cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD.

Secondary objectives are to:

* Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD
* Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD
* Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD


Eligibility Criteria:
Key Inclusion Criteria:

1. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit
2. Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits
3. IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits
4. ≥10% Body surface area (BSA) of AD involvement at the screening and baseline visits
5. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable

Key Exclusion Criteria:

1. Participation in a prior anti-Interleukin (IL)-33 medication clinical study
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
3. Having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

   1. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc)
   2. Phototherapy for AD
4. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
6. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit
7. Known or suspected history of immunosuppression
8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
9. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: Other protocol defined Inclusion/Exclusion Criteria apply
Clinical and Echocardiographic Management of Patients With Heart Failure and Diabetes: SCODIAC Follow up Study

The study has been carried out to determine diagnostic and therapeutic pathways in a group of HF diabetic patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy.

406 patients affected with heart failure and Type 2 Diabetes Mellitus, referred to Cardiologists and Diabetologists of pertaining healthcare districts in Campania, and followed for at least one year between 2018 and 2019, were enrolled in this retrospective study and divided in Group A, composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (\>45%) and Group B, formed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%). All patients had performed periodic clinical evaluations and an echocardiographic exam every 12 months. Anthropometric parameters, HF etiology, co-morbidities, complications and ongoing therapies were collected.

Eligibility Criteria:
Inclusion Criteria:

* age at least 65 years
* presence of chronic HF, defined as a stable clinical syndrome with typical symptoms and signs and echocardiographic evidence of cardiac involvement
* New York Heart Association (NYHA) class II-III
* diagnosis of T2DM from at least 2 years

Exclusion Criteria:

* cardiac surgery performed during the last year
* age less than 65 years
* significant valvulopathies
* malignant neoplasms
* advanced chronic kidney disease
Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology

This project aims to investigate the effects of an intervention involving minimalist piano music and bird singing on the anxiety of nursing professionals working in the Oncology sector of a hospital.

The demand for care with mental health of nursing professionals is increasingly present, considering the high rate of anxiety symptoms presented by the teams providing health care within hospitals. Oncology is one of the sectors where professionals have constant contact with situations of suffering and death, being a place where the enlargement of therapeutic tools for handling anxiety symptoms may bring benefits. Scientific literature has never described the effectiveness of works with minimalist music and birds singing used simultaneously with anxiety relief resources. Objective: Assess the effects of music intervention, with minimalist repertoire, with or without association to birds singing over anxiety of nursing professionals that work in Oncology. Method: Randomized Clinical controlled trial. The study will be performed in the Oncology sector of Israeli Hospital Albert Einstein located in São Paulo, Brazil and the population consists in 100 nursing professionals. The intervention will consist in a musical part, especially developed for this study and in recording of birds singing, played live for each one of the participants, individually with 10 to 15 minutes duration. The instrument for anxiety assessment chosen for this project is short-form of state-trait anxiety inventory (STAI-S-6). The project was approved by the research ethics committee, whose identification number on Plataforma Brasil (CAAE) is 59498222.6.0000.0071

Eligibility Criteria:
Inclusion Criteria:

* Nursing professionals working in oncology Unit
* Over 18 years old

Exclusion Criteria:

* Nursing professionals who, for whatever reason, are unable to fully participate of the proposed musical intervention.
Conservative Versus Non-conservative Treatment for Severe Dental Caries

The purpose of this study is to compare the effectiveness of the conservative (pulpectomy) versus non-conservative treatment (tooth extraction) of primary molars affected with severe dental caries associated to oral health-related quality of life, anthropometric and clinical outcomes.

Treatment: evaluate two interventions for treating severe dental caries in primary molared of preschool children.

SAMPLE: preschool children aged 3 to 5 years with severe dental caries (SDC) in primary molars. SDC will be indicated by the Pufa index. The Pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). Children with pufa-score \> 0 in primary molars will be included in the study. All children aged 3 to 5 years, who sought dental screening at the Dental School, University of São Paulo (USP) in August to October 2013 can be initially eligible.

CLINICAL GROUPS RANDOMLY ASSIGNED:

* Group A: Conservative treatment represented by pulpectomies + teeth restoration with composite resin crown.
* Group B: Dental extraction

  * Treatment of carious teeth with pufa score =0 will receive dental fillings (01 occlusal surface affected: ART; 02 surfaces affected: composite resin; ≥ 03 surfaces affected: composite resin crown).
  * One operator (specialists in paediatric dentistry) blinded to the outcomes will carry out the treatments.

FOLLOW-UP: 4, 8 and 12 months.

OUTCOMES: All outcomes will be assessed by a single person interviewer/examiner blinded to the oral treatments groups.

1. Oral Health-Related Quality of Life:

   * Brazilian SOHO-5
   * Brazilian ECOHIS
2. Anthropometric measures:

   * Weight-for-age Z-score (WAZ)
   * Height-for-age Z-score (HAZ)
   * BMI-for age Z-score (BAZ)
3. Dental anxiety (Facial Image Scale).
4. Dental pain (Wong-Baker Scale)
5. Problems in the developing occlusion: loss of space

Eligibility Criteria:
Inclusion Criteria:

* Preschool children with severe dental caries (SDC) in primary molars.
* SDC will be indicated by the Pufa index
* The Pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). Children with a pufa-score \> 0 will be included in the study.

Exclusion Criteria:

* Children with severe crowding of anterior teeth
* Severe arch length deficiencies
* Children with systemic and neurological diseases or those with illnesses that adversely affect growth according to parents reports
* Children on regular nutrition supplements
* Children who had undergone dental treatment in the last three months and who were not willing to participate in the study. Tooth with anomalies, extensive crown destruction and impossibility of absolute isolation in the conservative intervention group.
ISB with SSNB & ANB

This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline).

The study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.


Eligibility Criteria:
Inclusion Criteria:

* a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (MRI)
* acceptance of arthroscopic surgery including rotator cuff repair
* age same as or more than 20 years
* acceptance of preemptive regional block and PCA, and blood testing

Exclusion Criteria:

* did not undergo arthroscopic rotator cuff repair
* stopped PCA before 48 hours postoperatively because of associated side effects
* a history of previous ipsilateral shoulder operation or fracture
* a concomitant neurologic disorder around the shoulder
* a failure of blood sampling including hemolysis, etc.
Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma

A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma.

Patients with severe asthma can be broadly classified into three endotypes (T2, T1, and T17) based on inflammatory cell and cytokine profiles. Within these endotypes, many patients have high levels of neutrophils in the airways and mucosal epithelium. Our preliminary data suggest that neutrophils in the airways and blood of patients with severe asthma are heterogenous and that subsets exist. The nature of these subsets appears to differ between T2, T1, and T17 asthma endotypes.

In order to advance the field and determine the mechanisms that underpin severe neutrophilic asthma, investigators plan to longitudinally assess transcriptional profiles and functional properties of neutrophil subsets that migrate to the nasal cavity following exposure to a standardized dose of Clinical Reference Center endotoxin (IRB#HS-3131-528, IND 018580).

Investigators will recruit 15 subjects of each asthma endotype (45 total participants with asthma) and 15 healthy controls. LPS will be used to elicit migration of neutrophils into the nasal cavities. Neutrophils will be isolated from the nasal cavities using both nasal lavage and nasal brushes 20 minutes, 1 day and 3 days after endotoxin challenge. Neutrophil biology will be assessed using single-cell RNAseq and ex vivo functional assays.

Eligibility Criteria:
Inclusion Criteria:

* Participants will have asthma diagnosed by a health care provider. Healthy controls are individuals without asthma.
* Written informed consent

Exclusion Criteria:

* Current or recent illness (in the past 4 weeks)
* Recent asthma exacerbation (past 4 weeks)
* History of nasal perforation or nasal surgery
* Nasal polyposis
* Presence or prior history of cardiac or systemic disease
* Bleeding disorder, use of systemic anticoagulants, or antiplatelet therapy
* Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants excluding corticosteroids)
* Use of tobacco or marijuana in the past 2 months or greater than a 10 pack-year smoking history
* Currently pregnant or breastfeeding
Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain

Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.

Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients; age between 17-35 years old.
2. Males or Females.
3. Medically-free patients
4. Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
5. Positive patients' acceptance for participation in the study.

Exclusion Criteria:

* Patients who had any analgesic during proceeding 12 hours before the treatment.
* Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess).
* Pregnant females.
* Patients with history of significant medical conditions (contraindication of mannitol use).
* Addiction
* Psycological disturbance.
Intestinal Biomarker Analysis After ECP for ICI Colitis

It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the chnages of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.

It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the changes of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.

Eligibility Criteria:
Inclusion Criteria:

* ICI colitis

Exclusion Criteria:

* no informed consent
Food Allergy Challenge Diagnostic Study

The objective of this study is to correlate various diagnostic measurements taken during an escalating dose oral food challenge to the subject's response. This study will investigate whether non invasive objective biomarkers can indicate a positive response to an escalating dose OFC before a systemic reaction occurs.

Patients often discover their food allergies after consuming a given food and experiencing a subsequent allergic reaction. The majority of patients (75%) will then consult a food allergist for formal diagnosis and treatment information. With respect to patient quality of life, there is tremendous benefit in having a confirmed diagnosis of food allergy as often patients are unsure of the source of their reaction outside the office. Allergists will conduct a Skin Prick Test (SPT) and assess serum specific IgE levels to screen for specific food protein sensitivities. However, a positive response in SPT and specific IgE will confirm only sensitivity, and in more than 70% of cases patients that respond positively to SPT and specific IgE testing will NOT manifest an allergic response to food consumption. To address this issue, most food allergists will recommend an oral food challenge in a controlled setting to confirm the allergic response from consuming the suspected foods. The oral food challenge (OFC) consists of consuming escalating levels of the suspect food, (usually mixed in applesauce or controlled baked goods), until either a reaction manifests or until the challenge is complete with no reaction. The food challenge process poses significant risk to the patient. In 5% of cases, the patient experiences a severe allergic response which requires the use of epinephrine. These responses typically consist of severe reactions in GI or respiratory and arise from challenging patients with higher doses of food allergen then is necessary to prove a mild allergic response, which is directly linked to variability in diagnosis of a positive response, within subjects and within investigators.

The investigators hypothesize that measurements taken using minimally-invasive diagnostic tests during the course of an escalating-dose oral food challenge will be able to detect a positive response before a systemic reaction occurs in the patient and may be able to screen with individuals predisposed to EOE.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race, aged 5 - 35 years with planned clinical oral food challenge;
* Have provided verbal and written informed consent. If under the age of 18, a parent/guardian must provide verbal and written informed consent;
* Be willing and able to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;

Exclusion Criteria:

* Be unable to comply with all study parameters and procedures
Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Rectocele
* Intussusception

Exclusion Criteria:

* Non operability
* inflammatory bowel disease
Matching Glaucoma With Impaired Cognition

Glaucoma is the leading cause of irreversible blindness in the world. The current study is designed to find the underlying relationship between impairment of topological perception and incidence of glaucoma.

Glaucoma is currently the leading cause of irreversible blindness in the world. It has been a difficult task for ophthalmologists and researchers to diagnose glaucoma, especially in early stage. At present, glaucoma diagnosis mainly relies on OCT and visual field test, which have relatively low sensitivity and specificity at the early stage of glaucoma. Previous studies mainly focused on ocular manifestation of glaucoma. However, there was evidence that abnormalities of visual pathway also existed in patients with glaucoma, indicating cerebral cognitive defects may also be involved in glaucoma development. Thus, the current study was designed, in which subjects at high-risk of developing glaucoma are separated into two group based on test results of topological perception. After five years' follow-up, morbidity of primary open-angle glaucoma would be compared between groups to see if there was any relationship between impaired cognitive function and incidence of glaucoma.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18-55;
2. Best corrected visual acuity ≥ 0.6, capable of completing routine glaucoma examinations;
3. Spherical equivalent \< 3D；
4. No history of other ocular diseases (except mild cataract), including diabetic retinopathy, age-related macular degeneration, optical neuropathy, eye trauma, strabismus, nystagmus, severe dry eye, ptosis of the eyelid, etc.

Exclusion Criteria:

1. Unable or unwilling to sign informed consent, or cannot comply with the study protocol
2. Diagnosed with any kind of glaucoma (based on visual field and OCT, etc) or primary angle-closure diseases(primary angle closure suspect and primary angle closure, based on gonioscopy and UBM examination);
3. History of ocular surgeries or laser;
4. Diagnosed with specific neurologic diseases or psychiatric disorders: Parkinson's disease, Alzheimer's disease, anxiety, depression, schizophrenia, etc.(based on scale screening)
5. With severe systemic diseases: diabetes mellitus, hypertension(systolic pressure≥160mmHg or diastolic pressure≥100mmHg ), heart diseases, kidney diseases, rheumatological disorder, digestive diseases, cancer, etc.
6. Pregnancy or lactation
Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture

This study evaluated the outcomes in the early healing of palatal wounds after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique with placement of a collagen haemostatic sponge (CHS) without suturing the palate. The primary outcome of this study was to evaluate the early wound healing index (EHI).

The aim of this study was to compare the outcomes in the early wound healing after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique and collagen haemostatic sponge (CHS) placement, with and without suturing the palate. 36 subjects were randomized to receive (n=18, Suture group-SG) or not a suture (n=18, no Suture group-nSG). Outcomes variables were: Early healing index (EHI) at 7, 14 and 30 days, self-reported pain using a visual analogue scale (VAS) at 7 and 14 days, immediate (iB) and delayed bleeding (dB). Data obtained were compared by Fisher's exact test, T test for independent sample, Mann-Whitney test (U test) and Wilcoxon sign test as appropriate. The level of significance was set at p \< 0.05. Statistical analysis was performed with Infostat version 2015.

Eligibility Criteria:
Inclusion Criteria

* Subjects with an indication of mucogingival surgery for single gingival recession treatment that required harvesting a subepithelial connective tissue graft
* Age \>18 years ≤ 60 years.
* Periodontally and systemically healthy.
* Palatal fibromucosa width ≥ 2mm evaluated with a North Carolina probe placed perpendicular to the hard palate, prior to surgery.

Exclusion Criteria

* Smoking.
* Contraindications for periodontal surgery.
* Subjects presenting coagulation disorders (history of Haemophilia, von Willebrand disease or anticoagulant therapy).
* Subjects taking medications known to interfere with periodontal tissue health or healing.
* Subjects that had been operated on the palate (connective tissue removed) previously from that same donor area.
microRNA Profile in Umbilical Cord Blood NK Cells

Umbilical cords contain immature blood cells, including a group of lymphocytes, that are important in the so-called natural immunity. We want to study the cytokine levels in umbilical cord NK cells and its regulation a family of newly identified small RNAs (microRNAs).

Our preliminary data pointed to the possibility of cytokine regulation by microRNAs in NK lymphoma and NK lymphoma cell lines. We want to use umbilical cord blood as controls for the biological significance in normal NK cell development.

Eligibility Criteria:
Inclusion Criteria:

* Normal pregnant women

Exclusion Criteria:

* None