cyrilzakka/clinical-trials huggingface dataset:
ALADDIN Study - Phase III: Antigonadotropin-Leuprolide in Alzheimer's Disease Drug INvestigation (VP-AD-301)

The study is designed to investigate the activity of the hormone drug leuprolide acetate in stabilizing cognitive function in mild-to-moderate AD patients.

VP4896 is a gonadotropin releasing hormone (GnRH) agonist that binds to and inactivates GnRH receptors on the pituitary gland. This decreases the amount of luteinizing hormone released by the pituitary. The hypothesis upon which this trial is designed is that luteinizing hormone is the cause of Alzheimer's disease. VP4896 decreases the amount of luteinizing hormone in the body and, therefore, may decrease or halt the progression of Alzheimer's disease.

This is a double-blind, placebo-controlled, study designed to assess the safety and efficacy of VP4896 (a novel formulation of leuprolide acetate) in the treatment of subjects with mild-to-moderate AD. The study duration is 56 weeks. Approximately 555 participants will be recruited from approximately 80 sites in the United States, Canada, and South America.

The study drug will be administered every eight weeks over a 48 week period. Male subjects randomized to active treatment will also receive testosterone replacement gel.

The change from baseline in ADAS-Cog (cognitive test) score at Week 50 and ADCS-CGIC (global cognitive and behavioral measure) at Week 50 will be the primary efficacy endpoints. Safety will be assessed at all visits and by phone at Week 1.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Diagnosis of probable mild-to-moderate Alzheimer's Disease
* On a stable dose of an acetylcholinesterase inhibitor (including, but not limited to: donepezil, galantamine, rivastigmine, and tacrine) for at least 120 days prior to baseline and will likely remain on the drug throughout the trial; all participants must be on acetylcholinesterase inhibitors
* No other significant or interfering medical conditions

Exclusion Criteria:

* Significant neurological disease affecting the brain or psychiatric disease other than AD, such as current untreated major depression, schizophrenia, epilepsy, Parkinson's disease, Creutzfeldt-Jakob's disease, or clinical episode of stroke
* Laboratory or clinical signs of untreated, clinically significant abnormal thyroid function, in the Investigator's opinion
* Received other investigational drugs within 30 days or 5 half-lives prior to baseline, whichever is longer
* Taking other medications, with the exception of estrogen, known to affect serum gonadotropin (Gn) concentrations, including but not limited to goserelin, danazol, or leuprolide
* Other exclusion criteria exist--eligibility can be assessed by the trial site
An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516

The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.


Eligibility Criteria:
Inclusion Criteria:

* Normal MRI scan
* Healthy male or non-fertile females
* Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria:

* History of disease or condition that may interfere with the objectives of the study
* History of previous or ongoing psychiatric disease/condition
* Concomitant medication
An Electronic Alert System for In-Hospital Acute Kidney Injury

This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>=18 years
* Admitted to the Hospital of the University of Pennsylvania for greater than 24 hours.

Exclusion Criteria:

* Dialysis order within 24 hours of admission
* Dialysis order prior to AKI onset
* Initial creatinine \>=4.0mg/dl
* Prior admission in which patient was randomized.
* Nephrectomy during the admission
* Admission to hospice service
* Admission to observation status
Imaging of Atherosclerosis With 68Ga-MSA

Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with positron emitter is not yet available. Fortunately, some scientists made the major advance in the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter agent 18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque macrophages in carotid arteries. However, coronary and cerebral arterial segments remain uninterpretable due to metabolic property of 18F-FDG. Applying the character of the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, we investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of atherosclerotic lesion in PET.


Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome(acute myocardial infarction, unstable angina)
* chronic stable angina
* control without coronary artery disease

Exclusion Criteria:

* pregnancy, allergy to albumin, chronic inflammatory disease
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF

The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
* Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
* Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
* Subjects with an acute deterioration of liver function
* Subjects who meet one of the following criteria:

  1. Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
  2. Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of \> 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
  3. Subjects with two organ failures
* If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
* Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Exclusion Criteria:

* Known infection with HIV
* Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
* Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
* Subjects with clinical evidence of disseminated intravascular coagulation
* Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
* Subjects who are hypotensive (defined as mean arterial pressure \<70 mmHg) or require the use of inotropic support
* Subjects with evidence of significant and/or uncontrolled bleeding
* Subjects requiring mechanical ventilation
* Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
* Subjects previously exposed to IDN-6556
* History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of \> 480 milliseconds (msec)
Effects on Mortality and Clinical Course of a Patient's Choice Model for Opioid Maintenance Treatment for Opioid Dependence - Evaluation of a System Enabling a Large Expansion of Treatment Providers and Treatment Access

Opioid dependence, for example involving addiction to injected or inhaled heroin or similar compounds, is associated with high mortality, typically from opioid overdose, and causes major physical and mental health complications, social problems and crime. Opioid maintenance treatment (OMT) has proven effective in opioid dependence. In 2014, a patient's choice reform in Skåne county, Sweden, was introduced and led to a vast extension of OMT in the region, including a large number of treatment providers and high access to treatment. Still, opioid-related mortality in the region remains high. While patients' access to treatment has been increased, the content and nature of treatment in the present system has been questioned. The present system, which dramatically altered treatment conditions and access for OMT in this region, has never been formally evaluated in any large-scale study. This study aims to assess clinical course of patients receiving OMT before and during the patient choice reform system, and effects on the extent and nature of opioid-related mortality in the region.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in opioid maintenance treatment in Skåne region.

Exclusion Criteria:

* None.
Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (A single centre randomised controlled trial)


Eligibility Criteria:
Inclusion Criteria:

* histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy
* only first three ART cycles
* normal uterine cavity
* Eligible for ovarian stimulation with long agonist protocol

Exclusion Criteria:

* FSH\>20 IU/L
* presence of large intramural fibroids (\> 3 cm)
* \<4 oocytes obtained in any previous fresh ART cycle
* ART with sperm derived from testicular biopsy
* ART with Preimplantation Genetic Diagnosis/Screening
Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism.

Objectives: To evaluate the safety of outpatient treatment of patients with very low-risk pulmonary embolism (PE), and the satisfaction and quality of life of this management.

Methods: An experimental study of routine clinical practice will be carried out in which 300 consecutive hemodynamically stable patients with acute symptomatic PE will be included, who meet all the inclusion criteria and none of the exclusion criteria. All patients included in the study will be treated on an outpatient basis, that is, they will be discharged within the first 24 hours of the diagnosis of PE in the Emergency Department. The Computerized Registry of Thromboembolic Disease RIETE (Registro Informatizado de Enfermedad TromboEmbólica) will be used to collect the data in electronic case report form (CRF) and ensure the quality of the data.

Setting: Emergency, Pneumology and Internal Medicine Services of 10 Spanish hospitals.

Analysis: An intention-to-treat (ITT) analysis will be performed on all patients who sign the informed consent and are included in the study (regardless of whether or not they receive the assigned strategy). Additionally, an analysis of all patients who are treated on an outpatient basis without deviations or violations of the protocol will be performed. The primary outcome considered will be the composite of recurrent PE, major bleeding, or death from any cause during the first 30 days after enrollment in the study. Patient satisfaction and quality of life will be considered as secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of suspected pulmonary embolism (PE) by multidetector chest angio computed tomography (CT), if a contrast-encircled partial intraluminal defect or complete pulmonary artery occlusion is demonstrated on two consecutive CT slices (13);
* Right ventricle (RV) diameter equal to or less than that of the left ventricle (LV) (RV/LV ratio ≤1) on chest CT angiography (see Study Procedures); and
* Negatively modified simplified Pulmonary Embolism Severity Index (sPESI) scale at the time of evaluation of the patient in the Emergency Department.

Exclusion Criteria:

* Inability to obtain informed consent
* Pregnancy
* Hemodynamic instability at diagnosis (defined by systolic blood pressure (SBP) \<90 mm Hg, indication of fibrinolytic treatment or inferior vena cava filter, need for vasoactive drugs at the discretion of the attending physician, cardiopulmonary resuscitation or orotracheal intubation)
* Contraindication for anticoagulation, at the discretion of the responsible physician;
* Estimated survival of less than 3 months
* Need for thrombectomy, vena cava filter insertion, or need for fibrinolytic treatment of the PE episode at the time of diagnosis
* Participation in a clinical trial for the treatment of venous thromboembolic disease
* Impossibility of follow up
Defining the Sympathetic Skin Response of Migraineurs in the Facial Area

The aim of this study is to define the sympathetic skin response of migraineurs in the facial area. This will be achieved by exposing healthy volunteers and migraine patients to various stress stimuli (pain, visual stimulation, auditory stimulation and a mathematical challenge), and recording sympathetic skin response in the facial area.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with no history of any kind of recurrent headache
* Migraine patients according to ICH3 criteria
* Migraine patients with more than 1 attack per month

Exclusion Criteria:

* Patients with other heart or neurologic diseases
* Patients with hearing or visual decline
* Patients taking medication that effects the sympathetic system (except those taking beta blockers for migraine treatment)
Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk

Investigation of the cerebrospinal fluid proteom in preterm infants with posthemorrhagic hydrocephalus in our neonatology center with analysis for modulation of proteom in dependence of breastmilk feeding and way of application such as via gavage tube, oral or nasal application.

Since the nasal route might be highly effective for neurotrophins and other growth factors the cerebrospinal fluid will be investigated using mass spectrometry to identify modulating effects of intranasal breast milk application on the cerebrospinal fluid proteom.

Eligibility Criteria:
Inclusion Criteria:

* preterm infant with hydrocephalus and regular drainage

Exclusion Criteria:

* Inborn error of metabolism
Sequential Use of Propofol/Midazolam and Dexmedetomidine for Sedation in Mechenical Ventialtion Patients in ICU.

For the patient who passed the screen of weaning from ventilation, the traditional sedation drug such as propofol and midazolam should be decreased or stopped, then it would induce the stress response and agitation, such as hypertension,tachycardia etc. In order to resolve that problem, the sedation should be given again. but if renewed to sedation, it would cause prolonged sedation and ventilation duration.

So as to resolve above issues, after the patient passed the screen of weaning, sedation is changed to Dexmedetomidine, a new sedation drug, that could wake up at any time. So our study to compare the efficacy and safety of sequential sedation of propofol or midazolam and dexmedetomidine in mechanical ventilated ICU patients.


Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent
2. Anticipated Ventilation and sedation duration of at least 48 hours
3. Age≥18 years old
4. Weight is in the range of ±20% of standard weight.\[Standard weight= (Height(cm)-80)×70﹪ for male and (Height(cm)-70)×60﹪for female\] -

Exclusion Criteria:

1. Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite continuous infusions of vasopressors before the start of study drug infusion or shock；
2. Heart rate less than 50 bpm
3. Second or third degree heart block
4. Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia)
5. Acute hepatitis or severe liver disease (Child-Pugh class C)
6. Dialysis of all types 7）History of neuromuscular disease

8) Unstable mental status and metal illness 9) Sure or suspected abuse of narcotics and alcohol independence 10) Allergy to experimental drug and other contraindication 11) Advanced tumor patients 12) Neuromuscular blockade other than for intubation 13) Pregnancy or lactation 14) Patient that participate other trial at past 30 days -
Mortality, Gravity Predictive Factors and Clinical Evolution of Older COVID-19 Patients in Short Geriatric Services.

Since the beginning of the year 2020, clinical characteristics of a new disease as the global COVID-19 epidemic has spread in France. People over 70 years of age are the more concerned by this virus in proportion and in gravity with some atypical first symptoms compared to younger patients. Evolution of the disease is variable from forms with few symptoms to severe forms sometimes quickly lethal.

GERICOVID LYON is a descriptive analysis of all patients over 70 years of age hospitalised for COVID-19 in short geriatric unities of University Hospital of Lyon This study will allow more comprehension about COVID-19 in older people. The role of predictive factors, pre-existing comorbidities and the nature and frequency of complications in a short period will be investigate. Treatments practices will be analysed too.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 70 years of age.
* Patient hospitalized in short geriatric units in University Hospital of Lyon.
* Patient diagnosed with COVID-19 (positive Polymerase Chain Reaction or a high presumption of COVID-19 based on clinical and/or scannographic evidence).
* Patient Informed and non-opposed to the research (Patient informed of the study by his medical doctor during hospitalization or by post, thanks to a generic information sheet dedicated to COVID-19 researches).

Exclusion Criteria:

* Patient opposed to the research.
External Validation of Clinical Prediction Tools for Estimating Salt and Potassium Intake in Nephrology Patients.

There is no validated self-questionnaire to assess salt and potassium intake in nephrology patients.

Using Bayesian models, researchers developed clinical prediction tools to estimate salt and potassium intake in nephrology patients. These prediction tools performed well, with an accuracy of 89% for salt and 74% for potassium, and have undergone internal validation.

Currently, the investigators wish to conduct an external validation study of these clinical prediction tools using data from patients followed at 3 nephrologic centers to generalize the performance results of the tools.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Consultant or inpatient in the nephrology department
* Having performed a 24-hour urinary assessment as part of his usual management with analysis of natriuresis and/or kaliuresis.

Exclusion Criteria:

* Patient having lost salt by vomiting, diarrhea and intense sweating (sport) in the week preceding the 24-hour urine collection.
* Person protected by the french law
Underwater Endoscopic Mucosal Resection Versus Metal Clips With Hot Snare Polypectomy for Resection of Big Pedunculated Colorectal Polyps

Endoscopic resection of pedunculated polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedunculated polyps with different pedicle sizes. The head larger than 20mm or pedicle larger than 5mm are defined as large pedunculated polyps, which are at greater risk of bleeding. Current guidelines recommend hot removal by snare following preoperative saline injection, ligation of the pedicle with a nylon ring or metal clip, depending on the size of the polyp head and pedicle. However, the use of snares and metal clamps does not appear to reduce delayed postoperative bleeding, and the technical requirements of nylon ligation are relatively high. Recent studies have found that Underwater endoscopic mucosal resection (UEMR) is also safe and effective for the treatment of large and medium colorectal sessile polyps. Therefore, it is still necessary to further explore new safe and effective endoscopic resection strategies and techniques.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing endoscopic resection of small and medium pedicled polyps in the First Affiliated Hospital of Ningbo University from October 2023 to August 2026;
2. Age 18-75 years old;
3. Patients who voluntarily agreed to participate in this study and signed informed consent.

Exclusion Criteria:

1. Persons under 18 years of age
2. Persons unwilling or unable to provide informed consent
3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months
4. Malignant polyps have infiltrated the pedicle
5. Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea
6. Patients with inadequate intestinal preparation
7. Patients with lifelong anticoagulant therapy or severe bleeding diseases, patients who have recently taken anticoagulant drugs or antiplatelet drugs (within 1 week)
8. Pregnant or lactating