cyrilzakka/clinical-trials huggingface dataset:
System Accuracy of BGM GL22

This study assesses the system accuracy of a blood glucose monitoring system pursuant to ISO 15197


Eligibility Criteria:
Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015
Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery

The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.


Eligibility Criteria:
Inclusion Criteria:

* planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

* Under 10
Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Endoscopic retrograde cholangiopancreatography (ERCP (, a key tool that is used in diagnosis and treatment of pancreato-biliary diseases. Post-ERCP pancreatitis (PEP) is the most common and serious complication that can occur following this procedure and can lead to significant morbidity and mortality. A variety of patient-related and procedure-related factors have been associated with higher rates of PEP.


Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years old.
2. Gender: Males and Females
3. Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders.
4. Blood amylase and lipase levels before ERCP are within the normal limits.

Exclusion Criteria:

1. Age of less than18 years.
2. Uncontrolled diabetes mellitus (DM)
3. Severe bleeding tendency
4. Impaired renal function (serum creatinine \> 2 mg/dL), (creatinine clearance \<30 ml/min)
5. Patients with severe heart disease.
6. Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
7. Currently pregnant or nursing
8. Admission due to established pancreatitis before ECRP
9. Unwillingness to undergo ERCP.
10. Previously documented allergy to ondansetron.
Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) between 19.5 and 29.0 kg/m2
* Intraocular pressure (IOP) \<=21 mmHg
* Best Corrected Visual Acuity (BCVA) \>= 70 ETDRS
* Normal corneal and conjunctival assessment
* Normal funduscopy

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method
* Current relevant diseases according to the investigator's judgement.
* Previous relevant chronic processes according to the investigator's judgement
* Relevant visual alterations according to the investigator's judgement
* Administration of systemic medications
* Case history of hypersensitivity to medicinal products or any other allergic process
* Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
Financial Distress in Advanced Cancer Patients

This trial studies the severity of financial distress in advanced cancer patients. The cost of cancer care can often be very expensive. Financial distress from the burdens of high costs and debt may interfere with a patient's physical symptoms and quality of life.

PRIMARY OBJECTIVES:

I. To determine the frequency of high financial distress in advanced cancer patients.

SECONDARY OBJECTIVES:

I. To determine the association between high financial distress with clinical and demographic characteristics in advanced cancer patients.

II. To determine the correlation between In Charge Financial Distress/ Financial Well-Being Scale (IFDFW) and other financial distress instruments such as Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) and Edmonton Symptom Assessment Scale- Financial Distress (ESAS-FS).

III. To determine the association between high financial distress with patient symptoms in ESAS-FS and quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G).

OUTLINE:

Patients complete questionnaires about financial state and quality of life over 15 minutes. Patients' medical chart is also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have a diagnosis of advanced cancer, as defined by recurrent disease, locally advanced disease, metastatic disease, or refractory disease
* Patients must be able to understand, read, write, and speak English
* Patients must have no clinical evidence of severe cognitive impairment (Memorial Delirium Assessment Scale score of \>= 13) and should be able to consent and answer the questionnaires
* Patients must sign an informed consent
Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction

The research is planned as a prospective nested case-control study. The plan is to recruit about 1,200 consecutive subjects whose pharmacotherapy involves the drug(s) of interest within 4.5 years. The basic cohort - the subjects with the newly indicated indication for use: NOAC; platelet aggregation inhibitors from the P2Y12 receptor antagonist group; and HMG-CoA reductase inhibitors (statins); as monotherapy or without restriction with respect to any other concomitant pharmacotherapy. The ADRs will be analysed by CR by: age, gender, expectancy, severity, association, type (mechanism of event), and outcome, according to the classification of organ systems as well as association with the phenotype. Criteria for bleeding associated with the use of anticoagulant and antiplatelet therapy have been defined; as well as the myotoxicity and hepatotoxicity associated with statin therapy. Samples will be tested for biochemical, haematological, coagulation standard parameters and pharmacogenetic analyses of relevant genes depending on the used therapy. Pharmacogenetic analysis will be performed to genotype the polymorphisms of relevant pharmacogenes: Biological samples and clinical data will be anonymized plus all records of ADRs and other clinical variables will be protected. Possible drug-drug and drug-drug-gene interactions will be evaluated using the Clinical Decision Support System (CDSS) of Lexicomp, PharmGKB, the Flockhart Table, and other systems including panel consensus methods to determine the likelihood of an ADR being associated with drug interactions, and determine whether drug interactions contributed to the occurrence of ADRs to administered CV pharmacotherapy in subjects with variant pharmacogenes of interest (drug-drug-gene interaction). The overall project objective is to determine which pharmacogenes variants, together with clinical parameters, can be used as predictors of CV drug ADRs and are good candidates for inclusion in the clinical diagnostic panel for pre-emptive PGx testing.


Eligibility Criteria:
Inclusion Criteria:

a) age 18 years or older; b) a new indication for the administration of any of the medicinal products of primary interest (NOAC, clopidogrel, prasugrel, ticagrelor, statins) for which at least a 3-month administration is predicted; c) signed informed consent (for repeated evaluations and donation of blood samples for genetic and eventual pharmacokinetic analysis).

Exclusion Criteria:

the existence of contraindications to the medicines of primary interest.
A Randomized, Double-blind, Sham-controlled Pilot Study to Evaluate the Treatment Efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in College Students With ADHD

This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with ADHD. A total of 40 subjects will be treated.

This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with ADHD. A total of 40 subjects will be treated.

Twenty (20) subjects will receive active treatment with MeRT and the other 20 with sham. Subjects in each study group will be treated 30 min a day, 5 days a week for 4 weeks. This is known as Phase 1. During this study period, subjects and clinicians will be blind to treatment condition.

Subjects will be recruited from a flyer describing the study. The flyer will be posted at the Kortschak Center for Learning and Creativity, the McKay Center, and through Student Counseling Services in the Engemann Student Health Center. In addition, students who have been diagnosed with ADHD and have been seen at one of these facilities for ADHD may be provided contact information for the study.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:

1. College student 18-25 years of age
2. Diagnosed with ADHD using the standardized clinical interview and supported by the Pearson Quotient ADHD System and Conners Adult ADHD Rating Scales (CAARS)
3. Willing and able to adhere to the treatment schedule and all required study visits

Exclusion Criteria:

Subjects will be excluded from study participation if one of the following exclusion criteria applies:

1. Pregnant or trying to become pregnant; negative urine pregnancy test at screening will be required of females of child-bearing potential
2. Any antipsychotic or anticonvulsant medication.
3. Any type of rTMS treatment within 3 months prior to the screening visit
4. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
5. Any condition which in the judgment of the investigator would prevent the subject from completing the study
6. Any seizure history within the past 10 years
7. EEG abnormalities including indications of risk of seizure, i.e., abnormal focal or general slowing in spikes during the EEG recording
8. Unstable medical conditions such as uncontrolled endocrine, hepatic, cardiac, pulmonary and/or renal disorders.
Inflammatory Bowel Disease Cohort in Nantes

The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease

The CELESTE cohort will be a prospective cohort of IBD patients followed up at Nantes University Hospital, Jules Verne Clinic (Nantes) and/or Confluent Private Hospital (Nantes). The multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies.

It will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age;
* Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;
* Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;
* Patients who have given written consent to participate in the study and to keep biological samples for research purposes

Exclusion Criteria:

* Patients refusing to participate in the cohort;
* Patients with chronic inflammatory bowel disease quiescent at inclusion;
* Patients with a contraindication to general anaesthesia;
* Vulnerable patients (under court protection, curators, guardians);
Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

The aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.

All patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group C), dextrose 5%(group D5) or dextrose 10%(group D10).

Eligibility Criteria:
Inclusion Criteria:

* Female non-smokers adults (age 18-65 years)
* ASA I-II who were listed for elective surgery under general anesthesia (surgery which is risk for PONV).

Exclusion Criteria:

* Severe hypertension
* Coagulopathy
* Significant hepatic or renal disease
* Diabetes mellitus or abnormal blood glucose on the morning of surgery
* Withdrawal of consent
* Severe intraoperative hypotension requiring large volume intravascular fluid treatment
* Protocol violations including nitrous oxide administration.
IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents

This study will examine the long-term effects of HIV infection, highly active antiretroviral therapy (HAART), and experimental treatments on children who participated in PACTG 219C or select IMPAACT studies.

The use of HAART has been important in extending the lives of people with HIV infection. However, prolonged use of HAART may have long-term consequences. In addition, people participating in clinical trials using experimental therapies to treat HIV infection may experience negative health outcomes. The purpose of this study is to identify the long-term effects of HIV infection, HAART, and experimental treatments in infants, children, and adolescents.

This study will enroll children who participated in PACTG 219C or various IMPAACT studies. There will be no study visits specifically for this study. Researchers will review participants' medical records annually and collect information on illnesses, medications, CD4 cell count and viral load data, and body measurements.

Eligibility Criteria:
Inclusion Criteria:

* Past or current documentation of a confirmed diagnosis of HIV-1 infection defined as two separate peripheral blood specimens from different days, and each specimen must be positive. More information on this criterion can be found in the protocol.
* HIV-infected infants, children, or adolescents who participated in PACTG 219C during 5/1/06-5/31/07 and are not currently participating in ongoing long-term follow-up (LTFU) studies (e.g., Pediatric HIV/AIDS Cohort Study Adolescent Master Protocol \[PHACS AMP\], LEGACY). Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).

OR

* HIV-infected infants, children, and adolescents at domestic sites who have participated in or are currently participating in IMPAACT treatment studies (including studies that have rolled over from the PACTG into IMPAACT) designated by the IMPAACT Network Executive Committee (NEC) for subsequent LTFU in this study, and are not currently participating in ongoing LTFU studies. Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
* Parent or legally-accepted representative/guardian is able and willing to provide signed informed consent for minors (unless child has emancipated minor status)

Exclusion Criteria:

* Current participation in other ongoing LTFU studies (e.g., PHACS AMP, LEGACY). Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
Acceptance and Commitment Therapy for Religious OCD

The purpose of the study is to examine the effects and feasibility of a specific form of psychotherapy, acceptance and commitment therapy (ACT), on religiously oriented obsessive and compulsive disorder (OCD).


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Meet cutoff scores for scrupulosity

Exclusion Criteria:

* Presence of psychotic symptoms within six months of screening
* Current suicidal/homicidal plan/intent and/or a suicide/homicide attempt within 6 months of screening
* Non-suicidal self-injury within 6 months of screening
* Narcotics use within 3 months of screening
* Purging/restricting behavior within 3 months of screening.
Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis

The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.


Eligibility Criteria:
Inclusion Criteria:

* High surgical risk:

  * Comorbidity cardiopulmonary
  * Renal insufficiency
  * Hostile abdomen including ascites or portal hypertension
* Anatomic criteria:

  * Primitive iliac aneurysm superior to 25 mm without collar
  * Primitive iliac length superior to 40 mm
  * Primitive iliac distal diameter superior to 14 mm
  * Presence of internal iliac collar
* Affiliation to a social security system

Exclusion Criteria:

* Patient without surgical risk
* Non-respect of the Anatomic criteria
* Patient with known allergy to the materials of the device
* Patient with systemic infection
* Patient with severe renal insufficiency
* Patient unable to complete the oximetry test
* Persons under legal protection
Models for Evaluate the Proximity of the Moon on the Frequency of Births

The purpose of this study is to establish the relationship between moon and births through two analytic models.

Retrospective, descriptive and observational study. Classical model performs comparisons of births among lunar periods, lineal, cubical and exponential estimation was performed in the SPSS software and the inflection point of the curve was estimated using the formula x=\[In (1/ebx)\]/ebx in the Geogebra model. The significance was establish by a p value of ≤ 0.05 (95% IC).

The second analysis was performed by the difference of media between all the stages of the moon cycle as in another trials. The difference was establish by the T-student test. The difference between groups was performed by the one way ANOVA test.

This study had the review and approval from the Ethics Committee of the institution and according with Mexican regulation, and in adherence to the Helsinki declaration and International Conference for Harmonisation

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women from January 2009 until June 2013

Exclusion Criteria:

* Pregnant women from any other period of time
Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care

The purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support.


Eligibility Criteria:
Inclusion Criteria:

* Child \< 10 kg
* Hospitalization in the pediatric intensive care
* Presence of an atelectasis to the radiography and/or to the lung ultrasound
* Presence of an invasive ventilation or a non-invasive ventilation
* Criteria of cardio-respiratory stability met

Exclusion Criteria:

* Absence of the physiotherapist and the radiologist referents (by ex: at night)
* Prematurity
* Neuromuscular disease
* Ventilation by high-frequency oscillation
* Extraphysical Assistance
* Patient cardiac post-surgery with closure postponed from the thorax. In the closure of the thorax, the patient becomes eligible
* Intracranial pressure \> 20 mmHg or clinical signs of intracranial high blood pressure
Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions

Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child.

However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown.

PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.

The importance of parental participation in the feeding of preterm infants has been highlighted by Gianni. In his study of 81 preterm infants in the tertiary centre , the early parental bottle feeding and the skin-to-skin contact were factors promoting withdrawal from enteral nutrition. Moreover, actively participate in care even complex, is desired by parents.

Recently, a study compared 10 parent-child dyads and showed that enteral nutrition pushed by a parent (parental nutrition, NP) in comparison of the electric syringe pump , allowed a better perception of the tube by the parents and gave them a sense of utility. The same team randomized 17 preterm infants, born after 28 WA( week amenorrhoea), to receive or not à parent-pushed enteral nutrition The child's behavior changes during nutrition were analyzed in both arms, after scoring of the videos feeding according to the NICAP® ( individualized neonatal assessment and developmental care program) method. Signs of well-being and relaxation of members were more present in case of parental involvement in the delivery of nutrition. These preliminary studies suggest that parental nutrition is well tolerated and improves the comfort of the child and parent during nutrition.

However, the impact of parental nutrition on the subsequent active nutrition and on the quality of parent-child interactions is currently unknown.

Eligibility Criteria:
Inclusion Criteria:

Children born before 30 SA Age of child at start of study: 32 SA

Exclusion Criteria:

* Child with ongoing infection, neurological pathology More than one desaturation and/or bradycardia per hour within 12 last hours Balloon ventilation in last 12 hours
* Medical contraindication to oral nutrition
* Intubated child
* Parents with a disabling mental illness
* Parents not available
* Minor parents
* Parents under guardianship or protection of justice
* Refusal to sign consent
* Parents not affiliated with a social security system
Outcome of Patients After a Negative Oral Challenge to Amoxicillin

This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin

This is a prospective, single-center, non-interventional study of patients with negative Amoxicillin oral challenge performed at Angers University Hospital between 2017 and 2019.

An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone to answer the questionnaire. This questionnaire concerns the reintroduction of penicillins at home after the challenge.

Eligibility Criteria:
Inclusion Criteria:

* Patients whith a negative challenge to Amoxicillin in the Allergology Department of the CHU of Angers between 2017 and 2019.
* Major patients.

Exclusion Criteria:

* Poor comprehension of the French language or cognitive disorders affecting the reliability of the questionnaire
* Person objecting to participate in this research and to the processing of their medical data