cyrilzakka/clinical-trials huggingface dataset:
Appropriate Laryngeal Mask Airway Size in Patients With Overweight: A Comparison of the Actual Body Weight and Ideal Body Weight

The classic laryngeal mask airway is one of the keystones of modern anaesthetic practice. It achieves a reliable airway with a low incidence of major complications and pharynges-laryngeal morbidity. The manufactures of laryngeal mask airway recommend the proper size selection by actual body weight. It was recommended a size 3 for 30-70kg, a size 4 for 70-90 kg, and size 5 for \> 90 kg. Obesity increases the fat tissue around an upper airway and decreases the pharyngeal cross sectional area. Also it was reported that pharyngeal area was reduced according to the increasing of BMI. Therefore, the aim of this study is to determine which of actual body weight or ideal body weight is proper on the size selection of laryngeal mask airway.


Eligibility Criteria:
Inclusion Criteria:

* age 20\~70
* body mass index \> 25 kg/m2
* patient who needs surgery with laryngeal mask airway

Exclusion Criteria:

* difficult airway
* upper airway infection or disease of airway
* history of gastroesophageal reflux
* history of head and neck surgery
National Plaque Registry and Database

The ultimate goal of this project is to develop a risk score to identify patients with vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome. Early identification of vulnerable plaques may have an enormous impact on public health through primary and secondary prevention of acute myocardial infarction.

Investigators hypothesize that a risk score that incorporates non-invasive coronary CT imaging (calcium score and/or coronary CTA) in combination with clinical characteristics (classical risk prediction models) will improve the identification of patients who are at highest risk to suffer myocardial infarction or sudden cardiac death.

The overall goal of the OPeRA project is to develop, implement and validate a novel risk assessment tool based on image markers and clinical characteristics to identify patients who are at increased risk to suffer myocardial infarction or sudden cardiac death.

The primary goals of OPeRA consortium:

To develop a national coronary CTA registry with the collaboration of all major cardiac CT centers of Hungary (Országos Plaque Regiszter és Adatbázis - NatiOnal Plaque Registry and DAtabase, OPeRA).

1. To develop a novel risk assessment tool (OPeRA score) based on image markers and clinical characteristics.
2. To identify and validate novel vulnerable coronary plaque image markers and assess their prognostic value.

Secondary goals:

1. To develop a standardized and structured, national coronary CTA reporting system.
2. To establish a national quality control system that monitors the quantity of iodinated contrast agent and the patients' radiation dose.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Subject providing written informed consent
* Scheduled to undergo a clinically indicated coronary CTA

Exclusion Criteria:

* Age \<18 years
* Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
* Recent prior myocardial infarction within 30 days prior to coronary CTA or between coronary CTA and ICA
* Pregnancy or unknown pregnancy status in subject of childbearing potential
* Subject requires an emergent procedure
* Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
* Inability to comply with study procedures
What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials

An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.

The study focuses on defining the problem of geographical accessibility of patients to the Phase 1 facility of the European Institute of Oncology, based on an anonymized extraction of data from the enrolled patient database, to assess national territorial disparities in access to innovative experimental therapies, in relation to various socioeconomic determinants. Finally, information on relevant psychological factors for participation in clinical trials will also be collected.

Eligibility Criteria:
Inclusion Criteria :

* Patient with a histological or cytological diagnosis of solid or hematological tumor.
* Age ≥ 18 years.
* Patient enrolled in a phase 1 and early phase 2 study at our institution.
* The patient has received at least 1 administration of the experimental drug under study in the early phase trial.

Exclusion Criteria :

- Patients treated in phase 1 trials at other institutions, even if referred to our division or receiving standard therapies at IEO but outside of clinical trials, are not included.
Face-to-Face Versus Distance Learning of Basic Suturing Skills

The main objective of this study is to determine the acceptability and effectiveness of Distance Learning (DL) of basic suturing skills in novice learners.

A prospective randomized controlled trial involving 118 pre-medical and medical students with no previous experience in suturing was conducted. Participants were randomized into two groups for learning simple interrupted suturing: F-F and DL groups (59 students in each group) . Evaluation was conducted by two independent assessors. Agreement between the assessors was calculated, and performance scores of the participants were compared between the two groups.

All the participants demonstrated their ability to place three interrupted sutures, with no significant difference in the performance between the two groups. All the respondents positively rated the teaching sessions, found them useful and enjoyable.

Distance learning of basic suturing is as effective as the face-to-face approach in novice learners

At our hospital, during the initial lock-down period in March and April 2020, all medical students' clinical clerkships were temporarily cancelled, and their educational activities switched to web-based remote learning, utilizing teleconferencing and commercially available web-based interactive clinical modules. Teaching surgical technical skills, such as basic suturing, presented itself as a more challenging component of the clinical education under these unusual circumstances as compared to teaching cognitive skills and knowledge, which raised questions and concerns around the effectiveness and acceptability of distance learning of basic surgical skills.

In this study, the investigators aimed to compare the effectiveness and retention of distance learning to the traditional face-to-face learning of basic (simple interrupted) suturing in novice learners. This study entails a prospective randomized trial involving two arms (traditional face-to-face versus distance learning of basic simple interrupted suturing) in pre-medical students as well as first and second year medical students at the American University of Beirut (AUB). Immediately after the teaching session as part of research, two independent surgeons assessed the students' simple interrupted suturing performance using a validated checklist and OSATS global rating.

The difference in performance was used to determine the effectiveness of distance learning of basic suturing as compared to the traditional instructional method. In addition, the students in both groups were asked to complete a questionnaire (immediately after the teaching session) to investigate their satisfaction and confidence.

Eligibility Criteria:
Inclusion Criteria:

* Pre-medical, first, and second-year medical students with no previous experience in suturing.

Exclusion Criteria:

* Previous experience in suturing.Refusal of enrolment.
Iressa/Docetaxel in Non-Small-Cell Lung Cancer

Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may continue on daily Iressa until progressive disease and/or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer.
* Measurable, evaluable disease outside of a radiation port.
* ECOG performance status 0-2.
* Adequate hematologic function as defined by an absolute neutrophil count \>= 1,500/mm3, a platelet count \>= 100,000/mm3, a WBC \>= 3,000/ mm3, and a hemoglobin level of \>= 9 g/dl.
* One prior chemotherapy regimen. This may include chemoradiation treatment.
* Disease progression or recurrence within 6 months of last dose of chemotherapy in first chemotherapy regimen.
* At least a 2-week recovery from prior therapy toxicity.
* Signed informed consent.
* Prior CNS involvement by tumor are eligible if previously treated and clinically stable for two weeks after completion of treatment.

Exclusion Criteria:

* Prior Iressa or other EGFR inhibiting agents
* Prior docetaxel therapy
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
* Incomplete healing from previous oncologic or other major surgery.
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, St John's Wort, anti-coagulants.
* Absolute neutrophil counts less than 1500 x 109/liter (L) or platelets less than 100,000x 109/liter (L).
* Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
* In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
* A serum creatinine \>= 1.5 mg/dl and calculated creatinine clearance \<= 60 cc/minute.
* Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
* Pregnancy or breast feeding
* The patient has uncontrolled seizure disorder, active neurological disease, or Grade \>= 2 neuropathy
* The patient has received any investigational agent(s) within 30 days of study entry.
* The patient has signs and symptoms of keratoconjunctivitis sicca or incompletely treated eye infection.
Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder

The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.

The present study aimed at evaluating the efficacy of mindfulness skills (M) versus interpersonal effectiveness skills (IE) on borderline symptoms. For that purpose, a randomized, active-controlled clinical trial was designed. 64 participants with borderline personality disorder (BPD) diagnosis were allocated to mindfulness (n=32) or interpersonal effectiveness skills (n=32). Both interventions were delivered over a 10-week period. The borderline symptom list (BSL-23) was elected as the primary outcome measure. Mindfulness related capacities, decentering and cognitive processing of social interactions were also evaluated with the Five Facet Mindfulness Questionnaire (FFMQ), the Experiences Questionnaire (EQ) and the Multidimensional Scale of Social Expression (EMES-C), respectively. Assessments were conducted pre and post interventions.

Eligibility Criteria:
Inclusion criteria:

* Ages between 18 and 45 years
* BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)

Exclusion Criteria:

* Lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder or mental retardation
* Participating in any sort of psychotherapy during the study or having participated in dialectical behavioral therapy groups in the past
Treatment and Prognosis of Patients With Chronic HBV Infection

Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.

Patients with chronic HBV infection were recruited in the current study and divided in to peg-IFN-alpha alone group, NAs alone group and the combination therapy group. The serum HBV DNA level, HBV serological test and biochemical examination including serum transaminase level and AFP were recorded every three or six months. The serum, feces, urine and liver (if necessary) samples were collected during follow-up. And the clinical outcomes of patients were evaluated. The clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.

Eligibility Criteria:
Inclusion Criteria:

patients with evidence of chronic HBV infection

Exclusion Criteria:

chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.
Effect of Using Oxygen on the Diaper Dermatitis in Infants

Background: Airing the diaper area has a positive effect on dermatitis. In addition, it is reported in the literature that oxygen is effective in wound care. The aim of our study is to investigate the effect of oxygen on infant diaper dermatitis.

Method: The study population consisted of infants will admit to the neonatal intensive care unit of a public hospital in Istanbul between October 2022 and April 2023. Sixty newborns who met the study criteria will randomly divide into two as the experimental (n=30) and control (n=30) groups. Personal data form and diaper dermatitis observation form will be used to obtain the data. All babies' diapers will be changed 8 times a day. Oxygen flow will be applied to the experimental group for one hour after each diaper change. The degree of diaper dermatitis will be evaluated every 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Approved by the family for the study
* Born between 34-42. gestational weeks
* No skin disease other than diaper dermatitis
* No skin lesions of another disease other than dermatitis-related lesions in the gland area
* Newborns who has stable vital signs

Exclusion Criteria:

* Having a skin disease other than diaper dermatitis
* Having a lesion on the skin due to another disease
* Having a known skin allergy
* Born before 34. gestational weeks
* Having a gastrointestinal disease
A First-in-Human Study of BNZ132-1-40

This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.

This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.

Eligibility Criteria:
Inclusion Criteria:

* males and non-pregnant, non-lactating females
* no ongoing clinically significant medical condition
* willing and able to provide informed consent
* no use of Rx or OTC medications, other than oral contraceptives

Exclusion Criteria:

* Recent systemic infections
* Clinically-significant abnormal clinical labs, ECG or physical examination
* Immunization 30 days prior to study
Intense Airway Eosinophilia in Asthma

In asthma, the type and importance of the inflammatory response in the airways has allows identification of different phenotypes. Of these, one of the most common is eosinophilic asthma, based on induced sputum differential cell count. Patients with severe asthma and an eosinophilic asthma phenotype have different pathophysiological characteristics than those seen in patients with with mild asthma. However, few studies have compared patients with eosinophilic phenotype according to the severity of asthma. In addition, the stability of the phenotype based on the sputum results has been criticized.

This study aims to describe the characteristics of patients with eosinophilic asthma phenotype according to the severity of asthma and determine the stability of the phenotype.

Characteristics of asthmatic subjects with sputum eosinophilia will be compared according to asthma severity.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* With a proven diagnosis of asthma as defined by one of the above criteria of current guidelines (36):

  1. Forced expiratory volume in one second (FEV1) increase by at least 12% (and ≥200 ml) after administration of a bronchodilator
  2. Current asthma symptoms and a methacholine provocative concentration inducing a 20% fall in FEV1 (PC20) \<16 mg/ml
  3. A respirologist's current diagnosis of asthma found in the patient's medical report 3. Non-smokers or smokers/ex-smokers defined as someone with a smoking history \<10 pack-years 4. With sputum differential cell count result 5. Considered to receive optimal treatment for their disease (as per current guidelines except for patients included in exploratory objective 1.

     6. Stable asthma and asthma medication for at least 4 weeks before data analysis 7. Written informed consent obtained for inclusion in the database

     Exclusion Criteria:
     1. Any respiratory disease apart from asthma
     2. Current or ex-smokers should not have a smoking history ≥10 pack-year before data analysis. Patients who administer nicotine in other forms (patches, chew tobacco, e-cigarette, etc.) will be excluded
     3. Unstable asthma medication \<4 weeks before data analysis
     4. Asthma exacerbation (see definition below) \<4 weeks before data analysis
     5. Respiratory tract infection \<4 weeks before data analysis
Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers

The purpose of this study is to examine the changes of factors including Vascular Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area and ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser Therapy(LLLT).

Defects in vessels and neovascularization makes diabetic chronic wounds difficult to treat, A decrease of angiogenic factor expression such as Vascular Endothelial Growth Factor(VEGF) and its receptors is involved in angiogenesis inhibition in diabetic ulcers. LLLT as a therapeutic treatment modality can effect on release of these factors and angiogenesis in wound site.

The purpose of this study is to examine the changes of factors including VEGF, VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area in ischemic diabetic foot ulcers after LLLT, Therefore, the investigators can evaluate molecular process of angiogenesis, as a mechanism of useful effects of LLLT.

In order to patients with ischemic diabetic foot ulcers(DFU) assigned into LLLT with Ga-As(904 nm) laser and placebo groups and will be treated for 12 sessions, every other day. On the first and last (twelfth) treatment session, before and after intervention, Blood sample are taken from all patients in the both groups for VEGF, VEGFreceptor-2, NO and HIF-1α measurement. Wound surface area and oxygen saturation of peripheral blood and ankle-brachial index (ABI) are measured at first and twelfth treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic diabetic foot ulcer
* Wagner classification DFU 2
* 0.5\<ABI\<0.9
* Mild to moderate diabetic neuropathy

Exclusion Criteria:

* Fracture in a lower limb
* A severe infection
* A malignancy
* Kidney failure
* Skin diseases
* Osteomyelitis
* Pregnancy
Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

This study aims to identify differences and similarities between superficial pressure ulcers (category II and III) and incontinence-associated dermatitis (category IIA) at tissue level.

Skin biopsies will be obtained from 30 patients with pressure ulcers (n = 10), incontinence-associated dermatitis (n = 10), and combined lesions (n = 10).

The results from the histopathologic examination will be compared with the clinical diagnosis by wound care experts, which will be based on photographs and relevant patients' characteristics.

Despite current preventive strategies, prevalence of pressure ulcers and incontinence-associated dermatitis (IAD) is still estimated at 5.9-6.9% in hospitalised patients, and 5.0-5.9 in home care patients. Both skin conditions may occur in the same body region but are considered as separate entities, based on differences in etiology.

At tissue level, it is assumed that pressure ulcers are characterised by ischemia and tissue deformation. In contrast, IAD is assumed to be characterised by an irritative pattern. These assumptions are reflected in current preventive strategies. However, a small scale study, performed by Houwing et al. (2007), described the additional presence of an ischemic pattern in patients with IAD. More insights into the histopathologic pattern of pressure ulcers and IAD is needed to optimise current preventive strategies.

Tha aim of this study is to compare superficial pressure ulcers (category II and III) and IAD (category IIA) at tissue level.

A prospective interventional study will be performed during which skin biopsies (punch biopsies) will be collected from 30 incontinent patients. In each patient patient, two punch skin biopsies will be performed, one at the border of the skin lesion and one at the adjacent healthy skin. Sections from the biopsies will be stained with hematoxiline and eosine and examined by two independently working, blinded skin pathologists. In addition, photographs from the skin lesions will be analysed by 10 national and international wound care experts to promote correct diagnosis. Finally, findings from the histopathologic examination will be compared with the clinical diagnoses based on photographs.

Eligibility Criteria:
Inclusion Criteria:

* Incontinent for urine, stool, or both
* Superficial pressure ulcer (category II or III) and/or incontinence-associated dermatitis (category IIA)
* Expected length of stay of 7 days following punch skin biopsy

Exclusion Criteria:

* Skin infection at biopsy site
* Medical contraindication to obtain a biopsy
* End of life care
* Not able to provide informed consent