cyrilzakka/clinical-trials huggingface dataset:
Formula Identification (FID) 114657 in Contact Lens Wearers

The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.


Eligibility Criteria:
Inclusion Criteria:

* Must sign the informed consent form.
* Stable, tear lipid layer thickness ≤ 75 nm without contact lenses.
* Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit 1.
* Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit 1.
* Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study.
* Demonstrate symptoms of contact lens discomfort.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Routinely sleeping in lenses.
* Any active eye inflammation or condition that contraindicates contact lens wear.
* Any systemic diseases that could prevent successful contact lens wear.
* Use of systemic or ocular medications that contraindicate lens wear.
* Fit with only 1 contact lens.
* Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study.
* Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study.
* Other protocol-defined exclusion criteria may apply.
Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients

Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic diagnosis of PTCL according to the WHO-REAL classification;
* Age \> 18 years;
* Relapsed (³1) or refractory to conventional chemotherapy/radiotherapy;
* Stage I-IV according to the Ann Arbor staging System;
* Performance status \<2;
* Adequate bone marrow reserve: platelets \>50 x 10(9)/L, absolute neutrophil count
* (ANC) \> 1.0 x 10(9)/L, hemoglobin \>8 g/d;
* Normal renal and hepatic functions;
* Negative HIV, HCV, and HBV status;
* Informed consent prior to registration on study

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide.
* The development of erythema if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Any prior use of lenalidomide.
* Concurrent use of other anti-cancer agents or treatments.
* Known positive for HIV or infectious hepatitis, type A, B or C.
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 to 85 years
* On thrice-weekly hemodialysis for at least six months
* Clinically stable, adequately dialyzed (single-pool Kt/V \> 1.2), with polysulphone membrane for at least three consecutive months before the study
* Subjects with pre-dialytic systolic blood pressure between 110 and 170 mmHg.
* Subjects with a reduction of systolic blood pressure during hemodialysis equal to or greater than 30 mmHg, with associated symptoms such as nausea, vomiting, muscle cramps, dizziness, or anxiety.
* Hypotensive episodes should occur four times or more in four weeks (12 hemodialysis sessions).

Exclusion Criteria:

* Subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin
* Subjects with pre-dialytic systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
* History of myocardial infarction or cerebrovascular event within 3 months
* History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months
* Advanced liver disease
* Ejection fraction less than 30%
* Anticipated live donor kidney transplant
* A history of poor adherence to hemodialysis or medical regimen
* Severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions
* Use of immunosuppressive drugs within one month before study enrollment
* Active connective tissue disease
* History of acute infections disease within one month before study enrollment
* Inability to provide consent
* Pregnancy
Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy

To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.

3 groups.

Group (C) / (I):20 patient (control group) :

Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5.

Group (D)/ (II) :20 patient (Dexmetonidine group) :

Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine.

Group (M) / (III) : 20 patient (magnesium slphate group) :

Patient will receive 20ml 0.25% levobupivacaineas above + 0.7 mg/kg MgSo4 . The patient, the anesthesiologist who administered the drugs, and the data collector will be blinded to the study drugs.

Eligibility Criteria:
Inclusion Criteria:

* female patient
* American society of anesthesiologists (ASA) I and II physical status
* age from 25 to 70 years old
* scheduled for either left or right modified radical mastectomy (MRM).

Exclusion Criteria:

* infection of the skin at or near site of needle puncture
* coagulopathy
* drug hypersensitivity or allergy to the studied drugs
* central or peripheral neuropathy
* significant organ dysfunction cardiac dysrrhythmias
* obesity (BMI\>35kg/m2)
* recently use analgesic drugs
Validation of Dietary Calcium Questionnaires Using Diet Records

Dairy products continue to be an important source of calcium, providing over half the calcium intake for most individuals. Educational interventions promoting adequate calcium intake with tools estimating dietary calcium that can be easily utilized by consumers would be a valuable asset to promoting skeletal health. Validation of these tools against standard dietary assessment methods enhances their utility. The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement. It is hypothesized that both dietary calcium questionnaires will be a valid measurement of dietary calcium intake in women.

The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement.

Eligibility Criteria:
Inclusion Criteria:

* Independently living women over the age of 19 in generally good health.

Exclusion Criteria:

* Inability to keep a diet record
* Active gastrointestinal disease that limits or restricts diet
* Inability to understand and provide informed consent.
Genetics of Motor Learning

Background:

- New studies in human genetics have revealed information about genetic connections to memory and motor behavior. Researchers are interested in investigating the role of genetics in motor learning, in conjunction with related studies taking place in the Human Motor Control Section of the National Institute of Neurological Diseases and Stroke (NINDS). Participants in motor learning studies conducted at NINDS will be asked to provide blood samples for further evaluation.

Objectives:

- To create a repository of blood samples from patients and healthy subjects who are participating in NINDS motor learning studies.

Eligibility:

- Individuals between 18 and 100 years of age who are or will be participating in motor learning research studies at the National Institutes of Health.

Design:

* Blood draws for genetic testing will usually be done on the same day as the motor learning study. Participants will provide one blood sample for research.
* No treatment will be provided under this study....

OBJECTIVE:\<TAB\>

The objective of this study is to create a bio-repository of blood samples from patients and healthy subjects who are participating in NINDS motor learning studies. Blood will be analyzed for BDNF and samples stored for future genetic studies. . A variety of genes that may affect motor learning are being increasingly identified, and variations among these genes, referred to as polymorphisms, may help explain individual differences.

STUDY POPULATION: \<TAB\>

We will enroll up to five hundred healthy volunteers and five hundred volunteers with movement difficulties who are between the ages of 18 and 100 and who are already participating, or will be participating, in other protocols dealing with motor learning research studies at the National Institutes of Health (NIH).

DESIGN:\<TAB\>

This is an observational and repository protocol that involves a single blood sample for genetic analysis. This will allow the genetic characterization of subjects participating in motor learning protocols to be analyzed and tested for the role of genetics in motor learning results.

OUTCOME MEASURE:

We will compare genetic variations with the different behavioral, electrophysiologic, imaging, or other outcomes acquired in the associated motor learning studies. Thus, we will determine whether specific polymorphisms are associated with different measures of motor learning.

Eligibility Criteria:
* INCLUSION CRITERIA:

\<TAB\>

Anyone aged 18-100 years and participating in a motor learning study at NIH is eligible to participate in this study.

\<TAB\>

EXCLUSION CRITERIA:

Anyone with impaired decisional capacity, inability to provide informed consent, or who is unable to safely give blood is not eligible to participate in this study.
Retention of Knowledge and Skills of First Aid After Change in Concept of Teaching First Aid

The investigators will evaluate the effect of simulation-based education in First Aid practice on knowledge and skills retention.

In autumn semester 2020 a new concept of the subject First aid for the students of General medicine and Dentistry at Faculty of Medicine of Masaryk University was introduced. This concept based on evidence-based medical education puts different principles such as simulation-based education, learner-centred learning, peer learning and outcome-based education into practice.

First aid training (FAT) is indispensable part of the curriculum and knowledge of the first year medical students. The investigator´s aim is to evaluate if the new concept of the first aid training led to improvement in knowledge and mainly in skills of the students. Investigator´s null hypothesis is that the new concept does not lead to improvement in the long-term retention of the knowledge and the skills than the original concept. The investigators will compare tested knowledge and skills of the students who underwent FAT in autumn semester 2019 (original concept, group A) and the students who underwent FAT in autumn semester 2020 (new concept, group B).

The evaluation of the two groups will happen in the interval of 20-24 months after the completion of the FAT. Group A will be evaluated in autumn semester 2021, group B in autumn semester 2022. The evaluation method will be based on a knowledge test and a OSCE (objective structured clinical examination) stations.

Applying principles of evidence-based medical education into practice and designing FAT according to simulation-based education could lead better long-term retention of knowledge and skills of the students.

Eligibility Criteria:
Inclusion Criteria:

* Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme.

Exclusion Criteria:

* Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in different time intervals or who underwent FAT in autumn semester 2020 and 2021 and also have been involved in Student as Teacher programme.
Gutta-percha Solvent on Postoperative Pain After Root Canal Retreatment

The process of non-surgical retreatment includes removing the previous root canal filling materials, disinfecting and sealing the root canal system to prevent re-infection. Gutta-percha is the most common root canal filling material used with various types of sealers. To remove gutta-percha, solvent has been suggested because of its ability to dissolve gutta-percha. The new formula, under the brand name, GuttaClear, has been investigated for its comparable dissolving ability and lower cytotoxicity when compared with others that are currently used. However, no information is currently available of GuttaClear solvent concerning postoperative pain. Therefore, the present study will evaluate postoperative pain after non-surgical retreatment cases using GuttaClear as a solvent compared with no solvent used. Sixty participants are chosen and distributed into 2 groups, randomly. After the procedures, participants will receive the questionnaires about postoperative pain and the amount of medication intake. Both will be recorded at six time periods: (1) immediately after procedure; (2) 6 hours after procedure; (3) 12 hours after procedure; (4) 24 hours after procedure; (5) 48 hours after procedure and (6) 72 hours after procedure.


Eligibility Criteria:
Inclusion Criteria:

* not be contra-indicated with medication used in this study (ibuprofen)
* have a previously treated endodontic single-root tooth with the need of retreatment
* all those teeth must be restorable
* old root canal filling materials must be located at 1 to 3 mm from the radiographic apex in the periapical radiograph

Exclusion Criteria:

* open apex, root resorption or root perforation
* participants presenting pre-operative pain and/or swelling at the appointment visit
* taking analgesics or antibiotics less than one week before appointment visit
* experiencing problems in completing the pain questionnaires
* tooth which does not contain gutta-percha
* cannot be patent through the apex at the appointment visit
Testing the Effectiveness of Relationship Smarts and the Effects of Enhanced Facilitator Training

This project will test the effectiveness of offering healthy marriage and relation education for youth as part of the regular school curriculum and examine whether providing enhanced training and support for facilitators shows promise for enhancing the effects on high school students. The evaluation will examine a range of students' relationship outcomes, including their attitudes toward relationships, their knowledge of healthy relationships, their communication skills, and the characteristics of their current relationship.

Family Bridges will deliver the "Relationship Smarts +" program to students at 10 Chicago-area high schools. The RS+ curriculum will be delivered to 9th grade students in the target schools and classrooms during the 2016-2017 and 2017-2018 school years. The curriculum's 12 sessions will be delivered over a period of about 12 weeks during the winter quarter, with an average of one session taught per week.The lessons cover topics such as personal values, the principals of smart relationships, communication and conflict management, and sexual decision making. Using a three-arm randomized controlled trial design, this study will test the effectiveness of offering RS+ as part of the regular school curriculum on the students' knowledge of healthy relationships, their communication skills, and the characteristics of their current relationship. In addition to testing the effects of the curriculum, the study will also test the effects of providing enhanced training and support to facilitators.

Eligibility Criteria:
Inclusion Criteria:

* Students must be age 17 or younger
* have consent from a parent or guardian for evaluation activities
* provide assent for evaluation activities.

Exclusion Criteria:

* Students in evaluation classrooms who do not meet these criteria will still receive programming, but will not be included in the STREAMS data collection activities or in the study's analysis.
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age

The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:

  * Absence of changes in medical therapy within 60 days of Day 1 due to treatment failure or toxicity,
  * Absence of serious or significant medical events within 30 days of Day 1, and
  * Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
* A participant assigned female at birth is eligible to participate if they are postmenopausal or not a person of childbearing potential.

Key Exclusion Criteria:

* Close contact with someone with laboratory-confirmed influenza and/or RSV infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
* Participant has tested positive for influenza or RSV by local health authority-approved testing methods ≤6 months prior to Day 1.
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1 and Day 22) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study injections.
* Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤6 months prior to Day 1.
* Participant has received any RSV vaccine (authorized/approved by local health agency or investigational) prior to Day 1.

Note: Other protocol-defined inclusion and/or exclusion criteria may apply.
Study of the Vascular Compartment and Hypercoagulability During Coronavirus Infection COVID-19

Coronavirus COVID-19 is an emerging virus also called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Eighty percent of patients are poor or asymptomatic. However, there are major respiratory complications for some patients, requiring intensive care hospitalization and possibly leading to death in 5% of cases. One of the hypotheses put forward is that much of the pathophysiology is due to endothelial dysfunction associated with disseminated intravascular coagulation.

The covid-19 pathology could induce coagulation impairment as observed during sepsis. An increase in D-dimer levels during covid-19 disease is itself associated with excess mortality. While D-dimers are highly sensitive, they are not specific for clotting activity. They may be increased in many other circumstances, particularly in inflammation.

On the other hand, the infection stimulates the release of extracellular vesicles. These vesicles, of multiple cellular origin, are an actor of vascular homeostasis, and participate in the state of hyperactivation of coagulation. They have a major role in the prothrombotic state and the development of coagulopathy associated with sepsis.

The aim of our monocentric prospective study would be to study early and more specific markers of hypercoagulability and markers of routine endothelial dysfunction, as soon as the patient is hospitalized, in order to predict the risk of hospitalization in intensive care.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient admitted to Rouen University Hospital for documented SARS-Cov-2 infection (PCR Test or CT scan)
* Patient who accept to participate to research after reading the information note
* Patient affiliated with Social Security

Exclusion Criteria:

* Patient under protective guardianship or curatorship
Nerve Entrapment in Diabetic Patients

The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome
* Confirmed by nerve conduction studies.

Exclusion Criteria:

* Other focal nerve entrapments
* Cervical radiculopathy
* Inflammatory joint disease
* Renal failure
* Thyroid disorders
* Previous wrist fracture
* Long-term exposure to vibrating tools.