cyrilzakka/clinical-trials huggingface dataset:
Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis

Actinic cheilitis is a condition of the lower lip characterized by grayish-white areas of discoloration and blunting of the demarcation between the cutaneous lip and the mucosa.

While many studies have compared treatment options for actinic cheilitis, there is still significant debate over how to best manage this condition. The chosen treatment regimen must result in complete remission while also preventing recurrence and malignant transformation. Current treatment options are vast, including both non-surgical and surgical options. Common topical therapies include 5-fluorouracil, imiquimod, ingenol mebutate and diclofenac. More recently, photodynamic therapy has been brought forward as a potential treatment modality. From a surgical perspective, a vermilionectomy is typically the procedure of choice.

TCA is a popular topical treatment for treat fine rhytides, hyperpigmentation, photodamage, and premalignant changes, such as actinic keratoses. Despite this, TCA is not commonly used for actinic changes on the lips. Here, the investigators propose an expansion of the application of TCA to be used in the treatment of actinic cheilitis.

The proposed study will be a prospective cohort study of all patients with actinic cheilitis presenting to the study institution, the Queen Elizabeth II Health Science Center in Halifax, from March 1st 2021- March 1st 2023.

Patients will be consented to participate at the time of their initial consultation. They will fill out the demographics form, a preliminary survey and have the required photographs taken on that same day. A biopsy will be performed prior to treatment to establish the histological grade of their actinic cheilitis based on the degree of dysplasia. After the treatment is received, they will follow-up in 1 month for reassessment. At this point, a second treatment will be offered if clinical remission has not been achieved. Patients will continue TCA treatments at 1-month intervals until clinical remission is reached. Once remission is achieved, they will fill out the post-treatment questionnaire and have their second set of photos taken.

Final follow-up will occur 6 months post remission. At this point patients will be assessed for clinical recurrence. A third set of photos will be completed during this appointment.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will include all patients with actinic cheilitis that do not meet exclusion criteria.

Exclusion Criteria:

* Exclusion criteria will include patients younger than 18 years of age and patients with a biopsy proven malignancy of the lip.
Pharmacokinetics of Adrenaline After Administration of ARS -1 in Subjects With Upper Respiratory Tract Infection

This is a Phase 1, single-dose, two-period study that will consist of a combined screening and baseline period and an open-label treatment period. Subjects will be enrolled when they experience an Upper Respiratory Tract Infection with nasal congestion and edema.


Eligibility Criteria:
Inclusion Criteria:

* Treatment Period 1 only, subject has symptoms of an URTI at time of dosing based on the clinical judgement and the positive infectious cause of URTI to be confirmed by Respiratory Pathogens Panel.
* Has body weight more than 55 kg for male and 50 kg for female and body mass index between 18 and 32 kg/m2, inclusive.
* Has no declared medical history of hypertension and cardiovascular disease in the last 10 years.
* At screening, has stable vital signs in the following ranges (after 5 minutes of rest):

  * SBP ≥90 and ≤140 mmHg
  * DBP ≥50 and ≤90 mmHg
  * HR ≥45 and ≤100 beats per minute (bpm)
* Is a nonsmoker within the previous 2 months (calculated from first dosing) and does not use tobacco-containing products.

Exclusion Criteria:

* Has a stated history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
* Has current or past history of clinically significant asthma or angioedema.
* Has prior nasal fractures, severe nasal injuries or history of nasal disorders that could interfere with nasal spray administration.
* Has any clinically significant medical condition or physical exam (PE) finding as deemed inappropriate by the Investigator.
* Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
* Subject reports they have had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.
* Subject reports they have donated blood including platelets or plasma only or had an acute loss of blood (\>50 mL) during the 30 days before study drug administration or intends to donate blood or blood products within 30 days after the completion of the study.
* Has a history (within 12 months before screening) of drug use, or has a positive test for drugs of abuse at screening or upon admittance to the study center, or has a stated history of alcohol abuse.
* Has been on an abnormal diet during the four (4) weeks from Day 0. 10. Has participated in a clinical trial within 30 days prior to the first dose of study drug.

  11. Has had treatment with any adrenaline or noradrenaline containing products within 7 days of Day 0.

  12. Has inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.

Maintaining adequate blood pressure is important for survival of organs. Recent studies have demonstrated that higher blood pressures were necessary for prevention of acute kidney injury and myocardial injury after non-cardiac surgery. Hypotension after induction and maintenance of anesthesia is common. For maintaining adequate blood pressure in a euvolemic patient, vasopressor therapy is required. Norepinephrine (NOR) is commonly used to treat anesthesia-related hypotension.

The hepatic circulation has a large number of alpha and beta adrenergic receptors and is very sensitive for adrenergic stimulation such as norepinephrine infusion. Animal studies (Hiltebrand et al.) suggest that NOR has only minimal effect on hepatic blood flow however the effect of NOR on hepatic blood flow in clinical surgical patients remains unclear.

The aim of the study is to evaluate the effect of NOR on hepatic blood flow during.

goal directed haemodynamic therapy.

All patients receive standardized anesthesia care for pancreas surgery according to the existing departmental protocol for these interventions.

All patients receive individualized goal-directed haemodynamic therapy based on the transpulmonary thermodilution technique.

At designated times, hemodynamic variables will be recorded. These include:

* Heart rate (bpm)
* Central venous pressure (mmHg)
* Mean arterial pressure (mmHg)
* Cardiac index (L/min/m2)
* Pulse pressure variation (PPV)

Blood flow and pressure measurements performed by the surgeon :

* Hepatic flow : hepatic artery (HAF) and portal vein (PVF)
* Pressure measurements in portal vein (PPorta) and caval vein (PCava)

Both flow and pressure will be simultaneously recorded. To minimize the effect of ventilation on pressure, these measurements will be obtained during apnea.

Between each flow measurement there will be a minimum of 5 minutes.

NOR will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is \> 60 mmHg), NOR is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1).

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years ≤ 80 years (female or male)
* ASA I - II - III
* Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.
* Patient is scheduled for pancreatic surgery.

Exclusion Criteria:

* Allergy to the medication.
* Renal insufficiency (SCr \> 2 mg/dL).
* Severe heart failure (EF \< 25%).
* Hemodynamic instable patients.
* Atrial fibrillation.
* Sepsis.
* BMI \> 40.
* Severe coagulopathy (INR \> 2).
* Thrombocytopenia (\< 80 x 103 /mcL).
* End stage liver disease.
* Pregnancy and breastfeeding women
FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

To compare the results and understand the possible benefits from FDG-PET/MRI during different scanning time points after FDG, a type of contrast drug, is given.

Primary Objectives:

--To identify the optimal imaging time point using F18-FDG positron emission tomography (PET) that gives the best lesion conspicuity as defined by the best lesion to background (L/B) ratio when evaluating spinal cord lesions of unknown etiology.

Exploratory Objectives:

* To identify malignancy specific factors in F18-FDG metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), metabolic tumor volume (MTV) and L/B ratio.
* To identify patterns of metabolism derived from metrics such as SUVmax, SUVmean, TLG, MTV, L/B ratio and magnetic resonance imaging metrics such as regional perfusion abnormalities, apparent diffusion coefficient values and mean diffusivity measures.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minutes and then undergo PET-magnetic resonance imaging (MRI) over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with untreated intramedullary cord lesion(s)
* Ability to undergo FDG PET MR examination

Exclusion Criteria:

* No prior surgery or biopsy of the spinal cord
* No metal implanted in area of interest
* Spine radiation therapy
* Known allergy to FDG or gadolinium based contrast agents
* Blood glucose (\> 200 mg/dl)
* Pregnant women are excluded
* Children of less than 18 years of age
* Need for conscious sedation or anesthesia in order to tolerate study
Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia

To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.

Brain mapping of COVID-19 patients with or without anosmia will allow better understanding of the mechanisms leading to the onset of these symptoms and will provide a pathophysiological basis for the therapeutic interventions to improve the clinical prognosis of affected patients.

The study investigators hypothesize that in COVID-19 patients witch anosmia the brain mapping objectified by an MRI examination is modified and that there are functional abnormalities in the brain in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching hospital due to COVID-19 infection (fever, persistent cough, tiredness, shortness of breath, diarrhea, abdominal pain, chest pain, sore throat, loss of smell or taste)
* COVID-19 confirmed by RT-PCR and / or chest CT or clinical characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3 clinical manifestations)
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan "with anosmia" group:
* scoring \< 30 on a VAS 0-100 for olfactory ability
* Responding "yes" to question "have you lost your sense of smell in the last few days?"
* Negative result to olfactory test with n-Butanol diluted to 1/1000. "without anosmia" group:
* scoring \< 80 on a VAS 0-100 for olfactory ability
* Responding "no" to question "have you lost your sense of smell in the last few days?"
* Positive result to olfactory test with n-Butanol diluted to 1/16000.

Exclusion Criteria:

* Patient suffering from serious medical problems or hospitalized in an intensive care unit for invasive ventilation or severe dyspnea.
* Patient with neurological (motor, sensitive or cognitive), neuropsychiatric or vascular disorders.
* Patient with a contraindication to MRI (pace maker, claustrophobic patient, metallic heart valve, etc.).
* Patient with a history of rhinological pathology or a sense of smell problem.
* Patient with known neurological, psychiatric or neuroradiological manifestation.The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject is unable to express consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding
Pain Types and Pain Severity in Chronic Neck Pain

The aim of this study is to characterize the distribution of pain phenotypes in people with chronic neck pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life.

Participants will be examined to determine the type of pain and questions will be asked to assess pain severity and impact.


Eligibility Criteria:
Inclusion Criteria:

* having chronic neck pain
* be over 18 years old

Exclusion Criteria:

* those under the age of 18
* Those with major psychiatric illness,
* Those with communication problems
Swiss Hemophilia Registry

The Swiss Hemophilia Registry will collect data on the prophylactic and therapeutic use of factor concentrates in patients with hemophilia and other severe bleeding disorders in Switzerland.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of hemophilia or other severe bleeding disorders. Signed inform consent

Exclusion Criteria:

None
Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination

1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state
2. Subjects: Healthy subject
3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.

This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 20 and 45 years
* Subjects weighed ≥ 45 kg and were within 20% of their ideal body weight
* No clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test

Exclusion Criteria:

* Hypersensitivity or histories of sensitivity to either tramadol or acetaminophen
* Evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases
* Taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study
* Systolic blood pressure (SBP) ≥ 160 mmHg or ≤ 100 mmHg or diastolic blood pressure (DBP) ≥ 95 mmHg or ≤ 60 mmHg
* Any surgical or medical conditions that could affect drug absorption
Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian men
* Body mass index between 20-27 kg/m\^2
* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c\<69 mmol/l (\<8,5%)
* T1D duration between 2-20 years
* Stimulated C-peptide ≤ 100 pmol/mL)
* Treatment with a stable basal bolus or insulin pump regimen ≥ 3 months
* Informed consent

Exclusion Criteria:

* Anemia (hemoglobin below normal range)
* Liver disease (ALAT and/or ASAT \>2 times normal values) or history of hepatobiliary disorder
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Allergy or intolerance to ingredients included in the standardized meals
* Prior myocardial infarction or other cardiac events
* Any physical or psychological condition that the investigator fells would interfere with trial participation
* Treatment with any glucose-lowering drugs beside insulin
A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus

This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.

This is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of single and repeated dosing of AZD5004 compared with placebo.

Participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo.

The study will comprise:

1. A Screening Period of maximum 28 days.
2. A Treatment Period of 1 day(Part A) or 105 days (Part B).
3. A final Follow-up Visit approximately 7 days(Part A) or 14 days(Part B) after the last study intervention administration.

Eligibility Criteria:
Inclusion Criteria:

* Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent.

Inclusion Criteria for Part A:

* HbA1c ≤ 6.0%.
* Body weight ≥ 50.0 kg and BMI within the range 18.0-32.0 kg/m2.

Inclusion Criteria for Part B:

* HbA1c ≥ 6.5% and ≤ 10.5%.
* Not on any other diabetic medications.
* Body weight ≥ 60.0 kg and BMI within the range 24.0-35.0 kg/m2

Exclusion Criteria:

* Has a clinically relevant acute or chronic medical condition or disease.
* History of acute pancreatitis and chronic pancreatitis, gallstones.
* Abnormal renal function.
* Known clinically significant gastric emptying abnormality
* Significant hepatic disease.
* Uncontrolled thyroid disease
EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

The purpose of this study is to evaluate the efficacy of combination therapy with omeprazole and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of Eosinophilic Esophagitis (EoE) in children and adults. This study will be a double-blinded, randomized controlled trial. The primary outcome measured will be histologic assessment of esophageal tissue biopsies measuring number of eosinophils per high power field (eos/hpf). Secondary outcomes will be endoscopic findings and symptomatic changes following therapy using validated endoscopic scoring measures and participant surveys, respectively.

Subjects that meet study inclusion criteria will be recruited from the Adult and Pediatric Gastroenterology clinics at Walter Reed National Military Medical Center through routine clinic visits, will meet with an investigator, and complete informed consent/assent. The participants will then complete a validated clinical symptom reporting tool - the Eosinophilic Esophagitis symptom activity index (EEsAI) for age 18 and above, or the Pediatric Quality of Life Inventory (PedsQL) for age 6-17yrs - and have their initial Esophagogastroduodenoscopy (EGD) images evaluated via a validated Endoscopic Reference Score (EREFS). Esophageal biopsies taken at the patient's initial EGD will be assessed by 2 designated blinded pathologists to record the number of eosinophils per high power field (HPF), as well as perform tissue immunohistochemical staining for eotaxin-3. Participants will be block randomized to treatment or control groups and complete 8 weeks of therapy, with a phone follow up at 4 weeks for medication compliance. At the completion of 8 weeks of therapy, the participants will have repeat EGD to assess for mucosal healing, which is the standard of care in the treatment of EoE. At this EGD, the images will be assigned an EREFS and the biopsies will be evaluated for eosinophils per high powered field and eotaxin-3 staining. The patient will also complete an EEsAI or PedsQL. This procedure will end the 8 week study period.

Eligibility Criteria:
Inclusion Criteria:

* age 6 to 60 years old
* DEERS (defense enrollment eligibility reporting system) eligible
* diagnosis of eosinophilic esophagitis

Exclusion Criteria:

* Outside of age range
* Co-existing inflammatory gastroenterologic condition such as celiac disease, eosinophilic esophagitis, or inflammatory bowel disease.
* Concurrent use of oral steroids
* Pregnancy
* Refusal to undergo endoscopy
Observatory of Food Preferences in Infants and Children

Food habits form early in infancy and are likely to track into childhood until the beginning of adulthood. Understanding the factors driving the acceptance of foods in the early years is therefore of particular importance, since these foods will form the basis of a child's future food repertoire. This is especially important for vegetables, which consumption is recommended at all stages of life but is below the recommended levels and which acceptance is difficult to promote during late childhood.

The objective of the present study was to unravel the respective contribution of maternal feeding practices, of children's rate of exposure to vegetables and of children's sensory reactivity factors over the course of the first two years, to explain the development of liking for vegetables at the age of 2 years. This analysis took advantage of data recorded in a prospective cohort of children recruited before birth and followed up longitudinally until the age of 2 years.

This study is a cohort study with the aim to evaluate prospectively food liking in children, at to relate this outcome to children's food experience, acceptance of taste and olfactory stimulation, and to parental feeding style.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant mothers older than 18 years

Exclusion Criteria:

* Food allergies in the infant, as observed after the infant's birth
Longitudinal Pathogen-colonization in Cystic Fibrosis Airways and Ability to Smell

Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis.

The sub-study on the sense of smelling in CF has been finalized in the meantime. Results were published in 2012:

Smell in cystic fibrosis. Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of cystic fibrosis