cyrilzakka/clinical-trials huggingface dataset:
Effects of COVID-19 Forced Isolation Context on Adolescents With and Without Somatic Symptom Disorder

The purpose of this study is to evaluate whether a forced isolation context (such provided by the ongoing Covid-19 pandemic restrictive measures) could reduce the burden of somatic symptoms among a group of patients with Somatic Symptom Disorder (SSD). Secondary objective is to assess if a reduction in terms of depression tendency and anxiety occurs in this specific population and which are the effect of such a context among a group of adolescents without SSD. We want to compare these results with data obtained at the end of the pandemic.

This study aims to evaluate whether the forced isolation context provided by the ongoing Covid-19 pandemic is providing an advantage in terms of reduction of somatic symptoms burden among an Italian group of adolescents with SSD, assessed by the Patient Health Questionnaire (PhQ15) administered during and at the end of the pandemic.

Secondary objectives of the study are:

* To investigate the difference in anxiety and depression scores assessed by the Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory (CDI-2) questionnaires among a group of SSD adolescents, during and after the pandemic isolation context.
* To investigate the difference in anxiety and depression scores assessed by the Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory (CDI-2) questionnaires among a group of adolescents without SSD, during and after the pandemic isolation context.
* To compare the difference in anxiety and depression scores time modification between the two groups of adolescents.
* To explore through tailored questions which adolescents' coping strategies are during a pandemic isolation context among SSD patients and a group of controls without SSD.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged between 12 and 17 years old who received a diagnosis of SSD within the last six months or before unless assessed and confirmed by a specialist within the last six months
* Adolescents without a diagnosis of SSD, who previously accessed the Institute for maternal and child health "Burlo Garofolo" Emergency Department for traumatic injuries or the Pediatric Clinic/Day Hospital Service for oral immunotherapy because of food allergies.
* Adolescents experiencing a quarantine period during the Covid19 pandemic.

Exclusion Criteria:

* Adolescents with cognitive impairment.
* Adolescents with chronic diseases.
* Adolescents with other neuropsychiatric disorders according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorder (DSM V).
* For the group without SSD diagnosis, any access to Emergency Department for unexplained chronic pain or any history of other psychiatric comorbidities.
Recovery of Hand Function Through Mental Practice.

The purpose of this study is to assess the therapeutic benefits of motor imagery training in stroke patients with persistent motor weakness.

Stroke is a common and highly debilitating illness. Many patients (41-45%) experience chronic motor impairments (Dijkerman et al., 1996) and limitations in activities of daily living (Wade \& Langton Hewer, 1987) even after extensive neurological rehabilitation. They often result in long-term dependence at a considerable cost to the carers and the health service. It is therefore crucial to optimise motor recovery after stroke. This study investigates the therapeutic benefits of motor imagery training in stroke patients with a motor weakness.

Evidence for the idea that motor imagery training could enhance the recovery of hand function comes from several separate bases of evidence: the sports literature; neurophysiological evidence; evidence from health psychology research; as well as preliminary findings using motor imagery techniques in stroke patients.

There is evidence to suggest that mental rehearsal of movement can produce effects normally attributed to practising the actual movements. Imagining hand movements could stimulate the redistribution of brain activity, which accompanies recovery of hand function, thus resulting in a reduced motor deficit. Patients are assessed before and after a four-week evaluation period. In this randomised controlled trial 45 patients daily mentally rehearse movements with their affected hand under close supervision. Their recovery is compared to 45 patients who perform closely supervised non-motor mental rehearsal, and 45 patients who are not engaged in a training program.

Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of stroke in the last 1-6 months Persisting upper limb weakness -

Exclusion Criteria:

Alcohol/ Drug abuse Psychiatric history Previous illness that has impacted on individuals Activity of Daily living

- Dementia (assessed by MSQ) Severe Aphasia
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)

The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not using hormonal contraception


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteer
* Age: 18 - 38 years inclusive
* Body mass index (BMI)1: ≥ 19 and \< 28 kg/m²
* Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use
* Willingness to use non-hormonal methods of contraception during the complete trial OR previous tubal ligation

Exclusion Criteria:

* incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
* known or suspected sex-steroid influenced malignancies
* endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus
* known or suspected tumors of the liver and pituitary
* presence or history of severe hepatic disease as long as liver function values have not returned to normal
* severe renal insufficiency or acute renal failure
* thrombophlebitis, venous / arterial thromboembolic diseases; presence or history of prodromi of a thrombosis
* other conditions that increase susceptibility to thromboembolic diseases
* known neuropsychiatric diseases, especially known or suspected epilepsy, and/ or deficient status of folate or vitamin B12
* use of any other medication within 2 cycles before first study drug administration which could affect the study aim
* use of potassium sparing drugs; use of folic acid containing supplements or medicines or use of any medication within 2 cycles before first study drug administration known to interfere with folate metabolism
* inadequate folate and/or Vitamin B12 status, clinically relevant deviations in red cell folate concentrations
Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Must be at least one year of age.
* Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
* Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
* Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
* Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.
* Must be willing to discontinue contact lens wear for the duration of the study.
* Must be willing to avoid disallowed medications during the study period.
* Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits.
* If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

* Any uncontrolled systemic disease or debilitating disease.
* Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
* Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
* Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
* Pregnant or nursing females.
* Known hypersensitivity to SS734 or to any of the ingredients in the study medications.
* Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications.
* Ocular surgery (including laser surgery) in either eye within the past six weeks.
* Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
* Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye).
* History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
* Use of any antibiotic within 72 hours of enrollment.
* Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis
* Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study.
* Subjects who were immune compromised.
I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie

Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs as a conduit for tracheal intubation helps in securing airway. This will be further facilitated by using ventilating bougie, as it maintains oxygenation.

SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 60 years
* Gender : either sex
* American society of Anaesthesiologist's Physical Status (ASAPS) I and II
* Patients posted for surgery requiring general anaesthesia and endotracheal intubation.

Exclusion Criteria:

* age \<18 years and \> 60 years
* ASAPS III or IV
* Obesity body mass index \>25
* Patients with mouth opening \<2cms
* Patients with Malampatti grade III and IV
* Patients having history of gastro-esophageal reflux disease
* Patients with history of inadequate fasting
* Patients with known or anticipated difficult tracheal intubation or face-mask ventilation.
Long-term Follow-up in Severe Traumatic Brain Injury

The underlying pathophysiology following traumatic brain injury (TBI) in how different neurodegenerative conditions are developed are still unknown. Different neuroinflammatory and neurodegenerative pathways have been suggested.

The goal of this study is to follow-up patients that have been treated for TBI at the neurosurgical department about 10-15 years after their initial injury, in order to analyze fluid biomarkers of inflammation, injury and degeneration and associate these with structural imaging and long-term functional outcome.

The investigators aim to invite about 100 patients back and perform advanced magnetic resonance imaging protocols, sample cerebrospinal fluid and blood for different bio- and inflammatory markers, study genetic modifications and associate it with outcomes being assessed through questionnaires.

The investigators' hypothesis is that patients with ongoing inflammatory processes will present with more fluid biomarkers of neurodegeneration, worse clinical presentation and also more structural/atrophic signs on imaging. This will result in an increased understanding of the interplay between neuroinflammation and neurodegeneration in chronic TBI, as well as a panel of tentative biomarkers that could be used to assess level of disability following TBI and chronic traumatic encephalopathy (CTE).


Eligibility Criteria:
Inclusion Criteria:

* Having suffered a traumatic brain injury and being treated at the Karolinska University Hospital between 2007 and 2015.
* Age \>18 years of age

Exclusion Criteria:

- Pregnancy
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease

For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.

(1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the administration of PPI, 4weeks after and 8weeks after the study initiation.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 19 years old
* Patient with typical GERD symptom (heartburn or acid reflux more than once a week)

Exclusion Criteria:

* Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically
* Patient with active gastric/duodenal ulcer
* Patient who received esophagus, stomach or duodenum surgery
* Patient with hypersensitivity to esomezol®
* Patient with no achieved agreement on the study from the guardian or patient himself.
Effect of Malnutrition on the Prognosis in Hemodialysis Patients

The purpose of this study is to examined the effect of malnutrition and/or inflammation on atherosclerosis and prognosis in hemodialysis.

Malnutrition is known to affect their prognosis in hemodialysis patients. Furthermore, recent studies indicate that malnutrition is associated with inflammation and atherosclerosis in these patients. In this study we examine the effect of malnutrition and/or inflammation on atherosclerosis and 5-year survival rate in 600 hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis for at least 6 months

Exclusion Criteria:

* disabled patients
Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology

This prospective study of health care workers utilizes wearable sensors, surveys and symptom logs, and biospecimens in an effort to improve self-monitoring practices for COVID-19 among health care workers and to provide key data for the development of a predictive model for early detection of COVID-19 infection.

Health care workers work on the front lines of the COVID-19 pandemic, so early detection of COVID-19 infection is especially important in this population in order to prevent the spread of disease among the health care workforce, their patients, and their families. However, standard symptomatic COVID-19 testing is insufficient to protect health care workers and prevent the spread of disease. This study utilizes continuous physiological data from wearable sensors and surveys completed via smartphone technology, in conjunction with biospecimens, in order to assist health care workers in their self-monitoring for COVID-19 infection. Subjects will wear smart watches and temperature monitoring patches to collect continuous heart rate and temperature data. Subjects will also complete baseline and exit surveys, in addition to daily mood and symptom logging surveys. Finally, subjects will provide biospecimens - nasal and saliva samples and optional blood samples. Using wearable sensor data in conjunction with survey data and biospecimens, this study aims to prevent the spread of COVID-19 among health care workers, their patients, and their families, and to eventually develop a predictive model for early detection of COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult Michigan Medicine health care workers age 18 years and older.
* Health care workers who are involved in direct (in-person) face-to-face patient care or health care workers who are not involved in direct (in-person) face-to-face patient care but work on units where COVID-19 patients are/will likely be treated.
* Possession of a smartphone (Apple or Android).
* Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion Criteria:

* Unwilling or unable to comply with the study procedures or to allow the study team access to health data.
Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).


Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding and complying with the protocol
* Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, no psychopathologies)
* Body Mass Index between 18-30, inclusive
* Age 21-40 years
* Moderate alcohol drinkers (less than 20 drinks/week)
* Have a stable living situation with current postal address
* No contraindications to MR scanning (see MR scanning exclusion criteria below)

Exclusion Criteria:

* Concurrent diagnosis of Axis I disorder
* Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years.
* Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable.
* Subjects cannot be actively seeking treatment for any drug or alcohol dependence.
* Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are acceptable if the use criteria is met.
* Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions.
* Tobacco use greater than 10 cigarettes per day
* History of major head trauma resulting in cognitive impairment or history of seizure disorder
* Heavy caffeine use (greater than 500 mg on a regular, daily basis)
* For female volunteers, a positive pregnancy test
Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients: The EPIMOOSA Study

This study evaluates epigenetics in morbid obese patients who are waiting for bariatric surgery. A home cardiopulmonary polygraphy is performed to evaluate for the presence of sleep-disordered breathing. The principal investigator make the decision of starting CPAP among patients with obstructive sleep apnea according to current clinical guidelines. One year follow up after bariatric surgery will be performed. A total of 5 visits will be scheduled: two of them before bariatric surgery and 3 after (3, 6 and 12 months).

At every visit, all patients had: sleep questionaries, blood samples, EKG-Holter and spirometry are collected.


Eligibility Criteria:
Inclusion Criteria:

* BMI consistently \> 40 kg/m2 for 3-5 years, following more than 1 year of unsuccessful controlled medical treatment
* BMI 35-40 kg/m2 with comorbidities associated with morbid obesity (MO) susceptible to improvement with weight loss (high BP, Diabetes, dyslipidemia, OSA, etc.), following more than 1 year of unsuccessful controlled medical treatment.
* A signed informed consent form

Exclusion Criteria:

* Obesity hypoventilation syndrome or treatment with positive pressure devices.
* Diagnosis of systemic inflammatory disease.
* Neoplastic diseases in the last 5 years.
* A cardiovascular event in the last 6 months.
* Pregnancy
The Effects of Anger and Joy Expressions on Approach and Avoidance Behaviors in Healthy Volunteers

Social interactions are part of our daily lives. Communicating with others is a recurring choice which is based on emotional cues, such as facial expression. Our action must be adapted to the emotional state of our interlocutor, otherwise the investigators will have poor quality interactions An emotional stimulus would cause a conditioned response (innate reaction). Thus, the presence of an angry person would automatically trigger flight behavior. More recently, however, it has been envisioned that this same avoidance behavior could be the result of a goal-directed behvior. In this case, the avoidance behavior would be the result of an evaluation of the consequences of the selected action. These goal-directed behaviors are guided by a mental representation of consequences The project aims to study behavioral choices (approach and avoidance) in response to negative and positive social cues (anger and joy) in 40 healthy volunteers using a computerized neuropsychological task, and to determine wheter these choices are the result of goal-directed behavior.

The study also aims to assess the modulation of behavioral adaptation by the level of impulsivity, lonilness, empathy, and by the capcity to understand others' intenstions.


Eligibility Criteria:
Inclusion criteria:

* Being between 18 and 65 years old
* Absence of psychiatric pathology over the entire life
* Being able to understand the nature, purpose and methodology of the study

Exclusion criteria:

* Mental retardation or sever medical co-morbidity
* Sensory or cognitive disability
* Pregnant or breastfeeding woman
* Protection by law (guardianship or curatorship)
* Deprivation of liberty (by judicial or administrative decision)
* Exclusion period in relation to another protocol
* Inability to understand, speak and write French