cyrilzakka/clinical-trials huggingface dataset:
Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis

The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient subjects who have signed a written informed consent.
* A documented history of chronic sinusitis with clinical signs and symptoms suggestive of inflammation or infection for at least 90 consecutive days.
* A documented history of sinus surgery \> 90 days.
* Nasal endoscopic exam documenting purulence (pus) from an open sinus cavity with mucosal swelling/edema.
* Women of childbearing potential must have a negative serum pregnancy test and must use adequate birth control throughout the study.

Exclusion Criteria:

* Pregnant females and females unwilling to use adequate birth control.
* Use of any investigational drug/device within 30 days of study screening.
* The following medications will require a certain washout period as determined by the protocol: systemic corticosteroids, mast cells and/or leukotriene inhibitors, anti-inflammatories, decongestants, antihistamines, non-steroidal anti-inflammatory (NSAID) or cyclooxygenase (COX)-2 inhibitors, antibiotics or antifungals.
* Presence of other infections which may require use of systemic antibiotics.
* Known allergy or hypersensitivity to aminoglycosides or other study drug formulation components.
* Recent hospitalization for any reason and/or major surgeries within 30 days of study screening.
* Major elective and/or nasal and/or sinus surgical procedures (including sinuplasty) within 90 days before or 90 days after study screening.
* Known history of neurological or muscular disorders.
* Diagnosis of an immunodeficiency disease.
* Previous diagnosis of cystic fibrosis, ciliary dyskinesias, Kartagener syndrome, empty nose syndrome, Wegener granulomatosis, Churg-Strauss syndrome, Samter syndrome, or sarcoidosis.
* Current or known history of tinnitus, vertigo, or significant sensorineural hearing loss.
* Recent history of alcohol or drug abuse.
* Inability to understand the nature, scope, and possible consequences of the study or study procedures, unless cared for by a legally authorized representative.
* Inability to adhere to the study requirements.
* Previous participation in any Naryx Pharma protocol.
AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients

With the aging population, a high prevalence of obesity, systemic arterial hypertension and diabetes mellitus, we are facing an increased incidence of elderly patients with chronic kidney disease (CKD) initiating renal replacement therapy. The correct diagnosis of CKD, the prognosis of the elderly patient with CKD, mainly comparing initiated dialysis vs. remaining in conservative treatment, the nutritional prognostic markers (sarcopenia), cardiovascular, mineral and bone metabolism, geriatric syndromes and sleep disorders are still debatable. Elderly patients are usually excluded from clinical trials and the scientific evidence is either scarce or based on retrospective data. Thus, the present study is a prospective cohort to evaluate the long-term evolution of patients ≥ 70 years with stage 4 or 5 CKD. The main outcomes are mortality and dialysis as a combined event. These endpoints will be correlated with independent parameters: Klotho, FGF23, nutrition and sleep quality. Confounders variables are cognition, depression, demographic, clinical and laboratory parameters, and daytime somnolence. Patients will be followed at the nephrology outpatient clinic of the Hospital das Clinicas, Universidade de Sao Paulo. The sample size was calculated to be 200 subjects. The summary methodology will include a broad geriatric assessment, cognition test, fragility, Charlson comorbidity scores, biochemical measurements of urea, creatinine, alkaline phosphatase, parathyroid hormone, calcium, phosphorus, vitamin D, vitamin B12, folic acid, thyroid hormones, hepatitis virus, serum albumin, albumin/creatinine ratio, protein/creatinine ratio, 24-h urinary protein, Epworth Sleepiness Scale, Pittsburgh questionnaire, segmental electric bioimpedance, and nutritional evaluation by 24h dietary interview.

Main outcome: combined event mortality-dialysis

Independent variables: nutrition status, sleep quality, Klotho and FGF-23 Confounders: clinical and demographic variables, Charlson comorbidity index, Laboratory parameters, depression, functionality, cognition.

Eligibility Criteria:
* Clinical diagnosis of Chronic Kidney Disease stage 4 or 5
* Minimal age of 70 years
* Must be able to understand and sign the consent form

Exclusion Criteria:

* Patients who did not accept and sign the consent form
* Patients with cancer and life expectance lower than 6 months
* Moderate to advanced dementia
Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects

To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design.


Eligibility Criteria:
Main Inclusion Criteria:

* Prediabetic subjects: Male and female subjects with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 100 mg/dL and ≤ 125 mg/dL (in venous plasma) (twice confirmed at two independent days if HbA1c is \< 5.7%) or Healthy normo-glycaemic subjects: fasting glucose \<100 mg/dL and HbA1c is \< 5.7%
* Age: 18-70 years
* Body mass index 19-35 kg/m2
* Current Non-smoker
* Signed informed consent form
* No changes in food habits or physical activity 3 months prior to screening and during the study
* If applicable, stable intake of chronic medication of at least 4 weeks

Main Exclusion Criteria:

* Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment
* Presence of disease or drug(s) influencing digestion (incl. recent intake of antibiotics) and absorption of nutrients
* Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
* Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety
* Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST \>3 x ULN)
* Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
* Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
* Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids
* Drug-, alcohol- and medication abuses
* Pregnant or breast-feeding women
A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study

The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® \& Biotene®) in patients with xerostomia due to chronic hyposalivation.

National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design.

200 evaluable patients have been recruited

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Aged 18 years or more,
* Clinical diagnosis of xerostomia by a severe reduction of salivation, as detected by patient's answers to few specific questions and measured by saliva volume at screening visit (test of saliva weight absorbed ≤ 0.1g/min)
* Any medical condition or treatment leading to a severe reduction of salivation related to either:
* Head and neck radiation therapy for cancer,
* Gougerot-Sjögren syndrome
* Medications known to induce xerostomia (psychotropic drugs, antihypertensive drugs)
* Dehydration, hypothyroidism, Parkinson's disease and/or diabetes mellitus
* Female patients must be post-menopausal or using a highly effective method for avoidance of pregnancy throughout the whole study duration, if childbearing potential.
* Able to understand and comply with the protocol procedures
* Willing and able to give their written informed consent
* Affiliated to the French National Health Insurance Program

Exclusion Criteria:

* Known hypersensitivity to one of the study products or to one of their components
* Any planned change in dosing of all known medications inducing mouth dryness
* Concomitant treatment for xerostomia symptoms without a scheduled 3 to 7-day withdrawal window
* Oral candidiasis as diagnosed by a microbiological test obtained from an unstimulated whole saliva sample until 3-week period from disease release
* Oral ulceration
* Alcohol (\>2 glasses of wine/day), smoking (\>10 cigarettes/day), caffeine and/or theine intake (\>4 cups/day)
* Patients unable to fill out the questionnaires or to comply with the study protocol
* Dental infection
* Patients participating to another clinical trial at the time of the study entry or within 30 days prior to study enrolment
* Life-threatening condition at the time of the study
* Pregnant or lactating women and women of childbearing potential refusing to use adequate contraception.
Comparison of Insulin Detemir and NPH With Respect to Lowering the Blood Sugar and Symptoms Experienced by Type 1 Diabetics During Hypoglycaemia

This trial is conducted in UK. The aim of this clinical trial is to investigate lowering the blood sugar and symptoms experienced during hypoglycaemia


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent obtained before any trial-related activities.
* Type 1 diabetes
* Treatment with insulin for minimum three months
* Duration of diabetes for more than 12 months
* Body Mass Index (BMI) less than 30 kg/m2
* HbA1c equal to or greater than 10 % based on analysis from central laboratory

Exclusion Criteria:

* Participation in any other clinical trial involving other investigational products within the last three months
* Current treatment with insulin in a daily dose above 100 U
* Episode of symptomatic hypoglycaemia, or a capillary plasma glucose value of less than 3.5 mmol/L in the past two weeks
* Hypoglycaemic unawareness or severe autonomic neuropathy
* Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
* Current treatment with oral antidiabetic drugs
* Impaired hepatic function measured as ALAT of more than two times the upper reference limit
* Impaired renal function measured as creatinine of more than 150 micromol/L (1.7 mg/dL)
* Cardiac problems defined as decompensated heart failure (NYHA class III and IV) at any time and/or angina pectoris and/or myocardial infarction within the last 12 months
* Known or suspected allergy to trial product or related products
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Blood donation of more than 500 mL within the last three months
* Any condition that the Investigator and/or the Sponsor feels would interfere with study participation or evaluation of results
* Pregnancy or intention of becoming pregnant, breast-feeding or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods
* Previous participation in this trial
Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)

Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).


Eligibility Criteria:
Inclusion Criteria:

* PTLD with or without EBV association, confirmed after biopsy or resection
* Measurable disease of \> 2 cm in diameter and/or bone marrow involvement
* Patients having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or other or a combination of the organ transplantations mentioned
* Karnofsky scale \>50% or ECOG ≤ 3
* Reduction of immunosuppression with or without antiviral therapy
* A complete surgical extirpation of tumor was not performed
* A radiation therapy was not performed
* Effective contraception for women in childbearing age
* Patient's written informed consent and written consent for data collection
* Patients are \> 18 years (or ≥ 15 years with parental agreement )

Exclusion Criteria:

* Life expectancy less than 6 weeks
* Karnofsky-scale \<50% or ECOG =3
* Treatment with rituximab before
* Known allergic reactions against foreign proteins
* Concomitant diseases, which exclude the administration of therapy as outlined by the study protocol
* non-compensated heart failure
* Dilatative cardiomyopathy
* Myocardial infarction during the last 6 months
* Severe non-compensated hypertension
* Severe non-compensated diabetes mellitus
* Renal insufficiency (creatinine more than 3-fold of the upper normal value), not related to lymphoma.
* Hepatic insufficiency with transaminase values greater than 3-fold of the normal values and/or bilirubin levels \>3.0 mg/dl, not related to lymphoma
* Clinical signs of cerebral dysfunction
* Women during the lactation period, pregnant or of childbearing potential not using a reliable contraceptive method
* Involvement of the central nervous system by the disease
* Severe psychiatric disease
* Known to be HIV positive
* Missing written informed consent of the patient
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA

The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent executed prior to protocol screening assessments;
* Men or women 18 to 65 years of age, inclusive (Women may be surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are postmenopausal for \>1 year. Women who are of childbearing potential must agree to practice adequate contraception one month before the first dose of study medication and up to Day 16 of the study. Adequate contraception may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods.);
* No history of chronic diseases, except for subjects with well-controlled hypertension or well-controlled hyperlipidemia;
* BMI ≤30kg/m2;
* No significant medical history including diabetes or hypertension complicated by hyperlipidemia (metabolic syndrome);
* Negative urine drug and alcohol tests at Screening; and,
* No metformin or omega-3 products within 2 months.

Exclusion Criteria:

* Abnormal findings on physical examination, EKG, vital signs, and clinical laboratory testing, in the judgment of the investigator;
* Allergies to fish or shellfish;
* Impaired renal function (calculated eGFR \<60 mL/min);
* Abnormal laboratory values for T3, T4 and TSH at the Screening Visit;
* Aspartate aminotransferase/alanine aminotransferase (AST/ALT) \>2x upper limits of normal (ULN) or serum bilirubin \>1.5 mg/dL;
* Requirement of prescription medication within 14 days of the Screening Visit, with the exception of prescription medications for the prevention of pregnancy, anti hypertensives for hypertension, or statins for hyperlipidemia. Doses of one or two anti-hypertensives and/or a statin must be stable for \>1 month;
* Normal doses of over-the-counter medications, including vitamins are allowed but not within 3 days of Visit 2 (first day of dosing);
* Current or history of abuse of alcohol or illicit drugs within the preceding year to the Screening Visit;
* Participation in a dietary modification or an intensive weight loss program;
* Participation in another clinical trial of an investigational product within 3 months prior to the Screening Visit;
* Smokers (use of tobacco in the past 3 months); or,
* Donation or loss of 400 mL blood or more in the last 8 weeks.
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.


Eligibility Criteria:
Inclusion Criteria:

For GPI1 Participants:

- Participants who are unable or unwilling to use PAP therapy. Participants must not have used PAP for at least 4 weeks prior to screening.

For GPI2 Participants:

- Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study

For Both GPI1 and GPI2 Participants:

* Have an AHI ≥15 on PSG as part of the trial at screening
* Have a body mass index (BMI) ≥30 kilogram/square meter (kg/m²)
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

For GPI2 Participants:

* Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study
* Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study

For GPI1 and GPI2 Participants:

* Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
* Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma.
* Have HbA1c ≥ 6.5% (≥ 48 mmol/mol) at baseline
* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline
* Have significant craniofacial abnormalities that may affect breathing at baseline
* Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
* Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
* Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.
* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
* Have a self-reported change in body weight \>5 kg within 3 months prior to screening
* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed more than 1 year prior to screening)
* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)
First in Man Trial - BIOSOLVE-I

First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety


Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years and \< 80 years of age
* Written patient informed consent available prior to PCI
* Patients with stable or unstable angina pectoris or documented silent ischemia
* Patient eligible for PCI
* Patient acceptable candidate for coronary artery bypass surgery

Exclusion Criteria:

* Left ventricular ejection fraction of \< 30%
* Presence of a visible thrombus in the target vessel visualized by angiography
* Lesion and/or way to lesion extremely calcified (e.g. IVUS catheter can not reach/cross the lesion)
* Patients with three-vessel where all three vessels require treatment
* Patients with previous CABG in the target vessel(s)
* Patients with known coronary artery spasm
* Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
* Patients with planned major surgery within 12 months after coronary intervention
* Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
* Patients under current Phenprocoumon or Cumarine therapy
* Impaired renal function (serum creatinine \> 2.0mg/dl or 177micromol/l, determined within 72 hours prior to intervention)
* Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
* Totally occluded coronary artery (TIMI flow 0)
* Lesions located within arterial or venous graft
* Ostial lesions
* Previous and/or planned brachytherapy of target vessel
* Target lesion located in left main coronary artery
* Stroke or TIA \< 6 months prior to procedure
* Patient with signs of a cardiogenic shock
* Surgeries of any kind within 30 days prior to screening
* Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
* Pregnant and/or breast-feeding females or females who intend to become pregnant
* Patient currently enrolled in other investigational device or drug trial
* Patient with expected incompliance to medical (antiplatelet, anticoagulation) therapy
A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
* BRAF or NRAS mutation in tumor tissue
* All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
* Evidence of measurable tumor disease as per RECIST
* WHO performance status of 0-2
* Adequate organ function and laboratory parameters

Exclusion Criteria:

* History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO
* Patients with unstable CNS metastasis
* Prior treatment with a MEK- inhibitor
* Impaired cardiovascular function
* HIV, active Hepatitis B, and/or active Hepatitis C infection
* Pregnant or nursing (lactating) women
* Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements

Other protocol-defined inclusion/exclusion criteria may apply.