cyrilzakka/clinical-trials huggingface dataset:
Impact of the COVID-19 Pandemic on the Surgical Activity of Bellvitge University Hospital

COVID-19 has been a challenge for hospitals; there was an obvious need to reconvert many spaces in specific areas to attend this pathology, without forgetting the attention to other pathologies and surgery. The objective of the investigators is to evaluate the impact of this pandemic in the patients who underwent surgery in Bellvitge University Hospital, analyzing 2 periods of time: the months before the COVID-19 peak and the COVID-19 peak months.

A total of 2.530 procedures have been evaluated in this retrospective observational study. Two groups have been generated (pre-pandemic period and pandemic period), classified into scheduled and emergency surgery. The investigators determined age, type of surgery and specialty, hospital stay, destination at discharge including mortality and severity according to Diagnostic Related to Group (DRG) scale. The investigators have also determined the number of confirmed COVID-19 infections in patients who underwent surgery during these 2 periods and evaluated if the infection was due to a nosocomial infection (confirmation of the COVID-19 during the hospitalization period). Comparisons were made between subgroups: scheduled surgery performed during the 2 periods and emergency surgery performed during the 2 periods.

Eligibility Criteria:
Inclusion Criteria:

* All surgical patients operated, both elective scheduled and emergent cases

Exclusion Criteria:

* Minor-intermediate surgery that involves discharge from the hospital on the same day of the surgery from the Pre-pandemic period.
* Procedures related to medical treatment or complications of COVID-19 patients, such as chest tubes, extracorporeal oxygenation or tracheostomy.
* Those scheduled elective surgery patients in the Covid period that resulted RT-PCR positive, surgery was posponed, were not considered eligible for the analysis.
A Project to Study Probiotic Beauty Products on Skin Improvement

The aim of the study was to use probiotic beauty products for 4 weeks and evaluate the impact of products on healthy skin.

Twenty subjects were recruited and informed to apply the lotion gel twice per day (3\~5 mg/cm2 once) for 4 weeks. Two kinds of facial lotiongels, "A" gel and "B" gel, were provided to every subject. The "A" gel (TAC/Collagen lotiongel) was applied on subjects' right face and the "B" gel (placebo lotion) on their left face (formula showed as Table S2). Ordinary cosmetics usage was permitted but any change of usage was not allowed during the intervention. Outdoor activities (sun exposure) and the usage of sunscreen lotion were not limited in this study. Every subject was required to inspect his/her skin condition on week 0 and 4. Before inspection, the face was washed with water and waited for 30 min in an air-conditioned room (25°C, humility 55 ± 5%). Among these 20 subjects, eight of them had severe acne with at least two acne lesions on each side of face when participating this trial. They were instructed for more visits to evaluate the symptom of acne on week 1 and 2.

Skin hydration (Corneometer CM825, Courage + Khazaka Electroni, Germany), sebum (Callegari 1930, Italy), and inflammation detection (Chroma Meter MM-500, Minolta, Japan) of upper cheek were measured in every subject. The improvement in inflammation was positively correlated with a decrease of a\* value or an increase of L\* value. VISIA® Complexion Analysis (VISIA® Complexion Analysis, U.S.A.) was also employed to measure the skin inflammation, porphyrins numbers and brown spot numbers of whole face. The result was presented as the mean value and the relative percentage (%) to the baseline.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers aged above 20 years old

Exclusion Criteria:

1. Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
2. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
3. Female who is pregnant or nursing or planning to become pregnant during the course of the study.
4. Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
5. Involuntary subject
6. People who is taking chronic disease medication
A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD relationship.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Male, or female (of non-childbearing potential) subjects

For 'female of non-childbearing potential' at least one of the following criteria must be fulfilled:

* Permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
* Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR, or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria apply
Organizational Change in Dental Care

The proposed research will test the ability of the NIATx Organizational Change Model to improve patient no-show rates as compared to typical training approaches used in dental offices. The purpose of the pilot study is to improve no-show rates and, in the process, test an evidence-based organizational change model that can increase use of evidence-based practices in dental care.

NIATx is not an acronym, it is a proper noun.

For designing the pilot study, it is assumed that the no-show rates in dental clinics will have similar characteristics and response patterns to previous studies.

The preliminary summary data provided by the participating dental clinics, the current average no-show rate is approximately 20%, which would reduce to 10% using the upper limit of the confidence interval from the preliminary data. Based on a simulation study incorporating the above assumptions, with 5 sites each contributing 160 appointments before and after the intervention, the study will have 84% power to detect the hypothesized effect (OR=0.44) at a two-sided 5% significance level. The probability of observing a decrease in no-show rates in at least 4 out of 5 of the clinics is approximately 90%. We expect over 80 appointments per month in each clinic, so the target number of appointments would be expected to be available in 2-3 months.

For the NIATx Fidelity Scale, if an organization has an average score of 2 or higher on the NIATx Fidelity Scale for 8 of the 13 measures that will be considered significant. In a previous study using a similar process, 73% of the organizations that achieved gains of +10%, had 8 measures or more with an average score of 2 or greater, compared to 40% of those who had gains at \<10%.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, staff must be:

* 18 or older
* A paid staff member at a dental clinic participating in the study
* Willing to participate in the interviews and share their ideas and experiences
* Involved in an organizational improvement project at a participating clinic
* Be able and willing to provide verbal consent

Exclusion Criteria:

An individual who does not regularly interact with patients in a dental clinic.
Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer

RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

The study will be proposed to all patients with a metastatic colorectal cancer.

Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form

Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
* Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
* Patient information and written informed consent form signed
* Patient must be affiliated to a social security system
* Age : 18 years and older

Exclusion Criteria:

* Patient bearing non-metastatic colorectal cancer
* Patient with local relapse only
* Patient with exclusive nodal metastases
* Patient whose health contraindicates a 30 ml blood sample
* Blood transfusion within 1 week prior blood collection
* Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
* History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
* Persons deprived of liberty or under supervision
Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure

Cognitive-behavioral therapy (CBT) combined with medication is an established intervention for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded. Moreover, acceptance of drug treatment is partly very low. Professional recommendation of drug treatment besides nicotine-replacement aids is restrained considering side effects and contraindications. Currently, cue exposure is highly discussed as intervention for craving reduction supporting CBT. There is evidence for benefits of cue exposure optimizing smoking cessation outcomes, as well as evidence for efficacy of exposure in virtual reality (VR) up to date.

However, this is the first randomized controlled study focusing on efficacy increases by VR cue exposure supporting an established CBT smoking cessation manual. The control group receives a specific stress reduction treatment (independent of smoking cues), namely, the Progressive Muscle Relaxation (PMR, according to Jacobson) additionally to the established smoking cessation CBT.


Eligibility Criteria:
Inclusion Criteria:

* daily smokers for at least 2 years, smoking minimum 10 cigarettes a day

Exclusion Criteria:

* pregnancy
* current participation in another smoking cessation program within 6 months before assignment
* current diagnosis of a psychiatric disease including a depression or substance use disorder (excluding nicotine dependency)
* lifetime diagnosis of a psychiatric disease : psychosis, bipolar affective disorder, posttraumatic stress disorder, conversion disorder.
Psychological Study in Children With Mucoviscidosis

Cystic fibrosis is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression.

The aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Have cystic fibrosis
* Child aged over 8 years and under 18 years
* Presence of at least one parent at the time of inclusion
* To be present for a scheduled hospitalisation at the Resources and Competence Centres for Cystic Fibrosis
* Do not object to the research

Exclusion Criteria:

* Under 8 or over 18 years of age
* Lack of at least one parent at the time of inclusion
* Presence of chronic co-morbidities
* Difficulty reading and understanding French
* Objection to taking part in research
Median Effective Dose of Dexmedetomidine in Elective Upper Limb Lidocaine Intravenous Regional Anesthesia

Auxiliary drugs augment the effect of local anesthetic in intravenous regional anesthesia (IVRA). The purpose of our study was to estimate the median effective dose (ED50) of Dexmedetomidine in elective upper limb Lidocaine 0.5% IVRA.

Since its innovation in 1908 by Dr August Bier of Germany, Intravenous regional anesthesia (IVRA) has stood the test of time as simple, safe and effective technique of regional anesthesia. 1 The technique entails insertion of intravenous catheter into a surgical limb before isolating it from the general circulation by tourniquet then inject local anesthetic (LA) into this isolated limb. 2 IVRA block is preferably used with short surgical procedures or maneuvers of the upper or lower extremity. Nevertheless, the technique has gained popularity for procedures of the upper extremity because of tourniquet issues like tourniquet pain, and other safety concerns that arise more often with lower extremity IVRA, essentially leakage of the of LA.3 Unfortunately, using LA solely for IVRA has not achieved optimum intraoperative analgesia or overcome the frequently reported tourniquet pain.4 A long list of adjuvants, to mention few: morphine, muscle relaxant and clonidine, have been used to augment LA action and ameliorate tourniquet pain. 5 Dexmedetomidine (DEX) a potent α 2 agonist that have unique analgesic, anxiolytic and sedative profile has been called upon as attractive adjunct in general as well as regional anesthesia with enticing results. Several studies have pursued DEX median effective dose (ED50) in different settings e.g., co induction agent with Propofol, in laryngeal muscle insertion and with local anesthetic to enhance the quality of spinal anesthesia. 6 However, DEX effective median dose ED50 with IVRA for upper limb has not been investigated elsewhere, so far. The up and down sequential method of Dixon and Mood is a common sequential design method used in anesthesia research to detect the ED50. It is a sequence of experiments performed under the assumption that "satisfactory response" is followed by decrease in test dose for the next patient in the series, and "non- satisfactory response" is followed by increase in test dose for the next patient in the series. 7 The purpose of this study is to estimate the median effective dose of Dexmedetomidine (DEX) with Lidocaine 0.5% IVRA in upper limb elective surgeries, using modified Dixon's up and down method.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60 years
* American Society of Anesthesiologists physical status I or II
* Undergoing minor upper limb orthopedic surgical procedures in the hand, wrist and forearms including: metacarpal fracture, tendon injury, and carpal tunnel release.

Exclusion Criteria:

* Allergy to test drugs.
* vascular disease.
* contraindication to tourniquet applications.
* difficulty to manipulate the surgical limb.
* surgery expected to last more than an hour.
* patient refusal
High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.

Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.

All patients will receive prehabilitation preoperatively for 4 weeks, that is composed of 3 elements, exercise, nutritional supplements and psychological coping strategies. Both exercise protocol will be supervised, 3-time per week, in-hospital programs. Patients will be randomized to perform either HIT or MC training. Exercise intensity will be defined and personalized on the individual values at cardiopulmonary exercise testing (CPET). Patients' nutritional status and dietary intake will be assessed by the nutritionist, and supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible to enter the study will include those aged 18 and above and referred electively for resection of malignant colorectal lesions.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions interfering with the ability to perform exercise at home or to complete the testing procedures. Poor English and French comprehension.
Infrared for Peripheral Venous Catheterization in the Critically-ill

Peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications.

Venous access difficulties are frequent in critically-ill patients. Among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. Infrared illumination has never been evaluated in intensive care. However, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. Our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique The objective is to evaluate the interest of infrared illumination (AccuVein AV500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult.

It is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase III trial. Subjects will be divided into two groups with a 1: 1 ratio. Nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years; Hospitalization in intensive care;
* Need for a peripheral venous catheter;
* Risk of difficult peripheral venous catheterization. In practice, this risk will be considered present if it is impossible to palpate and / or visualize the upper end of the target vein and / or if the estimated vein diameter is smaller than 2mm. This definition is derived from the A-DIVA score (Loon FAJ van et al3).
* Affiliation to the social security

Exclusion Criteria:

* Patient who has already been enrolled in the ICARE study during the current hospitalization;
* Refusal of patient's participation
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0

Sexual violence (SV) is a significant public health problem particularly among 18-24 year old populations. A major risk factor for SV is alcohol use, which via its negative impact on cognitive abilities and decision-making acts as a barrier to intervening in situations at-risk for a SV. This study has two main goals: (1) to determine the effects of proximal alcohol use on young (age 21 to 25) men's prosocial bystander behavior in situations considered at-risk for SV, and (2) to determine the efficacy of an evidence-based, web-based program called RealConsent, which has been augmented to include alcohol-specific content within the context of bystander SV ("RealConsent2.0"), on men's prosocial bystander behavior. The primary study endpoint is prosocial bystander behavior and will be assessed via two modes: (1) a virtual reality (VR) environment ("B-SAVE") and (2) a validated self-report measure of bystander behavior that has been modified to include assessment of proximal alcohol use and presence of alcohol within the context.


Eligibility Criteria:
Inclusion Criteria:

* identify as a man or transgender man, age (21-25)
* consume weight-based amount of alcohol at least three times during the past year

Exclusion Criteria:

* weight over 250 pounds
* current treatment-seeking for an alcohol use disorder
* any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration.
* in a relationship over 6 months
* married/living together
* Neurological Disorder: diagnosis of a neurological disorder
* Psychiatric Disorder: past or current diagnosis of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, or any other psychotic disorder
* Treatment for Alcohol or Drug Use: currently being treated for alcohol, or drug problems; currently interested in seeking treatment for drinking or drug use
* Physical disability: anh physical disability that would prevent an individual from participating in the virtual reality task (self-report and determined)
* Significant Hearing Problems: significant hearing problems that would prevent an individual from hearing and responding to the virtual reality task (self-reported and determined)
* Cardiac Pacemaker
* Asthma: emergency room visit related to asthma in the past year; use of inhaler more frequently when drinking alcohol; use of oral steroid treatments for asthma in the past year;
* Legal: any legal restrictions against drinking (e.g., as a condition of probation or parole)
* Alcohol Abstinence: individuals who consume alcohol monthly or less; individuals who have consumed the amount of alcohol they would be expected to drink during the lab session (determined by their weight) less than 3 times in the last year
* Head Injury: any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
* Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory