cyrilzakka/clinical-trials huggingface dataset:
Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.

Autoimmune thyroiditis and goitres are frequent pathologies.

Autoimmune thyroiditis and goitres are frequent pathologies. On a predisposing genetic ground, environmental factors are potentially at their origin. Viral infections are the main factors involved in autoimmunity (herpes virus, viral hepatitis C, Erythrovirus B19 ..). However some viruses have an oncogenic potential and could be involved in goitrigenesis. It is also possible that some viruses are specifically implicated in the pathogenesis of Graves' disease or Hashimoto thyroiditis which combines goitre and autoimmunity.

The intrathyroidism of the viral genome of a polyomavirus, the BK virus, has recently been reported in patients with goitre or cancer. The BK virus is a small ubiquitous virus of 40 nm diameter with double-stranded DNA contained in a non-enveloped icosahedral capsid. It is mainly known for triggering renal and bladder pathologies including urothelial tumors in the immunocompromised patient, tubulo-interstitial nephropathy in the renal transplant patient, as well as hemorrhagic cystitis in the patient grafted to the bone marrow.

Eligibility Criteria:
Inclusion Criteria:

* Major Patient Age ≥ 18 years
* Patients referred to the ENT service of the CHU of Amiens for thyroidectomy in the context of a goitre, a Graves' disease or a thyroiditis of Hashimoto.
* Patients must have signed informed consent.
* Affiliation to a social security scheme

Exclusion Criteria:

* Minor Patients,
* Patient under tutorship or curatorship.
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with BMI of 18-32 kg/m2

Exclusion Criteria:

* Abnormal physical or lab findings
* Allergies to any sulfonylurea or related compounds
Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression

The purpose of this study is to determine if medical, biological, psychological, and social risk factors can be used to develop algorithms that will predict perinatal depression (PND). Data capture will include baseline participant medical, psychological and family history, blood biomarkers, and psychosocial assessments.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be English-speaking and able to understand and follow clinician/researcher/provider recommendations
* Participants must be able to read and comprehend written communications (English) and physically able to complete electronic patient-reported outcome (ePRO) assessments
* Participants must have access to a personal smartphone or a computer and an active personal email address for which they are willing to use for data collection
* Each participant must sign an informed consent form (ICF) indicating that she understands the purpose of and procedures required for this study and is willing to participate in and comply with all procedures in the study
* Participant must be willing and able to have blood draws and to complete the self-reported assessments via mobile electronic device during the study

Exclusion Criteria:

* Participant is not English speaking
* Lifetime mood disorder other than major depressive disorder (MDD) (example \[e.g.\], bipolar I) or anxiety disorder
* Lifetime psychotic disorder (eg, schizophrenia, schizoaffective disorder)
* Lifetime alcohol or illicit substance dependence (moderate-severe)
* Current Post-traumatic Stress Disorder (PTSD), significant alcohol or illicit drug use (Ethanol \[ETOH\]/nonprescription drug use) within 12 months greater than or equal to (\>=)occasional use
Effect of Variance on Error Correction During Coupling (Cerrebellar Lesions)

This study is a case-control study, involving persons with persons with cerebellar lesions and healthy controls. The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cerrebellar lesions
* walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)

Exclusion Criteria:

* cognitive impairment impeding understanding of
* instructions,
* beat amusia,
* deafness,
* pregnancy
A Study of Positive Emotions With Long COVID-19

This study is testing a new brief mindfulness practice for people suffering from long COVID-19 symptoms. People suffering from long COVID are particularly vulnerable to negative emotions, as they must also cope with the long-term uncertainty of physical and psychological stress beyond the acute infection. The goal of the study is to measure the ability of a brief mindfulness practice to promote a sense of well-being in people suffering from long COVID.

This is a pilot randomized waitlist-controlled clinical trial (RCT) testing a new brief self-care intervention for people suffering from post-acute sequelae SARS-CoV-2 infection (PASC). The overarching goal of this study is to establish the feasibility and early efficacy of microdosing mindfulness as a self-care intervention. The purpose of the intervention is to promote a sense of well-being among PASC patients who currently have limited access to other proven self-care modalities.

Our research question is whether our newly developed training can assist PASC patients to self-microdose mindfulness (5-15 seconds activities in everyday life) and improve on perceived metrics of well-being (primary outcome). Our hypothesis is that self-microdosing mindfulness will evoke positive emotions that can improve well-being on patients suffering of PASC-related symptoms beyond 3 months post COVID-19 infection. If effective, an increased frequency of the mindfulness activity will then help buffer negative emotions (e.g., anger, loneliness, etc.) experienced during the pandemic and associated with ongoing stress and/or somatic symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Able to participate in online zoom sessions and complete online surveys for 3 months
* English speakers
* Had a mild to moderate in severity COVID-19 infection \> 3 months ago, feeling unwell, and are still experiencing in the present at least one PASC-related symptoms:
* Coughing or feeling short of breath
* Loss of smell or change in taste
* Recurrent Fever
* Body aches, headaches, chest pain, or stomach pain
* Brain fog (feeling like you can't think clearly)
* Having trouble sleeping
* Feeling very tired
* Mood changes

Exclusion Criteria:

* Adults that were admitted to an intensive care unit or placed on a respirator, had invasive heart (heart catheterization) or lung tests (bronchoscopy) performed.
* Prisoners
Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

efficacy of adding azithromycin to cephalosporin before cesarean delivery

efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women

Eligibility Criteria:
Inclusion Criteria:

* age between 17 and 39 years
* gestaional age between 37 to 42 weeks
* elective cesarean delivery
* obese women

Exclusion Criteria:

* diabetic women on corticosteroids
* intraopertaive complication in previous section
* history of septic woun
* prelabour rupture of membrane \>12 hours
A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma

This study is a multicenter, prospective, observational cohort study of \~5000 Xolair-treated and \~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
* ≥12 years of age
* Physician diagnosis of moderate to severe persistent asthma
* Evidence or history of positive skin test or in vitro reactivity to an aeroallergen
* Willingness to participate fully for the duration of the study (5 years)
* For patients in the Xolair-treated cohort, have received at least one dose of Xolair therapy at the time of enrollment

Exclusion Criteria:

* Contraindication to Xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to Xolair)
* Acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
* Acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
* Use of an experimental drug within 30 days prior to study screening
* Diagnosis of cystic fibrosis
* For patients in the non-Xolair-treated cohort, any prior treatment with Xolair
A Pilot Study of the Effect of High Protein Supplement and Exercise Therapy on Preservation of Skeletal Muscle Mass and Quality of Life in Patients With Gastric Cancer and Pancreatic Cancer Treated With Chemotherapy

For gastric and pancreatic cancer patients scheduled for primary chemotherapy, we would like to report muscle mass preservation and improvement in quality of life in Chinese characters that received only exercise therapy and high protein supplements at the same time

Sixty patients with gastric and pancreatic cancer will be eligible, and 30 patients will be randomly assigned to the exercise therapy + high protein supplement group and 30 patients to the exercise therapy + placebo supplement group.

Eligibility Criteria:
Inclusion Criteria:

1. Has provided signed written informed Consent
2. Has a histologically confirmed gastric or pancreatic cancer
3. Has a patient scheduled for chemotherapy - Patients who are scheduled to be treated with TS-1 or Xelox for gastric cancer-adjuvant chemotherapy - Patients scheduled for primary chemotherapy for pancreatic cancer-progressive/transitional diseases

Exclusion Criteria:

1. Age under 19 or over 90 year of age
2. Eastern Cooperative Oncology Group (ECOG) ≥ 2
3. Patients with severe malnutritional evaluation (PG-SGAC)
4. Any of the following within 3 months prior to study recruitment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
5. A person with previous uncontrolled seizures, central nervous system or psychological disorders
6. Have uncontrolled active infection or sepsis
7. Have deep vein thrombosis occurs within 4 weeks prior to the start of test recruitment
8. Severe acute or chronic conditions that may reduce the patient's ability to participate in clinical trials or make it difficult to interpret clinical trial results
9. Pregnant or lactating women. Pregnancy test results are positive in childbearing women
10. Gastrointestinal obstruction, malabsorption syndrome, or diseases that significantly affect digestive functions
Single-center Prospective Cumulus Cell Test Study

Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle


Eligibility Criteria:
Inclusion Criteria:

* scheduled for intracytoplasmatic sperm injection (ICSI) and single or double embryo transfer on day 3
* patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with Highly Purified human Menopausal Gonadotropin (HP-hMG)
* undergoing first or second IVF or ICSI cycle with transfer
* Body Mass Index (BMI) between 17 and 33.
* regular menstrual cycle (between 24 and 35 days)

Exclusion Criteria:

* smokers (\> 10 cigarettes per day)
* patients requesting Pre-implantation Genetic Diagnosis (PGD)
* patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)
* couples where the partner has an extremely low sperm count e.g.: extreme oligo-astheno-teratozoospermia (OAT) (\< 100.000/ml) or scheduled for testicular sperm extraction (TESE)
* results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect
Reducing Cesarean Section Rates and Enhancing Vaginal Delivery in Greece: a Stepped-Wedge Randomized Controlled Trial

It is becoming increasingly apparent that there is an urgent need to systematically investigate the rising cesarean section (CS) rates in Greece and develop interventions to substantially reduce these rates. In this trial, to be conducted in Greece, the obstetricians will be exposed to educational, behavioral and/or organizational interventions while managing labor. The trial is expected to yield new information about effective interventions to reduce unnecessary cesarean sections in Greece, hopefully leading the way to their reduction worldwide.

The present study explains the planned implementation of a stepped-wedge trial in Greek maternity units. Twenty-two maternity units in Greece will participate in the trial involving 20,000 to 25,000 births, with two of the units entering the intervention period each month (stepped randomization). The maternity units will apply the interventions for a period of 6-16 months, depending on the time they enter the intervention stage of the trial. There will also be an initial baseline phase of the trial, lasting from 3 to 13 months; this phase will include observation and data collection of routine obstetric practices. The interventions are based on educational, behavioral and organizational modifications and will include the implementation of the Hellenic Society of Obstetrics and Gynecology (HSOG) guidelines on labor management and targeted training in cardiotocography (CTG), obstetric emergencies, and the classification of cesarean section through Robson criteria. During the trial period, the rates and indications for cesarean sections will be available to participating units on a live platform, using an anonymous reporting system. Participating obstetricians will be able to see their own and other units' performance and also get feedback on their rates. Τhe final three-month phase of the trial will be devoted to completion of questionnaires by the participating obstetricians. The total estimated duration of the trial will be 22 months. The primary outcome assessed will be the change in cesarean section rate and the secondary outcomes will be maternal and neonatal morbidity and mortality. The intervention and control periods will be compared using mixed effects logistic regression with adjustment for any underlying secular trends.

Eligibility Criteria:
Inclusion Criteria:

* A minimum of 5 years' provision of obstetric services for the participating units.
* Top 22 units in Greece according to the number of deliveries and the type of unit (National Health System, private, university) and the unit's willingness to participate.
* Up to 11 obstetricians in each unit (based on the number of deliveries and their willingness to participate)
* Consent obtained from all participating professionals
* Consent obtained from all participating women

Exclusion Criteria:

* None
Effectiveness of the Justice Diversion Halt-intervention

In the current study the effectiveness of the Dutch diversion measure Halt is investigated using a randomized controlled trial. Because of the thorough scientific substantiation of the intervention theory, it is hypothesized that receiving the Halt-intervention will lead to less recidivism in comparison to receiving no intervention.

The Halt-intervention is a widely used Dutch diversion measure for youth (aged 12-17) who committed a minor offence. In the current study, it will be investigated whether the Halt-intervention is successful in reducing recidivism and in achieving the intervention goals. The effectiveness will be assessed using a randomized controlled trial. Participants will be randomly assigned to the experimental condition in which participants will receive the halt intervention or to the control condition in which participants will not receive an intervention. Participants fill out three self-reported questionnaires over a time period of one year. With these questionnaires is it investigated whether the intervention is successful in achieving the different intervention goals (improving social skills, taking responsibility, correct wrongdoing or damage, improving conventional beliefs and improving support from the social network) and in achieving a reduction in recidivism. Furthermore, the adherence to children's rights in the practice of Halt is investigated. Lastly, two years after the first contact with Halt recidivism is assessed using official police and judicial records.

Eligibility Criteria:
Inclusion Criteria:

* Juveniles who have been referred to Halt after committing a minor offence that is eligible for the Halt-intervention.
* Juveniles between the ages of 12 and 18.

Exclusion Criteria:

* Participants who do not speak Dutch or who do not speak Dutch fluently.
* Participants who have already participated in the study before.
* Participants who are participating in the following Halt-programs: 'Hack_right', 'Respect Online' or 'Sport en Spel'.
* Participants of whom it is suspected that their are serious concerns for their safety.
ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are 30-70 years of age
* Female patients: postmenopausal, hysterectomized
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 in the Emergency Department

Children who present to the emergency department often require painful procedures (intravenous catheterization, laceration repair, fracture reduction, etc.). Virtual reality (VR) has been presented as a way of managing pain and anxiety in children undergoing painful procedures but most studies are limited to children 6 or older. The present study seeks to determine the youngest age (2-6) of future subjects in research of VR and clinical care.

Virtual Reality is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

Investigators will instruct and observe children age 2-6 in using a VR device and document how easy the device is to use for the child. The children will have the opportunity to select an application and play with the device for 10 minutes before being asked about their experience with the device. Parents/Guardians will also be asked about their child's experience with the device.


Eligibility Criteria:
Inclusion Criteria:

1. Children age 2-6 years of age
2. Patients arrived with a legal guardian to the emergency department
3. Parents will sign a consent form and children will agree verbally to participate
4. Triage category 4 or 5 (lowest acuity)

Exclusion Criteria:

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, neurological or other condition limiting communication)
2. Facial features or injury prohibiting wearing the VR goggles
3. Painful procedures in the emergency before being approached (such as blood testing, IV, catheterization, immunization, laceration repair)
4. Child is suffering pain or distress at a level that prohibit focusing on the study for 20 minutes, as assessed by the research assistant
Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers

Postoperative Pulmonary Complications (PPC) are common. It severely affects postoperative recovery, particularly in abdominal surgery. Several studies showed that intraoperative lung-protective ventilation with periodic lung recruitment maneuvers could reduce postoperative pulmonary complications. Other studies showed that intraoperative lung protective ventilation without periodic lung recruitment maneuvers could also reduce postoperative pulmonary complications. The purpose of this study was to compare the effects of the above two regimens on postoperative pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing elective major abdominal surgery (expected duration of mechanical ventilation ≥2 h)
2. had an intermediate to high risk of developing postoperative pulmonary complications as indicated by an Assess Respiratory Risk in Surgical Patients in Catalonia score (≥26)
3. Pulse oxygen saturation in room air ≥ 94%

Exclusion Criteria:

1. younger than 18 years
2. had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery
3. had a history of pneumonia within 1 month prior to surgery
4. had severe chronic obstructive pulmonary disease or pulmonary bullae
5. had a progressive neuromuscular illness
6. severe heart dysfunction (New York Heart Association classification ≥4)
7. with an American Society of Anesthesiologists (ASA) physical status of IV or higher
8. Intracranial hypertension
9. were pregnant (excluded by laboratory analysis)
10. were involved in other interventional studies