cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Virus RNA, and miRNA Levels Related to Viral Infection, and Inflammatory Response in Tears of Patients Affected by COVID-19 Disease

The aim of this study is to assess the virus RNA, and miRNA levels related to viral infection, and inflammatory response in tears of hospitalized patients with a diagnosis of COVID-19 with and without conjunctivitis and to correlate them with clinical condition.

Tears will be collected by using Schirmer Test I, a non invasive painless test which can be performed at the patient's bed. Tears will be collected on the graduated paper strips pulling the lower lid gently downward for 5 minutes. Following, the strip will be placed in a 2.0 mL Eppendorf tube and stored at -80◦C (or - 20°C)

The SARS-CoV-2 is a virus highly infectious whose main target of infection is the respiratory tract. Virus has been reported to target other mucus tissues, such as the conjunctiva of the eye and causes conjunctivitis. A recent study has detected the presence of SARS-CoV-2 in the tears of patients affected by COVID-19 with conjunctivitis, using real-time reverse transcription polymerase chain reaction (RT-PCR). This suggests that droplets and body fluids of infected people can contaminate the human conjunctival mucosa and it can be a view of transmission that it must not be ignored.

A role of miRNAs has been found in ocular infections such as fungal, bacterial, viral infections. It would be interesting to correlate tear fluid miRNA levels to patients clinical findings

Eligibility Criteria:
Inclusion Criteria (Group 1):

* A confirmed diagnosis of COVID-19 disease
* Age ≥ of 18 years.
* absence of conjuntivitis detected by portable slit lamp

Inclusion Criteria (Group 2):

* A confirmed diagnosis of COVID-19 disease
* Age ≥ of 18 years.
* Presence of bilateral conjunctivitis defined as red eyes (macroscopic signs of conjunctival congestion)

Exclusion Criteria (both groups):

* Pregnant women
* Any form Ocular surface diseases preceding Covid-19 diagnosis, Glaucoma, history of anterior segment inflammation, previous penetrating ocular trauma
* Ocular surgeries within previous 6 months
* Topical therapies
* History of ocular allergy
Bone Stimulator for Spondylolysis

This prospective study aims to investigate the effectiveness of bone stimulator therapy as adjunct treatment of spondylolysis in athletic populations. By evaluating its impact on pain reduction, functional improvement, osseous bony union and return-to-sport time, the investigators seek to provide valuable insights into the role of bone stimulation therapy as a potential treatment modality for this challenging condition.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 16 to 40 years of age diagnosed with symptomatic spondylolysis by one of the investigators
* Patients who plan to attend prescribed physical therapy
* Patients who participate in a regular sport whether that be professional, collegiate or recreational

Exclusion Criteria:

* Any condition which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions
* Patients with contraindications to bone stimulator therapy
* Patients with pacemaker and implantable cardioverter defibrillator
* Patients with previous spine surgery
* Patients with metabolic bone conditions
* Patients who use nicotine products
* Vulnerable populations
* Non-English speaking services
Visbiome Effect on Colorectal Anastomosis and Local Recurrence

Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence

Randomized study of Visbiome after colorectal surgery. Subjects will be randomized 1:1 to either VSL3 or no VSL3.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of biopsy proven rectal cancer (CT/MRI)
* Willing and able to comply with protocol requirements
* Able to tolerate surgery
* Able to comprehend and have signed the Informed Consent
* Absence of metastatic disease
* Clinical performance status of ECOG 0 or 1
* Life expectancy of greater than 3 months
* Planned ileostomy as part of their routine care

Exclusion Criteria:

* Severe or refractory ulcerative colitis defined as Mayo Score of greater than or equal to 10, endoscopic disease activity score 3
* Untreated enteric infection (positive stool test for any of the following: clostridium difficile, salmonella, shigella, yersinia, campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the Investigator
* Severe immunodeficiency, inherited or required (e.g. HIV, chemotherapy or radiation therapy)
* Patients with the following laboratory abnormalities: absolute neutrophil count \<1000/ul, platelets \<50 x 10\^9/L, hemoglobin \<6.5g/dL
* History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish)
* Active intestinal obstruction
* Non-steroidal anti inflammatory medications (NSAIDs) as long-term treatment, defined as for at least 4 days per week each month
* Cholestyramine use
* Any condition in which the Investigator thinks VSL3 administration may pose a health risk (e.g. severely immunocompromised)
* Simultaneous participation in another interventional clinical trial
* Patients who are pregnant, breast feeding or planning pregnancy during study trial period
* Patients with any other signification medical condition that could confound or interfere with evaluation of safety, tolerability or prevention compliance with the study protocol at the discretion of the Investigator
Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs

The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Several studies have reported the positive impact of antibiotic susceptibility testing performed on urine cultures on the appropriate use of antibiotics.

The "selective reporting for antibiotic susceptibility testing ", defined as the restriction of the list of antibiotics mentioned in the report according to the antibiotic resistance profile, would allow, according to observational studies, a reduction of 25 to 70% of the initial prescriptions of broad-spectrum antibiotics and a 20% rate of antibiotic de-escalation (=reduction of the antibacterial spectrum of an antibiotic treatment after re-evaluation).

The objective is to assess the impact of disseminating a selective reporting for antibiotic susceptibility testing on the dispensing of broad-spectrum antibiotics prescribed by general practitioners (GPs) for E. coli positive urine cultures in adult women, compared to the dissemination of a standard antibiotic susceptibility testing.


Eligibility Criteria:
Inclusion Criteria:

Patients :

* women ≥18 years of age,
* affiliated with the CPAM of Loire Atlantique (44) or Maine et Loire (49),
* with a urine culture: i) analyzed by LabOuest, ii) positive for E. coli, and iii) associated with a prescription for antibiotics by a general practitioner in the period 7 days before and 14 days after the antibiotic susceptibility testing.

General practitioners :

* practicing in primary care Loire Atlantique (44) and/or Maine et Loire (49),
* having been consulted by at least 100 different patients in the 12 months prior to baseline,
* having received at least one urine culture result for a woman ≥18 years of age analyzed by LabOuest over the 12 months prior to baseline.

Exclusion Criteria:

Patients :

* hospitalized in the period 7 days before and 14 days after antibiotic susceptibility testing (data on antibiotics dispensed in healthcare institutions are not accessible via DCIR data),
* with reimbursements for antibiotics prescribed by physicians in different practices over the period 7 days before and 14 days after antibiotic susceptibility testing.

General practitioners :

* with a special practice (acupuncture, allergology, angiology).
* not receiving any urine culture results analyzed by a laboratory of the LabOuest network in the year following the intervention
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma

The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of MM requiring treatment
* Refractory or Relapsed Disease
* At least one prior treatment regimen
* Male or Female
* \>18 years of age

Exclusion Criteria:

* Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
* Intracranial disease or epidural disease
* Clinically significant cardiac dysfunction or other significant organ dysfunction
Study of Safety and Immunogenicity of Fluzone® in Healthy Children

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Eligibility Criteria:
Inclusion Criteria :

* Participant is aged ≥ 6 months to \< 36 months.
* Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
* Participant is available for the duration of the study.
* Parent/guardian is willing and able to provide informed consent.
* Parent/guardian is willing and able to meet protocol requirements.

Exclusion Criteria :

* Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
* Previous history of influenza vaccination or documented history of influenza infection.
* An acute illness with or without fever (temperature \> 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
* Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
* Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study.
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay, neurologic disorder, or seizure disorder.
* Chronic medical, congenital, or developmental disorder.
* Known human immunodeficiency virus (HIV)-positive mother.
* Prior history of Guillain-Barré syndrome.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
Bioequivalence Study of Risperidone 1 mg Tablets of Torrent Pharmaceuticals Limited, India and Risperdal® (Risperidone) 1 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fed Conditions

Objective:

* To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical Products, LP, USA, in healthy human adult subjects, under fed conditions.

Study Design:

* A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult subjects of either sex between 18-55 years of age (inclusive) have a body mass index (BMI) between 18 and 27 kg/m2.
2. Subjects who had no evidence of underlying disease during screening and whose physical examination was performed within 21 days prior to commencement of the study.
3. Subjects whose screening laboratory values were within normal limits or considered by the Investigator to be of no clinical significance.
4. Informed consent given in written form according to section 11.3 of the protocol.
5. Female Subjects:

   * of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine contraceptive device, (IUD) or abstinence.
   * postmenopausal for at least 1 year.
   * surgically sterile (bilateral tubal ligation, bilateral oophorectomy,or hysterectomy).

Exclusion Criteria:

1. History or presence of significant:

   * Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
   * Alcohol dependence, alcohol abuse or drug abuse within past one year.
   * Moderate to heavy smoking (\>10 cigarettes/day) or consumption of tobacco products.
   * History of difficulty in swallowing tablets.
   * Clinically significant illness within 4 weeks before the start of the study.
   * Asthma, urticaria or other allergic type reactions after taking any medication.
   * Positive urine drug screening, HIV, hepatitis B \& C tests.
   * Any history of hypersensitivity to Risperidone.
2. Participation in any clinical trial within the preceding 12 weeks of study start.
3. Subjects who had:

   * Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg.
   * Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg Minor deviations (2-4 mm Hg) at check-in, if any, were acceptable at the discretion of the physician /Investigator.
   * Pulse rate below 50 /min or above 105 /min.
4. Female subjects demonstrating a positive pregnancy screen or currently breast-feeding or whose menstruation cycle coincides with the study dates.
The Effect Of AVANDIA On The Late Asthmatic Response

This study is to investigate the effects of AVANDIA on the asthmatic response.


Eligibility Criteria:
Inclusion criteria:

* Mild asthmatic treated with short-acting beta agonists only, non-smoker.

Exclusion criteria:

* Inability to abstain from medications other than short-acting beta agonists and paracetamol.
* Recent administration of steroids.
* Recent respiratory infection or exacerbation of asthma.
Dyadic Neurofeedback for Emotion Regulation in Youth With Maternal Adversity

This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

The current study will determine the effects of a real-time functional magnetic resonance imaging dyadic neurofeedback (rtfMRI-DNF) protocol that will train mothers with a history of adverse childhood experiences (ACEs) to regulate adolescents' activation in the anterior insular cortex (aIC) - a key brain region for ER. The proposed study will test the efficacy of this protocol to promote healthy ER-related neurodevelopment in adolescents with a maternal history of adversity. The proposed study will use DNF to provide neurofeedback from the adolescent's aIC to the parent as the parent and adolescent engage in an emotion discussion task together. Parents and adolescents (n=10 dyads) will communicate via microphones and noise-canceling headphones while the adolescent is undergoing fMRI scanning. Specific aims of the current study are: (1) to determine the brain response to aIC DNF adolescents, and (2) to determine effects of DNF on parenting behaviors. This study is significant because engaging with parents in DNF can promote positive ER development in adolescents at risk due to the intergenerational effects of ACEs.

Eligibility Criteria:
Inclusion Criteria:

All participants inclusion criteria:

* Biological female
* Sufficient English fluency to complete tasks
* Co-residing at least 4 days per week

Inclusion criteria for adult participants:

* Primary caregiver for more than 50% of child's lifespan
* History of at least two adverse childhood experiences
* Biological parent of adolescent participant

Inclusion criteria for adolescents:

* Eligible for fMRI
* Right-handed
* Body mass index between 16 and 40 (inclusive)
* Age 14-17 years

Exclusion Criteria:

Exclusion criteria for all participants:

* Current psychiatric diagnosis

Exclusion criteria for adolescent participants:

* Neurodevelopmental delay
* History of psychiatric disorder
* Medications influencing fMRI
* Medical conditions influencing fMRI
Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
* Male or female ≥ 8 years old.
* Subject has a clinical diagnosis of verruca vulgaris (common warts).
* Subject has up to 6 warts located on the trunk or extremities

Exclusion Criteria:

* Subject has clinically atypical warts on the trunk or extremities.
* Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
* Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.
Effects of Fixation Technique on Thoracic Epidural Catheter Displacement

The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok fixation bandage, two common, widely used techniques for epidural fixation.


Eligibility Criteria:
Inclusion Criteria:

* surgical patient
* receiving a thoracic epidural
* 18 years of age or older

Exclusion Criteria:

* Patient refusal
* allergy to adhesives or local anesthesia
* pregnancy
* contraindication to receiving an epidural including coagulopathy, infection, elevated ICP, or severe pre-existing neurologic disorders
Long Term Bowel Function Following Rectal Cancer Surgery

* In this longitudinal study, 171 patients were evaluated and compared based on the radiation therapy they received.
* Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.

Background Despite advances in the neoadjuvant chemoradiation therapy and anal sphincter-preserving surgeries for rectal cancer, bowel dysfunction is still unavoidable which negatively affect the patients' quality of life. In this longitudinal study, The aim of this study was to investigate the changes in bowel function with follow up time and the effect of the neoadjuvant chemo radiotherapy on bowel function following low anterior resection for rectal cancer.

Materials and methods In this study, 171 patients with rectal cancer who underwent low anterior resection between 2012 and 2018 were included. Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes,
* Aged between 18 and 75 years,
* Patients with mid and upper rectal cancer (6-15) cm from the anal verge(AV) with or without preoperative chemo radiotherapy.
* Patients who underwent low anterior resection(LAR).
* Patients who were followed up with at least two outpatient visits for bowel function assessment.

Exclusion Criteria:

* Patients with recurrent rectal tumors,
* Surgically unfit patients,
* Patients with tumors infiltrating the puborectalis muscle or external sphincter.
* Patients with preoperative fecal incontinence.
* Patients who were followed up only once in the outpatient clinic.
* Patients with lower rectal cancer less than 6cm from AV,
* Patients who underwent abdominoperineal resection(APR) or intersphincteric resection(ISR).
Pilot RCT of a Video-based Intervention for Suicide Prevention

The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in a pilot randomized controlled trial (n = 40) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.


Eligibility Criteria:
Inclusion Criteria:

* current psychiatric hospitalization for suicidal thoughts and behaviors
* 18 years or older
* ability to speak and read English
* access to means for viewing videos (computer, tablet, smartphone)

Exclusion Criteria:

* current psychotic symptoms
* current cognitive impairment
Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

The aim of this study is to compare blood pressure obtained using routine blood pressure sphygmomanometer, in patients with invasive arterial pressure monitoring that have septic shock, to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Eligibility Criteria:
Inclusion Criteria:

* Admitted with septic shock, with or without vasopressor support needed.
* Greater than or equal to 18 years of age.
* Have an arterial catheter already in place.

Exclusion Criteria:

* No arterial catheter in place.
* Contraindication to the application of the Caretaker device due to pre-existing finger injury.
* Patients in whom use of a BP cuff is contraindicated.