cyrilzakka/clinical-trials huggingface dataset:
Randomized, Double Blind, Efficacy Study of Escitalopram in ENT Cancer Patients Suffering From Emotional Distress

Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in France since 2002.

Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary regarding the tumor localisation, the population, intensity of the symptoms...

Incidence of ENT cancer is highly significant in France, it is one of the most important in the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of depression is the most important (22%-57%).

Researches appears necessary to assessed the efficacy of antidepressant treatments with as primary objective not only the decrease of depressive symptoms but also an ensemble of physic and psychological symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ENT cancer of stage I to IVb that have to go under surgery and/or radiotherapy and/or chemotherapy as first line treatment. It may be a primary cancer or a new localisation.
* Total score on HADS scale \>11
* Patients aged from 18 to 75 years
* Signed informed consent
* OMS \< 2, hospitalized or ambulatory
* Are authorized to inclusion, psychoactive treatments at stable dosage for two weeks for benzodiazepins, neuroleptics, antihistaminics or other anxiolytics or hypnotics

Exclusion Criteria:

* Patients in palliative treatments
* Previous bipolar disorder or schizophrenia
* Major depressive episode with severity criteria
* Suicidal patients
* Acute infection
* ASAT/ALAT \>3N
* Creatinine clearance \<30 ml/mn
* Natremia inferior to the laboratory standard
* For alcoholic patients non abstinent at the time of inclusion, previous "delirium tremens"
* Previous upper gist bleeding
* Inefficacy or intolerance of previous treatment by escitalopram
* Not compatible concomitant treatment:
* Other antidepressive than escitalopram (except clonazepam)
* all hypnotics (except zolpidem)
* all anxiolytics (except clonazepam, clorazepate and diazepam)
* medical treatment for smoking addiction like bupropion or varenicline
* Pregnant or breastfeeding women
* Patients under guardianship
* Patients without insurance
* Impossibility to follow the protocol for geographical, social or psychic reasons
* Insufficient knowledge of French
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients

The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.


Eligibility Criteria:
Inclusion Criteria:

* Any child 2-12 months old seen in the emergency department.
* A clinical bronchiolitis score \> 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
* Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.

Exclusion Criteria:

* No child will be excluded based on race or gender
* Patients under the age of 2 months or greater than 12 months
* Patients with cyanotic heart disease
* Patients with lobar pneumonia, defined by results of chest radiographs.
* The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
* Patients with croup.
* Patients with foreign body aspiration.
* Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
* Patients with liver or renal disease.
* Patients with sickle cell anemia.
* Patients requiring mechanical ventilation.
* Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
* Patients with tracheomalacia or bronchomalacia.
* Patients who had received bronchodilators within 2 hours of initiation of the study.
* Patients who had received systemic corticosteroids within 72 hours of enrollment
* Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
* Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy

The primary purpose of this study is to compare the remifentanil requirements in deep versus moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic herniorrhaphy.


Eligibility Criteria:
Inclusion Criteria:

* laparoscopic hernia repair

Exclusion Criteria:

* patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease
Molecular Characterization of Patients Affected by Williams Syndrome and Autism.

Williams Beuren syndrome (WBS) is a multiple malformations/intellectual disability (ID) syndrome caused by 7q11.23 microdeletion and clinically characterized by a typical neurocognitive profile including excessive talkativeness and social disinhibition, often defined as "overfriendliness" and "hypersociability". WBS is generally considered as the polar opposite phenotype to Autism Spectrum Disorder (ASD). Surprisingly, the prevalence of ASD has been reported to be significantly higher in WBS (12%) than in general population (1%). This study aims to investigate the molecular basis of the peculiar association of ASD and WBS. The investigator performed chromosomal microarray analysis and whole exome sequencing in six patients presenting with WBS and ASD, in order to evaluate the possible presence of chromosomal or gene variants considered as pathogenic.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of WBS was confirmed by fluorescent in situ hybridization.
* All patients met formal ASD criteria
* written informed consent

Exclusion Criteria:

* None
Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme

Elderly with visual impairment (VI) who undergo community eye screening often do not attend tertiary follow-up even if significant eye diseases are detected. Investigators evaluate an incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits of participants following community eye screening.

A randomized controlled study individuals with VI with baseline visual acuity (VA) and vision-related quality of life (VRQoL) assessed in the community. Participants were randomised to either receiving ICS or usual care (UC). ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals. Participants in UC received a standard GP referral letter advising them to seek further care. Our main outcome measure was compliance to tertiary eye-care referral. Our secondary outcome measure was VA and VRQoL assessed at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* the ability to speak English and/or Mandarin, have adequate hearing with/without hearing aids to respond to normal conversation, not currently undergoing regular assessment/care with an ophthalmologist (at least yearly), have the ability to undergo visual acuity testing and provide reliable results, and visual acuity of 6/12 or worse in either eye after best correction

Exclusion Criteria:

* refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant
Manual Wheelchair Skills Training for Long-term-care Residents

It is hypothesized that, compared to a control group, manual wheelchair users and their caregivers in the long-term-care setting who receive the wheelchair skills training program will improve their wheelchair skills to a statistically significant extent and will retain these improvements for at least one month.


Eligibility Criteria:
Inclusion Criteria (wheelchair user):

* be seventeen (17) or older
* be a manual wheelchair user, living in a long-term-care facility;
* be expected to require the long-term use of a wheelchair (at least four \[4\] hours/week for at least eight \[8\] weeks), as reported by a clinical therapist;
* be competent to give informed consent (as indicated by a Mini Mental State Examination score of 20 or higher) or have a proxy with power of attorney willing to provide consent,
* have the verbal endorsement of the clinical therapist (if any) to participate;
* have the written permission of the attending physician to participate;
* be willing to take part in the study, including signing the consent after carefully reading it.

Exclusion Criteria (wheelchair user):

* have an unstable medical condition (e.g. angina, seizures), as determined by the attending physician, house staff or ERN;
* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending physician, house staff or ERN.

Inclusion Criteria (caregiver):

* be seventeen (17) or older;
* provide at least part-time \[at least one (1) hour/week\] wheelchair-handling care for a wheelchair user in a long-term-care facility;
* be willing to take part in the study, including signing the consent form after carefully reading it.

Exclusion Criteria (caregiver):

* have an unstable medical condition (e.g. angina, seizures), as indicated by self-report;
* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by self-report.
Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia

This retrospective observational study aims to explore the impact of Nocardia infection on the pulmonary microbiota of lung transplant recipients (LTRs). The study will analyze both cross-sectional and longitudinal data from patients diagnosed with Nocardia pneumonia, comparing microbial composition and diversity between infected and non-infected groups. This research seeks to provide insights into the relationship between pulmonary microbiota alterations and clinical outcomes in LTRs.

This study is a single-center, retrospective, observational study designed to investigate the impact of Nocardia infection on the pulmonary microbiota of lung transplant recipients (LTRs). The study will include both cross-sectional and longitudinal analyses. In the cross-sectional study, 17 LTRs diagnosed with Nocardia pneumonia (Nocardia pneumonia group, NPG) will be compared with 51 non-infected LTRs (non-Nocardia infection group, NNIG) matched for age, sex, and underlying conditions.

The longitudinal study will follow LTRs over a 4-month period, collecting samples before, during, and after treatment. Patients in this group will be categorized into the Recovered group (RG) or Not Recovered group (NRG) based on treatment outcomes. The study will also include a subgroup analysis of patients with disseminated Nocardia infection, comparing pulmonary and systemic microbiota changes.

Microbial diversity and composition will be assessed using high-throughput sequencing of bronchoalveolar lavage fluid (BALF) samples. Statistical analyses will include the Kolmogorov-Smirnov test, ANOVA, and Kruskal-Wallis test for group comparisons, with linear mixed-effects models used to analyze changes over time.

The goal of this study is to provide a deeper understanding of how Nocardia infection affects the pulmonary microbiota in LTRs and to identify key microbial species associated with clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipients
* Diagnosed with Nocardia pneumonia (for the study group)
* Age ≥ 18 years

Exclusion Criteria:

* Patients with incomplete medical records
* Patients who survived ≤ 3 days after transplantation
* Patients lost to follow-up
A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt

Hepatitis C virus (HCV) is the major cause of chronic liver disease and has a long-term resultant complications4 and it considered as a major endemic medical health problem in Egypt. It affects multiple organs and reflect various manifestations on oral cavity.The purpose of this study is to assess the prevalence of oral mucosa conditions, type of oral manifestation and gingival lesions in patients with hepatitis C

Study design: It is a cross sectional observational study. Sample size estimation: 100 patients (50 in each groups) A total of 100 adult participants of both genders above 18 years will be included in the study, patients was able and willing to participate in the study. 50 patients will be recruited for study group from consecutive patients previously diagnosed by hepatitis C regardless of the etiology of the condition and regularly attending at Soad Kafay hospital. Participants with history of smoking and alcoholism that could affect their oral health status were excluded. The control group populations will be randomly recruited from the out-patient of dental diagnosis clinic in Misr University For science \& technology university to include total 50 clinically healthy participants, with no history of liver disease, or any other chronic debilitating illness, or habit of smoking or drinking, , as well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy and/or not receiving any medication that could affect oral health.

Changes in the oral cavity was recorded on the entire mucosal surface recording signs, symptoms, and oral lesion absence or presence. All the information will be recorded and the data will be analyzed after the end of the study . The prevalence of various oral manifestations in hepatitis C patients will be documented.

Eligibility Criteria:
Inclusion Criteria:

* patients previously diagnosed with hepatits c, with education, ability and willing to participate in the study

Exclusion Criteria:

* Patients with systemic diseases such as nutritional deficiency; cardiovascular, respiratory, metabolic, and endocrinal disorders; also smoking and alcoholism that could affect their oral health status were excluded. As well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy).
EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

This study intends to determine the effects of Electromyographic biofeedback on performance of pelvic floor muscles in urinary incontinence.

This is a single blinded randomized controlled trial ,will be conducted at Ripha Rehab Clinic,Rawalpindi. (EMG) biofeddback is a adjunct therapy to standard exercise regime for increasing muscle strength,this study is planned to determine the effects of electromyographic biofeedback on performance of pelvic floor muscles, strength,endurance ,rate of biofeedback and its impact on the qulatiy of life (QOL).The sample size was calculated to be n=28 through open-epitool version 3 ,with 95%confidence interval (CI),and power 80%.

After completion of therapeutic protocols, the participant will be assessed with the help EMG-biofeedback, Pelvic Floor distress inventory, King's Health Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Post-partum females
* Persistent urinary leakage at 3 months post-partum period
* Urine leakage with coughing, sneezing or exercise

Exclusion Criteria:

* Neurogenic bladder
* History of pelvic surgeries, pelvic tumors, UTI, urge incontinence, uncontrolled diabetes, cerebral stroke, previous injuries within pelvic
Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions

The Objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd. and distributed by TEVA Pharmaceuticals USA)with that of PROTONIX® 40mg delayed-released tablets (Wyeth- Ayerst) in Healthy, adult, non-smoking subjects under non- fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (Body Mass Index) of 30 or less.

Exclusion Criteria:

* Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular, disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result not to be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/ot plasma for at least thirty (30) days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
* All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be with drawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
Construction and Validation of a Stress Scale Specific to ICUs: Perceived Stressors in Intensive Care Units (PS-ICU)

This study aims to construct and validate an international professional perceived stress scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive Care Units).

Intensive care units take charge of patients who present serious pathological states with an immediate vital risk in an emergency situation. Their treatment requires extensive coordination of human means and sometimes the use of complex procedures and technical means. Moreover, caregivers face the extreme situations of patients and their families coping with death, illness, pain and uncertainty (Weibel et al., 2003).

In this context, numerous stress factors that can have psychological consequences on the professionals and their effectiveness at work are inherent in intensive care (Donchin, 2002; Tummers et al., 2002).

In numerous studies, perceived stress proves to be more predictive of the subsequent health state of the individual than real stress (Consoli et al., 2001). More precisely, the authors have shown the influence of perceived stress on mental health (Ramirez et al., 1996b), psychical health (Chang et al., 2007), burnout (Bourbonnais et al., 1999), job dissatisfaction (Golbasi et al., 2008), absenteeism (Hackett \& Bycio, 1996), turnover (Hayes et al., 2006) and more recently on the security of care (Endacott, 2012).

Identifying the factors of perceived stress is important in terms of mental health at work and the security of care. Studies on perceived stress have made it possible to elaborate stress scales specific to each profession (Borteyrou et al., 2013), with the aim of being as close as possible to the professionals' experience. However, to our knowledge, no stress scale for intensive care units has been published.

This study aims to construct and validate an international professional perceived stress scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive Care Units). Secondary objectives: To identify the factors of perceived stress having an impact on mental health, job satisfaction and the quality of care. To measure the impact of cultural and organizational dimensions on perceived stress in intensive care specific to each country. To measure the impact of socio-demographic variables on perceived stress. To measure the impact of coping abilities on perceived stress.

Eligibility Criteria:
Inclusion Criteria:

* In this step, we will include the services which:

  * Practise an activity of intensive care (whether this practice is medical or surgical, adult or paediatric).

The professionals of ICU who:

* volunteer to participate in the study (and with the consent of the head of the unit),
* Senior physicians, interns, and nurses who have been working in the service for more than three months.

Exclusion Criteria:

Administrative staff, nursing auxiliaries

* Senior physicians, interns, and nurses who have been working in the service for less than three months.
Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers

This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adult aged 19 and more at the time of screening visit
* Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
* No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination

Exclusion Criteria:

* Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
* History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
* As a result of laboratory tests, the following figures: ALT or AST\> 2 times upper limit of normal range
A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen

The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented colorectal cancer plus one of the following:
* Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
* Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.

Exclusion Criteria:

* Prior treatment in first line metastatic setting with more than one regimen
* Prior irradiation of more than 25% of bone marrow.