cyrilzakka/clinical-trials huggingface dataset:
Root Cause Determination of Catheter Obstructions

During this study, the investigators will perform a collection of biological and device samples (blood, catheters, insulin) in order to investigate the causes of catheter obstructions in patients with type 1 diabetes treated by implanted insulin pumps using intra-peritoneal delivery.

This multi-centre study is interventional with minimal constraints. After an inclusion visit, blood samples and an insulin sample from pump reservoir will be collected. During the following year, if a peritoneal catheter is blocked or changed, the explanted catheter and new blood and insulin samples will be collected for examination of the catheter obstruction and search for patient- or insulin-related reasons for obstructions.

In this study, 140 patients will be investigated.

In patients with type 1 diabetes treated by implanted pumps using intra-peritoneal delivery, the incidence of peritoneal catheter obstructions is close to 12 per 100 patient-years. Variability of occurrence is however important between patients. Fibrin, aggregates of insulin and fibrotic tissue have been found inside the catheter lumen at peritoneal tip or forming a capsule around the catheter. This study will investigate with more precision the nature of catheter blockages and look for potential causes of these obstructions such as stability of insulin in the pump reservoir, immune reactions against insulin or catheter components in patient plasma, prothrombotic factors in patient blood. Blood samples and insulin from pump reservoir will be collected at baseline (inclusion). During the following one year period, each catheter presenting an obstruction or needing a change associated with pump change will be collected and explored. Blood and insulin samples will be collected again for comparison with initial samples. Investigations will be performed in collaboration with Pr Burgess' team at the School of Pharmacy of the University of Connecticut. From obtained results, models replicating the conditions of obstruction will be elaborated and tested in rodents at the University of Connecticut. Solutions will be proposed to reduce the occurrence of obstruction of peritoneal catheters as an outcome of the study.

Eligibility Criteria:
Inclusion Criteria:

* Collection of catheters for intra-peritoneal insulin infusion from implanted pumps presenting obstructions or not

Exclusion Criteria:

-
Cholecystectomy in Patients With Silent Common Bile Duct Stones

Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones


Eligibility Criteria:
Inclusion Criteria:

* Patients with asymptomatic common bile duct stones.
* Patients with normal bilirubin levels.
* Patients with normal alkaline phosphates level.

Exclusion Criteria:

* Patients with history of jaundice.
* Patients with abnormal liver functions.
Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine

The purpose of this study is to determine if positive imagery therapy while using ketamine in procedural sedation reduces the number of emergence reactions and impacts pre and post-procedural anxiety.

This is a multi-center, randomized controlled trial looking at if positive imagery therapy while using ketamine during procedural sedation will reduce the number of emergence reactions and impacts pre and post procedural anxiety. After informed consent has been established and the subject is determined to meet eligibility criteria, participants will be randomized into 2 groups. The interventional group will undergo positive imagery therapy during sedation and the control will not. The duration of subject participation will be from the onset of sedation beginning until the patient is recovered.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* requires procedural sedation in the emergency department for whom ketamine is selected by the provider as the medication for procedural sedation

Exclusion Criteria:

* age below 18 years of age
* any patient with a contraindication to the use of ketamine for the procedural sedation
* any prisoners
* pregnant females
Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula

Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal with one or more than one external openings in the perianal skin Aim of the work This prospective randomized control trial, we will compare video-assisted anal fistula treatment (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital stay, pain score, healing time, return to work and continence


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders aging between 18-65 years with cryptoglandular anal fistula will be included.

Exclusion Criteria:

* We will exclude patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases, and patients on long acting corticosteroids or immunosuppressive drugs will be also excluded.
Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses

Somatosensory evoked potentials are crucial in determining the physiological changes of potentials in nerve pathways. Although their main function is diagnostic, the investigators have recently been used as a physiological test to determine physioelectric changes in healthy subjects to study applied stimuli, such as laser, pain or electrotherapy.

The general configuration of the study consists of a study before and after the block of sessions to be determined, and differences of all the variables measured before and after NESA therapy will be compared through the mechanisms of somatosensory evocations.

Given its potential use, the objective of this study is to determine if there are changes in the somatosensory evoked potentials of the ulnar, median, tibial, peroneal and vagus nerves when non-invasive neuromodulation NESA is applied, which is used as a physiotherapy treatment. for objectives such as pain, vegetative affectations and sleep disorders.

The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.

The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p \<0.05

Eligibility Criteria:
Inclusion Criteria:

* Healthy people
* Optimal cognitive abilities and mentally competent to participate in the study.
* In condition to complete the study questionnaires.

Exclusion Criteria:

* Focal mononeuropathies in both upper and lower limbs
* Peripheral neuropathy.
* Patients with implanted functioning pacemakers / defibrillators. Patients with bleeding disorders. Patients being treated with anticoagulants. Patients on antiplatelet therapy.
* Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, do not apply electrodes on skin in bad condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
* Not having signed the informed consent.
* Present any injury or pathology during the study
Efficacy of a Mobile Phone App for Depression and Anxiety in College Students

The goal of this clinical trial is to evaluate the efficacy of a mobile phone application for the early intervention of depression and anxiety among young university students in Chile. The main question it aims to answer is:

- Can a mobile app reduce depressive and anxious symptomatology in college students?

Researchers will compare the intervention arm (mobile app users) to the control group (receives psychoeducational material and mental health care resources) to see if the app leads to significant improvements in depressive and anxious symptoms and well-being.

Participants will:

* Be randomly assigned to either the intervention or control group.
* Use the mobile application, which includes psychoeducational materials, cognitive-behavioral therapy modules, and periodic personalized feedback.
* Complete assessments at baseline, post-intervention, and 3 and 6 months after randomization using online tools such as the PHQ-9 for depressive symptoms and the GAD-7 for anxious symptoms.


Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 and GAD-7 score between 5 and 14 points
* Have a stable internet connection
* To provide informed consent

Exclusion Criteria:

* High risk of suicide according to C-SSRS
* Currently undergoing psychological, psychiatric and/or psychopharmacological treatment
* Bipolar disorder, psychotic disorder or substance use disorder assessed with the respective modules of the MINI interview.
Should Colorectal Cancer Patients be Followed After Five Years? Study of Recurrence in a Population Cohort

The results of this study will make it possible, thanks to better understanding of the natural history of colorectal cancer, to define new treatment and surveillance strategies for colorectal cancers resected with curative intent, so as to improve management and thus improve patient survival.

These data will also make it possible to calculate the prevalence of patients who require treatment or surveillance because of their disease.


Eligibility Criteria:
Inclusion Criteria:

* with adenocarcinoma of the colon or rectum (ICD-O: C18, C19 and C20)
* residing in the département of Côte-d'Or (501,000 inhabitants according to the 1999 census) or Calvados (511, 012 inhabitants) at the moment of diagnosis
* recorded by either Registry between January 1985 and December 2000
* treated by resection with a curative intent.

Exclusion Criteria:

Will be excluded other morphologic tumours and initially metastatic colorectal cancers, anal cancers.
Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?

Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

For Patients:

* Aged ≥ 18 and ≤ 70 years
* Men or women
* With multiple sclerosis since 2 and 25 years
* Affiliates or beneficiaries of social security scheme
* Signed consent

For Healthy volunteers:

* Aged ≥ 18 and ≤ 70 years
* Men or women
* Matched in accordance with age, sex and level of physical activity

Exclusion Criteria:

For Patients and Healthy volunteers:

* High heart rate resting
* Blood pressure \> 144/94 mmHg
* Recent adjustment of drug or drug can have an impact on fatigue or stimulant for fatigue
* Taking neuroactive substances that can alter corticospinal excitability
* Contraindication at application magnetic field
* Contraindication at Magnetic Resonance Imaging (MRI)
* Currently participating in a structured exercise program
* Pregnant

For Patients only:

* Spasticity or cerebellar ataxia
* Abnormal range of motion (toe and/or ankle)
* Musculoskeletal injuries that impedes pedaling
* Appearance of symptoms of multiple sclerosis in the 90 days preceding the study

For Healthy volunteers:

- Neurological diseases, cardiovascular, musculoskeletal
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder

This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams \[mg\] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)
* Medically stable for 1 month and psychiatrically stable without symptom exacerbation for 6 weeks prior to baseline
* On stable treatment with a maximum of 2 antipsychotics

Exclusion Criteria:

* Change in regimen for any psychotropic or sleep medication within 1 month
* Treatment with more than (\>) 1 mood stabilizer or antidepressant
* Use of clozapine within 2 months
* Bipolar disorder, or more than mild anxiety disorder
Neonatologist-performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy to Prevent Extubation Failure

The objective of the study is to evaluate the role of neonatologist-performed lung ultrasound (NPLUS) after weaning from invasive mechanical ventilation and extubation. Our aim is to study the diagnostic accuracy of NPLUS and investigate whether LUS leads to earlier actions before clinical deterioration and hence prevents extubation failure.

In the past few years, lung ultrasound has been established as a tool to dynamically assess the lungs in various clinical conditions. Standardized protocols have been compiled to allow for an easy and fast evaluation. The point-of-care ultrasound (POCUS) is easily accessible and allows the clinician a readily available bed-side evaluation.

Although invasive mechanical ventilation displays a lifesaving strategy in neonatal intensive care, it is associated with numerous long-term complications especially in preterm infants. Despite a shift to lung-protective ventilation, time on mechanical ventilatory support should be kept as short as possible, considering timely weaning and switch to a non-invasive ventilation. Estimating the right time for discontinuation of invasive mechanical ventilation remains challenging and is influenced by several parameters. Extubation failure can be associated with respiratory failure following exhaustion on non-invasive ventilatory support.

Collapse of alveolar units lead to hypo-aerated areas. Small airway size, obstruction due to secretion and muscular weakness predispose to the development of atelectasis in neonates. Atelectasis occurring post extubation are a frequent cause of extubation failure. Lung consolidations can be sonographically detected. A sensitivity of 100% for the detection of neonatal pulmonary atelectasis has been described. In recent studies Lung Ultrasound Severity Score (LUSS) has been shown to be an independent predictor of successful extubation in mechanically ventilated preterm infants. However, once extubated, only limited data is available if extubation failure later in the process can be predicted. Lung aeration decreased after extubation to spontaneous breathing.

Early standardized evaluation of the lung via lung ultrasound can deliver important information on aeration of the lungs and whether action may be required. Using a standardized protocol (lung ultrasound score, LUS) on certain timepoints after extubation can lead to early detection of loss of aeration. Timely intervention with e.g., temporary PEEP increase for alveolar recruitment on non-invasive ventilatory support, positioning of the patient prior to clinical deterioration can impede the need of a reintubation and invasive mechanical ventilatory support.

Eligibility Criteria:
Inclusion Criteria:

* All preterm and full-term neonates receiving invasive mechanical ventilation at the Division of Neonatology of the Medical University of Graz AND
* Written informed consent was obtained from parents prior to extubation

Exclusion Criteria:

none
Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache

Based on established therapeutic effect of ibuprofen in the treatment of headache attacks, and the action of caffeine in promoting better results when combined with treatments of first choice in the treatment of headache, this study is designed to:

* evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared to ibuprofen alone;
* evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen alone.

The hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ability to read, understand and sign the IC;
* Patients with symptoms of frequent episodic tension headache, mild to moderate;
* Patients with symptoms of migraine with or without aura, of mild to moderate intensity;
* Patients who have had between two and five headache attacks in the last 30 days;
* Patients who accept the condition of ingesting less than three cups of coffee per day and / or reduce the intake of any beverage that contains caffeine;
* Patients who accept the condition not to drink any beverage that contains caffeine for 24 hours after drug administration.
* Patients able to understand and maintain the clinical protocol.
* Patients who started or changed prophylactic treatment for headache 30 days before inclusion.
* Female patients of childbearing age must agree to undergo pregnancy testing through urine.

Exclusion Criteria:

* Patients in whom headache began after 50 years of age;
* Patients with strong or disabling headaches;
* Patients with chronic daily headaches lasting up to 72 h or with cluster headaches not responsive to common analgesics;
* Patients with headaches occurring in 15 or more days per month;
* Patients with secondary headaches;
* Patients who overuse analgesics (acetylsalicylic acid up to 300 mg / day) or NSAIDs;
* Known hypersensitivity to components of both formulations of the drug test as the comparison;
* Known hepatic or renal diseases;
* Patients who are pregnant or intend to become pregnant or lactating;
* Patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart diseases, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders, pulmonary disorders and peptic diseases;
* History of alcoholism or substance abuse.
Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.

This study is an observational registry study evaluating the clinical outcomes of grid therapy. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained, baseline adverse event and QOL data will be collected and subjects will undergo grid therapy and follow-up at 2-4 weeks (for toxicity), and 3-6 months (for toxicities and radiographic control) then per clinical discretion up to 1 year. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 60 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure. See below for the clinical visit flowchart for data collected at baseline and standard clinic visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients with tumors of the head and neck, thorax, abdomen, pelvis, and extremities.
* Age ≥ 18 years.
* Histological confirmation of oncologic diagnosis.
* Completed oncologic imaging (per discretion of treating physician)
* ECOG Performance Status 0-3
* Ability to complete questionnaire(s) by themselves or with assistance.
* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
* Provide informed written consent.

Exclusion Criteria:

* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

  * Pregnant women
  * Nursing women
  * Women of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)

The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence has emerged as a crucial mechanism, particularly in elderly patients. Betablockers, drugs with negative chronotropic effect, are commonly used in HFpEF, despite current evidence does not support its routine use in these patients. The aim of this work is to evaluate the effect of betablockers withdrawal in patients with HFpEF and chronotropic incompetence on functional capacity assessed by the peak oxygen consumption at maximal exercise (peakVO2) at 15 and 30 days after the intervention

This is a prospective, crossover, randomized (1:1) and single center study. After randomization, clinical and cardiac rhythm will be continuously registered during 30 days. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 15 and 30-day in both groups. Patients with HFpEF, functional class NYHA II-III, chronic treatment with betablockers, and chronotropic incompetence will be enrolled. A sample size estimation \[alfa: 0.05, power: 90%, a 15% loss rate, and delta change of mean peakVO2: +1.2 mL/kg/min (SD±2.5)\] of 52 patients would be necessary to test our hypothesis.

In conclusion, optimizing therapy that improve quality of life and autonomy has become a health care priority in HFpEF. The investigators believe this study will add important knowledge for the treatment of a subgroup of HFpEF.

Eligibility Criteria:
Inclusion Criteria:

* Stable symptomatic patients with heart failure and preserved ejection fraction (NYHA class II-III).
* NT-proBNP \>125 pg/mL in the last month
* Previous treatment with beta-blockers during the last 3 months
* Documented chronotropic incompetence, defined as: \[(heart rate at peak exercise- heart rate at baseline)\] / \[(220 - age) - (heart rate at baseline)\] \< 0.62

Exclusion Criteria:

* Moderate to severe valvulopathy or miocardiopathy associated
* Patient with heart failure with recovered ejection fraction
* Acute Coronary Syndrome in the previous 12 months
* Angina or signs of myocardial ischemia on cardiopulmonary exercise testing
* Baseline heart rate\>75 bpm.
* Uncontrolled hypertension, defined as \>140mmHg systolic blood pressure and/or \>90 mmHg diastolic blood pressure.
* Moderate to severe pulmonary disease associated
* Extracardiac comorbidity with a life expentancy less than 1 year.
* Unable to perform an adequate cardiopulmonary exersice test
* Previous treatment with digitalis or calcium channel blockers