate the body clock. Sub-study 5 is an optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.


Eligibility Criteria:
Inclusion criteria:

* blindness for at least one year, verified by an ophthalmologic exam
* ability to comply with the requirements of the experimental protocol
* competency to sign informed consent

Exclusion criteria (as determined by medical history and/or physical examination):

* abnormal heart, liver or kidney function
* a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
* possibly external demands that limit the ability to maintain a regular schedule (e.g., night shift work)
* sexually active female subjects of child-bearing potential will be asked to avoid pregnancy using accepted methods and will be notified that the effects of melatonin on a fetus are not known (we will ask subjects monthly if they are pregnant or trying to become pregnant)
* if a subject reports she is pregnant or is trying to become pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study
Suicidal Poisoning in Emergency Units

Poisoning is the deterioration of the body's functions by the ingestion of any substance being toxic to the body or by overdosing a nontoxic substance. Poisoning cases may vary according to the geographical and seasonal characteristics of the region, sociocultural structure of the population, life index and the age groups.

Worldwide, intentional self-poisoning (ISP) is the most common form of suicide attempt and the most common method that results in medical hospitalization.

Questionnaire is prepared including the following items:

Demographic data:

Gender -age-marital status -occupation- socioeconomic state -special habit -history of psychiatric innless-history of chronic diseases-history of drug dependence -previous suicidal attempts-toxic substance used in suicide- time of poisoning, season and time of arrival .

Data regarding poisoned substance:

Dose, type of the substance used and rout of administration. Presenting symptoms of intoxication and management

Complete clinical examination:

General condition: conscious level and vital signs. Local examination: chest, heart, abdomen, etc.

Investigation:

(Arterial blood gases - ECG -otherwise according to case presentation)

Prognosis:

Complete recovery, complications, death.

Eligibility Criteria:
Inclusion Criteria:

* suicidal poisoning cases

Exclusion Criteria:

* other causes of suicide
Comparison of Quadratus Lumborum Block and Epidural Analgesia Following Kidney Transplant Surgery

Quadratus lumborum block as an alternative for postoperative analgesia compared with epidural block

Epidural analgesia is the main choice of analgesia following kidney transplant surgery. However, continuous epidural technique had some concerning side effects such as hemodynamic instabilities, urine retention, motor/sensory disturbances/weakness, and mobilisation comfort, it could also cause hypotension which could affect graft success. Quadratus lumborum (QL) block had lesser side effects thus could be an option for postoperative analgesia, however there are no study showing the safety and success rate of QL block techniques for patients who underwent kidney transplant surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective kidney transplant laparotomy surgery
* Agrees to participate in research
* BMI \< 30 kg/m2

Exclusion Criteria:

* Declines to participate in research
* Contraindications to intervention procedures (epidural or quadratus lumborum block)
* History of local anaesthetic allergy
* Systemic allergic reactions, anaphylactic reaction, cardiac arrest
* Failure of intervention procedures (epidural or quadratus lumborum block)
* Intraoperative complications (massive bleeding, hypotension)
NKT Role in the Regulation of the Inflammatory Bowel Disease

Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.

Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PSC alone, IBD alone or PSC + IBD
* Obtention of oral and written consent
* Patients affiliated with the social security system

Exclusion Criteria:

* Minor patient
* Suspicion of malignant lesion of the colon
* Inability for information
* person unable to consent, and not benefiting from a legal protection regimen
* Person deprived of liberty
Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Prospective, randomized, open-label, single-center, investigator-initiated trial, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) within 12 hours of the symptom's onset. The study aims to compare platelet inhibition (pharmacodynamics and pharmacokinetics) of pre-hospital Ticagrelor in patients with STEMI according to two different analgesia protocols using Fentanyl or Morphine.

Consecutive patients with acute STEMI within 12 hours of the symptoms' onset and candidates for PPCI will be screened for inclusion in the study. Eligible patients who require analgesia for the relief of acute chest pain, defined as Visual Analogue Scale ≥3, will be randomized in a 1:1 ratio into one of the two treatment arms to receive analgesia with either Morphine or Fentanyl following administration of a pre-hospital loading dose of Ticagrelor. Randomized patients will undergo primary PCI and managed according to the current guidelines of the European Society of Cardiology. Blood samples (10 ml) will be collected at 0, 1, 2, 4, 6, 12 and 24 hours after the loading dose of Ticagrelor to assess platelet inhibition using the VerifyNow P2Y12 function and the Vasodilator-Stimulated-phosphoprotein Phosphorylation (VASP) assays, plasma concentration of Ticagrelor and its active metabolite (AR-C124910XX) using a validated liquid chromatography/mass spectrometry detection method and the procoagulant action of platelets.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18-year-old
* STEMI within 12 hours of symptoms' onset eligible for primary PCI with stent implantation.
* Patient able to give written informed consent.

Exclusion Criteria:

* Contraindication, intolerance or hypersensitivity to Ticagrelor, or any excipients
* Contraindication, intolerance or hypersensitivity to Morphine, Fentanyl, or any excipients
* Active bleeding or bleeding diathesis
* History of intracranial haemorrhage
* Chronic oral anticoagulation treatment
* Previous antiplatelet treatment
* Contraindications to antiplatelet therapy
* Severe renal insufficiency (creatinine clearance \<30 mL/min)
* Severe hepatic dysfunction
* Severe chronic obstructive pulmonary disease
* Periprocedural glycoprotein IIb/IIIa inhibitors administration
* Relevant haematological disease
* Patient who is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
* If female, patient pregnant or breastfeeding.
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del

This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for F508del.


Eligibility Criteria:
Key Inclusion Criteria:

* Homozygous for the F508del mutation (F/F)
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply
Differences in Postoperative Symptoms With Four Ureteral Stents

This is a prospective randomized controlled trial designed to assess the differences in postoperative symptoms related to placement of a 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents, 4.8Fr Percuflex ureteral stents, and 4.8Fr Tria ureteral stents after ureteroscopy with laser lithotripsy for treatment of upper tract urinary stones. 272 participants will be enrolled and will be on study for up to approximately 10 weeks.

The investigators will compare Ureteral Stent Symptom Questionnaire (USSQ) scores with each ureteral stent. Laser lithotripsy is a surgical procedure performed during stone surgeries. The Percuflex ureteral stent and Tria ureteral stent are FDA approved and clinically used in the United States.

A total of 3 clinic visits (i.e., pre-operative visit, the stent removal 1-2 weeks after surgery, and one post-operative visit 3-6 weeks after surgery) in addition to the surgery will be needed for this study. The patient's demographic information and medical background data will be collected from the medical record.

The USSQ will be administered twice:

1. At the time of stent removal (1-2 weeks after surgery ) (This is standard of care)
2. At the first postoperative follow-up after stent removal (3-6 weeks) (This is the standard of care).

The following information will be collected as secondary outcomes:

1. WisQOL which will be administered three times. It is UW standard of care for stone patients to complete the WisQOL at every clinic visit.
2. ER visits documented in patients chart
3. Unscheduled clinic follow-up documented in patient chart
4. Additional prescriptions for stent related symptoms documented by patient chart
5. Stent complications by fluoroscopy or image
6. Physician evaluation of the stent. Physicians will complete a one page survey at the end of the case evaluating the stent.

Eligibility Criteria:
Inclusion Criteria:

* Patients with renal or ureteral urinary stones who require endoscopic treatment and stent placement in the outpatient operating room.

Exclusion Criteria:

* Pregnant patients
* Patients with transplant kidneys
* Patients with irreversible coagulopathy
* Patients with known ureteral stricture disease
* Non-English speaking, vulnerable patients such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.
* Patients with planned staged procedures.
* Patients who have stent placed before surgery.
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for more than 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
* Body mass index (BMI) between 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subjects who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Impact of Age on the Prevalence of Allergic Sensitization

Worldwide, respiratory diseases have a significant impact on morbidity and mortality of individuals.Tobacco, lifestyle and certain allergens such as dust mites play an important role in the prevalence and morbidity of these diseases. Scientific literature indicates that sensitization to allergens and respiratory diseases (asthma, rhinitis, chronic obstructive pulmonary disease) are closely linked. Moreover, smoking has an effect on allergen sensitivity.

To make a diagnosis of allergic sensitization, skin tests are performed in the patient. One of the methods used is the technique of "prick test". In practice, a drop of purified allergen extract is placed on the patient's skin (arms or back). A little dosis of the product is then injected in the epidermis. If fifteen minutes later, there is an edematous reaction, its diameter is measured in millimeters. From 4 mm, it is considered that the patient is sensitized to the tested foods or allergens.This technique is painless and convenient to patients of all ages, including newborns or conversely very aged patients.

This is a retrospective study based on the encoding and statistical analysis of data collected in patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.

At least 1400 files will be analyzed.

Patients will be distributed in six age groups.The results of the allergen skin tests will be encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI and residential area on the allergic reactivity will also be assessed in the overall population and within each age group.

The main objective is to evaluate the effect of age on the skin test positivity. The secondary objective is to highlight the environmental factors that have an impact on allergic diseases.


Eligibility Criteria:
Inclusion Criteria:

* All patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital
* Who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.

Exclusion Criteria:

* Negative histamine patients
Plasma Concentration of Biological Markers in Placental Abruption

This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1), vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if will examine the correlation between placental micro-particles, biomarkers, and extent of placental abruption.

The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. The knowledge gained from this study has the potential to develop a diagnostic test for PA with the ability to improve outcomes for mother and baby through earlier diagnosis and targeted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - to 45-years old, inclusive
* Suspected or confirmed PA or phenotypically matched controls
* All modes of delivery
* Gestational age greater than 28 weeks
* Singleton pregnancy

Exclusion Criteria:

* Intrauterine fetal demise,
* Severe fetal anomalies (infant not expected to survive)
* Inability to communicate in English
Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study

The primary objective is to assess the quality of life of intramuscular (IM) Interferon Beta-1a in participants with relapsing remitting multiple sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) in a clinical practice setting.


Eligibility Criteria:
Key Inclusion Criteria:

* Decision to treat with Interferon Beta-1a (IFN beta-1a) must precede enrollment, independently of the study and in compliance with the marketing authorization
* Study enrollment must occur prior to 4th weekly administration of IFN beta-1a
* Able to understand and complete a self-administered questionnaire
* No contra-indications for IFN beta-1a

Key Exclusion Criteria:

* Subjects with history of hypersensitivity to natural or recombinant IFN beta or to any component
* Subjects with primary or secondary progressive MS
* Subjects with current severe depression and/or suicidal ideation
* Pregnant women
* Subjects participating in another clinical trial
* Subjects who do not want to participate in the study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study

Localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which inhibit fibrotic activity . We propose that topical imiquimod 5% cream is efficacious and safe in treating plaque-type morphea. Twenty adults will be enrolled for a pilot study. A screening and baseline clinic visit will be required for each patient enrolled in the study. Each visit will involve completing a medical history, skin examination, digital pictures, histologic examination if the patient consents and an ultrasonographic score. One morphea plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with vehicle cream. Patients will be asked about side effects (local and systemic). Patients will be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of treatment period (month 12).


Eligibility Criteria:
Inclusion Criteria:

* Adults and children \> 6 years with plaque-type morphea
* Subject has not participated in previous study involving imiquimod for three months
* In the investigator's judgement, imiquimod treatment may benefit the patient over conventional treatment
* Subject has provided informed written consent
* Female subjects of childbearing potential have a pregnancy urine test that is negative prior to treatment
* Sexually active subjects agree to practice effective birth control throughout the duration of the study

Exclusion Criteria:

* Patients with a non-morphea skin disorder in the region of interest
* Subjects previously undergoing morphea therapy within four weeks of the study
* Subjects have a known hypersensitivity to imiquimod or component of the cream preparation
* Subjects who are pregnant or nursing