cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Risk Factors of Anxiety and Depression Among Policemen During the Health Crisis Linked to COVID-19

To date, there is little international data on depression and anxiety among police officers apart from studies carried out after an attack or natural disaster. At the national level, no mental health data exists for police officers, apart from those from the Paris attacks, and the work of investigators after the Strasbourg attack (article in press).

During the covid crisis, in Alsace, the police, like the rest of the population, took the full brunt of the pandemic. The police, however, are part of essential professions and have not been confined, but on the contrary, have remained in contact with the population, in particular to carry out traffic controls. Studies published to date show varying mental health outcomes for essential occupations during the pandemic.

The investigators hypothesize that the police officers had a feeling of being more exposed and that their mental health could be affected. For this it was decided to compare two populations of departments of similar size, but with different exposure to the pandemic: Bas Rhin and Hérault French departments


Eligibility Criteria:
Inclusion Criteria:

* Any major agent in office in June 2020 of the national police of the Bas Rhin department, and Hérault
* Supported between June and September 2020
* Subject not opposing, after information, the reuse of their data for the purposes of this research

Exclusion Criteria:

* Subject having expressed his opposition to his data being reused for study purposes
Effect of the Imera Cultivar Carob in Postprandial Glycemia

An acute randomized crossover study on the effect of a carob beverage on postprandial glycemic response

This is an acute randomized crossover study on the effect of an Imera cultivar carob beverage on postprandial glycemic response in healthy individuals as opposed to sucrose-based beverage containing sugar in alike concentration

Eligibility Criteria:
Inclusion Criteria:

* healthy male adults of normal body fat mass

Exclusion Criteria:

* obesity (according to body fat mass), type 1 Diabetes, hypertension and other cardiovascular diseases, thyroid disorder, liver, kidney, gastrointestinal disease, mental illness, use of nutraceutical supplements or natural products for weight loss and the background of dietitian/nutritionist.
Study to Evaluate Markers of Response in Locally Advanced Breast Cancer

The purpose of this study is to compare the association between image and certain molecular markers with complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.

This is a pharmacogenomic phase II, multicenter, prospective clinical trial whose main objective is to evaluate the association of molecular and imaging markers with the response to bevacizumab administration in combination with docetaxel and doxorubicin as neoadjuvant chemotherapy in patients diagnose with locally advanced breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Signed Informed consent form
* Ages between 18 and 70
* 12 months of life expectancy at least
* Histologically confirmed breast cancer
* No previous treatment for locally advanced breast cancer
* Her2+ o Her2-
* Disease measurable by PET and/or MRI
* ECOG 0-1
* Adequate organic function
* Negative pregnancy test; fertile women must use anticonceptive methods after ICF and 30 days after last study drug administration
* Enough capability to follow the procedures and follow-up test included in the protocol

Exclusion Criteria:

* Metastatic disease
* Inadequate health to receive the study chemotherapy
* Previous breast cancer treatment
* Pregnant or lactating women
* Major surgery or significative traumatic injure in the 28 days previous to inclusion, or during treatment.
* Minor surgery 24 hours before first bevacizumab infusion
* Concomitant or recent aspirin(\>325mg/day)or clopidogrel(\>75mg/day) treatment
* Concomitant or recent oral anticoagulant treatment
* History or evidence or bleeding diathesis or hereditary coagulopathy with bleeding risk
* Uncontrolled arterial hypertension
* Clinical significative heart disease, or uncontrolled severe arrhythmia disorder
* Unhealed wounds, peptic ulcer or bone fracture
* History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess, 6 months before inclusion
* Evidence of any other disease, neurological or metabolical disorder or physical examination or laboratory finding related with any disease that makes the subjet ineligible for the study treatment or that put the subject in risk because of the study treatment.
* Psychiatric disorders that may prevent the subject to complete the study treatment
* Current participation in any other trial involving an investigational drug, or participation in any kind of trial 28 days before inclusion
* Chronical corticosteroid treatment
* Hypersensitivity reaction to bevacizumab or any of its components or any of the other study drugs or components
* Patients diagnosed with different neoplasms the previous 5 years excluding non melanoma skin cancer and resected cervical cancer
Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The purpose of this study is to evaluate the radiological results in the single-stage bilateral TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.

Investigators will enroll 136 participants with primary bilateral symptomatic knee osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA under single anaesthesia after 15.06.2020. Investigators will include patients who were less than 75 years old, with no history of malignancy, without severe extra-articular deformities, and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid obesity (\>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An informed consent form will be obtained from all patients.

Eligibility Criteria:
Inclusion Criteria:

Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization

Exclusion Criteria:

no history of malignancy less than 75 years old without severe extra-articular deformities severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases
Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit

The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results from a study on healthy subjects.

Both studies are done with the use of Motilis 3D-Transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. Position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed.

The study is mainly descriptive and is designed to test and evaluate the usefulness of the Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe inflammation.

Motilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a whole during severe illness.

We expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. We do not expect any drop out, but in case of drop out a new patient will be included.


Eligibility Criteria:
Inclusion Criteria:

* Severe Ulcerative colitis (modified Truelove and Witt score)
* Signed informed consent obtained
* Fasted since midnight

Exclusion Criteria:

* Known GI related symptoms complaints or GI diseases
* Swallowing disorders
* Cancer or other life threatening diseases or conditions
* Pregnancy or breast-feeding
* Previous abdominal surgery
* Abdominal diameter \>140cm?
* Drug abuse or alcoholism
* Irregular bowel movements
* Known cardiovascular or pulmonary diseases
* Participation in any clinical study within the last 30 days
* Cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
* Medication affecting GI motility
* MRI within the next four weeks
Treatment of Clozapine-Induced Hypersalivation Ipratropium Bromide

Hypersalivation (Too much saliva) and drooling is a side effect experienced by 31% of people taking the antipsychotic clozapine. This study aims to determine if using the medication ipratropium bromide(IPB)at bedtime will reduce the amount of salivation and the distress people may feel.

With the recent questions regarding the effectiveness of newer atypical antipsychotic medications in treating schizophrenia, clozapine continues to remain the gold standard for treatment-refractory schizophrenia. However, treatment with clozapine continues to be limited by its many side effects. The second most common side effect, occurring in 31% of clozapine treated patients, is hypersalivation or sialorrhea. Sialorrhea can be profoundly stigmatizing and functionally disabling in certain patients, and may increase discontinuation rates in this high-risk patient population. Several studies have evaluated the efficacy of anticholinergic agents mainly in small, uncontrolled studies or anecdotal reports and are often complicated by difficulties in medication administration and systemic side effects. Open label and case series studies have demonstrated promising results with ipratropium bromide (IPB) treatment of clozapine-induced hypersalivation, acting on anticholinergic receptors with minimal systemic absorption. However, no randomized controlled trials have evaluated IPB in the treatment of this problematic side effect.The primary goals of this study is to determine the efficacy of ipratropium bromide in reducing clozapine-induced hypersalivation, as per the Toronto Nocturnal Hypersalivation Scale, which is a modified hypersalivation scale incorporating the Drooling Severity Scale and the Nocturnal Hypersalivation Rating Scale, and reduced measurements on visual analogue scales for hypersalivation distress and severity. Our hypothesis that Ipratropium bromide use at bedtime will result in a significant reduction in nocturnal clozapine-induced hypersalivation as measured by the Toronto Nocturnal Hypersalivation Scale (TNHS) through its local anticholinergic activity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder as per DSM IV-TR criteria
* Receiving clozapine for at least 2 months
* No change in their clozapine dose for at least 2 weeks
* Have a Clinical Global Impression scale score for hypersalivation of greater than or equal to 4
* Have the capacity to provide voluntary, informed consent
* Able to speak English
* Have a minimum score of 2 on the TNHS prior to study entry
* No change in medications for at least 2 weeks

Exclusion Criteria:

* Subjects with co-morbid medical conditions that could influence hypersalivation (e.g. Idiopathic Parkinson's Disease)
* Subjects currently receiving ipratropium bromide for the treatment of hypersalivation or other medical conditions
* History of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction
* History of an allergic reaction to ipratropium bromide
A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers

This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are:

Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* History of febrile illness within 5 days prior to the first dose.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Accuracy of Scoring Systems for Risk Assessment in Neonatal Intensive Care Unit

Early detection of neonates with higher risk of death is quite important for paying more attention to these cases, timely referral to tertiary neonatal intensive care unit (NICU), and provision of meticulous critical care, which ultimately may improve outcomes. Several scoring systems have recently been developed for assessment of the intensity of illness and prognosticate the risk of not only neonatal mortality but also short- and long-term morbidities. The accuracy of these scoring systems has been investigated in several NICUs from different countries, such as USA, UK, Canada, Brazil, India, and Iran. Previous Egyptian studies have investigated the accuracy of Clinical Risk Index for Babies II (CRIB II), Score for Neonatal Acute Physiology II (SNAP-II) and its Perinatal Extension II (SNAPPE-II). However, the accuracy of Sensorium, temperature, oxygenation, perfusion, skin color, and blood sugar (STOPS), Modified Sick neonatal Score (MSNS), and neonatal sequential organ failure assessment (nSOFA) has not been investigated in Egyptian NICUs. Therefore, more studies are required to investigate the utility and accuracy of neonatal risk assessment scores in Egyptian NICUs.


Eligibility Criteria:
Inclusion Criteria:

* Admission within 24 hours after birth.
* Length of hospital stay at the first admission to NICU ≥12 hours

Exclusion Criteria:

* Major congenital anomalies.
* Discharge against medical advice
* Transportation to other places.
* Missing data on items of scoring systems
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention should be continued and to which time a patient with schizophrenia is protected enough, so that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome.

The main objective of the trial is to evaluate for the first time, how long an antipsychotic relapse-prevention should be continued and to which time a patient is protected enough, so that a guided withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome. We include patients with schizophrenia or schizoaffective disorder in remission for at least 3 years under a stable antipsychotic medication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* The participants have to be in remission for at least 3 years (i.e. no psychiatric hospitalisation) under a stable antipsychotic medication. Remission will be measured using the remission criteria by Andreasen et al. (2005) Score ≤3 for the items concerning psychosis of the "Positive and Negative Syndrom Scale" (PANSS; Kay et al., 1987): "Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) and a score ≤3 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976)
* Able to give informed consent

Exclusion Criteria:

* Actively suicidal
* Serious medical illnesses
* Known non-complience concerning the medication
* Medication with clozapin
* Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment
* Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline
* Unability to give informed consent
* Pregnancy
Water-based Zinc Intervention Trial in Zinc Deficient Children

The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations in developing country rural settings with poor access to potable water.

To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc enriched water) a double blind controlled field efficacy trial will take place over a period of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc enriching filter), placebo (filter) and control group (disinfection tables). During the trial the following outcomes will be monitored: zinc status and growth rate of the participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment of water, and modality and consistency of use of the LSF-device by the study population.

The study hypotheses are: 1) the use of the LSF-device will reduce microbiological contamination of the household water, 2) the use of the LSF-device will increase zinc intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device will increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea episodes in participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy outcome and lower frequency and length of diarrhea episodes in participating pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea episodes in participating households members.


Eligibility Criteria:
Inclusion Criteria:

* 2-5 year old children
* subjects residing in the study area for the whole study period

Exclusion Criteria:

* subject with severe anemia (Hb \< 7 g/dl)
* subjects affected by chronic medical illnesses known to interact with zinc metabolism
* subjects receiving zinc supplementation or other medicines that may affect zinc metabolism
A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial

Traditional directive style of requesting or demanding compliance to set behavior is found to have little effect on patient's self-care behavior. It is reported that patients prefer to restate or rephrase their understanding in a care setting, instead of a directive/didactic approach where the clinician provides 'one-way' information. In fact, directive persuasion is thought to lead to resistance to change and is counter-effective.

New approaches such as open ended communication, interview style and collaborative approach is found to engage patients better in their own care and elicit patient's own intrinsic motivations for making changes. One way to do this is to

1. invite patient to share their thoughts or concerns then
2. clarify patient's understanding

From their responses:

(3a) affirm patient's correct understanding or (3b) address misconceptions with permission.

In this study, the investigators will randomize 240 subjects into two groups: Group A will undergo the above describe collaborative approach to patient education and counselling; Group B will undergo current (traditional, didactic approach) patient education. It is hypothesized that the collaborative approach group (Group A) should experience better understand of their health condition and foot ulcer, be better able to adhere to treatment plan through collaborative participation and overall be more satisfied with the treatment. Outcomes will be tracked at (i) post intervention and (ii) 4 months post intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed type II diabetes
2. Above age 21
3. Plantar foot ulcer - high risk with active full-thickness ulcer
4. Pedal pulses palpable or min toe pressure of 30mmHg
5. Medium of language: English
6. Activities of daily living (ADL) independent (without carer)

Exclusion Criteria:

1. Diagnosed mental health conditions
2. Diagnosed cognitive impairment
3. Diagnosed visual impairment
4. Diagnosed hearing and speech disabilities
Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study

The purpose of this study is to investigate the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment in schizophrenia. To do so the effect of a 3-mA stimulation protocol on neurocognitive functions will be investigated using behavioral performance and fMRI.

Thirty schizophrenic patients will be recruited after meeting the inclusion criteria and will be randomly assigned to active and sham stimulation groups. A single session of concurrent prefrontal tDCS/fMRI will be conducted. Participants will undergo baseline task performance before the intervention. One week later, they will undergo the tDCS intervention (active or sham) next to the scanner during which they perform the working memory task varying in cognitive load. They will perform the task 24 h later again. They will be then transferred to MRI scanner right after stimulation

Eligibility Criteria:
Inclusion Criteria:

* men or women (18-50 yrs old) with a DSM 5 SCZ diagnosis,
* If female, negative urine pregnancy test
* significant cognitive impairment (1 SD below the norm on the working memory/executive functioning task performance)
* feasibility for tDCS interventions according to safety guidelines
* stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment
* fluency in the native language
* right-handed
* ability to provide informed consent.

Exclusion Criteria:

* pregnancy
* alcohol or substance dependence
* history of seizure
* history of neurological disorder
* history of head injury
* Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant.