cyrilzakka/clinical-trials huggingface dataset:
Sensitive Periods in Human Flavor Learning

The goals of the proposed research are to specify the timing and consequences of the sensitive period for flavor learning in infants who are being breastfed or formula fed. The investigators will conduct a randomized within- and between-subject study of women and their infants during a 15-month window.

This is a randomized clinical trial on both breastfeeding and formula feeding infants to determine the effects of the timing of flavor experiences on subsequent food acceptance in both members of the dyad.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, term infants and their mothers
* Infants 2 wks (+/- 2 wk of age)
* Mothers and infants exclusively breastfeeding or exclusively feeding a cows-milk based formula
* Mothers must be older than 18 years of age

Exclusion Criteria:

* Infants who were preterm or have medical conditions that interfere with feeding or eating
* Mothers who had gestational diabetes or are diagnosed with a major illness requiring treatment or surgery
* Mothers who will be going back to work full-time before the infant is 4 months old
* Mothers who are allergic to any vegetables
* Subjects will not be excluded because of economic status, gender, race or ethnicity.
Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.

This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.


Eligibility Criteria:
Inclusion Criteria:

* Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator.
* Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.
* Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.

Exclusion Criteria:

* Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.
* Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo.
* Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation.
* Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs).
* Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
Clinical Effectiveness of PAPILOCARE® in Regression of Cervix HPV Cytological Abnormalities (PAPILOBS GR).

The present study is a multicenter, open, non-interventional, prospective observational clinical study for the evaluation of the effectiveness of Papilocare® (medical device with CE mark) in the regression of cervix cytological abnormalities caused by HPV.

524 participants were enrolled in the study from approximately 44 Greek sites. At baseline (Visit 1) written informed consent was obtained, participants' eligibility criteria were checked and medical history data were collected. Participants were advised to be treated with Papilocare® for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months). At 6 months (Visit 2) primary and secondary objectives were evaluated. If needed and based on physician's decision, treatment was extended to a total of 12 months (Visit 3) and primary and secondary endpoints were evaluated as well.

Eligibility Criteria:
Inclusion Criteria:

Women over 18 years of age who have been or not vaccinated against HPV.

1. Able to read and understand the Informed Consent Form and agree to participate in the study by signing the Informed Consent Form.
2. Patients with ASCUS or LSIL routine cytological examination and positive High Risk (HR) HPV molecular test, up to 3 months before inclusion in the study.
3. Patients who, due to this condition, undergo a colposcopy and have a concordant result with cytology.

Exclusion Criteria:

1. Any gynecological or non-gynecological condition / lesion / pathology for which, according to clinical judgment, the use of Papilocare® is not recommended or its use has contraindications.
2. Fertile women who do not use effective contraceptive methods, pregnant women, women with suspected pregnancy or intention to become pregnant within the next 6 months, or breastfeeding women.
3. Women who use vaginal contraceptives or other vaginal hormone treatments during the study.
4. Participation in another clinical trial either currently or 4 weeks before enrolling in the study.
5. Any scheduled surgery that precludes compliance with treatment.
6. Known allergies to any of the ingredients of Papilocare®.
Use of Dexamethasone in Uterine Artery Embolization

The primary purpose of this study is to investigate the effects of dexamethasone on inflammatory reactions after uterine artery embolization. The secondary purpose of this study it to investigate the effects of dexamethasone on postembolization syndrome (severe pain, nasea and vomiting).


Eligibility Criteria:
Inclusion Criteria:

* Uterine artery embolization due to multiple myoma or adenomyosis

Exclusion Criteria:

* Diabetic mellitus
* Steroid administration
* Liver or kidney dysfuntion
* High baseline CRP or leukocytosis (\>11,000/μL )
* Drug allergy
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following HTO/DFO/TTO

A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years of age
* Patients undergoing HTO/DFO/TTO.
* American Society of Anesthesiologists (ASA) I or II

Exclusion Criteria:

* Patients younger than 18 and older than 75.
* Patients with multi-ligament injury
* Patients undergoing concomitant cartilage procedure or ACLR.
* Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
* Patients who are allergic to oxycodone;
* Patients with diagnosed or self-reported cognitive dysfunction;
* Patients with a history of neurologic disorder that can interfere with pain sensation;
* Patients with a history of drug or recorded alcohol abuse;
* Patients who are unable to understand or follow instructions;
* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
* Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
* Patients with a BMI over 45;
* Any patient that the investigators feel cannot comply with all study related procedures;
* Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education

Our primary goal is to conduct a pilot study of the effects of a new potential strategy for youth substance abuse prevention - science-based drug education integrated into the high school science curriculum. Through this pilot study we propose to: (1) demonstrate that this new strategy shows promise, and (2) estimate the effect size for the intervention.

NIDA, in recent years, has put resources into summarizing and synthesizing cutting-edge medical and basic science research discoveries about the short-term and long-term effects of drug use on the developing brain. One outcome of this results was the production of a science-based drug education program entitled "The Brain: Understanding Neurobiology Through the Study of Addiction." This is a 5-lesson module for high school science classes that teaches about brain structure and function, how drugs affect and change the biology and chemistry of the brain, how addiction occurs in the brain, and that addiction is a chronic, recurring disease. However, the effect of receipt of this program on students' substance use knowledge, attitudes, perceived risk of harm, and behavior has not been systematically evaluated to date.

The specific aims of this project are:

1. To evaluate the effects of receipt of the curriculum on specific cognitive contributors to substance use including a)students' knowledge about the short- and long-term effects of substance use on the brain; b)perceived risk of harm from substance use; and c)intention to use substances in the next 3 months.
2. To evaluate the effects of the intervention on actual substance use behavior. We hypothesize that the effectiveness of this approach may be modified by the students' level of prior and current substance use, with the effect being stronger among those who have not already initiated use, or among those who have very low use. Therefore, we will specifically examine whether the intervention a)prevents substance use initiation among students who had no previous use, b)stops use among students with low lifetime use, and c) reduces use among those with higher levels of use.

Eligibility Criteria:
Inclusion Criteria:

* Student in 9th/10th/11th grade science classes at Fenway High School at start of study or student in 11th grade science classes at Boston Arts Academy at start of study
* Parental permission to participate

Exclusion Criteria:

* No parental permission to participate
* Unable to read English
Diurnal Variation in Tear Osmolarity

The purpose of this study is to measure the change in Tear Osmolarity during the course of the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and differentiate between the two forms of dry eye.

The premise of this study is that dry eye disease, specifically tear osmolarity, changes during the course of the day based on the etiology of the dry eye and that aqueous-deficiency dry eye will worsen during the course of the day while meibomian gland deficiency will stabilize or possibly even improve during the course of the day.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females ≥ 18 years old
2. Negative urine pregnancy results for females of childbearing potential
3. Able to read and sign an informed consent form and show willingness to comply with the study protocol visits and procedures
4. Has 20/40 BCVA or better in at least one eye
5. Does not currently wear contact lenses
6. For Aqueous-Deficiency Group:

   * Has symptoms of Dry Eye
   * Schirmer testing ≤ 10 mm
   * Tear Break Up Time ≤ 8 seconds
   * Conjunctival staining ≥ 1+
   * Meibomian gland inspissations ≤ 1+
   * No lid thickening, lid erythema, or thickened, turbid meibomian gland secretions
7. For Meibomian Gland Disease Group:

   * Has symptoms of Dry Eye
   * Schirmer testing ≥ 10 mm
   * Tear Break Up Time ≤ 8 seconds
   * Conjunctival staining ≥ 1+
   * Meibomian gland inspissations ≥ 2+
8. For Normal Group:

   * Has no symptoms of Dry Eye
   * Schirmer testing \> 10 mm
   * Tear Break Up Time \> 8 seconds
   * No or trace Conjunctival staining
   * No Meibomian gland inspissations

Exclusion Criteria:

1. Any topical medication within the last three months, except for artificial tears
2. Unable to discontinue use of artificial tears during the course of the day for Visit 2
3. Any Systemic disease, which in the opinion of the Investigator, may affect ocular health or confound study results
4. Any active ocular disease other than Dry Eye Disease, Meibomian Gland Disease or Sjogren's Syndrome, which in the opinion of the Investigator, may affect ocular health or confound study results
5. Clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
6. Clinically significant limbal or bulbar injection, or corneal staining not due to DES
7. Has worn hard or rigid gas permeable contact lenses within 1 year
8. Has worn soft contact lenses within 1 week
9. Has had eye surgery or an eye injury within 6 months
10. Positive urine pregnancy results for females of childbearing potential
11. Any changes in current medication within 30 days of Visit 2 or anticipated change during course of study, which in the opinion of the Investigator may confound study results
Estimation of Neuromuscular Recovery - a Validation Study

Neuromuscular blocking (NMB) agents are used in the vast majority of surgical interventions. Although pharmacokinetic and pharmacodynamic data are available, there is a large interindividual variability in the time needed for recovery after neuromuscular blocking agents. In a previous study (NTC03550664) a mathematical model in order to estimate for each patient the time needed for full recovery based on the first measurable elements of train-of-four (TOF) recovery was established. After the first 14 TOF measurements, the estimated time to reach a recovery of 90%, expressed as % of recovery per 10 min, is calculated.

In this study, this algorithm will be evaluated on a new cohort of patients in order to measure its accuracy and precision. Patients scheduled for surgery with a single dose of 0.6 mg/kg of rocuronium will be included in this prospective observational study. Neuromuscular transmission will be measured at the adductor pollicis using the TOFScan (IdMed, Marseille, France), a CE approved, commercially available monitor for neuromuscular transmission. TOF ratios will be measured every 30 s and recorded on a PC connected to the TOFScan. According to our algorithm, patients will be classified as slow, intermediate or fast recovery; speed of recovery will be measured as % of recovery per 10 min. A McNemar test will be used to assess the correct classification of patients in each group. Accuracy of the estimated speed of recovery will be assessed by comparing to the 95% confidence interval of our model. If real speed of recovery falls within the 95% confidence interval of the model, the model will be classified as accurate. These measurements will be done at 2 time points: - first estimation available and - after TOF ratio has recovered to 40%.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients scheduled for surgery with a single bolus administration of 0.6 mg/kg of rocuronium

Exclusion Criteria:

* patient refusal to participate
* known or suspected allergy to rocuronium
* Body mass index \< 20 kg/m2
* Body mass index \> 30 kg/m2
* hepatic insufficiency, either clinical or hepatic test abnormalities
* renal insufficiency defined as a clearance \< 40 mL/min (calculated by the Modification of diet in renal disease (MDRD) formula
ESWT for Shoulder Pain in Patients With Brain Damage

This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.

6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/mm\^2, tolerable range) on subscapularis and lesser and greater tuberlces of humerus to reduce pain in patients with brain damage

Eligibility Criteria:
Inclusion Criteria:

* Brain damaged patient confirmed in the brain image
* 1 month after brain damage
* Pain in hemiplegic shoulder areas more than 4 points on the numerical scale (NRS)
* Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
* Age: 20 and older
* Person who has agreed in writing to decide his or her participation and comply with the precautions

Exclusion Criteria:

* Pain due to trauma
* Injection treatments two weeks before participating in the study
* Severe coagulopathy (excluding antiplatelet use)
* Impaired cognition
Effects of Intranasal Oxytocin on Emotion Regulation in Adolescents

The purpose of this study is to determine the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with parents.

Emotional dysregulation and impaired attachment in adolescence are seen by clinical researchers as potential contributors to development of psychopathology. Recent evidence suggests that administration of intranasal OT may facilitate social interaction by attenuating the stress response to interpersonal conflict. However, to date there have been no studies investigating the effects of intranasal OT on parent-adolescent interaction and on neurophysiological emotional strategies in adolescence. To understand these mechanisms, this study examines the effects of OT on interpersonal emotional regulation in adolescent-parent stressful interaction, and on individual visual and physiological strategies in the visualizing attachment-related emotions pictures.

The main objective will be to evaluate the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with one of his parents.

Secondary is determine the effect of OT on visual exploration strategies and on the physiological responses (heart rate, galvanic skin response) on images elicited attachment-related emotions in insecure adolescents.

In this randomized, double-blind, placebo-controlled, parallel designs, 60 healthy male adolescents classified with an insecure attachment will receive 24 IU of intranasal OT or placebo, 45 min before the experimental tasks. Adolescent will be invited with his/her parent to an experimental conflict discussion. The conflict session will be videotaped and coded for verbal and nonverbal interaction behavior (e.g., eye contact, nonverbal positive/negative behavior, and self-disclosure) with GPACS. Eye tracking and physiological responses will be recorded simultaneously and continuously during pictures viewing.

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of insecure attachment according to the Attachment Scale Interview
* Male adolescents (and parents) enrolled in high school or college
* Not hospitalized
* Without current or past history of neurological or psychiatric illness, including substance abuse or dependence
* Aged from 13 to 20 years
* Speaking French
* Have signed informed consent
* Affiliation to a French social security

Exclusion Criteria:

* Females
* Intellectual deficit
* Severe neurological symptoms
* Known allergies to oxytocin or to preservatives in the nasal spray
* Not speaking French
* Visual disturbances
* Chronic disease (liver failure, kidney failure, cardiovascular disease)
* Antihypertensive therapy
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.

This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.

Clostridioides difficile (C. diff) is a germ (bacteria) that causes life-threatening diarrhea. It is usually a side-effect of taking antibiotics that affect the normal balance of bacteria in the intestines. When the "good bacteria" in the intestine are killed by antibiotics, the C.diff bacteria begin to grow and produce toxins, causing frequent diarrhea and other symptoms such as abdominal pain or tenderness, loss of appetite, low-grade fever, nausea and vomiting. C. diff can be treated by using special antibiotics, but it tends to come back in about 20% of patients. C-diff is problematic because of frequent relapses after apparent cure. The greatest risk factor for relapse is receipt of subsequent antibiotics, in the hospital, shortly after being treated.

Zinplava™(bezlotoxumab) is an FDA approved human monoclonal antibody designed to prevent the recurrence of C.diff.This is not an antibiotic, as it does not kill C. diff, but is an antibody to C. diff toxins, which stops the damage. When Bezlotoxumab is given during a C. diff infection together with antibiotics to kill C. diff, it decreases the risk that C. diff will come back by about one-half. Bezlotoxumab is approved for use when given during a C. diff infection, but it has not been used to prevent C diff in other situations, such as the one being studied in this research.

Eligibility Criteria:
Inclusion Criteria:

* C diff diagnosed within 90 days
* Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an inpatient setting
* Age 60 years and older

Exclusion Criteria:

* Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin, metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs.
* Not Expected to survive 8 weeks
* Prior or planned fecal microbiota transplant or Bezlotoxumab use
* Congestive heart failure (a potential risk of Bezlotoxumab)
Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery

Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This study is aimed at evaluating the relationship between Staphylococcus aureus strains colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing otorhinolaryngologic surgery, unknown Staphylococcus aureus carriage state
* Patient affiliated to French Social Security
* Written consent

Exclusion Criteria:

* Antibiotherapy or infectious episode during the month prior enrollment
* coagulation disorder
* neoplasia of the nasal cavity
Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer

This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in combination with erlotinib or cetuximab administered to patients with certain types of cancer.


Eligibility Criteria:
Inclusion Criteria include, but are not limited to, the following:

1. Confirmed diagnosis of certain unresectable or metastatic cancers
2. Adequate Eastern Cooperative Oncology Group (ECOG) performance status
3. Adequate hepatic, renal and bone marrow function
4. Resolution of toxicity from prior therapy to grade less than/ = to 1

Exclusion Criteria include, but are not limited to, the following:

1. Active brain metastases
2. Thromboembolic events \< 6 months prior to study
3. Patients with a recent history (within 5 years) of another malignancy.
4. Investigational or any antitumor treatment with a maximum of 4 half-lives or administered 30 days prior to the initial administration of REGN1400
5. Patients who are pregnant or nursing
6. Prior treatment with ErbB3 inhibitors